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terms & dosage forms

PharDose Appendix B: Glossary of Pharmaceutical Terms and Dosage Forms

TermDefinition
Active Ingredient: (also medicament, drug substance, active pharmaceutical ingredient). the ingredient or ingredients of a pharmaceutical product responsible for its pharmacologic activity.
Aerosol: a dosage form that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system.
Ampul: (also ampoule, ampule, [French] carpule). a final container that is all glass in which the open end, after filling with product, is sealed by heat.
Aseptic: lacking disease-producing microorganisms; not the same as sterile.
Aseptic Processing: manufacturing dosage forms without terminal sterilization.
Bead: (also pellet). a solid dosage form in the shape of a small sphere.
Bolus: a large, long tablet intended for administration to animals.
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, 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.
Collodion: a liquid preparation composed of pyroxylin dissolved in a solvent mixture of alcohol and ether and applied externally.
Concentrate: a liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Concentrate for Dip: a preparation 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.
Cream: a semisolid dosage form containing one or more drug substances dissolved or dispersed in a suitable base.
Douche: a liquid preparation intended for the irrigative cleansing of the vagina; prepared from powders, liquid solutions, or liquid concentrates.
Drops, Oral: a solution, emulsion, or suspension that is administered in small volumes, such as drops, by means of a suitable device.
Dressing: the application of various materials for protecting a wound.
Effervescent: a dosage form containing ingredients that rapidly release carbon dioxide when in contact with water.
Elixir: a clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved active ingredients intended for oral use.
Emulsion: a two-phase system in which one liquid is dispersed throughout another liquid in the form of small droplets.
Enema: a rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Excipient: an inactive ingredient of a dosage form.
Extract: a concentrated preparation of vegetable or animal drug obtained by removal of the active constituents with suitable menstrua, by evaporation of all or nearly all of the solvent, and by adjustment of the residual mass or powder to the prescribed standards.
Film: a thin layer or coating.
Fluidextract: a liquid preparation of a vegetable drug containing alcohol as a solvent, preservative, or both and so made that unless otherwise specified in an individual monograph, each milliliter contains the therapeutic constituents of 1 g of the standard drug.
Foam: an emulsion packaged in a pressurized aerosol container that has a fluffy, semisolid consistency when dispensed.
For solution: a product, usually a solid, intended for solution prior to administration.
For suspension: a product, usually a solid, intended for suspension prior to administration.
Gel: (also jelly) a semisolid system consisting of either a suspension of small inorganic particles or large organic molecules interpenetrated by a liquid.
Granules: a preparation of dry aggregates of powder particles that may contain one or more active ingredients with or without other ingredients.
Gum: a mucilaginous excretion from various plants.
Gum, Chewing: a sweetened and flavored insoluble plastic material which, when chewed, releases a drug substance into the oral cavity.
Implant: A small sterile solid mass consisting of a highly purified drug with or without excipients made by compression or molding and put in place by injection or incision.
Infusion, Intramammary: a suspension of a drug in a suitable oil vehicle; intended for veterinary use only.
Inhalation: a solution or suspension of one or more drug substances administered by the nasal or oral respiratory route for local or systemic effect.
Injection: a preparation intended for parenteral administration or for constituting or diluting a parenteral product prior to administration.
Injection, Liposomal: an injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance).
Insert: a specially formulated and shaped nonencapsulated solid preparation intended to be placed into a nonrectal orifice of the body, where drug is released, generally for localized effects.
Intrauterine Device: a device inserted and left in the uterus to prevent effective conception.
Irrigation: a sterile solution intended to bathe or flush open wounds or body cavities.
Liniment: an alcoholic or oleaginous solution or emulsion applied by rubbing on the skin for treating pain and stiffness of underlying musculature.
Lotion: a fluid suspension or emulsion applied to the surface of the skin.
Lozenge: (also troche) a solid preparation that is intended to dissolve or disintegrate slowly in the mouth.
Lyophilization: removal of water or other solvent from a frozen solution by sublimation caused by a combination of temperature and pressure differentials (syn freeze drying).
Modified Release: a release pattern of the active ingredient from the dosage form that has been deliberately changed from that of the conventional form.
Molded Tablet: a tablet that has been formed by dampening the ingredients and pressing them into a mold, then removing and drying the resulting solid mass.
Mouthwash: an aqueous solution used to rinse the oral cavity.
Ointment: a semisolid preparation intended for external application to the skin or mucous membrane.
Ophthalmic Preparation: drug in a dosage form intended to be applied to the eye.
Ophthalmic Ointment: a sterile ointment intended for solution to the eye.
Ophthalmic Solution: a sterile solution, essentially free from foreign particles, suitably prepared and packaged for solution to the eye.
Ophthalmic Suspension: a sterile liquid preparation containing solid particles dispersed in a liquid vehicle intended for solution to the eye.
Ophthalmic Strip: a sterile single-use container or sterile impregnated paper strip containing the drug to be applied to the eye.
