D C150113 EDQM-HC Basic Dose Form Terminology C149346 Additive Dosage Form Additive (unspecified) 89 A type of pharmaceutical dose form that may be liquid, semi-solid or solid, to be added to a large volume of diluent, such as in a bath. A pharmaceutical dose form that is added to a diluent. D C150113 EDQM-HC Basic Dose Form Terminology C42891 Block Dosage Form Block 49 A type of solid pharmaceutical dose form consisting of a large, compact mass, usually formed by compression of the component material into a cuboid or similar shape. A solid or semi-solid in the shape of a square or rectangle. D C150113 EDQM-HC Basic Dose Form Terminology C64878 Cachet Dosage Form Cachet 50 A type of solid pharmaceutical dose form consisting of a disc inside which a single dose of the active substance(s) is enclosed. Capsule is excluded. A solid composed of dry powdered active and/or inert ingredient(s) covered by an edible shell. The shell consists of two concave pieces of wafer made of flour and water. D C150113 EDQM-HC Basic Dose Form Terminology C25158 Capsule Dosage Form Capsule 51 A type of solid pharmaceutical dose form consisting of a shell inside which a single dose of the active substance(s) is enclosed. Cachet is excluded. A solid contained within either a hard or soft soluble shell, usually prepared from gelatin. D C150113 EDQM-HC Basic Dose Form Terminology C45414 Cement Dosage Form Cement 103 A type of semi-solid pharmaceutical dose form that hardens after application to form a seal or bond. A base composed of bonding agents intermingled with active and/or inert ingredient(s), which rapidly hardens into a firm mass upon application. D C150113 EDQM-HC Basic Dose Form Terminology C149373 Collodion Dosage Form Collodion 77 A type of liquid pharmaceutical dose form usually consisting of a solution of pyroxylin in ether and ethanol. (EDQM-HC Code: 77). Liquid preparation usually containing pyroxylin in a mixture of ether and ethanol. D C150113 EDQM-HC Basic Dose Form Terminology C42898 Concentrated Solution Dosage Form Concentrate 78 A type of liquid pharmaceutical dose form consisting of a concentrated preparation that must be diluted before administration. A concentrate which is usually diluted prior to administration and exists as a solution in its final form. D C150113 EDQM-HC Basic Dose Form Terminology C28944 Cream Dosage Form Cream 71 A type of semi-solid pharmaceutical dose form consisting of an oil-in-water or water-in-oil emulsion. (EDQM-HC Code: 71). A semi-solid composed of an emulsion of lipids, hydrocarbons, waxes, or polyols in water. D C150113 EDQM-HC Basic Dose Form Terminology C148443 Dispersion Dosage Form Dispersion 79 A type of liquid pharmaceutical dose form consisting of one or more substances, excluding solid particles and large liquid droplets, that are dispersed in an appropriate liquid vehicle. Liposomes, microbubbles, cells and colloidal dispersions (droplets with a nominal diameter less than approximately 1 micrometre in size) are included; for solid particle dispersions, see 'Suspension'; for non-miscible, large-droplet liquid dispersions, see 'Emulsion'. A type of liquid pharmaceutical dose form consisting of one or more substances, excluding solid particles and large liquid droplets, that are dispersed in an appropriate liquid vehicle. D C150113 EDQM-HC Basic Dose Form Terminology C29012 Drop Dosage Form Drops (unspecified) 90 A type of liquid pharmaceutical dose form that may be a dispersion, an emulsion, a solution or a suspension, and that is administered in small volumes by instillation; to be used only when further details of the specific form (e.g. dispersion, emulsion, solution, suspension) are unknown. A substance intended for administration in a drop-wise fashion. D C150113 EDQM-HC Basic Dose Form Terminology C42913 Emulsion Dosage Form Emulsion 80 A type of liquid pharmaceutical dose form consisting of a stable dispersion of non-miscible liquids; it consists either of oil droplets in an aqueous continuous phase (oil-in-water emulsion) or aqueous droplets in an oily continuous phase (water-in-oil emulsion); for colloidal dispersions (droplets with a nominal diameter less than approximately 1 micrometre in size), see 'Dispersion'. A semi-solid composed of at least two immiscible liquids, one of which is dispersed as droplets within the other liquid, and stabilized with one or more emulsifying agents. D C150113 EDQM-HC Basic Dose Form Terminology C42932 Film Dosage Form Film 52 A type of solid pharmaceutical dose form consisting of a thin, single- or multilayer sheet of material, which usually dissolves or otherwise dissipates in an aqueous environment. A thin layer of water soluble or insoluble polymer intended to coat the site of administration. D C150113 EDQM-HC Basic Dose Form Terminology C42888 Aerosol Foam Dosage Form Foam 72 A type of semi-solid pharmaceutical dose form consisting of a large volume of gas dispersed in a liquid or sometimes a solid phase. A foam that is packaged under pressure and released upon activation of an appropriate valve system. D C150113 EDQM-HC Basic Dose Form Terminology C42934 Gel Dosage Form Gel 73 A type of semi-solid pharmaceutical dose form consisting of a colloidal dispersion of a liquid in a solid; lipophilic gels (oleogels) usually consist of liquid paraffin with polyethylene or fatty oils gelled with colloidal silica or aluminium or zinc soaps; hydrophilic gels (hydrogels) usually consists of water, glycerol or propylene glycol gelled with suitable gelling agents such as poloxamers, starch, cellulose derivatives, carbomers and magnesium-aluminium silicates. (EDQM-HC Code: 73). A semi-solid composed of a solid, three dimensional, cross linked matrix of polymers within a liquid, yielding a jelly-like material unable to flow at steady state. D C150113 EDQM-HC Basic Dose Form Terminology C42938 Granule Dosage Form Granules 53 A type of solid pharmaceutical dose form consisting of dry aggregates of powder particles that are sufficiently resistant to withstand handling. (EDQM-HC Code: 53). A solid composed of small particles or grains. D C150113 EDQM-HC Basic Dose Form Terminology C42941 Gum Dosage Form Gum 54 A type of solid pharmaceutical dose form consisting of a basis composed of gum(s) or with a gum-like consistency. A semi-solid composed of a sticky, mucilaginous polysaccharide. D C150113 EDQM-HC Basic Dose Form Terminology C149558 Herbal Material (Unprocessed) Dosage Form Herbal material (unprocessed) 114 A type of solid pharmaceutical dose form consisting of whole, broken or fragmented plants or parts of plants (including algae, fungi, lichen) in an unprocessed state, and which may be dried or fresh. Teas, as well as preparations that are processed or formulated into capsules, granules, powders, etc., are excluded. A type of solid pharmaceutical dose form consisting of whole, broken or fragmented plants or parts of plants (including algae, fungi, lichen) in an unprocessed state, and which may be dried or fresh. D C150113 EDQM-HC Basic Dose Form Terminology C42942 Implant Dosage Form Implant 55 A type of solid pharmaceutical dose form consisting of a mass with a size and shape suitable for implantation, allowing release of active substance(s) over an extended period of time. (EDQM-HC Code: 55). A solid intended for insertion securely within the body. D C150113 EDQM-HC Basic Dose Form Terminology C149570 Impregnated Material Dosage Form Impregnated material 56 A type of solid pharmaceutical dose form consisting of a material onto or into which active substance(s) are absorbed for subsequent release after administration, often over an extended period of time. A type of solid pharmaceutical dose form consisting of a material onto or into which active substance(s) are absorbed for subsequent release after administration, often over an extended period of time. D C150113 EDQM-HC Basic Dose Form Terminology C60933 Insert Dosage Form Insert 88 A type of solid pharmaceutical dose form consisting of a material of an appropriate shape and size to be placed inside an orifice of the body, and which dissolves or disintegrates over time. Pessaries and suppositories are excluded. A solid or semi-solid intended for administration within the body. D C150113 EDQM-HC Basic Dose Form Terminology C149612 Intraruminal Device Dosage Form Intraruminal device 57 A type of solid pharmaceutical dose form intended for administration to ruminant animals where it is retained in the rumen for release of the active substance(s), usually over an extended period of time. A type of solid pharmaceutical dose form intended for administration to ruminant animals where it is retained in the rumen for release of the active substance(s), usually over an extended period of time. D C150113 EDQM-HC Basic Dose Form Terminology C149626 Lacquer Dosage Form Lacquer 81 A type of liquid pharmaceutical dose form consisting of one or more substances dissolved or suspended in a volatile solvent that evaporates to leave a hard coating. A type of liquid pharmaceutical dose form consisting of one or more substances dissolved or suspended in a volatile solvent that evaporates to leave a hard coating. D C150113 EDQM-HC Basic Dose Form Terminology C42953 Liquid Dosage Form Liquid 82 A type of liquid pharmaceutical dose form consisting of a pure substance in a liquid state. A substance in the fluid state of matter having no fixed shape but a fixed volume. D C150113 EDQM-HC Basic Dose Form Terminology C42955 Lozenge Dosage Form Lozenge 58 A type of solid pharmaceutical dose form consisting of a hard mass formed by moulding or compression, intended to dissolve or disintegrate slowly in the oral cavity when sucked. (EDQM-HC Code: 58). A solid composed of active and/or inert ingredient(s), sweeteners, other flavorings and mucilage, intended for oral administration. D C150113 EDQM-HC Basic Dose Form Terminology C148552 Lyophilized Dosage Form Lyophilisate 59 A type of solid pharmaceutical dose form consisting of a powder or disc formed by freeze-drying of a liquid or semi-solid preparation. When referring to a powder, the use of this term is restricted to veterinary medicines. A type of solid pharmaceutical dose form consisting of a powder or disc formed by freeze-drying of a liquid or semi-solid preparation. When referring to a powder, the use of this term is restricted to veterinary medicines. D C150113 EDQM-HC Basic Dose Form Terminology C148452 Medicinal Gas Dosage Form Medicinal gas 87 A type of gaseous pharmaceutical dose form consisting of a pure substance or mixture of substances that exist in the form of a gas at normal atmospheric pressure and room temperature. A type of gaseous pharmaceutical dose form consisting of a pure substance or mixture of substances that exist in the form of a gas at normal atmospheric pressure and room temperature. D C150113 EDQM-HC Basic Dose Form Terminology C42966 Ointment Dosage Form Ointment 74 A type of semi-solid pharmaceutical dose form consisting of a single-phase basis in which solids or liquids may be dispersed; ointments may be composed of a variety of bases including hydrocarbons, emulsifiers, vegetable oils and animal fats; they may be hydrophobic (bases made from substances such as hard, liquid, or light liquid paraffins, vegetable oils, animal fats, synthetic glycerides, waxes and liquid polyalkylsiloxanes, and which are only able to absorb a small amount of water), hydrophilic (with a water-miscible basis, usually a mixture of liquid and solid macrogols) or water-emulsifying (capable of absorbing larger amounts of water and forming emulsions, with bases containing water-in-oil emulsifiers such as wool alcohols, sorbitan esters, monoglycerides and fatty alcohols, or oil-in-water emulsifiers such as sulfated fatty alcohols, polysorbates, macrogol cetostearyl ether, esters of fatty acids with macrogols). (EDQM-HC Code: 74). A semi-solid, viscous in texture, that may be composed of a variety of bases including hydrocarbons, emulsifiers or vegetable oils, and mixed with active and/or inert ingredient(s). D C150113 EDQM-HC Basic Dose Form Terminology C42967 Paste Dosage Form Paste 75 A type of semi-solid pharmaceutical dose form consisting of a large proportion of solid particles dispersed in a hydrophobic or hydrophilic basis. A semi-solid composed of a large proportion of solids and finely dispersed active and/or inert ingredient(s) in a fat-based vehicle. D C150113 EDQM-HC Basic Dose Form Terminology C60985 Pastille Dosage Form Pastille 60 A type of solid pharmaceutical dose form consisting of a soft, flexible mass formed by moulding, intended to dissolve or disintegrate slowly in the oral cavity when sucked. (EDQM-HC Code: 60). A solid or semi-solid composed of a