Dosage Forms Course Practicum in Health Science Pharmacology Rationale The effectiveness of a pharmaceutical agent depends on its form and route of administration; therefore it is important to understand the various forms in which drugs are dispensed. Unit VI Multi-Competent Health Care Worker Objectives Upon completion of this lesson, the student will be able to: Differentiate between solid, semi-solid, and liquid dosage forms Name forms in which drugs are manufactured and their subcategories List examples of drugs for each dosage form Define the medical terms associated with drug forms Essential Question What are the three divisions of dosage forms? TEKS 130.205 (c) 1A, 3A, 3D, 7A Prior Student Learning none Estimated time 1-2 hours Engage With administration approval first, bring in different kinds of medicine samples or medicine from home that show the different types of dosage forms. You can bring in tablets, capsules, lozenges, hard shell, liquids, creams, or ointments. If you can’t bring them in you could print photos of them and show them to the class. Key Points I. Basically three divisions of dosage forms: solid, semisolid, liquid II. Solid dosage forms A. Tablet is the most commonly known dosage form. In prescription usually abbreviated as tab or tabs - contains active drug in dried powder form as well as binders and fillers to give the tablet bulk and ensure the proper size 1. Scored tablets have indented lines, usually dividing the tablet into two equal halves, sometime three or four parts 2. Enteric coated tablets have special coating designed to allow tablet to pass through acid in stomach and not dissolve until in alkaline environment of small intestine – this avoids irritating the stomach, e.g., Ecotrin vs. regular Aspirin 3. Slow-release tablets designed to provide continuous, sustained release of a certain drug over time B. Caplets – coated tablets in form of tablets; elongated shape may make it easier for some to swallow, as does the coating C. Lozenges – tablets formed from hardened base or sugar and water containing drug and other flavors; usually available in OTC medications such as Cepacol lozenges. They are designed to dissolve slowly in the mouth and release the drug topically to the Copyright © Texas Education Agency, 2013. All rights reserved. tissues of mouth and throat; they are not to be swallowed. D. Some tablets may be designed to dissolve in water before taking orally to facilitate administration; examples: Alka Seltzer, Klorvess effervescent tablets, etc. E. Capsule -- in prescription usually abbreviated as cap or caps, comes basically in two varieties 1. Soft gelatin shell manufactured in one piece with drug usually in liquid form inside the shell, e.g., fat-soluble vitamins A and E, Procardia (nifidepine), etc. 2. Hard shell manufactured in two pieces that fit together and hold the drug, either in powdered or granular form; may be separated and sprinkled over food F. Pellet/Bead -- a drug can be implanted in the body in form of pellet or bead for sustained release of the drug into surrounding tissues, e.g. Septopal – gentamycin beads on a surgical wire to be implanted into bone to treat chronic osteomyelitis after traumatic injury G. Suppository -- a solid base of glycerin or cocoa butter containing the drug 1. Manufactured in appropriate size for rectal and vaginal insertion a. vaginal suppositories most often used to treat vaginal infections but may also be used orally to treat yeast infections (Troche) b. rectal suppositories offer alternate route of administration for patients who are vomiting, e.g. Tylenol ( antipyretic and analgesic), Phenergan (antiemetic) 2. Available in pediatric and adult strength III. Semi-solid dosage forms -- dosage forms that are too soft in structure to qualify for solids but too thick to be considered liquid; while most creams and ointments are applied to the skin without exact measurement, nitroglycerin ointment (antianginal) is precisely measured in inches on specially marked applicator paper that is then taped to the patient’s skin A. Cream – a semisolid emulsion of oil, e.g. lanolin or petrolatum, and water, the main ingredient being water 1. Oil and water remain well mixed by adding emulsifying agents 2. A large number of topical drugs are manufactured in a cream base, e.g. hydrocortisone cream B. Ointment – a semisolid emulsion of oil and water, the main ingredient being oil 1. Many topical drugs are produced in ointment form 2. Specially formulated ophthalmic ointments are made to be Copyright © Texas Education Agency, 2013. All rights reserved. applied topically to the eye without causing irritation IV. Liquid dosage forms: come in solutions and suspensions. Generally described as either aqueous from the Latin meaning watery consistency or viscous designating a non-watery or thick liquid A. Solutions never need to be mixed as the drug-to-water concentration remains the same in every part