Orally Disintegrating: a solid oral dosage form that disintegrates rapidly in the mouth to facilitate release of the active ingredient.
Otic Solution: a solution intended for instillation in the outer ear.
Otic Suspension: a liquid preparation containing micronized particles intended for instillation in the outer ear.
Paste: a semisolid dosage form that contains one or more drug substances intended for topical application. It generally contains a high concentration of solids and has a stiff consistency.
Pastille: an aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.
Patch: a drug delivery system that often contains an adhesive backing usually applied to an external site on the body.
Pellet: a solid granule or regular shape prepared by compaction, molding, or granulation.
Pill: a solid spherical dosage form usually prepared by a wet massing technique.
Plaster: a solid or semisolid mass supplied on a backing material and intended to provide prolonged contact with the skin.
Powder: an intimate mixture of dry, finely divided drug and/or chemicals that may be intended for internal (oral) or external (topical) use.
Premix: a mixture of one or more drug substances with a suitable vehicle.
Pulsatile Release: a release pattern of the active ingredient from the dosage form modified to release aliquots of the total dose at two or more time intervals.
Rinse: a solution used to cleanse by flushing.
Shampoo: a solution, emulsion, or suspension used to clean the hair and scalp.
Soap: the alkali salt(s) of one or more fatty acids.
Solution: a liquid preparation that contains one or more dissolved (molecularly dispersed) chemical substances in a suitable solvent or mixture of miscible solvents.
Spirit: an alcoholic or hydroalcoholic solution of volatile substances prepared usually by simple solution or by admixture of the ingredients.
Spray: a liquid minutely divided as by a jet of air or steam.
Sterile: completely lacking living (viable) microbial life.
Sterility: an acceptably high level of probability that a product processed in an aseptic system does not contain viable microorganisms.
Stick: a slender, cylindrical dosage form of rigid consistency.
Suppository: a solid body adapted for introduction into the rectal, vaginal, or urethral orifice.
Suppository Tablet or Insert: a vaginal suppository prepared by compression of powdered materials into a suitable shape; it can also be prepared by encapsulation in soft gelatin.
Suspension: a liquid preparation that consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble.
Syrup: a solution containing a high concentration of sucrose or other sugars.
System: a dosage form developed to allow for uniform release or targeting of drugs to the body.
System, Transdermal: a self-contained, discrete dosage form that is designed to deliver drug(s) through the intact skin to the systemic circulation.
System, Ocular: a dosage form intended for placement in the lower conjunctival fornix, from which the drug diffuses through a membrane at a constant rate.
System, Intrauterine: a system that is intended for release of drug over a long period, such as a year.
Tablet: a solid dosage form containing medicinal substance(s) with or without diluents.
Tablet, Chewable: a tablet formulated so that it may be chewed, producing a pleasant-tasting residue that is easily swallowed and does not leave a bitter or unpleasant aftertaste.
Tablet, Delayed-release: a tablet with a coating that is intended to postpone the release of the medication until the tablet has passed through the stomach.
Tablet, Effervescent: a solid dosage form containing mixtures of acids and sodium bicarbonate which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.
Tablet, Extended-release: a tablet that is formulated so as to make the contained medication available over an extended period following ingestion.
Tablet, Orally Disintegrating: a solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Targeted Release: release of the active ingredient from a dosage form modified to preferentially deliver most of the drug to a specific region, organ, or tissue.
Terminal Sterilization: a process used to produce sterility in the final product contained in its final packaging system.
Tincture: an alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances.
Transdermal Delivery System, Electroporation: a transdermal delivery system enhanced by the application of short, high-voltage electric pulses to create aqueous pores in the lipid bilayer of the skin and thereby facilitate drug diffusion.
Transdermal Delivery System, High-Velocity Powder Particles: a transdermal drug delivery system using supersonic shock waves of helium gas to enhance drug diffusion through the skin.
Transdermal Delivery System, Iontophoresis: a transdermal drug delivery system enhanced by the use of applied electric current to facilitate drug diffusion through the skin.
Transdermal Delivery System, Phonophoresis: a transdermal drug delivery system enhanced by the application of low-frequency ultrasound to facilitate drug diffusion through the skin.
Transdermal Matrix Patch: a transdermal matrix system using a polymeric matrix containing drug intended for systemic delivery through the skin; generally the skin is the rate-controlling membrane for drug diffusion.
Transdermal Membrane Patch: a transdermal system containing a drug reservoir entrapped between backing and adhesive layers and a drug diffusion–controlling membrane; the reservoir is usually a semisolid dispersion or solution of the drug.
Urethral: a dosage form intended for insertion into the urethra to provide a local effect of the active ingredient.
Validation: scientific study to prove that a process is doing what it is supposed to do and is under control.
Wafer: a thin slice of a material containing a medicinal agent.
Water, Aromatic: a clear, saturated aqueous solution (unless otherwise specified) of one or more volatile oils or other aromatic or volatile substances.
Created by: purple_amethyst