lozenge, that contains active and/or inert ingredient(s) that dissolves when sucked in the mouth. D C150113 EDQM-HC Basic Dose Form Terminology C42968 Patch Dosage Form Patch 61 A type of solid pharmaceutical dose form consisting of a flexible preparation, with an adhesive layer and a reservoir of active substance(s) that is usually behind a semi-permeable membrane. Plasters are excluded. A solid composed of an impermeable occlusive backing and a formulation matrix in which the active and/or inert ingredient(s) are dissolved or dispersed; possibly includes an adhesive layer. D C150113 EDQM-HC Basic Dose Form Terminology C42969 Pellet Dosage Form Pellets 62 A type of solid pharmaceutical dose form consisting of usually cylindrical masses, usually formed by extrusion. A solid composed of a small granular or compressed mass that contains highly purified active and/or inert ingredient(s). D C150113 EDQM-HC Basic Dose Form Terminology C149755 Pessary Dosage Form Pessary 63 A type of solid pharmaceutical dose form consisting of a material that is usually ovoid and formed by moulding, of a suitable volume and consistency for insertion into the vagina where it dissolves, disperses or melts. (EDQM-HC Code: 63). Solid, single-dose preparation usually prepared by molding, of various shapes, usually ovoid, with a volume and consistency suitable for insertion into the vagina to obtain a local effect. It contains one or more active substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature. D C150113 EDQM-HC Basic Dose Form Terminology C149758 Pillule Dosage Form Pillules 64 A type of solid pharmaceutical dose form consisting of small spheroids that are sufficiently resistant to withstand handling, used for homeopathic medicine. (EDQM-HC Code: 64). Solid preparation for homoeopathic use, obtained from sucrose, lactose or other suitable excipients. Pillules may be prepared by impregnation of preformed pillules with a dilution or dilutions of homoeopathic stocks or by progressive addition of these excipients and the addition of a dilution or dilutions of homoeopathic stocks. Pillules are intended for oral or sublingual use. D C150113 EDQM-HC Basic Dose Form Terminology C42970 Plaster Dosage Form Plaster 65 A type of solid pharmaceutical dose form consisting of a flexible preparation with an adhesive layer containing active substance(s). Patches are excluded. A semi-solid composed of a soft, smooth mass with relatively thick consistency and strong adhesiveness that becomes solid when dry. D C150113 EDQM-HC Basic Dose Form Terminology C149765 Pouch Dosage Form Pouch 102 A type of solid pharmaceutical dose form that consists of a small bag that is intended to be placed in a body cavity for release of the active substance(s) contained within. (EDQM-HC Code: 102). Small bag made of a suitable material containing a single dose of a medicinal product, to be placed in a cavity of the body for release of the active substance(s). D C150113 EDQM-HC Basic Dose Form Terminology C47913 Poultice Dosage Form Poultice 76 A type of semi-solid pharmaceutical dose form consisting of a moist mass, such as meal, herbs, seeds, etc., usually held within or spread upon an appropriate permeable material or dressing. (EDQM-HC Code: 76). A semi-solid composed of a soft, moist mass that is made by wetting an absorbent solid substance. D C150113 EDQM-HC Basic Dose Form Terminology C42972 Powder Dosage Form Powder 66 A type of solid pharmaceutical dose form consisting of dry, finely divided, loose particles, or freeze-dried preparations thereof. A solid composed of a mixture of dry, finely divided active and/or inert ingredient(s). D C150113 EDQM-HC Basic Dose Form Terminology C149863 Unspecified Premix Dosage Form Premix (unspecified) 91 A type of specialised pharmaceutical dose form that is used in the preparation of products such as medicated feeding stuffs. A type of specialized pharmaceutical dose form that is used in the preparation of products such as medicated feeding stuffs. D C150113 EDQM-HC Basic Dose Form Terminology C148548 Radiopharmaceutical Dosage Form Radiopharmaceutical 92 A type of specialised pharmaceutical dose form that is used in the preparation of radiopharmaceuticals. A type of specialized pharmaceutical dose form that is used in the preparation of radiopharmaceuticals. D C150113 EDQM-HC Basic Dose Form Terminology C42981 Shampoo Dosage Form Shampoo 93 A type of liquid (or occasionally semi-solid) pharmaceutical dose form that contains surface-active agents and usually forms a foam after rubbing on the scalp with water. (EDQM-HC code: 93). A solution or suspension composed of an anionic surfactant and intended for administration to the hair and/or scalp. D C150113 EDQM-HC Basic Dose Form Terminology C42986 Solution Dosage Form Solution 83 A type of liquid pharmaceutical dose form consisting of one or more substances dissolved in, or miscible with, an appropriate solvent, forming a single-phase liquid. A clear, homogeneous liquid composed of one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. D C150113 EDQM-HC Basic Dose Form Terminology C148549 Solvent Dosage Form Solvent 84 A type of liquid pharmaceutical dose form consisting of a vehicle that contains no active ingredient itself, and is used to dissolve, disperse or dilute another product. A type of liquid pharmaceutical dose form consisting of a vehicle that contains no active ingredient itself, and is used to dissolve, disperse or dilute another product. D C150113 EDQM-HC Basic Dose Form Terminology C42989 Spray Dosage Form Spray (unspecified) 94 A type of pharmaceutical dose form that may be liquid, semi-solid or solid, administered as a dispersion in air; to be used only when further details of the specific form (e.g. solution, suspension, powder) are unknown. A solution or suspension composed of active and/or inert ingredient(s) in oil or water, typically dispensed from an atomizer or nebulizer. D C150113 EDQM-HC Basic Dose Form Terminology C42991 Stick Dosage Form Stick 67 A type of solid pharmaceutical dose form consisting of a preparation usually in a cylindrical or conical shape, usually prepared by compression or moulding, intended for insertion in or application to a specific area of the body. A solid composed active and/or inert ingredient(s) in a long, slender cylindrical shape. D C150113 EDQM-HC Basic Dose Form Terminology C42993 Suppository Dosage Form Suppository 68 A type of solid pharmaceutical dose form consisting of a material that is usually formed by moulding, of a suitable shape, volume and consistency for insertion into the rectum where it dissolves, disperses or melts. (EQM-HC code: 68). A solid or semi-solid composed of active and/or inert ingredient(s) in a wax, fat or a glycerin gelatin jelly and that is conical or oval in shape. It is intended to be inserted into a body orifice. D C150113 EDQM-HC Basic Dose Form Terminology C42994 Suspension Dosage Form Suspension 85 A type of liquid pharmaceutical dose form consisting of one or more substances dispersed in a liquid vehicle; the dispersed substance(s) are solid particles that are practically insoluble in the vehicle. Insoluble solid particles composed of active and/or inert ingredient(s) that are dispersed in a liquid. D C150113 EDQM-HC Basic Dose Form Terminology C42996 Syrup Dosage Form Syrup 86 A type of liquid pharmaceutical dose form consisting of a viscous liquid usually with a high concentration of sugar or other sweetening agent. (EDQM-HC code: 86). A solution or suspension composed of a viscid vehicle that contains a high concentration of sucrose or other sugars and active and/or inert ingredient(s). D C150113 EDQM-HC Basic Dose Form Terminology C17423 Drug Delivery System System 95 A type of pharmaceutical dose form consisting of one or more components that are used to deliver active substance(s) in a specified manner, usually with a modified release mechanism, after administration to a specified location on or in the body; to be used only where more specific terms are not applicable. Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. D C150113 EDQM-HC Basic Dose Form Terminology C42998 Tablet Dosage Form Tablet 69 A type of solid pharmaceutical dose form consisting of a mass that is formed by compression of uniform volumes of particulate solids, or by other means such as extrusion or moulding. (EDQM-HC code: 69). A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form of a relatively flat and round, square or oval shape. D C150113 EDQM-HC Basic Dose Form Terminology C149984 Tea Dosage Form Tea 70 A type of solid pharmaceutical dose form consisting of one or more herbal drugs intended for preparation of a solution by decoction or maceration, or a lyophilised preparation of such a solution. A type of solid pharmaceutical dose form consisting of one or more herbal drugs intended for preparation of a solution by decoction or maceration, or a lyophilized preparation of such a solution. D C150113 EDQM-HC Basic Dose Form Terminology C150001 Unknown Dosage Form Unknown 96 The type of pharmaceutical dose form is unknown, or has unspecified or variable physical characteristics. The type of pharmaceutical dose form is unknown, or has unspecified or variable physical characteristics. C C150112 EDQM-HC Administration Method Terminology C149578 Inhalation Method of Administration Inhalation 10 Administration of a pharmaceutical product by breathing it into the lungs, usually via the mouth. Administration of a pharmaceutical product by breathing it into the lungs, usually via the mouth. C C150116 EDQM-HC State of Matter Terminology C45299 Gas Gas 100 A state of matter consisting of molecules in an elastic aeriform fluid, separated from one another and with freedom of movement, no independent shape or volume and the ability to expand indefinitely. A fluid in the gaseous state having neither independent shape nor volume and being able to expand indefinitely. C C150116 EDQM-HC State of Matter Terminology C150000 Unclear State of Matter Unclear 101 A state of matter of unknown, unspecified or variable physical characteristics. A state of matter of unknown, unspecified or variable physical characteristics. C C150114 EDQM-HC Intended Site of Administration Terminology C149484 Endocervical Endocervical 105 Relating to the cervix uteri as the intended site of administration. Relating to the cervix uteri as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C13307 Gastric Gastric 106 Relating to the stomach as the intended site of administration, where direct administration is achieved using an appropriate device. Relating to the stomach. C C150114 EDQM-HC Intended Site of Administration Terminology C13359 Gastrointestinal Gastroenteral 107 Relating to the stomach or duodenum as the intended site of administration, where direct administration is achieved using an appropriate device. Pertaining to the stomach and intestines. C C150114 EDQM-HC Intended Site of Administration Terminology C25266 Intestinal Intestinal 108 Relating to the intestines (duodenum, jejunum, ileum, colon) as the intended site of administration, where direct administration is achieved using an appropriate device. Of, or related to, or referring to the intestines. C C150114 EDQM-HC Intended Site of Administration Terminology C13352 Intraperitoneal Intraperitoneal 109 Relating to the peritoneal cavity as the intended site of administration. Relating to the peritoneal cavity as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C149702 Oculonasal Oculonasal 110 Relating to the eyes and nares of a bird as the intended site of administration. Relating to the eyes and nares of a bird as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C96901 Auricular Auricular 21 Relating to the ear as the intended site of administration, usually where the pharmaceutical product is intended for action in the auditory canal (external auditory meatus). Relating to the ear as the intended site of administration, usually where the pharmaceutical product is intended for action in the auditory canal (external auditory meatus). C C150114 EDQM-HC Intended Site of Administration Terminology C149423 Cutaneous/Transdermal Cutaneous/Transdermal 22 Relating to the skin or its appendages (e.g. hair, nails) as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the skin, within the skin, or systemically after passing through the skin. Relating to the skin or its appendages (e.g. hair, nails) as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the skin, within the skin, or systemically after passing through the skin. C C150114 EDQM-HC Intended Site of Administration Terminology C41136 Dental Dental 23 Relating to the teeth as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the