of the solution, even after prolonged standing 1. Elixirs -- solutions that contain an alcohol and water base, added sugar and flavorings; commonly used for pediatric and elderly patients who have difficulty swallowing tablets or capsules 2. Syrups -- do not contain alcohol and are concentrated solutions of sugar, water, and flavorings. They are sweeter and more viscous than elixirs. Most OTC cough medications are syrup based and don’t only carry the drug but also act to soothe the inflamed mucous membranes of the throat 3. Tinctures -- solutions that have an alcohol and water base and are applied topically, e.g. tincture of iodine 4. Liquid sprays -- solutions of a drug combined with water or alcohol a. Sprayed by pump or aerosol propellant b. Commonly used for topical application 5. Foams -- another form of liquid medication propelled by spraying, e.g., Proctofoam B. Suspensions -- contain fine, undissolved particles of drug suspended in a liquid base. These particles will settle to the bottom of the container after prolonged standing, making it necessary to shake the suspension well before use to evenly distribute the drug particles. This should be noted on an auxiliary label on the bottle, e.g., antacids 1. Emulsion -- a suspension of fat particles in a watery base, e.g., intralipid intravenous fat solution 2. Lotion -- topically applied suspension of an active drug in a water base, usually some skin-moisturizing agent added, e.g., Keri lotion; sometimes may be without moisturizer, e.g., Calamine lotion 3. Gel -- a suspension in which the drug particles are suspended in a thickened water medium, e.g., MetroGel for acne rosacea V. Other Forms A. Ophthalmic – sterile preparations for use in the eye 1. Ointment 2. Solution 3. Suspension Copyright © Texas Education Agency, 2013. All rights reserved. B. Otic – sterile preparation for use in the ear 1. Solution 2. Suspension C. Nasal – preparation for use in the nose or on the nostril. 1. Ointment 2. Solution – nose drops 3. Aerosol – nasal spray, pressurized container, or manual pump; for local use in the nose or system absorption through the nasal membrane; not to be inhaled into the lungs D. Respiratory -- administered into the respiratory tract 1. Metered Dose Inhaler (MDI) pressurized container 2. Powder inhaler – mechanical system for inhaling very fine powders for local effect in the lungs 3. Nebulizer -- changes liquid medicine into fine droplets (in aerosol or mist form) that are inhaled through a mouthpiece or mask E. Vaginal 1. Suppository 2. Medicated douche – contains a drug for local effect 3. Vaginal Ring/Cervical ring – non-biodegradable ring containing drug to be placed in the vagina F. Rectal 1. Suppository 2. Medicated enema – contains a drug for local or systemic effect G. Powder/granule – a finely ground form of an active drug 1. Can be contained in capsules for oral administration 2. Can be used for topical application 3. Can be found in glass vials as dried form of the drug where it must be reconstituted by adding sterile water or sterile NaCL for purpose of injection, e.g., i.v. ampicillin may come premeasured in package and needs to be reconstituted with water before oral administration H. Injectable – drug in a water or oil solution for injection through the skin into the muscle (IM), vein (IV), or subcutaneous tissue I. Implant – non-biodegradable drug reservoir implanted beneath the skin for systemic absorption Activity I. Survey home medicine cabinet and local drug store to identify different dosage forms of pharmaceuticals. Students will need to list at least 10 OTC drugs from their home medicine cabinet or will need to go to their local drug store and identify all available dosage forms for each. Have Copyright © Texas Education Agency, 2013. All rights reserved. students collect information on each drug like, drug name(s), dosage form, number of capsules, dosage, uses, active ingredient, etc. II. Complete Dosage Forms Vocabulary III. Design posters depicting various dosage forms or create threedimensional models. Assessment Dosage Forms Materials Dosage Forms Definitions Examples of drug forms Drug references, e.g., PDR, etc. Dosage Forms Key Teachers Note Pharmacy may give samples; close supervision of students! Accommodations for Learning Differences For reinforcement, the student will create a poster depicting pictures of drug forms and why a physician would order one form versus the other. For enrichment, the student will discuss in small groups (3-4) the advantages and disadvantages of each dosage form considering the perspective of the prescriber, e.g., physician, dispenser, e.g., pharmacist, administrator, e.g., nurse, and consumer, e.g., patient and then create an informative pamphlet for the consumer describing the results of the discussion. National and State Education Standards HLC 10.01 Technical Skills Healthcare workers will apply technical skills required for all