Dosage Forms
Course Practicum in Health Science - Pharmacology Unit VI Multi-Competent Health Care Worker Essential QuestionWhat are the three divisions of dosage forms? TEKS 130.205 (c) 1A, 3A, 3D, 7A Prior Student Learning none Estimated time 1-2 hours 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.
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 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
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
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
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 pre-measured 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
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 three-dimensional 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
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.
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 _____ 9. solution _____ 2. slow release tablet _____ 10. elixir _____ 3. caplet _____ 11. syrup _____ 4. lozenge _____ 12. tincture _____ 5. capsule _____ 13. suspension _____ 6. powder _____ 14. emulsion _____ 7. cream _____ 15. lotion _____ 8. ointment _____ 16. gel _____
A. has indented lines that facilitate dividing into two equal parts, sometimes three of four parts
B. 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 C. coated tablets in form of capsules; elongated form and coating makes easier to swallow
for some
D. solution of alcohol and water base; usually applied topically
E. concentrated solution of sugar, water, and flavoring; does not contain alcohol F. designed to promote continuous, sustained release of a certain drug over time
G. tablets formed of hardened base of sugar and water containing drug and other flavors H. contains fine, undissolved particles of drug suspended in liquid base
I. solid base of glycerin or cocoa butter containing the drug
J. semisolid emulsion of oil and water, the main ingredient being water K. semisolid emulsion of oil and water, the main ingredient being oil L. topically applied suspension of active drug in watery base
M. 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
N. drug that can be implanted in the body for sustained release of drug into surrounding tissue
O. solution containing alcohol and water base, added sugar, and flavoring
P. never needs mixing as drug-to-water concentration remains the same in every part, even after prolonged standing
Q. suspension of fat particles in watery base
R. designed to dissolve in water before taking orally to facilitate administration S. finely ground form of an active drug
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 A 2 F 3 C 4 G 5 M 6 S 7 J 8 K 9 P 10 O 11 E 12 D 13 H 14 Q 15 L 16 T
Dosage Forms
NAME DEFINITION SHORT NAME
AEROSOL A product that is packaged under pressure and 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).
AER
AEROSOL, FOAM A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous 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-in-oil type), a spray or a quick-breaking foam is discharged.
AER FOAM
AEROSOL, METERED A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
AER MET
AEROSOL, POWDER A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon
activation of an appropriate valve system.
AER PWD
AEROSOL, SPRAY An aerosol product which utilizes a compressed 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.
AER SPRAY
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.
CAPSULE A solid oral dosage form consisting of a shell and 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.
CAP
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. Enteric-coated articles are delayed release dosage forms.
CAP DR
CAPSULE, DELAYED RELEASE 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 enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
CAP DR PELLETS
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, EXTENDED RELEASE
A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, 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.
CAP FILM COATED ER
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
enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a
somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
CAP LIQ FILLED
CEMENT A substance that serves to produce solid union between two surfaces.
CEMENT CLOTH A large piece of relatively flat, absorbent material
that contains a drug. It is typically used for applying medication or for cleansing.
CLOTH
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
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 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”.
CREAM AUG
CRYSTAL A naturally produced angular solid of definite 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.
CRYSTAL
CULTURE The propagation of microorganisms or of living tissue sells in special media conducive to their growth.
CULTURE
DIAPHRAGM A device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection.
DIAPHRAGM
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.
ELIXIR A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.
ELIXIR
EMULSION A dosage form consisting of a two-phase system 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.)
EMULSION
ENEMA A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
ENEMA EXTRACT A concentrated preparation of vegetable or
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.
EXTRACT
FIBER, EXTENDED RELEASE
A slender and elongated solid thread-like
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.
FIBER ER
FILM A thin layer or coating. FILM
FILM, EXTENDED RELEASE
A drug delivery system in the form of a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue.
FILM ER
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
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 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.
GLOBULE
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 enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines.
GRAN DR
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
capability to release gas, resulting in effervescence.
GRANULE, FOR SOLUTION
A small medicinal particle or grain made 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.
GRAN F/SOL
GRANULE, FOR SUSPENSION
A small medicinal particle or grain made 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.
GRAN F/SUSP
GRANULE, FOR SUSPENSION,
EXTENDED RELEASE
A small medicinal particle or grain made available in its more stable dry form, to be 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.
GRAN F/SUSP ER
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 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.
INHALANT
INJECTABLE, 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).
INJECTION A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
INJ
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 form a suspension 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).
INJ PWD F/SUSP ER 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.
INJ PWD LYO F/LS
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process 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. INJ PWD LYO F/SOL INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension
INJ PWD LYO F/SUSP
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).
INJ PWD LYO F/SUSPER
INJECTION, SOLUTION A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
INJ SOL
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.
INJ SOL CONC
INJECTION, SUSPENSION
A liquid preparation, suitable for injection, which 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 vice-versa.
INJ SUSP
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).
INJ SUSP ER
INJECTION, SUSPENSION, LIPOSOMAL
A liquid preparation, suitable for injection, which consists of an oil phase dispersed throughout an 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.
INJ SUSP LIPOS
INJECTION, SUSPENSION, SONICATED
A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not
soluble. In addition, the product is sonicated
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
non-encapsulated 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
non-encapsulated 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 effective conception.
IUD IRRIGANT A sterile solution intended to bathe or flush open
wounds or body cavities; they're used topically, never parenterally.
IRRIGANT
JELLY A class of gels, which are semisolid systems that 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.
JELLY
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,
alcoholic solutions of soap, or emulsions intended for external application.
LINIMENT
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
conventional dosage form.
LOTION An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
LOTION
LOTION, AUGMENTED A lotion dosage form that enhances drug 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 AUG
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.
LOTION SHAMPOO
LOZENGE A solid preparation containing one or more 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.
LOZENGE
MOUTHWASH An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
MOUTHWASH 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
OINTMENT, AUGMENTED An ointment dosage form that enhances drug 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".
OINTMENT AUG
PACKING A material, usually covered by or impregnated with a drug that is inserted into a body cavity or
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
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
PATCH, EXTENDED RELEASE
A drug delivery system in the form of a patch 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).
PATCH ER
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).
PATCH ER ELCON
PELLET A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
PELLET
PELLET, IMPLANTABLE A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by
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 the form of granules to which varying amounts of 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.
PELLETS COATED ER
PILL A small, round solid dosage form containing a medicinal agent intended for oral administration.
PILL PLASTER Substance intended for external application
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.
PLASTER
POULTICE A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency.
POULTICE
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.
RING A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects.
RING
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 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.
SOL CONC
SOLUTION, FOR SLUSH A solution for the preparation of an iced saline 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.
SOL F/SLUSH
SOLUTION, GEL FORMING / DROPS
A solution, which, after usually being
administered in a drop-wise fashion, forms a gel.
SOL GF DROPS
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
nasal-pharyngeal 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 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 drug-releasing, conventional solid dosage form).
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
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.
SWAB
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
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
(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.
TAB EFFRV
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 substances with or without suitable diluents and 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.
TAB FILM COATED ER
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-a-tablet, 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-a-tablet, 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
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 water-soluble sugar.
TAB SUGAR COATED
TAMPON A plug made of cotton, sponge, or oakum variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions.
TAMPON
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.
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
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 FILLEDCEMENT 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
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
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
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
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
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
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
