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 continuous 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. Films are used in dients. They may be swallowed as such, dis- various routes of administration including as persed in food, or dissolved in water. Granules a means of oral administration of material in are frequently compacted into tablets or filled a rapidly dissolving form. The term may also into capsules, with or without additional be used as an attribute when applied to solid ingredients. oral dosage forms for taste masking, product Gum: a mucilaginous excretion from various identification, and aesthetic purposes. plants. A dosage form in which the base consists Fluidextract: a liquid preparation of a vegetable of a pliable material that, when chewed, releases drug containing alcohol as a solvent, preserva- the API into the oral cavity. tive, or both and so made that unless otherwise Gum, Chewing: a sweetened and flavored insolu- specified in an individual monograph, each ble plastic material that, when chewed, releas- milliliter contains the therapeutic constituents es a drug substance into the oral cavity. of 1 g of the standard drug. Gum, Resin: natural mixture of gum and resin, Foam: an emulsion packaged in a pressurized usually obtained as exudations from plants. aerosol container that has a fluffy, semisolid consistency when dispensed. An emulsion H dosage form containing dispersed gas bubbles. Hard-Shell Capsule: a type of capsule in which For Solution: a product, usually a solid, intended one or more APIs, with or without other ingre- for solution prior to administration. dients, are filled into a two-piece shell. For Suspension: a product, usually a solid, intended for suspension prior to administration. I Immediate-Release: descriptive term for a dosage G form in which no deliberate effort has been Gas: one of the states of matter having no definite made to modify the API release rate. In the shape or volume and occupying the entire con- case of capsules and tablets, the inclusion or tainer when confined. exclusion of a disintegrating agent is not inter- Gastro-Resistant: descriptive term for a solid dos- preted as a modification. age form in which a polymer coating has been Implant: see Pellet. A small sterile solid mass applied to prevent the release in the gastric consisting of a highly purified drug with or environment. without excipients made by compression or Gel: a semisolid system consisting of either a molding and put in place by injection or incision. suspension of small inorganic particles or large Infusion, Intramammary: a suspension of a drug organic molecules interpenetrated by a liquid. in a suitable oil vehicle; intended for veterinary It may contain suspended particles. It may use only. contain a gelling agent to promote stiffness. Inhalant: a special class of inhalations consisting Gel, Dentifrice: a combination of a dentifrice of a drug or combination of drugs that by vir- (formulation intended to clean and/or pol- tue of their high vapor pressure can be carried ish the teeth and which may contain certain by an air current into the nasal passage where additional agents) and a gel. It is used with they exert their effect; the container from a toothbrush for the purpose of cleaning and which the inhalant generally is administered is polishing the teeth. known as an inhaler.