career specialties. They will demonstrate skills and knowledge as appropriate. TEKS 130.205(c)(1)(A) interpret data from various sources in formulating conclusions 130.205 (c)(3)(A) demonstrate proficiency in medical terminology and skills related to the health care of an individual 130.205 (c)(3)(D) develop new problem-solving strategies based on previous knowledge and skills 130.205 (c)(7)(A) Interpret knowledge and skills that are transferable among health science professions Texas College and Career Readiness Standards Copyright © Texas Education Agency, 2013. All rights reserved. English Language Arts II. B. Understand new vocabulary and concepts and use them accurately in reading writing and speaking. III. B. Develop effective speaking styles for both group and one on one situations. IV. A. Apply listening skills as an individual and as a member of a group in a variety of settings. Copyright © Texas Education Agency, 2013. All rights reserved. NAME: DATE: Dosage Forms 1. The three basic divisions of dosage forms are: _____________________ _____________________ _____________________ 2. Complete the sentence: The purpose of enteric coating on tablets is _____________________________________________________________________________ 3. Match the following (not all apply): 1. scored tablet _____ 2. slow release tablet _____ 3. caplet _____ 4. lozenge _____ 5. capsule _____ 6. powder _____ 7. cream _____ 8. ointment _____ A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T. 9. solution 10. elixir 11. syrup 12. tincture 13. suspension 14. emulsion 15. lotion 16. gel _____ _____ _____ _____ _____ _____ _____ _____ has indented lines that facilitate dividing into two equal parts, sometimes three of four parts has special coating designed to allow tablet to pass through acid in stomach and not dissolve until in alkaline environment of small intestines; avoids irritating the stomach coated tablets in form of capsules; elongated form and coating makes easier to swallow for some solution of alcohol and water base; usually applied topically concentrated solution of sugar, water, and flavoring; does not contain alcohol designed to promote continuous, sustained release of a certain drug over time tablets formed of hardened base of sugar and water containing drug and other flavors contains fine, undissolved particles of drug suspended in liquid base solid base of glycerin or cocoa butter containing the drug semisolid emulsion of oil and water, the main ingredient being water semisolid emulsion of oil and water, the main ingredient being oil topically applied suspension of active drug in watery base comes in two varieties: soft gelatin shell in one piece with drug usually in liquid form, and hard shell in two pieces with drug in either granular or powdered form drug that can be implanted in the body for sustained release of drug into surrounding tissue solution containing alcohol and water base, added sugar, and flavoring never needs mixing as drug-to-water concentration remains the same in every part, even after prolonged standing suspension of fat particles in watery base designed to dissolve in water before taking orally to facilitate administration finely ground form of an active drug suspension in which drug particles are suspended in thickened water medium Copyright © Texas Education Agency, 2013. All rights reserved. Dosage Forms -- Key 1. solid semisolid liquid 2. to allow the tablet to pass through acid in stomach and not dissolve until in alkaline environment of small intestine; this avoids irritating the stomach 3. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 A F C G M S J K P O E D H Q L T Copyright © Texas Education Agency, 2013. All rights reserved. Dosage Forms NAME DEFINITION SHORT NAME AEROSOL A product that is packaged under pressure and AER contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). AEROSOL, FOAM A dosage form containing one or more active AER FOAM ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; 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-inoil type), a spray or a quick-breaking foam is discharged. AEROSOL, METERED A pressurized dosage form consisting of metered AER MET dose valves which allow for the delivery of a uniform quantity of spray upon each activation. AEROSOL, POWDER A product that is packaged under pressure and AER PWD contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system. AEROSOL, SPRAY An aerosol product which utilizes a compressed AER SPRAY gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents. BAR, CHEWABLE A solid dosage form usually in the form of a rectangle that is meant to be chewed. BAR CHEW BEAD A solid dosage form in the shape of a small ball. BEAD BEAD, IMPLANT, EXTENDED RELEASE A small sterile solid mass consisting of a highly purified drug intended for implantation in the body which would allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. BEAD IMP ER BLOCK Solid dosage