Acidifying
Agent
- Used in liquid preparations to provide acidic medium for product stability.
- Examples: acetic acid, citric acid, fumaric acid, hydrochloric acid, nitric acid
Alkanizing
Agent
- Used in liquid preparations to provide alkaline medium for product stability.
- Examples: ammonia solution, ammonium carbonate, diethanolamine, monoethanolamine, potassium hydroxide, sodium borate, sodium carbonate, sodium hydroxide, triethanolamine and trolamine
Adsorbent
- An agent capable of holding other molecules onto its surface by physical or chemical (chemisorption) means.
- Examples: powdered cellulose, activated charcoal
Aerosol
Propellant
- An agent responsible for developing the pressure within an aerosol container and expelling the product when the valve is opened.
- Examples: carbon dioxide, dichlorodifluoromethane, dichlorotetrafluoroethan, trichloromonofluoromethan
Air
Displacement
- An agent which is employed to displace air in a hermetically sealed container to enhance product stability.
- Examples: nitrogen
Antifungal
Preservative
- Used in liquid and semi-solid preparations to prevent the growth of fungi. The effectiveness of the parabens is usually enhanced when they are used in combination.
- Examples: benzoic acid, butylparaben, ethylparaben, methylparaben, propylparaben, sodium benzoate, sodium propionate
Antimicrobial
Preservative
- Used in liquid and semi-solid preparations to prevent the growth of microorganisms.
- Examples: benzalkonium chloride, benzethonium chloride, benzyl alcohol, cetylpyridinium chloride, chlorobutanol, phenol, phenylethyl alcohol, phenylmercuric nitrate, thimerosal
Antioxidant
- An agent which inhibits oxidation and thus is used to prevent the deterioration of preparations by the oxidative process.
- Examples: ascorbic acid, ascorbyl palmitate, butylated hydroxyanisole, butylated hydroxytoluene, hypophosphorous acid, monothioglycerol, propyl gallate, sodium ascorbate, sodium bisulfite, sodium formaldehyde sulfoxylate, sodium metabisulfite
Buffering
Agent
- Used to resist change in pH upon dilution or addition of acid or alkali
- Examples: potassium metaphosphate, potassium phosphate monobasic, sodium acetate, sodium citrate anhydrous and dihydrate
Chelating
Agent
- A substance that forms stable, water soluble complexes (chelates) with metals. Chelating agents are used in some liquid pharmaceuticals as stabilizers to complex heavy metals which might promote instability. In such use they are also called sequestering agents.
- Examples: edetate disodium, edetic acid
Colorant
- Used to impart color to liquid and solid (e.g., tablets and capsules) pharmaceutical preparations.
- Examples: FD&C Red No.3. FD&C Red No. 20, FD&C Yellow No. 6, FD&C Blued No. 2, D&C Green No. 5, D&C Orange No. 5, D&C Red No. 8, caramel, ferric oxide (red)
Clarifying
Agent
- Used as filtering aid because of adsorbent qualities.
- Examples: bentonite
Emulsifying
Agent
- Used to promote and maintain the dispersion of finely subdivided particles of a liquid in a vehicle in which it is immiscible. The end product may be a liquid emulsion or semi-solid emulsion (e.g., a cream)
- Examples: acacia, cetomacrogol, cetyl alcohol, glyceryl monostearate, sorbitan monooleate, polyoxyethylene 50 stearate
Encapsulating
Agent
- Used to form shells for the purpose of enclosing a drug substances or drug formulation for ease of administration.
- Examples: gelatin, cellulose acetate phthalate
Flavorant
- Used to impart a pleasant flavor and often odor to a pharmaceutical preparation. In addition to the natural flavorants listed, many synthetic flavorants are also used.
- Examples: anise oil, cinnamon oil, cocoa, menthol, orange oil, lemon oil, peppermint oil, vanillin
Humectant
- Used to prevent the drying out of preparations – particularly ointments and creams – due to the agent's ability to retain moisture.
- Examples: glycerin, propylene glycol, sorbitol
Levigating
Agent
- A liquid used as an intervening agent to reduce the particle size of a drug powder by grinding together, usually in a mortar.
- Examples: mineral oil, glycerin
Ointment
Base
- The semi-solid vehicle into which drug substances may be incorporated in preparing medicated ointments.
- Examples: lanolin, hydrophilic ointment, polyethylene glycol ointment, petrolatum, hydrophilic petrolatum, white ointment, yellow ointment, rose water ointment
Plasticizer
- Used as a component of film-coating solutions to enhance the spread of the coat over tablets, beads, and granules.
- Examples: diethyl phthalate, glycerin
Solvent
- An agent used to dissolve another pharmaceutic substance or a drug in the preparation of a solution. The solvent may be aqueous or nanaqueous (e.g., oleaginous). Cosolvents, such as water and alcohol (hydroalcoholic) and water and glycerin, may be used when needed. Solvents rendered sterile are used in certain preparations (e.g., injections).
- Examples: alcohol, corn oil, cottonseed oil, glycerin, isoproply alcohol, mineral oil, oleic acid, peanut oil, purified water, water for injection, sterile water for injection, sterile water for irrigation
Stiffening
Agent
- Used to increase the thickness or hardness of a pharmaceutical preparation, usually an ointment.
