Glossary of Pharmaceutical Terms and Dosage Forms PDF

Appendix B: Glossary of Pharmaceutical Terms and Dosage Forms **Active Ingredient:** the ingredient or ingredients of a pharmaceutical product responsible for its pharmacologic activity (also known as medicament, drug substance, active pharmaceutical ingredient or API). **Aerosol:** a dosage form...

Appendix B: Glossary of Pharmaceutical Terms and Dosage Forms **Active Ingredient:** the ingredient or ingredients of a pharmaceutical product responsible for its pharmacologic activity (also known as medicament, drug substance, active pharmaceutical ingredient or API). **Aerosol:** a dosage form that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system. A dosage form consisting of [a liquid or solid preparation packaged under pressure and intended for administration as a fine mist.] The descriptive term aerosol also refers to the fine mist of small droplets or solid particles that are emitted from the product. Aerosol Foam: a dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous liquids, and the propellant; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. Aerosol, **Metered**: a pressurized dosage form consisting of metered-dose valves, which [allow for the delivery of a uniform quantity of spray upon each activation.] **Ampule:** [a final container that is all glass in which the open end, after filling with product, is sealed by heat] (also ampoule, ampule, carpule). **Aromatic Water[:]** [a clear, saturated, aqueous solution of volatile oils or other aromatic or volatile substances.] Aseptic: lacking disease-producing microorganisms; not the same as sterile. Aseptic Processing: manufacturing dosage forms without terminal sterilization. The dosage form is sterile filtered, aseptically filled into the final package, and then aseptically sealed. **Aural (Auricular)**: for administration into or by way of, the [ear]. Bead: a solid dosage form in the shape of a small sphere. The dosage form generally contains multiple beads (aka pellet). Blocks: large veterinary products intended to be licked by animals and containing API(s) and nutrients such as salts, vitamins, and minerals. Bolus: a large, long tablet intended for administration to animals. Caplet: tablet dosage form in the shape of a capsule. **Capsule:** [a solid dosage form in which the drug is enclosed within a hard or soft soluble container or shell.] Capsule, Delayed-Release: a coated capsule or more commonly encapsulated granules that may be coated to resist releasing the drug in the stomach because the drug will irritate gastric mucosa or gastric fluid will inactivate the drug. Capsule, Extended-Release: a capsule that is formulated in such a manner as to make the contained medication available over an extended period following ingestion. Capsule, Film-Coated Extended-Release: a solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. Capsule, Gelatin-Coated: a solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal. Capsule, Liquid-Filled: a solid dosage form in which the drug is enclosed within a soluble, gelatin shell, which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard-shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle. Capsule, Soft-Shell: a solid dosage form in which one or more active ingredients, normally in solution or suspension or in the form of a paste, are filled into a one-piece shell. Chewable: attribute of a solid dosage form that is intended to be chewed or crushed before swallowing. Coated: attribute of a solid dosage form that is covered by deposition of an outer solid that is different in composition from the core material. **Collodion:** a liquid preparation composed of [pyroxylin] dissolved in a solvent mixture of [alcohol and ether] and applied externally. **Colloidal Dispersion:** [an attribute of a preparation or formulation in which particles of colloidal dimension (i.e., typically between 1 mm and 1 micrometer) are distributed uniformly throughout a liquid.] **Concentrate[: ]**[a liquid preparation of increased strength and reduced volume, which is usually diluted prior to administration or use.] Concentrate for Dip: a preparation containing one or more active ingredients usually in the form of a paste or solution; it is used to prepare a diluted suspension, emulsion, or solution of the active ingredient(s) for the prevention and treatment of ectoparasitic infestations of animals. **Conventional-Release:** descriptive term for a dosage form in which [no deliberate effort has been made to modify the release rate of the API.] In the case of capsules and tablets, the inclusion or exclusion of a disintegrating agent is not interpreted as a modification. **Cream:** a semisolid dosage form containing one or more drug substances dissolved or dispersed in a suitable base. An emulsion dosage form often containing [more than 20% water and volatiles and/or containing \