form, usually in the shape of a square or rectangle. BLOCK Copyright © Texas Education Agency, 2013. All rights reserved. CAPSULE A solid oral dosage form consisting of a shell and CAP a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed. CAPSULE, 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; additionally, the capsule is covered in a designated coating. CAP COATED CAPSULE, COATED PELLETS 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; the drug itself is in the form of granules to which varying amounts of coating have been applied. CAP COATED PELLETS CAPSULE, 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 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. CAP COATED ER CAPSULE, DELAYED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, which releases a drug (or drugs) at a time other than promptly after administration. Entericcoated articles are delayed release dosage forms. CAP DR CAPSULE, DELAYED RELEASE PELLETS A solid dosage form in which the drug is CAP DR enclosed within either a hard or soft soluble PELLETS container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. Copyright © Texas Education Agency, 2013. All rights reserved. CAPSULE, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. CAP ER CAPSULE, FILM COATED, A solid dosage form in which the drug is CAP FILM EXTENDED RELEASE enclosed within either a hard or soft soluble COATED ER container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and 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 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. CAP GELATIN COATED CAPSULE, LIQUID FILLED A solid dosage form in which the drug is CAP LIQ enclosed within a soluble, gelatin shell which is FILLED 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. CEMENT A substance that serves to produce solid union between two surfaces. CLOTH A large piece of relatively flat, absorbent material CLOTH that contains a drug. It is typically used for applying medication or for cleansing. CONCENTRATE A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration. CONC CONE A solid dosage form bounded by a circular base and the surface formed by line segments joining every point of the boundary of the base to a common vertex. A cone (usually containing antibiotics) is normally placed below the gingiva CONE Copyright © Texas Education Agency, 2013. All rights reserved. CEMENT after a dental extraction. CORE, EXTENDED RELEASE An ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period. CORE ER CREAM An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. CREAM CREAM, AUGMENTED A cream dosage form that enhances drug CREAM AUG delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented”. CRYSTAL A naturally produced angular solid of definite CRYSTAL form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. CULTURE The propagation of microorganisms or of living tissue sells in special media conducive to their growth. DIAPHRAGM A device usually dome-shaped, worn during DIAPHRAGM copulation over the cervical mouth for prevention of conception or infection. DISC A circular plate-like organ or structure. DISC DOUCHE A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents. DOUCHE DRESSING The application of various materials for protecting a wound. DRESSING DRUG DELIVERY SYSTEM 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. DDS Copyright © Texas Education Agency, 2013. All rights reserved. CULTURE ELIXIR A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. EMULSION A dosage form consisting of a two-phase system EMULSION comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.) ENEMA A rectal preparation for therapeutic, diagnostic, or nutritive purposes. EXTRACT A concentrated preparation of vegetable or EXTRACT animal drugs obtained by removal of the active constituents of the respective drugs with a suitable menstrua, evaporation of all or nearly all of the solvent, and adjustment of the residual masses or powders to the prescribed standards. FIBER, EXTENDED RELEASE A slender and elongated solid thread-like FIBER ER substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. FILM A thin layer or coating. FILM, EXTENDED RELEASE A drug delivery system in the form of a film that FILM ER releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue. FILM, SOLUBLE A thin layer or coating which is susceptible to being dissolved when in contact with a liquid. FILM SOLUBLE FOR SOLUTION A product, usually a solid, intended for solution prior to administration. FOR SOL FOR SUSPENSION A product, usually a solid, intended for suspension prior to administration. FOR SUSP FOR SUSPENSION, EXTENDED RELEASE A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified FOR SUSP ER Copyright © Texas Education Agency, 2013. All rights reserved. ELIXIR ENEMA FILM period. GAS Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths. GAS GEL A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles. GEL