tooth, inside the tooth, or around the tooth. Pertaining to a tooth or teeth, or to odontology. C C150114 EDQM-HC Intended Site of Administration Terminology C149494 Environmental Environmental 24 Relating to the surroundings in which the target of the pharmaceutical product is found, as the intended site of administration, e.g. an enclosed volume of water or air; usually the product disperses in the area and is subsequently taken up by the subject. Relating to the surroundings in which the target of the pharmaceutical product is found, as the intended site of administration, e.g. an enclosed volume of water or air; usually the product disperses in the area and is subsequently taken up by the subject. C C150114 EDQM-HC Intended Site of Administration Terminology C149497 Extracorporeal Extracorporeal 25 Relating to a body substance or tissue as the intended site of administration, after being removed from the body in order to be treated with the pharmaceutical product and then subsequently returned to the body. Relating to a body substance or tissue as the intended site of administration, after being removed from the body in order to be treated with the pharmaceutical product and then subsequently returned to the body. C C150114 EDQM-HC Intended Site of Administration Terminology C149603 Intramammary Intramammary 26 Relating to the milk-producing organs (mammae) of a female mammal as the intended site of administration, to describe veterinary-only pharmaceutical products that are administered via the teat canal. Relating to the milk-producing organs (mammae) of a female mammal as the intended site of administration, to describe veterinary-only pharmaceutical products that are administered via the teat canal. C C150114 EDQM-HC Intended Site of Administration Terminology C96903 Intrauterine Intrauterine 27 Relating to the cavity of the uterus as the intended site of administration. Relating to the cavity of the uterus as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C149623 Intravesical/Urethral Intravesical/Urethral 28 Relating to the urinary bladder or the urethra (the urogenital canal, connecting the bladder to the outside of the body) as the intended site of administration. Relating to the urinary bladder or the urethra as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C27958 Nasal Nasal 29 Relating to the nose as the intended site of administration, including where the pharmaceutical product is intended for local action in the nasal cavity or for systemic action after absorption through the mucous membrane; the lower respiratory tract is excluded. In reference to the nose. C C150114 EDQM-HC Intended Site of Administration Terminology C87163 Ocular Ocular 30 Relating to the eye as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the eye or conjunctiva, around the eye, or within the eye. Of or relating to the eye. C C150114 EDQM-HC Intended Site of Administration Terminology C25311 Oral Oral 31 Relating to the mouth as the intended site of administration, but where the pharmaceutical product is administered with the intention of passing into the stomach via the oesophagus; the mucosa of the mouth itself is not the intended site of action (see oromucosal). Of, or relating to, or affecting, or for use in the mouth. C C150114 EDQM-HC Intended Site of Administration Terminology C149731 Oromucosal Oromucosal 32 Relating to the mouth as the intended site of administration, where the pharmaceutical product is administered with the intention of acting on the mucosa of the mouth, whether for local or systemic use. Relating to the mouth as the intended site of administration, where the pharmaceutical product is administered with the intention of acting on the mucosa of the mouth, whether for local or systemic use. C C150114 EDQM-HC Intended Site of Administration Terminology C150414 Parenteral Parenteral 33 Relating to the internal body as the intended site of administration, other than the natural openings and cavities such as the gastrointestinal tract, auditory canal, nasal cavity, lungs, etc.; the pharmaceutical product is usually administered by breaking the skin, such as by injection, infusion, and implantation. Relating to the internal body as the intended site of administration, other than the natural openings and cavities such as the gastrointestinal tract, auditory canal, nasal cavity, lungs, etc.; the pharmaceutical product is usually administered by breaking the skin, such as by injection, infusion, and implantation. C C150114 EDQM-HC Intended Site of Administration Terminology C13304 Pulmonary Pulmonary 34 Relating to the lungs as the intended site of administration, where the pharmaceutical product is administered, usually by inhalation, for local action in the lower respiratory tract or for systemic action after absorption via the lower respiratory tract. Relating to the lungs as the intended site of administration, where the pharmaceutical product is administered, usually by inhalation, for local action in the lower respiratory tract or for systemic action after absorption via the lower respiratory tract. C C150114 EDQM-HC Intended Site of Administration Terminology C25224 Rectal Rectal 35 Relating to the rectum as the intended site of administration, where the pharmaceutical product is administered via the anal canal, for local action in the rectum or for systemic action after absorption via the rectum. Of or pertaining to the rectum. C C150114 EDQM-HC Intended Site of Administration Terminology C13309 Vaginal Vaginal 36 Relating to the vagina as the intended site of administration, where the pharmaceutical product is administered via the vaginal opening, usually for local action in the vagina but sometimes for systemic action after absorption via the vagina. Of or relating to the vagina. C C150114 EDQM-HC Intended Site of Administration Terminology C150004 Unknown/Miscellaneous Anatomical Location Unknown/Miscellaneous 37 Relating to various unspecified parts of the body as the intended site of administration, or where the intended site of administration is unknown or not specified. Relating to various unspecified parts of the body as the intended site of administration, or where the intended site of administration is unknown or not specified. C C150115 EDQM-HC Release Characteristics Terminology C149427 Delayed Release Mechanism of Action Delayed 44 Release of the substance(s) at a later time than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method; enteric-coated and other gastro-resistant products are included. Release of the substance(s) at a later time than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method; enteric-coated and other gastro-resistant products are included. C C150115 EDQM-HC Release Characteristics Terminology C149870 Prolonged Release Mechanism of Action Prolonged 45 Release of the substance(s) over a longer duration than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method. Release of the substance(s) over a longer duration than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method. C C150115 EDQM-HC Release Characteristics Terminology C149662 Modified-release Mechanism of Action Modified 46 Release of the substance(s) in a way that differs from that which would be achieved with a conventional-release product, which is achieved by a special formulation design and/or manufacturing method, but which is not classified as delayed-release or prolonged-release; pulsatile-release products are included. Release of the substance(s) in a way that differs from that which would be achieved with a conventional-release product, which is achieved by a special formulation design and/or manufacturing method, but which is not classified as delayed-release or prolonged-release; pulsatile-release products are included. C C150115 EDQM-HC Release Characteristics Terminology C149409 Conventional Release Mechanism of Action Conventional 47 Release of the substance(s) in a way that is not deliberately modified by a special formulation design and/or manufacturing method. Release of the substance(s) in a way that is not deliberately modified by a special formulation design and/or manufacturing method. C C150115 EDQM-HC Release Characteristics Terminology C150002 Unknown Mechanism of Action Unknown 48 Release of the substance(s) in a way that is unknown or not specified. Release of the substance(s) in a way that is unknown or not specified. C C150116 EDQM-HC State of Matter Terminology C45299 Gas Gas 100 A state of matter consisting of molecules in an elastic aeriform fluid, separated from one another and with freedom of movement, no independent shape or volume and the ability to expand indefinitely. A fluid in the gaseous state having neither independent shape nor volume and being able to expand indefinitely. C C150116 EDQM-HC State of Matter Terminology C150000 Unclear State of Matter Unclear 101 A state of matter of unknown, unspecified or variable physical characteristics. A state of matter of unknown, unspecified or variable physical characteristics. C C150116 EDQM-HC State of Matter Terminology C45300 Solid Solid 97 A state of matter consisting of molecules in a rigid structure that is resistant to change in shape or volume. The state in which a substance has no tendency to flow under moderate stress; resists forces (such as compression) that tend to deform it; and retains a definite size and shape. C C150116 EDQM-HC State of Matter Terminology C149895 Semi-solid Semi-solid 98 A state of matter consisting of molecules in a non-rigid structure that can retain its shape and volume but that is not resistant to such change. A state of matter consisting of molecules in a non-rigid structure that can retain its shape and volume but that is not resistant to such change. C C150116 EDQM-HC State of Matter Terminology C45298 Liquid Liquid 99 A state of matter consisting of molecules in a non-rigid structure that retains its volume but conforms to the shape of any container applying pressure to it, and is subject to flow. A substance in the fluid state of matter having no fixed shape but a fixed volume. C C150117 EDQM-HC Transformation Terminology C64657 Dilute Dilution 38 Transformation of a concentrate into a liquid of greater volume and lower concentration by mixing it with a specified solvent. To reduce in strength or concentration, especially by the addition of water. C C150117 EDQM-HC Transformation Terminology C150035 Dispersion Activity Dispersion 39 Transformation of a solid or gas into a dispersion or suspension by mixing it with a specified liquid. Transformation of a solid or gas into a dispersion or suspension by mixing it with a specified liquid. C C150117 EDQM-HC Transformation Terminology C113023 Dissolution Mixing Dissolution 40 Transformation of a solid into a solution by mixing it with a specified liquid. Mixing by adding solids to agitated liquids. C C150117 EDQM-HC Transformation Terminology C64925 Mix Mixing 41 Transformation of a product into another product by mixing with a specified product. To bring or combine together or with something else; add as an additional element or part. C C150117 EDQM-HC Transformation Terminology C149700 No Transformation No transformation 42 No transformation of the product takes place. No transformation of the product takes place. C C150117 EDQM-HC Transformation Terminology C150003 Unknown Transformation Unknown 43 It is unknown whether any transformation of the product takes place. It is unknown whether any transformation of the product takes place. A C150113 EDQM-HC Basic Dose Form Terminology C148443 Dispersion Dosage Form Category Dispersion 0079 A type of liquid pharmaceutical dose form consisting of one or more substances, excluding solid particles and large liquid droplets, that are dispersed in an appropriate liquid vehicle. Liposomes, microbubbles, cells and colloidal dispersions (droplets with a nominal diameter less than approximately 1 micrometre in size) are included; for solid particle dispersions, see 'Suspension'; for non-miscible, large-droplet liquid dispersions, see 'Emulsion'. A type of liquid pharmaceutical dose form consisting of one or more substances, excluding solid particles and large liquid droplets, that are dispersed in an appropriate liquid vehicle. A C150113 EDQM-HC Basic Dose Form Terminology C148452 Medicinal Gas Dosage Form Category Medicinal gas 0087 A type of gaseous pharmaceutical dose form consisting of a pure substance or mixture of substances that exist in the form of a gas at normal atmospheric pressure and room temperature. A type of gaseous pharmaceutical dose form consisting of a pure substance or mixture of substances that exist in the form of a gas at normal atmospheric pressure