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Glossary of Pharmaceutical Terms and Dosage Forms

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Glossary of Pharmaceutical Terms and Dosage Forms APPENDIX B Glossary of Pharmaceutical Terms and Dosage Forms A Blocks: large veterinary products intended to be Active Ingredient: the ingredient or ingredients licked by animals and containing API(s) and of a pharmaceutical product responsible for nutrients such as salts, vitamins, and minerals. its pharmacologic activity (also medicament, Bolus: a large, long tablet intended for adminis- drug substance, active pharmaceutical ingre- tration to animals. dient [API]). Aerosol: a dosage form that is packaged under pres- C sure and contains therapeutically active ingredi- Caplet: tablet dosage form in the shape of a ents that are released upon activation of an appro- ­capsule. priate valve system. A dosage form consisting Capsule: a solid dosage form in which the drug of a liquid or solid preparation packaged under is enclosed within a hard or soft soluble con- pressure and intended for administration as a tainer or shell. fine mist. The descriptive term aerosol also refers Capsule, Delayed-Release: a coated capsule or to the fine mist of small droplets or solid particles more commonly encapsulated granules that that are emitted from the product. may be coated to resist releasing the drug in the Aerosol Foam: a dosage form containing one or stomach because the drug will irritate gastric more active ingredients, surfactants, aqueous mucosa or gastric fluid will inactivate the drug. or nonaqueous liquids, and the propellant; if Capsule, Extended-Release: a capsule that is for- the propellant is in the internal (discontinuous) mulated in such a manner as to make the con- phase (i.e., of the oil-in-water type), a stable tained medication available over an extended foam is discharged, and if the propellant is in the period following ingestion. external (continuous) phase (i.e., of the water- Capsule, Film-Coated Extended-Release: a solid in-oil type), a spray or a quick-breaking foam is dosage form in which the drug is enclosed discharged. within either a hard or soft soluble container Aerosol, Metered: a pressurized dosage foam or “shell” made from a suitable form of gel- consisting of metered-dose valves, which atin; additionally, the capsule is covered in a allow for the delivery of a uniform quantity of designated film coating, which releases a drug spray upon each activation. (or drugs) in such a manner to allow at least Ampul: a final container that is all glass in which the a reduction in dosing frequency as compared open end, after filling with product, is sealed by to that drug (or drugs) presented as a conven- heat (also ampoule, ampule, [French] carpule). tional dosage form. Aromatic Water: a clear, saturated, aqueous solu- Capsule, Gelatin-Coated: a solid dosage form in tion of volatile oils or other aromatic or volatile which the drug is enclosed within either a hard substances. or soft soluble container made from a suitable Aseptic: lacking disease-producing microorgan- form of gelatin; through a banding process, isms; not the same as sterile. the capsule is coated with additional layers of Aseptic Processing: manufacturing dosage forms gelatin so as to form a complete seal. without terminal sterilization. The dosage Capsule, Liquid-Filled: a solid dosage form in form is sterile filtered, aseptically filled into which the drug is enclosed within a solu- the final package, and then aseptically sealed. ble, gelatin shell, which is plasticized by the Aural (Auricular): for administration into, or by addition of a polyol, such as sorbitol or glyc- way of, the ear. erin, and is therefore of a somewhat thicker consistency than that of a hard-shell capsule; B typically, the active ingredients are dissolved Bead: a solid dosage form in the shape of a small or suspended in a liquid vehicle. sphere. The dosage form generally contains Capsule, Soft-Shell: a solid dosage form in which multiple beads (also pellet). one or more active ingredients, normally in 763 0002064525.INDD 763 11/29/2013 4:59:37 PM 764 APPENDIX B solution or suspension or in the form of a Dosage Form: a formulation that typically con- paste, are filled into a one-piece shell. tains the API(s) and excipients in quantities Chewable: attribute of a solid dosage form that and physical form designed to all the accurate is intended to be chewed or crushed before and efficient administration of the API to swallowing. the human or animal patient. Coated: attribute of a solid dosage form that is Douche: a liquid preparation intended for the irri- covered by deposition of an outer solid that is gative cleansing of the vagina; prepared from different in composition from the core material. powders, liquid solutions, or liquid concentrates. Collodion: a liquid preparation composed of Dressing: the application of various materials for pyroxylin dissolved in a solvent mixture of protecting a