- Examples: cetyl alcohol, cetyl esters wax, microcrystalline wax, paraffin, stearyl alcohol, white wax, yellow wax
Suppository
Base
- Used as a vehicle into which drug substances are incorporated in the preparation of suppositories.
- Examples: cocoa butter, polyethylene glycols (mixture)
Surfactant
(surface active agent)
- Substances which absorb to surfaces or interfaces to reduce surface or interfacial tension. May be used as wetting agents, detergents or emulsifying agents.
- Examples: benzalkonium chloride, nonoxynol 10, oxtoxynol 9, polysorbate 80, sodium lauryl sulfate, sorbitan monopalmitate
Suspending
Agent
- A viscosity increasing agent used to reduce the rate of sedimentation of (drug) particles dispersed throughout a vehicle in which they are not soluble. The resultant suspensions may be formulated for use orally, parenterally, ophthalmically, topically, or by other routes.
- Examples: agar, bentonite, carbomer (e.g., Carbopol), carboxymethylcellulose sodium, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, kaolin, methycellulose, tragacanth, veegum
Sweetening
Agent
- Used to impart sweetness to a preparation.
- Examples: aspartame, dextrose, glycerin, mannitol, saccharin sodium, sorbitol, sucrose
Tablet
Antiadherents
- Agents which prevents the sticking of tablet formulation ingredients to punches and dies in a tableting machine during production.
- Magnesium stearate, talc
Tablet
Binders
- Substances used to cause adhesion of powder particles in tablet granulations.
- Examples: acacia, alginic acid, carboxymethylcellulose sodium, compressible sugar (e.g., NuTab), ethylcellulose, gelatin, liquid glucose methylcellulose, povidone, pregelatinized starch
Tablet
and Capsule Diluent
- Inert substances used as fillers to create the desired bulk, flow properties, and compression characteristics in the preparation of tablets and capsules.
- Examples: dibasic calcium phosphate, kaolin, lactose, mannitol, microcrystalline cellulose, powdered cellulose, precipitated calcium carbonate, sorbitol, starch
Tablet
Coating Agent
- Used to coat a formed tablet for the purpose of protecting against drug decomposition by atmospheric oxygen or humidity, to provide a desired release pattern for the drug substance after administration, to mask the taste or odor of the drug substance, or for aesthetic purposes. The coating may be of various types, including sugar-coating, film coating, or enteric coating. Sugar coating is water based and results in a thickened covering around a formed tablet. Sugar-coated tablets generally start to break up in the stomach. A film coat is a thin cover around a formed tablet or bead. Unless it is an enteric coat, the film coat will dissolve in the stomach. An enteric-coated tablet or bead will pass through stomach and break up in the intestines. Some coatings that are water-insoluble (e.g., ethylcellulose) may be used to coat tablets and beads to slow the release of drug as they pass through the gastrointestinal tract.
- Examples: sugar coating – liquid glucose, sucrose; film-coating – hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methycellulose (e.g., Methocel), ethylcellulose (e.g., Ethocel); enteric coating – cellulose acetat phthalate, shellac (35% in alcohol, “pharmaceutical glaze”)
Tablet
Direct Compression Excipient
- Used in direct compression tablet formulations.
- Examples: dibasic calcium phosphate (e.g., Ditab)
Tablet
Disintegrant
- Used in solid dosage forms to promote the disruption of the solid mass into smaller particles which are more readily dispersed or dissolved.
- Examples: alginic acid carboxymethylcellulose calcium, polacrilin potassium (e.g., Amberlite), microcrystalline cellulose (e.g., Avicel), sodium alginate, sodium starch glycollate, starch
Tablet
Glidant
- Agents used in tablet and capsule formulations to improve the flow properties of the powder mixture.
- Examples: colloidal silica, cornstarch, talc
Tablet
Lubricant
- Substances used in tablet formulations to reduce friction during tablet compression.
- Examples: calcium stearate, magnesium stearate, mineral oil, stearic acid, zinc stearate
Tablet/Capsule
Opaquant
- Used to render a capsule or a tablet coating opaque. May be used alone or in combination with a colorant.
- Examples: titanium dioxide
Tablet
Polishing Agent
- Used to impart an attractive sheen to coated tablets.
- Examples: carnauba wax, white wax
Tonicity
Agent
- Used to render a solution similar in osmotic characteristics to physiologic fluids. Ophthalmic, parenteral, and irrigation fluids are examples of preparations in which tonicity is a consideration.
- Examples: dextrose, sodium chloride
Vehicle
- A carrying agent for a drug substances. They are used in formulating a variety of liquid dosage for oral and parenteral administration. Generally, oral liquids are aqueous preparations (as syrups) or hydroalcoholic (as elixirs). Parenteral solutions for intravenous use are aqueous, whereas intramuscular injections may be aqueous or oleaginous.
- Examples: flavored/sweetened – acacia syrup, aromatic syrup, aromatic elixir, cherry syrup, cocoa syrup, orange syrup, syrup; oleaginous – corn oil, mineral oil, peanut oil, sesame oil; sterile – bacteriostatic sodium chloride injection, bacteriostatic water for injection
Viscosity
Increasing Agent
- Used to change the consistency of a preparation to render it 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.
- Examples: alginic acid, bentonite, carbomer, carboxymethylcellulose sodium, methylcellulose, povidone, sodium alginate, tragacanth