and room temperature. A C150113 EDQM-HC Basic Dose Form Terminology C148548 Radiopharmaceutical Dosage Form Category Radiopharmaceutical 0092 A type of specialised pharmaceutical dose form that is used in the preparation of radiopharmaceuticals. A type of specialized pharmaceutical dose form that is used in the preparation of radiopharmaceuticals. A C150113 EDQM-HC Basic Dose Form Terminology C148549 Solvent Dosage Form Category Solvent 0084 A type of liquid pharmaceutical dose form consisting of a vehicle that contains no active ingredient itself, and is used to dissolve, disperse or dilute another product. A type of liquid pharmaceutical dose form consisting of a vehicle that contains no active ingredient itself, and is used to dissolve, disperse or dilute another product. A C150113 EDQM-HC Basic Dose Form Terminology C148552 Lyophilized Dosage Form Category Lyophilisate 0059 A type of solid pharmaceutical dose form consisting of a powder or disc formed by freeze-drying of a liquid or semi-solid preparation. When referring to a powder, the use of this term is restricted to veterinary medicines. A type of solid pharmaceutical dose form consisting of a powder or disc formed by freeze-drying of a liquid or semi-solid preparation. When referring to a powder, the use of this term is restricted to veterinary medicines. A C150113 EDQM-HC Basic Dose Form Terminology C149346 Additive Dosage Form Category Additive (unspecified) 0089 A type of pharmaceutical dose form that may be liquid, semi-solid or solid, to be added to a large volume of diluent, such as in a bath. A type of pharmaceutical dose form that may be liquid, semi-solid or solid, to be added to a large volume of diluent, such as in a bath. A C150113 EDQM-HC Basic Dose Form Terminology C149558 Herbal Material (Unprocessed) Dosage Form Category Herbal material (unprocessed) 0114 A type of solid pharmaceutical dose form consisting of whole, broken or fragmented plants or parts of plants (including algae, fungi, lichen) in an unprocessed state, and which may be dried or fresh. Teas, as well as preparations that are processed or formulated into capsules, granules, powders, etc., are excluded. A type of solid pharmaceutical dose form consisting of whole, broken or fragmented plants or parts of plants (including algae, fungi, lichen) in an unprocessed state, and which may be dried or fresh. A C150113 EDQM-HC Basic Dose Form Terminology C149570 Impregnated Material Dosage Form Category Impregnated material 0056 A type of solid pharmaceutical dose form consisting of a material onto or into which active substance(s) are absorbed for subsequent release after administration, often over an extended period of time. A type of solid pharmaceutical dose form consisting of a material onto or into which active substance(s) are absorbed for subsequent release after administration, often over an extended period of time. A C150113 EDQM-HC Basic Dose Form Terminology C149612 Intraruminal Device Dosage Form Category Intraruminal device 0057 A type of solid pharmaceutical dose form intended for administration to ruminant animals where it is retained in the rumen for release of the active substance(s), usually over an extended period of time. A type of solid pharmaceutical dose form intended for administration to ruminant animals where it is retained in the rumen for release of the active substance(s), usually over an extended period of time. A C150113 EDQM-HC Basic Dose Form Terminology C149626 Lacquer Dosage Form Category Lacquer 0081 A type of liquid pharmaceutical dose form consisting of one or more substances dissolved or suspended in a volatile solvent that evaporates to leave a hard coating. A type of liquid pharmaceutical dose form consisting of one or more substances dissolved or suspended in a volatile solvent that evaporates to leave a hard coating. A C150113 EDQM-HC Basic Dose Form Terminology C149863 Unspecified Premix Dosage Form Category Premix (unspecified) 0091 A type of specialised pharmaceutical dose form that is used in the preparation of products such as medicated feeding stuffs. A type of specialized pharmaceutical dose form that is used in the preparation of products such as medicated feeding stuffs. A C150113 EDQM-HC Basic Dose Form Terminology C149984 Tea Dosage Form Category Tea 0070 A type of solid pharmaceutical dose form consisting of one or more herbal drugs intended for preparation of a solution by decoction or maceration, or a lyophilised preparation of such a solution. A type of solid pharmaceutical dose form consisting of one or more herbal drugs intended for preparation of a solution by decoction or maceration, or a lyophilized preparation of such a solution. A C150113 EDQM-HC Basic Dose Form Terminology C150001 Unknown Dosage Form Category Unknown 0096 The type of pharmaceutical dose form is unknown, or has unspecified or variable physical characteristics. The type of pharmaceutical dose form is unknown, or has unspecified or variable physical characteristics. A C150113 EDQM-HC Basic Dose Form Terminology C154383 Aerosol Foam Dosage Form Category Foam 0072 A type of semi-solid pharmaceutical dose form consisting of a large volume of gas dispersed in a liquid or sometimes a solid phase. A type of semi-solid pharmaceutical dose form consisting of a large volume of gas dispersed in a liquid or sometimes a solid phase. A C150113 EDQM-HC Basic Dose Form Terminology C154384 Block Dosage Form Category Block 0049 A type of solid pharmaceutical dose form consisting of a large, compact mass, usually formed by compression of the component material into a cuboid or similar shape. A type of solid pharmaceutical dose form consisting of a large, compact mass, usually formed by compression of the component material into a cuboid or similar shape. A C150113 EDQM-HC Basic Dose Form Terminology C154406 Cachet Dosage Form Category Cachet 0050 A type of solid pharmaceutical dose form consisting of a disc inside which a single dose of the active substance(s) is enclosed. Capsule is excluded. A type of solid pharmaceutical dose form consisting of a disc inside which a single dose of the active substance(s) is enclosed. Capsule is excluded. A C150113 EDQM-HC Basic Dose Form Terminology C154433 Capsule Dose Form Category Capsule 0051 A type of solid pharmaceutical dose form consisting of a shell inside which a single dose of the active substance(s) is enclosed. Cachet is excluded. A type of solid pharmaceutical dose form consisting of a shell inside which a single dose of the active substance(s) is enclosed. Cachet is excluded. A C150113 EDQM-HC Basic Dose Form Terminology C154434 Cement Dosage Form Category Cement 0103 A type of semi-solid pharmaceutical dose form that hardens after application to form a seal or bond. A type of semi-solid pharmaceutical dose form that hardens after application to form a seal or bond. A C150113 EDQM-HC Basic Dose Form Terminology C154435 Collodion Dosage Form Category Collodion 0077 A type of liquid pharmaceutical dose form usually consisting of a solution of pyroxylin in ether and ethanol. A type of liquid pharmaceutical dose form usually consisting of a solution of pyroxylin in ether and ethanol. A C150113 EDQM-HC Basic Dose Form Terminology C154437 Concentrated Solution Dosage Form Category Concentrate 0078 A type of liquid pharmaceutical dose form consisting of a concentrated preparation that must be diluted before administration. A type of liquid pharmaceutical dose form consisting of a concentrated preparation that must be diluted before administration. A C150113 EDQM-HC Basic Dose Form Terminology C154438 Cream Dosage Form Category Cream 0071 A type of semi-solid pharmaceutical dose form consisting of an oil-in-water or water-in-oil emulsion. A type of semi-solid pharmaceutical dose form consisting of an oil-in-water or water-in-oil emulsion. A C150113 EDQM-HC Basic Dose Form Terminology C154464 Drop Dosage Form Category Drops (unspecified) 0090 A type of liquid pharmaceutical dose form that may be a dispersion, an emulsion, a solution or a suspension, and that is administered in small volumes by instillation; to be used only when further details of the specific form (e.g. dispersion, emulsion, solution, suspension) are unknown. A type of liquid pharmaceutical dose form that may be a dispersion, an emulsion, a solution or a suspension, and that is administered in small volumes by instillation; to be used only when further details of the specific form (e.g. dispersion, emulsion, solution, suspension) are unknown. A C150113 EDQM-HC Basic Dose Form Terminology C154465 Drug Delivery System Category System 0095 A type of pharmaceutical dose form consisting of one or more components that are used to deliver active substance(s) in a specified manner, usually with a modified release mechanism, after administration to a specified location on or in the body; to be used only where more specific terms are not applicable. A type of pharmaceutical dose form consisting of one or more components that are used to deliver active substance(s) in a specified manner, usually with a modified release mechanism, after administration to a specified location on or in the body; to be used only where more specific terms are not applicable. A C150113 EDQM-HC Basic Dose Form Terminology C154466 Emulsion Dosage Form Category Emulsion 0080 A type of liquid pharmaceutical dose form consisting of a stable dispersion of non-miscible liquids; it consists either of oil droplets in an aqueous continuous phase (oil-in-water emulsion) or aqueous droplets in an oily continuous phase (water-in-oil emulsion); for colloidal dispersions (droplets with a nominal diameter less than approximately 1 micrometre in size), see 'Dispersion'. A type of liquid pharmaceutical dose form consisting of a stable dispersion of non-miscible liquids; it consists either of oil droplets in an aqueous continuous phase (oil-in-water emulsion) or aqueous droplets in an oily continuous phase (water-in-oil emulsion); for colloidal dispersions (droplets with a nominal diameter less than approximately 1 micrometre in size), see 'Dispersion'. A C150113 EDQM-HC Basic Dose Form Terminology C154467 Film Dosage Form Category Film 0052 A type of solid pharmaceutical dose form consisting of a thin, single- or multilayer sheet of material, which usually dissolves or otherwise dissipates in an aqueous environment. A type of solid pharmaceutical dose form consisting of a thin, single- or multilayer sheet of material, which usually dissolves or otherwise dissipates in an aqueous environment. A C150113 EDQM-HC Basic Dose Form Terminology C154468 Gel Dosage Form Category Gel 0073 A type of semi-solid pharmaceutical dose form consisting of a colloidal dispersion of a liquid in a solid; lipophilic gels (oleogels) usually consist of liquid paraffin with polyethylene or fatty oils gelled with colloidal silica or aluminium or zinc soaps; hydrophilic gels (hydrogels) usually consists of water, glycerol or propylene glycol gelled with suitable gelling agents such as poloxamers, starch, cellulose derivatives, carbomers and magnesium-aluminium silicates. A type of semi-solid pharmaceutical dose form consisting of a colloidal dispersion of a liquid in a solid; lipophilic gels (oleogels) usually consist of liquid paraffin with polyethylene or fatty oils gelled with colloidal silica or aluminium or zinc soaps; hydrophilic gels (hydrogels) usually consists of water, glycerol or propylene glycol gelled with suitable gelling agents such as poloxamers, starch, cellulose derivatives, carbomers and magnesium-aluminium silicates. A C150113 EDQM-HC Basic Dose Form Terminology C154480 Granule Dosage Form Category Granules 0053 A type of solid pharmaceutical dose form consisting of dry aggregates of powder particles that are sufficiently resistant to withstand handling. A type of solid pharmaceutical dose form consisting of dry aggregates of powder particles that are sufficiently resistant to withstand handling. A C150113 EDQM-HC Basic Dose Form Terminology C154491 Gum Dosage Form Category Gum 0054 A type of solid pharmaceutical dose form consisting of a basis composed of gum(s) or with a gum-like consistency. A type of solid pharmaceutical dose form consisting of a basis composed of gum(s) or with a gum-like consistency. A C150113 EDQM-HC Basic Dose Form Terminology C154497 Implant Dosage Form Category Implant 0055 A type of solid pharmaceutical dose form consisting of a mass with a size and shape suitable for implantation, allowing release of active substance(s) over an extended period of time. A type of solid pharmaceutical dose form consisting of a mass with a size and shape suitable for implantation, allowing release of active substance(s) over