0002064525.INDD 765 11/29/2013 4:59:38 PM 766 Appendix B

Inhalation: a route of administration for aerosols M characterized by dispersion of the API into the Modified-Release: a release pattern of the active airways during inspiration. ingredient from the dosage form that has been Injection, Liposomal: an injection, which either deliberately changed from that of the conven- consists of or forms liposomes (a lipid bilayer tional form. It includes accelerated release, vesicle usually composed of phospholipids, delayed release, extended release, pulsatile which is used to encapsulate an active drug release, and targeted release. substance). Molded Tablet: a tablet that has been formed by Injection: a preparation intended for parenteral dampening the ingredients and pressing them administration or for constituting or diluting into a mold, then removing and drying the a parenteral product prior to administration. resulting solid mass. A route of administration of a liquid or semi- Mouthwash: an aqueous solution used to rinse solid deposited into a body cavity, fluid, or the oral cavity. tissue by use of a needle. Insert: a specially formulated and shaped non- N encapsulated solid preparation intended to Nasal: route of administration (mucosal) charac- be placed into a nonrectal orifice of the body, terized by deposition in the nasal cavity for where drug is released, generally for localized local or systemic effect. effects. Intraocular: a route of administration to deliver a O sterile preparation within the eye. Ocular: route of administration indicating deposi- Intrauterine Device: a device inserted and left in tion of the API within the eye. the uterus to prevent effective conception. Oil: an unctuous, combustible substance that Irrigation: a sterile solution intended to bathe or is liquid, or easily liquefiable, on warming flush open wounds or body cavities. and is soluble in ether but insoluble in water. Such substances, depending on their origin, J are classified as animal, mineral, or vegetable Jelly: see Gel. oils. Ointment: a semisolid preparation intended for L external application to the skin or mucous Liniment: an alcoholic or oleaginous solution membrane. A semisolid dosage form, usually or emulsion applied by rubbing on the skin containing < 20% water and volatiles and more for treating pain and stiffness of underlying than 50% hydrocarbons, waxes, or polyols as musculature. the vehicle. This dosage form generally is for Liposomes: microvesicles composed of a bilayer external application to the skin or mucous and/or concentric series of multiple bilayers membranes. separated by aqueous compartments formed Ophthalmic: a route of administration character- by amphipathic molecules such as phos- ized by application of a sterile preparation to pholipids, which enclose a central aqueous the external parts of the eye. compartment. Ophthalmic Ointment: a sterile ointment intend- Lipstick: a waxy solid, usually colored cosmetic, ed for application to the eye. in stick form for the lips. Ophthalmic Preparation: drug in a dosage form Liquid: a dosage form consisting of a pure chem- intended to be applied to the eye. ical in its liquid state. This dosage form term Ophthalmic Solution: a sterile solution, essential- should not be applied to solutions. ly free from foreign particles, suitably prepared Lotion: a fluid emulsion applied to the surface and packaged for application to the eye. of the skin. See Solution or Suspension. The Ophthalmic Strip: a sterile single-use container term has also been applied to suspensions and or sterile impregnated paper strip containing solutions. the drug to be applied to the eye. Lozenge: a solid preparation that is intended to Ophthalmic Suspension: a sterile liquid prepa- dissolve or disintegrate slowly in the mouth. ration containing solid particles dispersed in Lyophilization: removal of water or other sol- a liquid vehicle intended for application to vent from a frozen solution by sublimation the eye. caused by a combination of temperature Orally Disintegrating: a descriptive term for and pressure differentials (also called freeze a solid oral dosage form that disintegrates drying). rapidly in the mouth prior to swallowing. The