wound. alcohol and ether and applied externally. Drops, Oral: a solution, emulsion, or suspension Colloidal Dispersion: an attribute of a prepara- that is administered in small volumes, such as tion or formulation in which particles of col- drops, by means of a suitable device. loidal dimension (i.e., typically between 1 nm Drug Delivery System: modern technology, dis- and 1 μm) are distributed uniformly through- tributed with or as a part of a drug product out a liquid. that allows for the uniform release or targeting Concentrate: a liquid preparation of increased of drugs to the body. strength and reduced volume, which is usually Dry Powder Inhaler: a device used to administer diluted prior to administration or use. an inhalation powder in a finely divided state Concentrate for Dip: a preparation containing one suitable for oral inhalation by the patient. or more active ingredients usually in the form of a paste or solution; it is used to prepare a E diluted suspension, emulsion, or solution of the Effervescent: a dosage form containing ingredi- active ingredient(s) for the prevention and treat- ents that rapidly release carbon dioxide when ment of ectoparasitic infestations of animals. in contact with water. Conventional-Release: descriptive term for a Elixir: a clear, pleasantly flavored, sweetened dosage form in which no deliberate effort has hydroalcoholic liquid containing dissolved been made to modify the release rate of the active ingredients intended for oral use. API. In the case of capsules and tablets, the Emollient: attribute of a cream of ointment indi- inclusion or exclusion of a disintegrating agent cating an increase in the moisture content of is not interpreted as a modification. the skin following application of bland, fatty, Cream: a semisolid dosage form containing one or or oleaginous substances. more drug substances dissolved or dispersed in Emulsion: a two-phase system in which one a suitable base. An emulsion dosage form often liquid is dispersed throughout another liquid containing more than 20% water and volatiles in the form of small droplets. A dosage form and/or containing < 50% hydrocarbons, waxes, consisting of a two-phase system composed of or polyols, as the vehicle for the API. Creams at least two immiscible liquids, one of which are generally intended for external application is dispersed as droplets (internal or dispersed to the skin or mucous membranes. phase) within the other liquid (external or con- tinuous phase), generally stabilized with one D or more emulsifying agents. Delayed-Release: a type of modified-release dos- Enema: a rectal preparation for therapeutic, diag- age form. A descriptive term for a dosage nostic, or nutritive purposes. form deliberately modified to delay release of Enteric-Coated: descriptive term for a solid dos- the API for some period of time after initial age form in which a polymer coating has been administration. For example, release of the API applied to prevent the release of the API in the is prevented in the gastric environment but gastric environment. promoted in the intestinal environment; this Excipient: an ingredient of a dosage form other term is synonymous with Enteric-Coated or than an API. Gastro-Resistant. Extended-Release: descriptive term for a dosage Dental: descriptive term for a preparation that is form that is deliberately modified to protract applied to the teeth or gums for local action. the release of the API compared to that observed Dermal: a topical route of administration where for an immediate-release dosage form. The term the article is intended to reach or be applied to is synonymous with prolonged or sustained the dermis. release. Many extended-release dosage forms 0002064525.INDD 764 11/29/2013 4:59:37 PM APPENDIX B 765 have a pattern of release that begins with a Gel, Metered: a gel preparation, with meter ed-dose “burst effect” that mimics an immediate release valves, which allow for the delivery of a uni- followed by a slower release of the remaining form quantity of gel upon each activation. API in the dosage form. Globule: also called pellets or pilules, are made of Extract: a concentrated preparation of vegetable pure sucrose, lactose, or other polysaccharides. or animal drug obtained by removal of the They are formed into small globular masses of active constituents with suitable menstrua, by various sizes and are medicated by placing them evaporation of all or nearly all of the solvent, in a vial and adding the liquid drug attenuation and by adjustment of the residual mass or in the proportion not less than 1% (w/v). After powder to the prescribed standards. shaking, the medicated globules are dried at temperatures not to exceed 40°C. F Granules: a preparation of dry aggregates of Film: a thin layer or coating. A term used to powder particles that may contain one or more describe a thin, flexible sheet of material, usu- active ingredients with or without other ingre- ally composed of a polymer.
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