Excipients list + drug terms-pharmaceutics Flashcards
Acidifying agent
Used in liquid preparations to provide an acidic medium for product stability
1) Citric acid
2) Acetic acid
3) Fumaric acid
Adsorbent
An agent capable of holding other molecules onto its surface by physical or chemical (chemisorption) means
1) Powdered cellulose
2) Activated charcoal
Alkalinizing agent
Used in liquid preparations to provide an alkaline medium for product stability
1) Ammonia solution
2) Ammonium carbonate
3) Diethanolamine
Aerosol propellant
Agent responsible for developing the pressure within an aerosol container and expelling the product when the valve is opened
1) Carbon dioxide
2) Dichlorodifluoromethane 3) Dichlorotetrafluoroethane
Air displacement
Agent employed to displace air in a hermetically sealed container to enhance product stability
1) Nitrogen
2) Carbon dioxide
Antifungal preservative
Used in liquid and semisolid preparations to prevent the growth of fungi. The effectiveness of parabens is usually enhanced by use in combination
1) Butylparaben
2) Ethylparaben
3) Methylparaben
Antimicrobial preservative
Used in liquid and semisolid preparations to prevent the growth of microorganisms
1) Benzalkonium chloride
Antioxidant
Used to prevent deterioration of preparations by oxidation
1) Ascorbic acid
2) Ascorbyl palmitate
3) Butylated hydroxyanisole
Buffering agent
Used to resist change in pH upon dilution or addition of acid or alkali
1) Potassium metaphosphate
2) Potassium phosphate,
monobasic
3) Sodium acetate
Chelating agent
A substance that forms stable water- soluble complexes (chelates) with metals; used in some liquid pharmaceuticals as stabilizers to complex heavy metals that might promote instability. In such use, they are also called sequestering agents
1) Edetic acid
2) Edetate disodium
Colorant
Used to impart color to liquid and solid (e.g., tablets and capsules) preparations
1) FD&C Red No.3
2) FD&C Red No. 20
3) FD&C Yellow No. 6
Clarifying agent
Used as a filtering aid for its adsorbent qualities
1) Bentonite
Emulsifying agent
Used to promote and maintain dispersion of finely subdivided particles of liquid in a vehicle in which it is immiscible. The end product may be a liquid emulsion or semisolid emulsion (e.g., a cream)
1) Acacia
2) Cetomacrogol
3) Cetyl alcohol
maintains dispersion of particles
Encapsulating agent
Used to form thin shells to enclose a drug for ease of administration
1) Gelatin
Flavorant
Used to impart a pleasant flavor and often odor to a preparation. In addition to the natural flavorants listed, many synthetic ones are used
1) Anise oil
2) Cinnamon oil
3) Cocoa
Humectant
Used to prevent drying of preparations, particularly ointments and creams
1) Glycerin
2) Propylene glycol
3) Sorbitol
Levigating agent
Liquid used as an intervening agent to reduce the particle size of a powder by grinding, usually in a mortar
1) Mineral oil
2) Glycerin
3) Propylene glycol
liquid used to reduce particle size
Ointment base
Semisolid vehicle for medicated ointments
1) Lanolin
2) Hydrophilic ointment
3) Polyethylene glycol
ointment
Plasticizer
Component of film-coating solutions to make film more pliable, enhance spread of coat over tablets, beads, and granules
1) Diethyl phthalate
2) Glycerin
Solvent
Used to dissolve another substance in preparation of a solution; may be aqueous or not (e.g., oleaginous). Cosolvents, such as water and alcohol (hydroalcoholic) and water and glycerin, may be used when needed. Sterile solvents are used in certain preparations (e.g., injections)
1) Alcohol
2) Corn oil
3) Cottonseed oil
used to dissolve another substance in
Stiffening agent
Used to increase the thickness or hardness of a preparation, usually an ointment
1) Cetyl alcohol
2) Cetyl esters wax
3) Microcrystalline wax
Suppository base
Vehicle for suppositories
1) Cocoa butter
2) Polyethylene glycols
(mixtures)
3) PEG 3350
Surfactant (surface active agent)
Substances that absorb to surfaces or interfaces to reduce surface or interfacial tension. May be used as wetting agents, detergents, or emulsifying agents
1) Benzalkonium chloride
2) Nonoxynol 10
3) Octoxynol 9
Suspending agent
Viscosity-increasing agent used to reduce sedimentation rate of particles in a vehicle in which they are not soluble; suspension may be formulated for oral, parenteral, ophthalmic, topical, or other route
1) Agar
2) Bentonite
3) Carbomer (e.g., Carbopol)
Sweetening agent
Used to impart sweetness to a preparation
1) Aspartame
2) Dextrose
3) Glycerin
Tablet anti adherents
Prevent tablet ingredients from sticking to punches and dies during production
1) Magnesium stearate
Tablet binders
Substances used to cause adhesion of powder particles in tablet granulations
1) Acacia
2) Alginic acid
3) Carboxymethylcellulose
sodium
binds powder particles in tablets
Tablet and capsule diluent
Inert filler to create desired bulk, flow properties, and compression characteristics of tablets and capsules
1) Dibasic calcium phosphate
2) Kaolin
3) Lactose
used to create desired bulk, flow and compression qualities of tabs and caps
Tablet coating agent
Used to coat a tablet to protect against decomposition by atmospheric oxygen or humidity, to provide a desired release pattern, to mask taste or odor, or for aesthetic purposes. The coating may be sugar, film, or thick covering around a tablet. Sugar-coated tablets generally start to break up in the stomach. The film forms a thin cover around a formed tablet or bead. Unless it is enteric, the film dissolves in the stomach. Enteric coating passes through the stomach to break up in the intestines. Some water-insoluble coatings (e.g., ethylcellulose) are used to slow the release of drugs in the gastrointestinal tract.