an extended period of time. A C150113 EDQM-HC Basic Dose Form Terminology C154518 Insert Dosage Form Category Insert 0088 A type of solid pharmaceutical dose form consisting of a material of an appropriate shape and size to be placed inside an orifice of the body, and which dissolves or disintegrates over time. Pessaries and suppositories are excluded. A type of solid pharmaceutical dose form consisting of a material of an appropriate shape and size to be placed inside an orifice of the body, and which dissolves or disintegrates over time. Pessaries and suppositories are excluded. A C150113 EDQM-HC Basic Dose Form Terminology C154551 Liquid Dose Form Category Liquid 0082 A type of liquid pharmaceutical dose form consisting of a pure substance in a liquid state. A type of liquid pharmaceutical dose form consisting of a pure substance in a liquid state. A C150113 EDQM-HC Basic Dose Form Terminology C154554 Lozenge Dosage Form Category Lozenge 0058 A type of solid pharmaceutical dose form consisting of a hard mass formed by moulding or compression, intended to dissolve or disintegrate slowly in the oral cavity when sucked. A type of solid pharmaceutical dose form consisting of a hard mass formed by moulding or compression, intended to dissolve or disintegrate slowly in the oral cavity when sucked. A C150113 EDQM-HC Basic Dose Form Terminology C154557 Ointment Dosage Form Category Ointment 0074 A type of semi-solid pharmaceutical dose form consisting of a single-phase basis in which solids or liquids may be dispersed; ointments may be composed of a variety of bases including hydrocarbons, emulsifiers, vegetable oils and animal fats; they may be hydrophobic (bases made from substances such as hard, liquid, or light liquid paraffins, vegetable oils, animal fats, synthetic glycerides, waxes and liquid polyalkylsiloxanes, and which are only able to absorb a small amount of water), hydrophilic (with a water-miscible basis, usually a mixture of liquid and solid macrogols) or water-emulsifying (capable of absorbing larger amounts of water and forming emulsions, with bases containing water-in-oil emulsifiers such as wool alcohols, sorbitan esters, monoglycerides and fatty alcohols, or oil-in-water emulsifiers such as sulfated fatty alcohols, polysorbates, macrogol cetostearyl ether, esters of fatty acids with macrogols). A type of semi-solid pharmaceutical dose form consisting of a single-phase basis in which solids or liquids may be dispersed; ointments may be composed of a variety of bases including hydrocarbons, emulsifiers, vegetable oils and animal fats; they may be hydrophobic (bases made from substances such as hard, liquid, or light liquid paraffins, vegetable oils, animal fats, synthetic glycerides, waxes and liquid polyalkylsiloxanes, and which are only able to absorb a small amount of water), hydrophilic (with a water-miscible basis, usually a mixture of liquid and solid macrogols) or water-emulsifying (capable of absorbing larger amounts of water and forming emulsions, with bases containing water-in-oil emulsifiers such as wool alcohols, sorbitan esters, monoglycerides and fatty alcohols, or oil-in-water emulsifiers such as sulfated fatty alcohols, polysorbates, macrogol cetostearyl ether, esters of fatty acids with macrogols). A C150113 EDQM-HC Basic Dose Form Terminology C154559 Paste Dosage Form Category Paste 0075 A type of semi-solid pharmaceutical dose form consisting of a large proportion of solid particles dispersed in a hydrophobic or hydrophilic basis. A type of semi-solid pharmaceutical dose form consisting of a large proportion of solid particles dispersed in a hydrophobic or hydrophilic basis. A C150113 EDQM-HC Basic Dose Form Terminology C154562 Pastille Dosage Form Category Pastille 0060 A type of solid pharmaceutical dose form consisting of a soft, flexible mass formed by moulding, intended to dissolve or disintegrate slowly in the oral cavity when sucked. A type of solid pharmaceutical dose form consisting of a soft, flexible mass formed by moulding, intended to dissolve or disintegrate slowly in the oral cavity when sucked. A C150113 EDQM-HC Basic Dose Form Terminology C154587 Patch Dosage Form Category Patch 0061 A type of solid pharmaceutical dose form consisting of a flexible preparation, with an adhesive layer and a reservoir of active substance(s) that is usually behind a semi-permeable membrane. Plasters are excluded. A type of solid pharmaceutical dose form consisting of a flexible preparation, with an adhesive layer and a reservoir of active substance(s) that is usually behind a semi-permeable membrane. Plasters are excluded. A C150113 EDQM-HC Basic Dose Form Terminology C154590 Pellet Dosage Form Category Pellets 0062 A type of solid pharmaceutical dose form consisting of usually cylindrical masses, usually formed by extrusion. A type of solid pharmaceutical dose form consisting of usually cylindrical masses, usually formed by extrusion. A C150113 EDQM-HC Basic Dose Form Terminology C154591 Pessary Dosage Form Category Pessary 0063 A type of solid pharmaceutical dose form consisting of a material that is usually ovoid and formed by moulding, of a suitable volume and consistency for insertion into the vagina where it dissolves, disperses or melts. A type of solid pharmaceutical dose form consisting of a material that is usually ovoid and formed by moulding, of a suitable volume and consistency for insertion into the vagina where it dissolves, disperses or melts. A C150113 EDQM-HC Basic Dose Form Terminology C154592 Pillule Dosage Form Category Pillules 0064 A type of solid pharmaceutical dose form consisting of small spheroids that are sufficiently resistant to withstand handling, used for homeopathic medicine. A type of solid pharmaceutical dose form consisting of small spheroids that are sufficiently resistant to withstand handling, used for homeopathic medicine. A C150113 EDQM-HC Basic Dose Form Terminology C154593 Plaster Dosage Form Category Plaster 0065 A type of solid pharmaceutical dose form consisting of a flexible preparation with an adhesive layer containing active substance(s). Patches are excluded. A type of solid pharmaceutical dose form consisting of a flexible preparation with an adhesive layer containing active substance(s). Patches are excluded. A C150113 EDQM-HC Basic Dose Form Terminology C154594 Pouch Dosage Form Category Pouch 0102 A type of solid pharmaceutical dose form that consists of a small bag that is intended to be placed in a body cavity for release of the active substance(s) contained within. A type of solid pharmaceutical dose form that consists of a small bag that is intended to be placed in a body cavity for release of the active substance(s) contained within. A C150113 EDQM-HC Basic Dose Form Terminology C154595 Poultice Dosage Form Category Poultice 0076 A type of semi-solid pharmaceutical dose form consisting of a moist mass, such as meal, herbs, seeds, etc., usually held within or spread upon an appropriate permeable material or dressing. A type of semi-solid pharmaceutical dose form consisting of a moist mass, such as meal, herbs, seeds, etc., usually held within or spread upon an appropriate permeable material or dressing. A C150113 EDQM-HC Basic Dose Form Terminology C154596 Powder Dosage Form Category Powder 0066 A type of solid pharmaceutical dose form consisting of dry, finely divided, loose particles, or freeze-dried preparations thereof. A type of solid pharmaceutical dose form consisting of dry, finely divided, loose particles, or freeze-dried preparations thereof. A C150113 EDQM-HC Basic Dose Form Terminology C154597 Shampoo Dosage Form Category Shampoo 0093 A type of liquid (or occasionally semi-solid) pharmaceutical dose form that contains surface-active agents and usually forms a foam after rubbing on the scalp with water. A type of liquid (or occasionally semi-solid) pharmaceutical dose form that contains surface-active agents and usually forms a foam after rubbing on the scalp with water. A C150113 EDQM-HC Basic Dose Form Terminology C154598 Solution Dosage Form Category Solution 0083 A type of liquid pharmaceutical dose form consisting of one or more substances dissolved in, or miscible with, an appropriate solvent, forming a single-phase liquid. A type of liquid pharmaceutical dose form consisting of one or more substances dissolved in, or miscible with, an appropriate solvent, forming a single-phase liquid. A C150113 EDQM-HC Basic Dose Form Terminology C154599 Spray Dosage Form Category Spray (unspecified) 0094 A type of pharmaceutical dose form that may be liquid, semi-solid or solid, administered as a dispersion in air; to be used only when further details of the specific form (e.g. solution, suspension, powder) are unknown. A type of pharmaceutical dose form that may be liquid, semi-solid or solid, administered as a dispersion in air; to be used only when further details of the specific form (e.g. solution, suspension, powder) are unknown. A C150113 EDQM-HC Basic Dose Form Terminology C154600 Stick Dosage Form Category Stick 0067 A type of solid pharmaceutical dose form consisting of a preparation usually in a cylindrical or conical shape, usually prepared by compression or moulding, intended for insertion in or application to a specific area of the body. A type of solid pharmaceutical dose form consisting of a preparation usually in a cylindrical or conical shape, usually prepared by compression or moulding, intended for insertion in or application to a specific area of the body. A C150113 EDQM-HC Basic Dose Form Terminology C154601 Suppository Dosage Form Category Suppository 068 A type of solid pharmaceutical dose form consisting of a material that is usually formed by moulding, of a suitable shape, volume and consistency for insertion into the rectum where it dissolves, disperses or melts. A type of solid pharmaceutical dose form consisting of a material that is usually formed by moulding, of a suitable shape, volume and consistency for insertion into the rectum where it dissolves, disperses or melts. A C150113 EDQM-HC Basic Dose Form Terminology C154602 Suspension Dosage Form Category Suspension 085 A type of liquid pharmaceutical dose form consisting of one or more substances dispersed in a liquid vehicle; the dispersed substance(s) are solid particles that are practically insoluble in the vehicle. A type of liquid pharmaceutical dose form consisting of one or more substances dispersed in a liquid vehicle; the dispersed substance(s) are solid particles that are practically insoluble in the vehicle. A C150113 EDQM-HC Basic Dose Form Terminology C154604 Syrup Dosage Form Category Syrup 0086 A type of liquid pharmaceutical dose form consisting of a viscous liquid usually with a high concentration of sugar or other sweetening agent. A type of liquid pharmaceutical dose form consisting of a viscous liquid usually with a high concentration of sugar or other sweetening agent. A C150113 EDQM-HC Basic Dose Form Terminology C154605 Tablet Dosage Form Category Tablet 0069 A type of solid pharmaceutical dose form consisting of a mass that is formed by compression of uniform volumes of particulate solids, or by other means such as extrusion or moulding. A type of solid pharmaceutical dose form consisting of a mass that is formed by compression of uniform volumes of particulate solids, or by other means such as extrusion or moulding. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C149365 Oral Cachet Dosage Form Cachet 10209000 Solid discoid preparation consisting of a wafer enclosing a unit dose intended for oral use. Solid discoid preparation consisting of a wafer enclosing a unit dose intended for oral use. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C149373 Collodion Dosage Form Collodion 10520000 Liquid preparation usually containing pyroxylin in a mixture of ether and ethanol. When applied to the skin, the preparation forms a flexible film on the site of application. Liquid preparation usually containing pyroxylin in a mixture of ether and ethanol. When applied to the skin, the preparation forms a flexible film on the site of application. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C149755 Pessary Dosage Form Pessary 10909000 Solid, single-dose preparation usually prepared by moulding, of various shapes, usually ovoid, with a volume and consistency suitable for insertion into the vagina to obtain a local effect. It contains one or more active substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature. Solid, single-dose preparation usually prepared by molding, of various shapes, usually ovoid, with a volume and consistency suitable for insertion into the vagina to obtain a local effect. It contains one or more active substances dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C149758 Pillule Dosage Form Pillules 10231000 Solid preparation for homoeopathic use, obtained from sucrose, lactose or other suitable excipients. Pillules may be prepared by impregnation of preformed pillules with a dilution or dilutions of homeopathic stocks or by progressive addition of these excipients and the addition of a dilution or dilutions of homeopathic stocks. Pillules are intended for oral or sublingual use. Solid preparation for homoeopathic use, obtained from sucrose, lactose or other suitable excipients. Pillules may be prepared by impregnation of preformed pillules with a dilution or dilutions of homoeopathic stocks or by progressive addition of these excipients and the addition of a dilution or dilutions of homoeopathic stocks. Pillules are intended for oral or sublingual use. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C149765 Pouch Dosage Form Pouch 30047500 Small bag made of a suitable material containing a single dose of a medicinal product, to be placed in a cavity of the body for release of the active substance(s). Small bag made of a suitable material containing a single dose of a medicinal product, to be placed in a cavity of the body for release of the active substance(s). C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C28944 Cream Dosage Form Cream 10502000 Semi-solid single-dose or multidose preparation of homogeneous appearance consisting of a lipophilic phase and an aqueous phase, one of which is finely dispersed in the other. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic. Creams are intended for cutaneous use. In certain cases, transdermal delivery may be obtained. A semi-solid composed of an emulsion of lipids, hydrocarbons, waxes, or polyols in water. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42934 Gel Dosage Form Gel 10503000 Semi-solid single-dose or multidose preparation consisting of a single-phase basis of liquids gelled by a suitable gelling agent, intended for cutaneous use. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic or hydrophobic. A semi-solid composed of a solid, three dimensional, cross linked matrix of polymers within a liquid, yielding a jelly-like material unable to flow at steady state. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42938 Granule Dosage Form Granules 10204000 Solid single-dose or multidose preparation consisting of solid, dry aggregates of powder particles that are sufficiently resistant to withstand handling. Granules are intended for oral use to release active substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of the active substance(s) (conventional release). They may be swallowed as such and/or chewed before swallowing, and some may also be dissolved or dispersed in water or another suitable liquid before oral administration. Granules for oral solution and Granules for oral suspension are excluded. A solid composed of small particles or grains. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42942 Implant Dosage Form Implant 11301000 Solid sterile preparation of a size and shape suitable for implantation. It may be prepared by moulding or other means other than compression. Each implant is presented in a sterile container that may be provided with an administration device. Implants are intended for release over an extended period of time in order to obtain local or systemic effect. 'Implantation tablet', 'Implantation chain' and 'Implantation matrix' are excluded. A solid intended for insertion securely within the body. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42955 Lozenge Dosage Form Lozenge 10321000 Solid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity and the throat. Lozenges are hard preparations prepared by moulding. They usually contain flavouring and sweetening agents. Lozenges dissolve or disintegrate slowly when sucked. A solid composed of active and/or inert ingredient(s), sweeteners, other flavorings and mucilage, intended for oral administration. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42966 Ointment Dosage Form Ointment 10504000 Semi-solid single-dose or multidose preparation consisting of a single-phase basis in which solids or liquids may be dispersed. Active substance(s) are dissolved or dispersed in the basis, which may be hydrophilic, hydrophobic or water-emulsifying. Ointments are intended for cutaneous use. In certain cases, transdermal delivery may be obtained. A semi-solid, viscous in texture, that may be composed of a variety of bases including hydrocarbons, emulsifiers or vegetable oils, and mixed with active and/or inert ingredient(s). C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42981 Shampoo Dosage Form Shampoo 10508000 Liquid or, occasionally, semi-solid, usually multidose preparation intended for application to the scalp by rubbing and subsequent washing away with water. Upon rubbing with water, shampoos usually form foam. Shampoos are solutions, suspensions or emulsions containing surface-active agents. A solution or suspension composed of an anionic surfactant and intended for administration to the hair and/or scalp. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42993 Suppository Dosage Form Suppository 11013000 Solid single-dose preparation of a shape, size and consistency suitable for rectal use, containing active substance(s) dispersed or dissolved in a suitable basis that may be soluble or dispersible in water or may melt at body temperature. A solid or semi-solid composed of active and/or inert ingredient(s) in a wax, fat or a glycerin gelatin jelly and that is conical or oval in shape. It is intended to be inserted into a body orifice. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42996 Syrup Dosage Form Syrup 10117000 Liquid single-dose or multidose aqueous preparation characterised by a sweet taste and a viscous consistency and usually containing aromatic or other flavouring agents, intended for oral use. Each dose from a multidose container is administered by means of a device suitable for measuring the prescribed volume, generally 5 mL or multiples thereof. A solution or suspension composed of a viscid vehicle that contains a high concentration of sucrose or other sugars and active and/or inert ingredient(s). C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42998 Tablet Dosage Form Tablet 10219000 Solid single-dose uncoated preparation obtained by compressing uniform volumes of particulate solids or by other means such as extrusion or moulding. Tablets include single-layer tablets resulting from a single compression of particles and multi-layer tablets consisting of concentric or parallel layers obtained by successive compressions of particles of different composition. Tablets are intended for oral use to release active substance(s) in the gastrointestinal fluids by a rate depending essentially on the intrinsic properties of active substance(s) (conventional release). A solid composed of a mixture of that active and/or inert ingredient(s) are pressed or compacted together, usually in the form of a relatively flat and round, square or oval shape. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C60985 Pastille Dosage Form Pastille 10323000 Solid single-dose preparation intended to be sucked to obtain, usually, a local effect in the oral cavity and the throat. Pastilles are soft, flexible preparations prepared by moulding of mixtures containing natural or synthetic polymers or gums and sweeteners. They dissolve or disintegrate slowly when sucked. A solid or semi-solid composed of a lozenge, that contains active and/or inert ingredient(s) that dissolves when sucked in the mouth. A C150107 EDQM-HC Routes and Methods of Administration Terminology C111326 Transmammary Route of Administration Transmammary 20082000 Exposure of a breast-feeding infant to a medicinal product administered to the lactating mother. Comment: This term is not intended to describe an authorized route of administration for use in marketing aurhoriations, and does not cover intentional administration of a medicinal product to a breastfeeding infant. It is intended for use in adverse eveent reporting for pharmacovigilance purposes. Administration into the body through colostrum or milk. A C150105 EDQM-HC Combined Term Terminology C153578 Powder and Solvent for Suspension for Injection in Multidose Container Powder and solvent for suspension for injection in multidose container 13108000 Medicinal product consisting of a powder and solvent for suspension for injection presented in a multidose container; usually the powder is presented in the multidose container while the solvent is presented in a separate container, and is added to the powder in order to prepare the suspension for injection in the multidose container. Medicinal product consisting of a powder and solvent for suspension for injection presented in a multidose container; usually the powder is presented in the multidose container while the solvent is presented in a separate container, and is added to the powder in order to prepare the suspension for injection in the multidose container. A C150105 EDQM-HC Combined Term Terminology C153625 Solution for Injection in Multidose Container Solution for injection in multidose container 13109000 Medicinal product consisting of a solution for injection presented in a multidose container. Medicinal product consisting of a solution for injection presented in a multidose container. A C150105 EDQM-HC Combined Term Terminology C153627 Suspension for Injection in Multidose Container Suspension for injection in multidose container 13110000 Medicinal product consisting of a suspension for injection presented in a multidose container. Medicinal product consisting of a suspension for injection presented in a multidose container. D C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C149933 Solution for Spray Dosage Form Solution for spray 13034000 Liquid preparation consisting of a solution intended for use in the preparation of a spray. Liquid preparation consisting of a solution intended for use in the preparation of a spray. D C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42990 Spray Suspension Dosage Form Suspension for spray 13038000 Liquid preparation consisting of a suspension intended for use in the preparation of a spray. A spray composed of a suspension that contains active and/or inert ingredient(s). A C150107 EDQM-HC Routes and Methods of Administration Terminology C38307 Transplacental Route of Administration Transplacental 20083000 In utero exposure of an embryo/foetus to a medicinal product administered to the pregnant mother. Comment: This term is not intended to describe an authorised route of administration for use in marketing authorisations, and does not cover intentional administration of a medicinal product to an embryo/foetus. It is intended for use in adeverse event reporting for pharmacovigilance purposes. Administration of a drug to an embryo in utero via systemic administration of the substance to the pregnant mother. Drugs cross the placenta through passive diffusion, active transport, pinocytosis and filtration. The properties of drugs that determine placental transfer by passive diffusion include molecular weight, pKa, lipid solubility and protein binding. Drugs with molecular weight of over 500 D are transferred incompletely. Drug metabolism and uptake can be altered by placental enzymes. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C87539 Tag Dosage Form Ear tag 10528000 Solid preparation consisting of a matrix impregnated with active substance(s), which is fixed to a device to be tagged on the animal's ear. The active substance(s) are released by diffusion, by mechanical means or by vaporisation over a period of time. A pharmaceutical dosage form containing active substance(s) that are delivered via a tag device. C C150112 EDQM-HC Administration Method Terminology C70962 Agent Administration Administration 0004 Administration of a pharmaceutical product by one of a variety of non-specific methods. To be used only where a more-specific term does not apply. The act of the dispensing, applying, or tendering a medical product or other agent. C C150112 EDQM-HC Administration Method Terminology C149348 Application Method of Administration Application 0005 Administration of a pharmaceutical product by placing or spreading it onto the affected area. The technique of administration of a pharmaceutical product by placing or spreading it onto the affected area. C C150112 EDQM-HC Administration Method Terminology C149352 Bathing Method of Administration Bathing 0006 Administration of a pharmaceutical product by immersing all or part of the affected area in the product, sometimes for an extended period of time. The technique of administration of a pharmaceutical product by immersing all or part of the affected area in the product, sometimes for an extended period of time. C C150112 EDQM-HC Administration Method Terminology C149363 Smoking Method of Administration Burning 0111 Administration of a pharmaceutical product by lighting it in order to evolve smoke that is taken in by the subject. The technique of administration of a pharmaceutical product by lighting it in order to evolve smoke that is taken in by the subject. C C150112 EDQM-HC Administration Method Terminology C149370 Chewing Method of Administration Chewing 0007 Administration of a pharmaceutical product by crushing or grinding it with the teeth; after chewing, some products are intended to be swallowed, some are intended to be spat out. The technique of administration of a pharmaceutical product by crushing or grinding it with the teeth; after chewing, some products are intended to be swallowed, some are intended to be spat out. C C150112 EDQM-HC Administration Method Terminology C149433 Dialysis Method of Administration Dialysis 0112 Administration of a pharmaceutical product by inclusion in a dialysis system (e.g. haemodialysis, haemofiltration, peritoneal dialysis), as a dialysis or substitution product. The technique of administration of a pharmaceutical product by inclusion in a dialysis system as a dialysis or substitution product. C C150112 EDQM-HC Administration Method Terminology C149523 Gargling Method of Administration Gargling 0008 Administration of a pharmaceutical product by rinsing the throat and/or mouth with it, holding it in the throat and keeping it in motion by releasing a stream of air from the lungs; after gargling, the product is usually intended to be spat out. The technique of administration of a pharmaceutical product by rinsing the throat and/or mouth with it, holding it in the throat and keeping it in motion by releasing a stream of air from the lungs; after gargling, the product is usually intended to be spat out. C C150112 EDQM-HC Administration Method Terminology C149562 Implantation Method of Administration Implantation 0113 Administration of a pharmaceutical product by placing it within a tissue of the body, usually as part of a surgical procedure. The technique of administration of a pharmaceutical product by placing it within a tissue of the body, usually as part of a surgical procedure. C C150112 EDQM-HC Administration Method Terminology C149577 Infusion Method of Administration Infusion 0009 Administration of a pharmaceutical product, usually slowly and in larger volumes than for an injection, by introducing it into the body, usually after puncturing the skin; it is usually administered intravenously, but occasionally by other routes, e.g. subcutaneously. The technique of administration of a pharmaceutical product, usually slowly and in larger volumes than for an injection, by introducing it into the body, usually after puncturing the skin; it is usually administered intravenously, but occasionally by other routes, e.g. subcutaneously. C C150112 EDQM-HC Administration Method Terminology C149578 Inhalation Method of Administration Inhalation 0010 Administration of a pharmaceutical product by breathing it into the lungs, usually via the mouth. The technique of administration of a pharmaceutical product by breathing it into the lungs, usually via the mouth. C C150112 EDQM-HC Administration Method Terminology C149592 Injection Method of Administration Injection 0011 Administration of a pharmaceutical product by introducing it into the body, usually after puncturing the skin; one or more of a variety of routes may be specified, the most common being intravenous, intramuscular and subcutaneous. The technique of administration of a pharmaceutical product by introducing it into the body, usually after puncturing the skin; one or more of a variety of routes may be specified, the most common being intravenous, intramuscular and subcutaneous. C C150112 EDQM-HC Administration Method Terminology C149594 Insertion Method of Administration Insertion 0012 Administration of a pharmaceutical product by placing it into a body cavity, lesion, wound etc. The technique of administration of a pharmaceutical product by placing it into a body cavity, lesion, wound etc. C C150112 EDQM-HC Administration Method Terminology C149596 Instillation Method of Administration Instillation 0013 Administration of a pharmaceutical product drop by drop onto or into the affected area. The technique of administration of a pharmaceutical product drop by drop onto or into the affected area. C C150112 EDQM-HC Administration Method Terminology C149701 Unspecified Method of Administration Not specified 0020 Administration of a pharmaceutical product by an unspecified method. The technique of administration of a pharmaceutical product by an unspecified method. C C150112 EDQM-HC Administration Method Terminology C149730 Oral Disintegration Method of Administration Orodispersion 0014 Administration of a pharmaceutical product by placing it in the mouth and allowing it to dissipate; the product is usually then swallowed. The technique of administration of a pharmaceutical product by placing it in the mouth and allowing it to dissipate; the product is usually then swallowed. C C150112 EDQM-HC Administration Method Terminology C149887 Rinsing/Washing Method of Administration Rinsing/washing 0015 Administration of a pharmaceutical product by bringing it into contact with the affected area for a short period of time, e.g. by pouring it over the area and allowing it to drain away, or swilling it around the area and then removing it. The technique of administration of a pharmaceutical product by bringing it into contact with the affected area for a short period of time, e.g. by pouring it over the area and allowing it to drain away, or swilling it around the area and then removing it. C C150112 EDQM-HC Administration Method Terminology C149950 Spraying Method of Administration Spraying 0017 Administration of a pharmaceutical product by atomising or otherwise dissipating it into a fine dispersion of particles in air, directing it such that it comes into contact with the affected area. The technique of administration of a pharmaceutical product by atomizing or otherwise dissipating it into a fine dispersion of particles in air, directing it such that it comes into contact with the affected area. C C150112 EDQM-HC Administration Method Terminology C149961 Sucking Method of Administration Sucking 0018 Administration of a pharmaceutical product by placing it in the mouth and encouraging it to dissolve in the saliva, usually by moving the tongue. The technique of administration of a pharmaceutical product by placing it in the mouth and encouraging it to dissolve in the saliva, usually by moving the tongue. C C150112 EDQM-HC Administration Method Terminology C149973 Swallowing Method of Administration Swallowing 0019 Administration of a pharmaceutical product by introducing it into the stomach via the mouth and oesophagus with a voluntary muscular action. The technique of administration of a pharmaceutical product by introducing it into the stomach via the mouth and esophagus with a voluntary muscular action. C C150114 EDQM-HC Intended Site of Administration Terminology C96901 Auricular Auricular 0021 Relating to the ear as the intended site of administration, usually where the pharmaceutical product is intended for action in the auditory canal (external auditory meatus). Relating to the ear as the intended site of administration, usually where the pharmaceutical product is intended for action in the auditory canal (external auditory meatus). C C150114 EDQM-HC Intended Site of Administration Terminology C149423 Cutaneous/Transdermal Cutaneous/Transdermal 0022 Relating to the skin or its appendages (e.g. hair, nails) as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the skin, within the skin, or systemically after passing through the skin. Relating to the skin or its appendages (e.g. hair, nails) as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the skin, within the skin, or systemically after passing through the skin. C C150114 EDQM-HC Intended Site of Administration Terminology C41136 Dental Dental 0023 Relating to the teeth as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the tooth, inside the tooth, or around the tooth. Pertaining to a tooth or teeth, or to odontology. C C150114 EDQM-HC Intended Site of Administration Terminology C149484 Endocervical Endocervical 0105 Relating to the cervix uteri as the intended site of administration. Relating to the cervix uteri as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C149494 Environmental Environmental 0024 Relating to the surroundings in which the target of the pharmaceutical product is found, as the intended site of administration, e.g. an enclosed volume of water or air; usually the product disperses in the area and is subsequently taken up by the subject. Relating to the surroundings in which the target of the pharmaceutical product is found, as the intended site of administration, e.g. an enclosed volume of water or air; usually the product disperses in the area and is subsequently taken up by the subject. C C150114 EDQM-HC Intended Site of Administration Terminology C149497 Extracorporeal Extracorporeal 0025 Relating to a body substance or tissue as the intended site of administration, after being removed from the body in order to be treated with the pharmaceutical product and then subsequently returned to the body. Relating to a body substance or tissue as the intended site of administration, after being removed from the body in order to be treated with the pharmaceutical product and then subsequently returned to the body. C C150114 EDQM-HC Intended Site of Administration Terminology C13307 Gastric Gastric 0106 Relating to the stomach as the intended site of administration, where direct administration is achieved using an appropriate device. Relating to the stomach. C C150114 EDQM-HC Intended Site of Administration Terminology C13359 Gastrointestinal Gastroenteral 0107 Relating to the stomach or duodenum as the intended site of administration, where direct administration is achieved using an appropriate device. Pertaining to the stomach and intestines. C C150114 EDQM-HC Intended Site of Administration Terminology C25266 Intestinal Intestinal 0108 Relating to the intestines (duodenum, jejunum, ileum, colon) as the intended site of administration, where direct administration is achieved using an appropriate device. Of, or related to, or referring to the intestines. C C150114 EDQM-HC Intended Site of Administration Terminology C149603 Intramammary Intramammary 0026 Relating to the milk-producing organs (mammae) of a female mammal as the intended site of administration, to describe veterinary-only pharmaceutical products that are administered via the teat canal. Relating to the milk-producing organs (mammae) of a female mammal as the intended site of administration, to describe veterinary-only pharmaceutical products that are administered via the teat canal. C C150114 EDQM-HC Intended Site of Administration Terminology C13352 Intraperitoneal Intraperitoneal 0109 Relating to the peritoneal cavity as the intended site of administration. Relating to the peritoneal cavity as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C96903 Intrauterine Intrauterine 0027 Relating to the cavity of the uterus as the intended site of administration. Relating to the cavity of the uterus as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C149623 Intravesical/Urethral Intravesical/Urethral 0028 Relating to the urinary bladder or the urethra (the urogenital canal, connecting the bladder to the outside of the body) as the intended site of administration. Relating to the urinary bladder or the urethra as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C27958 Nasal Nasal 0029 Relating to the nose as the intended site of administration, including where the pharmaceutical product is intended for local action in the nasal cavity or for systemic action after absorption through the mucous membrane; the lower respiratory tract is excluded. In reference to the nose. C C150114 EDQM-HC Intended Site of Administration Terminology C87163 Ocular Ocular 0030 Relating to the eye as the intended site of administration, including where the pharmaceutical product is intended for action on the surface of the eye or conjunctiva, around the eye, or within the eye. Of or relating to the eye. C C150114 EDQM-HC Intended Site of Administration Terminology C149702 Oculonasal Oculonasal 