GEL, DENTIFRICE A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth. GEL DENT GEL, METERED A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. GEL MET GENERATOR An apparatus for the formation of vapor or gas from a liquid or solid by heat or chemical action. The term GENERATOR also applies to radioactive columns from which radionuclides are provided. GENERATOR GLOBULE Also called pellets or pilules, are made of pure GLOBULE sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade. GRAFT A slip of skin or of other tissue for implantation. GRAFT GRANULE A small particle or grain. GRAN GRANULE, DELAYED RELEASE A small medicinal particle or grain to which an GRAN DR enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines. GRANULE, EFFERVESCENT A small particle or grain containing a medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the Copyright © Texas Education Agency, 2013. All rights reserved. GRAN EFFRV capability to release gas, resulting in effervescence. GRANULE, FOR SOLUTION A small medicinal particle or grain made GRAN F/SOL available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutical ingredient. GRANULE, FOR SUSPENSION A small medicinal particle or grain made GRAN F/SUSP available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutical ingredient. GRANULE, FOR SUSPENSION, EXTENDED RELEASE A small medicinal particle or grain made GRAN F/SUSP available in its more stable dry form, to be ER reconstituted with solvent just before dispensing to form a suspension; the extended release system achieves slow release of the drug over an extended period of time and maintains constant drug levels in the blood or target tissue. GUM A mucilaginous excretion from various plants. GUM GUM, CHEWING A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity. GUM CHEWING GUM, RESIN Natural mixture of gum and resin, usually obtained as exudations from plants. GUM RESIN IMPLANT A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union. IMP INHALANT A special class of inhalations consisting of a drug INHALANT or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler. INJECTABLE, LIPOSOMAL An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually Copyright © Texas Education Agency, 2013. All rights reserved. INJ LIPOS composed of phospholipids which is used to encapsulate an active drug substance). INJECTION A sterile preparation intended for parenteral use; INJ five distinct classes of injections exist as defined by the USP. INJECTION, EMULSION An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally. INJ EMULSION INJECTION, LIPID COMPLEX [definition pending] INJ LIPID COMPLEX INJECTION, POWDER, FOR SOLUTION A sterile preparation intended for reconstitution to form a solution for parenteral use. INJ PWD F/SOL INJECTION, POWDER, FOR SUSPENSION A sterile preparation intended for reconstitution to form a suspension for parenteral use. INJ PWD F/SUSP INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE A dried preparation intended for reconstitution to INJ PWD form a suspension for parenteral use which has F/SUSP ER been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner that would allow liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) to be formed upon reconstitution. INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION A dosage form intended for the solution prepared INJ PWD LYO by lyophilization ("freeze drying"), a process F/SOL which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections. INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION A liquid preparation, intended for parenteral use INJ PWD LYO that contains solids suspended in a suitable fluid F/SUSP medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension Copyright © Texas Education Agency, 2013. All rights reserved. INJ PWD LYO F/LS are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). INJECTION, SOLUTION A liquid preparation containing one or more drug INJ SOL substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection. INJECTION, SOLUTION, CONCENTRATE A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections. INJECTION, SUSPENSION A liquid preparation, suitable for injection, which INJ SUSP consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or viceversa. INJECTION, SUSPENSION, EXTENDED RELEASE A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). INJECTION, SUSPENSION, LIPOSOMAL A liquid preparation, suitable for injection, which INJ SUSP consists of an oil phase dispersed throughout an LIPOS aqueous phase in such a manner that liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) are formed. INJECTION, SUSPENSION, SONICATED A liquid preparation, suitable for injection, which INJ SUSP SON consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. In addition, the product is sonicated Copyright © Texas Education Agency, 2013. All rights reserved. INJ PWD LYO F/SUSPER INJ SOL CONC INJ SUSP ER while a