only definition :)
Sugar coating
1) Liquid glucose
2) Sucrose
Film coating
1) Hydroxyethyl cellulose
2) Hydroxypropyl cellulose
3) Hydroxypropyl
methylcellulose
Enteric coating
1) Cellulose acetate phthalate
2) Shellac (35% in alcohol,
pharmaceutical glaze)
Tablet direct compression excipient
Used in direct compression tablet formulations
1) Disbasic calcium phosphate (e.g., Ditab)
Tablet disintegrant
Used in solid forms to promote disruption of the mass into smaller particles more readily dispersed or dissolved
1) Alginic acid
2) Polacrilin potassium (e.g.,
Amberlite)
3) Sodium alginate
Tablet glidant
Used in tablet and capsule formulations to improve flow properties of the powder mixture
1) Colloidal silica
2) Cornstarch
3) Talc
Tablet lubricant
Used in tablet formulations to reduce friction during tablet compression
1) Calcium stearate
2) Magnesium stearate
3) Mineral oil
Tablet or capsule opaquant
Used to render a coating opaque. May be used alone or with a colorant
1) Titanium dioxide
Tablet polishing agent
Used to impart an attractive sheen to coated tablets
- so to shine tablets
1) Carnauba wax
2) White wax
Tonicity agent
Used to render solution similar in osmotic-dextrose characteristics to physiologic fluids, e.g., in ophthalmic, parenteral, and irrigation fluids
1) Sodium chloride
Vehicle
Carrying agent used in formulating a variety of liquids for oral and parenteral administration.
Generally, oral liquids are aqueous (e.g., syrups) or hydroalcoholic (e.g., elixirs). Solutions for intravenous use are aqueous, whereas intramuscular injections may be aqueous or oleaginous
definition only :)
Flavored, sweetened
1) Acacia syrup
2) Aromatic syrup
3) Aromatic elixir
Oleaginous
1) Corn oil
2) Mineral oil
3) Peanut oil
Sterile
1) Bacteriostatic sodium chloride injection
Viscosity-increasing agent
Used to render preparations more resistant to flow. Used in suspensions to deter sedimentation, in ophthalmic solutions to enhance contact time (e.g., methylcellulose), to thicken topical creams, etc.
1) Alginic acid
2) Bentonite
3) Carbomer
Batch
a specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture
1 set of products with unifrom quality and quantity
Batch wise control
the use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch
Certification
documented testimony by qualified authorities that a system qualifications, calibration, validation or revalidation has been performed appropriately and that the results are acceptable
Compliance
determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices
Component
any ingredient used in the manufacture of a drug product, including those that may be present in the finished product
Drug Product
a finished form that contains an active drug and active ingredients. the term may also include a form that does not contain an active ingredient
finsihed form of all the components
Active Ingredient or active pharmaceutical ingredient (API)
any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man or other animals.
Inactive ingredient
Any component other than the active ingredients in a drug product.
Lot
: A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number.
batch becomes a lot when assigned lot number
Lot number, control number, or batch number:
Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.
master record
Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product.
Quality assurance
Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately.
Quality audit
A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.
Quality control
The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference.
Quality control unit
An organizational element designated by a firm to be responsible for the duties relating to quality control.
Reprocessing
The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process.
Strength
The concentration of the drug substance per unit dose or volume.
Verified
Signed by a second individual or recorded by automated equipment.
Validation
Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do.
diethyl phthalate is which exicipient
plasticizer