0110 Relating to the eyes and nares of a bird as the intended site of administration. Relating to the eyes and nares of a bird as the intended site of administration. C C150114 EDQM-HC Intended Site of Administration Terminology C25311 Oral Oral 0031 Relating to the mouth as the intended site of administration, but where the pharmaceutical product is administered with the intention of passing into the stomach via the oesophagus; the mucosa of the mouth itself is not the intended site of action (see oromucosal). Of, or relating to, or affecting, or for use in the mouth. C C150114 EDQM-HC Intended Site of Administration Terminology C149731 Oromucosal Oromucosal 0032 Relating to the mouth as the intended site of administration, where the pharmaceutical product is administered with the intention of acting on the mucosa of the mouth, whether for local or systemic use. Relating to the mouth as the intended site of administration, where the pharmaceutical product is administered with the intention of acting on the mucosa of the mouth, whether for local or systemic use. C C150114 EDQM-HC Intended Site of Administration Terminology C150414 Parenteral Parenteral 0033 Relating to the internal body as the intended site of administration, other than the natural openings and cavities such as the gastrointestinal tract, auditory canal, nasal cavity, lungs, etc.; the pharmaceutical product is usually administered by breaking the skin, such as by injection, infusion, and implantation. Relating to the internal body as the intended site of administration, other than the natural openings and cavities such as the gastrointestinal tract, auditory canal, nasal cavity, lungs, etc.; the pharmaceutical product is usually administered by breaking the skin, such as by injection, infusion, and implantation. C C150114 EDQM-HC Intended Site of Administration Terminology C13304 Pulmonary Pulmonary 0034 Relating to the lungs as the intended site of administration, where the pharmaceutical product is administered, usually by inhalation, for local action in the lower respiratory tract or for systemic action after absorption via the lower respiratory tract. Relating to the lungs as the intended site of administration, where the pharmaceutical product is administered, usually by inhalation, for local action in the lower respiratory tract or for systemic action after absorption via the lower respiratory tract. C C150114 EDQM-HC Intended Site of Administration Terminology C25224 Rectal Rectal 0035 Relating to the rectum as the intended site of administration, where the pharmaceutical product is administered via the anal canal, for local action in the rectum or for systemic action after absorption via the rectum. Of or pertaining to the rectum. C C150114 EDQM-HC Intended Site of Administration Terminology C150004 Unknown/Miscellaneous Anatomical Location Unknown/Miscellaneous 0037 Relating to various unspecified parts of the body as the intended site of administration, or where the intended site of administration is unknown or not specified. Relating to various unspecified parts of the body as the intended site of administration, or where the intended site of administration is unknown or not specified. C C150114 EDQM-HC Intended Site of Administration Terminology C13309 Vaginal Vaginal 0036 Relating to the vagina as the intended site of administration, where the pharmaceutical product is administered via the vaginal opening, usually for local action in the vagina but sometimes for systemic action after absorption via the vagina. Of or relating to the vagina. C C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C42927 Extended Release Tablet Dosage Form Prolonged-release tablet 10226000 Solid single-dose preparation consisting of a tablet showing a slower release of the active substance(s) than that of a conventional-release tablet. Prolonged release is achieved by a special formulation design and/or manufacturing method. Prolonged-release tablets are intended for oral use. A tablet designed to release active and/or inert ingredient(s) at a controlled, prolonged rate so as to reduce dosing frequency. C C150115 EDQM-HC Release Characteristics Terminology C149409 Conventional Release Mechanism of Action Conventional 0047 Release of the substance(s) in a way that is not deliberately modified by a special formulation design and/or manufacturing method. Release of the substance(s) in a way that is not deliberately modified by a special formulation design and/or manufacturing method. C C150115 EDQM-HC Release Characteristics Terminology C149427 Delayed Release Mechanism of Action Delayed 0044 Release of the substance(s) at a later time than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method; enteric-coated and other gastro-resistant products are included. Release of the substance(s) at a later time than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method; enteric-coated and other gastro-resistant products are included. C C150115 EDQM-HC Release Characteristics Terminology C149662 Modified-release Mechanism of Action Modified 0046 Release of the substance(s) in a way that differs from that which would be achieved with a conventional-release product, which is achieved by a special formulation design and/or manufacturing method, but which is not classified as delayed-release or prolonged-release; pulsatile-release products are included. Release of the substance(s) in a way that differs from that which would be achieved with a conventional-release product, which is achieved by a special formulation design and/or manufacturing method, but which is not classified as delayed-release or prolonged-release; pulsatile-release products are included. C C150115 EDQM-HC Release Characteristics Terminology C149870 Prolonged Release Mechanism of Action Prolonged 0045 Release of the substance(s) over a longer duration than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method. Release of the substance(s) over a longer duration than would be achieved with a conventional-release product, achieved by a special formulation design and/or manufacturing method. C C150115 EDQM-HC Release Characteristics Terminology C150002 Unknown Mechanism of Action Unknown 0048 Release of the substance(s) in a way that is unknown or not specified. Release of the substance(s) in a way that is unknown or not specified. C C150116 EDQM-HC State of Matter Terminology C45299 Gas Gas 0100 A state of matter consisting of molecules in an elastic aeriform fluid, separated from one another and with freedom of movement, no independent shape or volume and the ability to expand indefinitely. A fluid in the gaseous state having neither independent shape nor volume and being able to expand indefinitely. C C150116 EDQM-HC State of Matter Terminology C45298 Liquid Liquid 0099 A state of matter consisting of molecules in a non-rigid structure that retains its volume but conforms to the shape of any container applying pressure to it, and is subject to flow. A substance in the fluid state of matter having no fixed shape but a fixed volume. C C150116 EDQM-HC State of Matter Terminology C149895 Semi-solid Semi-solid 0098 A state of matter consisting of molecules in a non-rigid structure that can retain its shape and volume but that is not resistant to such change. A state of matter consisting of molecules in a non-rigid structure that can retain its shape and volume but that is not resistant to such change. C C150116 EDQM-HC State of Matter Terminology C45300 Solid Solid 0097 A state of matter consisting of molecules in a rigid structure that is resistant to change in shape or volume. The state in which a substance has no tendency to flow under moderate stress; resists forces (such as compression) that tend to deform it; and retains a definite size and shape. C C150116 EDQM-HC State of Matter Terminology C150000 Unclear State of Matter Unclear 0101 A state of matter of unknown, unspecified or variable physical characteristics. A state of matter of unknown, unspecified or variable physical characteristics. C C150117 EDQM-HC Transformation Terminology C64657 Dilute Dilution 0038 Transformation of a concentrate into a liquid of greater volume and lower concentration by mixing it with a specified solvent. To reduce in strength or concentration, especially by the addition of water. C C150117 EDQM-HC Transformation Terminology C150035 Dispersion Activity Dispersion 0039 Transformation of a solid or gas into a dispersion or suspension by mixing it with a specified liquid. Transformation of a solid or gas into a dispersion or suspension by mixing it with a specified liquid. C C150117 EDQM-HC Transformation Terminology C113023 Dissolution Mixing Dissolution 0040 Transformation of a solid into a solution by mixing it with a specified liquid. Mixing by adding solids to agitated liquids. C C150117 EDQM-HC Transformation Terminology C64925 Mix Mixing 0041 Transformation of a product into another product by mixing with a specified product. To bring or combine together or with something else; add as an additional element or part. C C150117 EDQM-HC Transformation Terminology C149700 No Transformation No transformation 0042 No transformation of the product takes place. No transformation of the product takes place. C C150117 EDQM-HC Transformation Terminology C150003 Unknown Transformation Unknown 0043 It is unknown whether any transformation of the product takes place. It is unknown whether any transformation of the product takes place. C C150109 EDQM-HC Container Terminology C43168 Blister Pack Blister 30007000 Container (usually multidose) consisting of two layers of which one is shaped to contain the individual doses. Strips and unit-dose blisters are excluded. A package that consists of molded plastic or laminate that has indentations (viewed as 'blisters' when flipped) into which a dosage form, is placed. A covering, usually of laminated material, is then sealed to the molded part. A strip pack is a specialized type of blister pack where there are no pre-formed or molded parts; in this case there are two flexible layers that are sealed with the dosage form in between. Suppositories that are strip packed between two layers of foil are also considered a blister pack. C C150109 EDQM-HC Container Terminology C149860 Pre-filled Injector Pre-filled injector 13063000 Filled container, usually fitted with an injection needle, containing a sterile, single-dose parenteral preparation. This term is only to be used when a more-specific term such as 'Pre-filled syringe' or 'Pre-filled pen' is not appropriate. Comment: This term may be used to describe, for example, an item of packaging that is intended to be used by puncturing the skin and squeezing a small reservoir to administer its contents. Filled container, usually fitted with an injection needle, containing a sterile, single-dose parenteral preparation. C C150109 EDQM-HC Container Terminology C149862 Pre-filled Oral Syringe Pre-filled oral syringe 13073000 Filled container for administering a liquid or semi-solid pharmaceutical form to the oral cavity, containing the final preparation in one compartment, or the components necessary for its preparation in different compartments. Comment: For certain products that are usually associated with administration by injection, such as vaccines, the term "Pre-filled oral applicator" may be used instead in order to reduce any risk of administration by injection. Filled container for administering a liquid or semi-solid pharmaceutical form to the oral cavity, containing the final preparation in one compartment, or the components necessary for its preparation in different compartments. C C150107 EDQM-HC Routes and Methods of Administration Terminology C38205 Endocervical Route of Administration Endocervical use 20006000 Administration of a medicinal product to the cervix uteri. Administration of the drug within the canal of the cervix uteri. C C150110 EDQM-HC Administration Device Terminology C50296 Pipette Device Pipette 30046000 Administration device, tubular, used for the administration in drops or in accurately measured quantity of liquid pharmaceutical forms. A measuring device, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes. A C150108 EDQM-HC Closure Terminology C154642 Pipette Closure Device Pipette applicator 30047000 Closure with pipette. Closure with pipette. A C150103 EDQM-HC Pharmaceutical Dosage Form Terminology C154663 Powder for Vaginal Solution Powder for vaginal solution 13111000 Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a vaginal solution. Solid preparation consisting of one or more powders, including freeze-dried powders, intended to be dissolved in the specified liquid to obtain a vaginal solution.