gas is bubbled through the suspension, and this results in the formation of microspheres by the solid particles. INSERT A specially formulated and shaped nonencapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects. INSERT INSERT, EXTENDED RELEASE A specially formulated and shaped nonencapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where the medication is released, generally for localized effects; the extended release preparation is designed to allow for a reduction in dosing frequency. INSERT ER INTRAUTERINE DEVICE A device inserted and left in the uterus to prevent IUD effective conception. IRRIGANT A sterile solution intended to bathe or flush open IRRIGANT wounds or body cavities; they're used topically, never parenterally. JELLY A class of gels, which are semisolid systems that JELLY consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water. KIT A packaged collection of related material. KIT LINER, DENTAL A material applied to the inside of the dental cavity, for protection or insulation of the surface. LINER DENTAL LINIMENT A solution or mixture of various substances in oil, LINIMENT alcoholic solutions of soap, or emulsions intended for external application. LIPSTICK A waxy solid, usually colored cosmetic, in stick form for the lips. LIPSTICK LIQUID A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions. LIQ LIQUID, EXTENDED RELEASE A liquid that delivers a drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a LIQ ER Copyright © Texas Education Agency, 2013. All rights reserved. conventional dosage form. LOTION An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2 LOTION, AUGMENTED A lotion dosage form that enhances drug LOTION AUG delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented". LOTION/SHAMPOO A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. LOZENGE A solid preparation containing one or more LOZENGE medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick. MOUTHWASH An aqueous solution which is most often used for MOUTHWASH its deodorant, refreshing, or antiseptic effect. OIL An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. OIL OINTMENT A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. OINTMENT LOTION LOTION SHAMPOO OINTMENT, AUGMENTED An ointment dosage form that enhances drug OINTMENT delivery. Augmentation does not refer to the AUG strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented". PACKING A material, usually covered by or impregnated with a drug that is inserted into a body cavity or Copyright © Texas Education Agency, 2013. All rights reserved. PACKING between the tooth enamel and the gingival margin. PASTE A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes. PASTE PASTE, DENTIFRICE A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. PASTE DENT PASTILLE An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. PASTILLE PATCH A drug delivery system that often contains an PATCH adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’. PATCH, EXTENDED RELEASE A drug delivery system in the form of a patch that PATCH ER releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED A drug delivery system in the form of a patch which is controlled by an electric current that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). PELLET A small sterile solid mass consisting of a highly PELLET purified drug (with or without excipients) made by the formation of granules, or by compression and molding. PELLET, IMPLANTABLE A small sterile solid mass consisting of a highly PELLET IMP purified drug (with or without excipients) made by Copyright © Texas Education Agency, 2013. All rights reserved. PATCH ER ELCON the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. PELLETS, COATED, EXTENDED RELEASE A solid dosage form in which the drug itself is in PELLETS the form of granules to which varying amounts of COATED ER coating have been applied, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. PILL A small, round solid dosage form containing a medicinal agent intended for oral administration. PLASTER Substance intended for external application PLASTER made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. POULTICE A soft, moist mass of meal, herbs, seed, etc., POULTICE usually applied hot in cloth that consists of gruellike consistency. POWDER An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. PWD POWDER, DENTIFRICE A powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. PWD DENT POWDER, FOR SOLUTION An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution. PWD F/SOL POWDER, FOR SUSPENSION An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle). PWD F/SUSP POWDER, METERED A powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity. PWD MET Copyright © Texas Education Agency, 2013. All rights reserved. PILL RING A small circular object with a vacant circular RING center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. RINSE A liquid used to cleanse by