0002064525.INDD 766 11/29/2013 4:59:38 PM Appendix B 767

API is generally intended for gastrointestinal Premix: a mixture of one or more drug substances delivery and/or absorption. with a suitable vehicle. Oropharyngeal: a route of administration charac- Prolonged-Release: see Extended-Release. terized by deposition of a preparation into the Pulsatile Release: a release pattern of the active oral cavity and/or pharyngeal region to exert ingredient from the dosage form modified to a local or systemic effect. release aliquots of the total dose at two or more Otic: a route of administration characterized by time intervals. deposition of a preparation into, or by way of, the ear. Also referred to as aural. R Otic Solution: a solution intended for instillation Radiopharmaceuticals: “radioactive pharmaceu- in the outer ear. ticals,” or substances labeled with radioisotope Otic Suspension: a liquid preparation containing and used for diagnostic imaging or therapy. micronized particles intended for instillation Each name specifies the substance, the isotope, in the outer ear. and the dosage form. Rectal: a route of administration (mucosal) char- P acterized by deposition into the rectum to Paste: a semisolid dosage form that contains one provide local or systemic effect. or more drug substances intended for topical Rinse: a solution used to cleanse by flushing. application. It generally contains a high concentration of solids (20% to 50%) and has a stiff S consistency. It is intended for application to the Salve: a thick ointment or cerate (a fat- or wax- skin, oral cavity, or mucous membranes. based preparation with a consistency between Pastille: an aromatic preparation, often with a an ointment and a plaster). pleasing flavor, usually intended to dissolve Semisolid: attribute of a material characterized in the mouth. by a reduced ability to flow or conform to its Patch: a drug delivery system that often contains container at room temperature. A semisolid an adhesive backing usually applied to an does not flow at low shear stress and generally external site on the body. Its ingredients either exhibits plastic flow behavior. passively diffuse from or are actively trans- Shampoo: a solution, emulsion, or suspension ported from some portion of the patch. used to clean the hair and scalp. Pellet: see Bead. A small solid dosage form of Soap: the alkali salt(s) of one or more fatty acids. uniform, often spherical, shape. Spherical pel- Soft Gel Capsule: a specific capsule type char- lets are sometimes referred to as beads. Pellets acterized by increased levels of plasticizers intended as implants must be sterile. (Also a producing a more pliable and thicker-walled solid granule or regular shape prepared by material than hard gelatin capsules. Soft gel compaction, molding, or granulation.) capsules are further distinguished because they Periodontal: descriptive term for a preparation that are single-piece sealed dosages. Frequently is applied around a tooth for localized action. used for delivering liquid compositions. Pill: a solid spherical dosage form usually pre- Solution: a liquid preparation that contains one pared by a wet massing technique. or more dissolved (molecularly dispersed) Plaster: a solid or semisolid mass supplied on a chemical substances in a suitable solvent or backing material and intended to provide pro- mixture of miscible solvents; it may be oral, longed contact with the skin. topical, otic, or ophthalmic. A clear, homog- Pledget: a small compress or tuft, usually of cot- enous liquid dosage form that contains one ton or cotton wool, used to apply disinfectant or more chemical substances dissolved in or medicament to the skin. a solvent or mixture of mutually miscible Poultice: a soft, moist mass of meal, herbs, seed, solvents. etc., usually applied hot on a cloth that consists Solution, Concentrate: a liquid preparation (i.e., a of gruel-like consistency. substance that flows readily in its natural state) Powder: an intimate mixture of dry, finely divid- that contains a drug dissolved in a suitable sol- ed drug and/or chemicals that may be intend- vent or mixture of mutually miscible solvents; ed for internal (oral) or external (topical) use. the drug has been strengthened by the evapo- Powder, Inhalation: a powder containing an API ration of its nonactive parts. for oral inhalation. The powder is used with a Spirit: an alcoholic or hydroalcoholic solution of device that aerosolizes and delivers an accu- volatile substances prepared usually by simple rately metered amount. solution or by admixture of the ingredients.

0002064525.INDD 767 11/29/2013 4:59:38 PM 768 Appendix B

Sponge: a porous, interlacing, absorbent material Tablet, Chewable: a tablet formulated so that it that contains a drug. It is typically used for may be chewed, producing a pleasant-tasting applying or introducing medication or for residue that is easily swallowed and does not cleansing. A sponge usually retains its shape. leave a bitter or unpleasant aftertaste. Spray: a liquid minutely divided as by a jet of air Tablet, Delayed-Release: a tablet with a coating or steam; used to facilitate application to the that is intended to postpone the release of the intended area medication until the tablet has passed through Stent, Drug-Eluting: a specialized form of implant the stomach. used for extended local delivery of the API to Tablet, Effervescent: a solid dosage form contain- the immediate location of stent placement. ing mixtures of acids and sodium bicarbonate, Sterile: completely lacking living (viable) micro- which release carbon dioxide when dissolved bial life. in water; it is intended to be dissolved or dis- Sterility: an acceptably high level of probability persed in water before administration. that a product processed in an aseptic system Tablet, Extended-Release: a tablet that is formu- does not contain viable microorganisms. lated so as to make the contained medication Stick: a slender, cylindrical dosage form of rigid available over an extended period following consistency. ingestion. Strip: see Tape, Medicated. Tablet, Orally Disintegrating: a solid dosage Sublingual: a route of administration (mucosal) form containing medicinal substances, which characterized by placement underneath the disintegrates rapidly, usually within a matter tongue and for release of the API for absorp- of seconds, when placed upon the tongue. tion in that region. Tape, Medicated: a dosage form or device com- Suppository: a solid dosage form in which one or posed of a woven fabric or synthetic material more APIs are dispersed in a suitable base and onto which an API is placed, usually with an molded or otherwise formed into a suitable adhesive on one or both sides to facilitate top- shape for insertion into the rectum to provide ical application. local or systemic effect. Targeted Release: release of the active ingredient Suspension: a liquid preparation that consists of from a dosage form modified to preferentially solid particles dispersed throughout a liquid deliver most of the drug to a specific region, phase in which the particles are not soluble; it organ, or tissue. may be oral, topical, otic, or ophthalmic. Terminal Sterilization: a process used to produce Swab: a small piece of relatively flat absorbent sterility in the final product contained in its material that contains a drug. A swab may also final packaging system. be attached to one end of a small stick. A swab Tincture: an alcoholic or hydroalcoholic solution is typically used for applying medication or prepared from vegetable materials or from for cleansing. chemical substances. Syrup: a solution containing a high concentration Topical: a route of administration characterized of sucrose or other sugars. See Solution. by application to the outer surface of the body. System, Intrauterine: a system that is intended Transdermal Delivery System, Electroporation: a for release of drug over a long period, such as transdermal delivery system enhanced by the a year. application of short, high-voltage electric puls- System: a dosage form developed to allow for uni- es to create aqueous pores in the lipid bilayer of form release or targeting of drugs to the body. the skin and thereby facilitate drug diffusion. System, Ocular: a dosage form intended for place- Transdermal Delivery System, High-Velocity ment in the lower conjunctival fornix, from Powder Particles: a transdermal drug deliv- which the drug diffuses through a membrane at ery system using supersonic shock waves of a constant rate. helium gas to enhance drug diffusion through System, Transdermal: a self-contained, discrete the skin. dosage form that is designed to deliver drug(s) Transdermal Delivery System, Iontophoresis: a through the intact skin to the systemic circu- transdermal drug delivery system enhanced lation. by the use of applied electric current to facilitate drug diffusion through the skin. T Transdermal Delivery System, Phonophoresis: a Tablet: a solid dosage form containing medicinal transdermal drug delivery system enhanced by substance(s) with or without diluents. the application of low-frequency ultrasound to

0002064525.INDD 768 11/29/2013 4:59:38 PM Appendix B 769

facilitate drug diffusion through the skin (also Vaginal Tablet or Insert: a vaginal insert prepared ultrasound, sonophoresis, ultrasonophoresis, by compression of powdered materials into ultraphonophoresis). a suitable shape; it can also be prepared by Transdermal Matrix Patch: a transdermal matrix encapsulation in soft gelatin. system using a polymeric matrix containing Validation: scientific study to prove that a process drug intended for systemic delivery through is doing what it is supposed to do and is under the skin; generally, the skin is the rate- control. controlling membrane for drug diffusion. Vehicle: a term commonly encountered that refers Transdermal Membrane Patch: a transdermal to a component for internal or external use system containing a drug reservoir entrapped that is used as a carrier or diluent in which between backing and adhesive layers and liquids, semisolids, or solids are dissolved or a drug diffusion-controlling membrane; the suspended. Examples include water, syrups, reservoir is usually a semisolid dispersion or elixirs, oleaginous liquids, solid and semisolid solution of the drug. carriers, and proprietary products. Troche: see Lozenge. Veterinary: descriptive term for dosage forms intended for nonhuman use. U Urethral: a dosage form intended for insertion W into the urethra to provide a local effect of the Wafer: a thin slice of a material containing a active ingredient. medicinal agent. Water, Aromatic: a clear, saturated aqueous solu- V tion (unless otherwise specified) of one or Vaginal: a route of administration (mucosal) char- more volatile oils or other aromatic or volatile acterized by deposition into the vagina. substances.

0002064525.INDD 769 11/29/2013 4:59:38 PM