flushing. RINSE SALVE A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster). SALVE SHAMPOO A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. SHAMPOO SHAMPOO, SUSPENSION A liquid soap or detergent containing one or more solid, insoluble substances dispersed in a liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. SHAMPOO SUSP SOAP Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic. SOAP SOLUTION A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. SOL SOLUTION, CONCENTRATE A liquid preparation (i.e., a substance that flows SOL CONC readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its non-active parts. SOLUTION, FOR SLUSH A solution for the preparation of an iced saline SOL F/SLUSH slush, which is administered by irrigation and used to induce regional hypothermia (in conditions such as certain open heart and kidney surgical procedures) by its direct application. SOLUTION, GEL FORMING / DROPS A solution, which, after usually being SOL GF administered in a drop-wise fashion, forms a gel. DROPS Copyright © Texas Education Agency, 2013. All rights reserved. SOLUTION, GEL FORMING, EXTENDED RELEASE A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency. SOL GF ER SOLUTION/ DROPS A solution which is usually administered in a drop-wise fashion. SOL DROPS SPONGE A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape. SPONGE SPRAY A liquid minutely divided as by a jet of air or steam. SPRAY SPRAY, METERED A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation. SPRAY MET SPRAY, SUSPENSION A liquid preparation containing solid particles dispersed in a liquid vehicle and in the form of coarse droplets or as finely divided solids to be applied locally, most usually to the nasalpharyngeal tract, or topically to the skin. SPRAY SUSP STICK A dosage form prepared in a relatively long and slender often cylindrical form. STICK STRIP A long narrow piece of material. STRIP SUPPOSITORY A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. SUPP SUPPOSITORY, EXTENDED RELEASE A drug delivery system in the form of a suppository that allows for a reduction in dosing frequency. SUPP ER SUSPENSION A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle. SUSP SUSPENSION, EXTENDED RELEASE A liquid preparation consisting of solid particles SUSP ER dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drugreleasing, conventional solid dosage form). Copyright © Texas Education Agency, 2013. All rights reserved. SUSPENSION/ DROPS A suspension which is usually administered in a drop-wise fashion. SUSP DROPS SUTURE A strand or fiber used to hold wound edges in apposition during healing. SUTURE SWAB A small piece of relatively flat absorbent material SWAB that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. SYRUP An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. SYRUP TABLET A solid dosage form containing medicinal substances with or without suitable diluents. TAB TABLET, CHEWABLE A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste. TAB CHEW TABLET, COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating. TAB COATED TABLET, COATED PARTICLES A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. TAB COATED PART TABLET, DELAYED RELEASE A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. TAB DR TABLET, DELAYED RELEASE PARTICLES A solid dosage form containing a conglomerate of medicinal particles that have been covered with a coating which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. TAB DR PARTICLES TABLET, DISPERSIBLE A tablet that, prior to administration, is intended to be placed in liquid, where its contents will be TAB DISP Copyright © Texas Education Agency, 2013. All rights reserved. distributed evenly throughout that liquid. Note: The term ‘tablet, dispersible’ is no longer used for approved drug products, and it has been replaced by the term ‘tablet, for suspension’. TABLET, EFFERVESCENT A solid dosage form containing mixtures of acids TAB EFFRV (e.g., citric acid, tartaric acid) 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 solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form. TAB ER TABLET, FILM COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer. TAB FILM COATED TABLET, FILM COATED, EXTENDED RELEASE A solid dosage form that contains medicinal TAB FILM substances with or without suitable diluents and COATED ER is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. TABLET, FOR SOLUTION A tablet that forms a solution when placed in a liquid. TAB FOR SOL TABLET, FOR SUSPENSION A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’). TAB FOR SUSP TABLET, MULTILAYER A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-atablet, the inner tablet being the core and the outer portion being the shell. TAB MULTILAYER TABLET, MULTILAYER, EXTENDED RELEASE A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-atablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a TAB MULTILAYER ER Copyright © Texas Education Agency, 2013. All rights reserved. reduction in dosing frequency as compared to that drug presented as a conventional dosage form. TABLET, ORALLY DISINTEGRATING A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. TAB ORALLY DIS TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. TAB ORALLY DIS DR TABLET, SOLUBLE A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids. TAB SOLUBLE TABLET, SUGAR COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored watersoluble sugar. TAB SUGAR COATED TAMPON A plug made of cotton, sponge, or oakum TAMPON variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions. TAPE A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides. TAPE TINCTURE An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances. TINCTURE TROCHE A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients. TROCHE WAFER A thin slice of material containing a medicinal agent. WAFER Footnotes: 1 A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. 2 Previously the definition of a lotion was “The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin.” The current definition of a lotion is restricted to an emulsion. Copyright © Texas Education Agency, 2013. All rights reserved. 3 A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. 4 A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 µm) are distributed uniformly throughout a liquid. 5 Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105°C until constant weight is achieved. Adapted from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements /ElectronicSubmissions/DataStandardsManualmonographs/ucm071666.htm accessed 5/30/13 Copyright © Texas Education Agency, 2013. All rights reserved. Dosage Forms Worksheet NAME DEFINITION AEROSOL AEROSOL, FOAM AEROSOL, METERED AEROSOL, POWDER AEROSOL, SPRAY BAR, CHEWABLE BEAD BEAD, IMPLANT, EXTENDED RELEASE BLOCK CAPSULE CAPSULE, COATED CAPSULE, COATED PELLETS CAPSULE, COATED, EXTENDED RELEASE CAPSULE, DELAYED RELEASE CAPSULE, DELAYED RELEASE PELLETS CAPSULE, EXTENDED RELEASE CAPSULE, FILM COATED, EXTENDED RELEASE CAPSULE, GELATIN COATED CAPSULE, LIQUID FILLED Copyright © Texas Education Agency, 2013. All rights reserved. CEMENT CLOTH CONCENTRATE CONE CORE, EXTENDED RELEASE CREAM CREAM, AUGMENTED CRYSTAL CULTURE DIAPHRAGM DISC DOUCHE DRESSING DRUG DELIVERY SYSTEM ELIXIR EMULSION ENEMA EXTRACT FIBER, EXTENDED RELEASE FILM FILM, EXTENDED RELEASE FILM, SOLUBLE FOR SOLUTION FOR SUSPENSION FOR SUSPENSION, EXTENDED RELEASE Copyright © Texas Education Agency, 2013. All rights reserved. GAS GEL GEL, DENTIFRICE GEL, METERED GENERATOR GLOBULE GRAFT GRANULE GRANULE, DELAYED RELEASE GRANULE, EFFERVESCENT GRANULE, FOR SOLUTION GRANULE, FOR SUSPENSION GRANULE, FOR SUSPENSION, EXTENDED RELEASE GUM GUM, CHEWING GUM, RESIN IMPLANT INHALANT INJECTABLE, LIPOSOMAL INJECTION INJECTION, EMULSION INJECTION, LIPID COMPLEX INJECTION, POWDER, FOR SOLUTION Copyright © Texas Education Agency, 2013. All rights reserved. INJECTION, POWDER, FOR SUSPENSION INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE INJECTION, SOLUTION INJECTION, SOLUTION, CONCENTRATE INJECTION, SUSPENSION INJECTION, SUSPENSION, EXTENDED RELEASE INJECTION, SUSPENSION, LIPOSOMAL INJECTION, SUSPENSION, SONICATED INSERT INSERT, EXTENDED RELEASE INTRAUTERINE DEVICE Copyright © Texas Education Agency, 2013. All rights reserved. IRRIGANT JELLY KIT LINER, DENTAL LINIMENT LIPSTICK LIQUID LIQUID, EXTENDED RELEASE LOTION LOTION, AUGMENTED LOTION/SHAMPOO LOZENGE MOUTHWASH OIL OINTMENT OINTMENT, AUGMENTED PACKING PASTE PASTE, DENTIFRICE PASTILLE PATCH PATCH, EXTENDED RELEASE PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED PELLET PELLET, IMPLANTABLE Copyright © Texas Education Agency, 2013. All rights reserved. PELLETS, COATED, EXTENDED RELEASE PILL PLASTER POULTICE POWDER POWDER, DENTIFRICE POWDER, FOR SOLUTION POWDER, FOR SUSPENSION POWDER, METERED RING RINSE SALVE SHAMPOO SHAMPOO, SUSPENSION SOAP SOLUTION SOLUTION, CONCENTRATE SOLUTION, FOR SLUSH SOLUTION, GEL FORMING / DROPS SOLUTION, GEL FORMING, EXTENDED RELEASE SOLUTION/ DROPS SPONGE SPRAY SPRAY, METERED Copyright © Texas Education Agency, 2013. All rights reserved. SPRAY, SUSPENSION STICK STRIP SUPPOSITORY SUPPOSITORY, EXTENDED RELEASE SUSPENSION SUSPENSION, EXTENDED RELEASE SUSPENSION/ DROPS SUTURE SWAB SYRUP TABLET TABLET, CHEWABLE TABLET, COATED TABLET, COATED PARTICLES TABLET, DELAYED RELEASE TABLET, DELAYED RELEASE PARTICLES TABLET, DISPERSIBLE TABLET, EFFERVESCENT TABLET, EXTENDED RELEASE TABLET, FILM COATED TABLET, FILM COATED, EXTENDED RELEASE TABLET, FOR SOLUTION Copyright © Texas Education Agency, 2013. All rights reserved. TABLET, FOR SUSPENSION TABLET, MULTILAYER TABLET, MULTILAYER, EXTENDED RELEASE TABLET, ORALLY DISINTEGRATING TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE TABLET, SOLUBLE TABLET, SUGAR COATED TAMPON TAPE TINCTURE TROCHE WAFER Copyright © Texas Education Agency, 2013. All rights reserved.