CHAPTER' 4 • PHAMACEU7CAL AND FO 'MUTATION CONSIDERATIONS 151

CPA EXAMP ES OF PHA MACEUT N ED EN S

INOREDIENT T¥'PE DEFINITION Example
Acidifying agent Used in liquid preparations to provide acidic Citric acid
medium for product stability Acetic acid
Fumaric acid
Hydrochloric acid
Nitric acid
Alkalinizing Used in liquid preparations to provide alkaline Ammonia solution
agent medium for product stability Ammonium carbonate
Diethanolamine
Monoethanolamide
Potassium hydroxide
Sodium bicarbonate
Sodium borate
Sodium carbonate
Sodium hydroxide
Trolamine
Adsorbent An agent capable of holding other molecules onto Powdered cellulose
its surface by physical or chemical (chemisorption) Activated charcoal
means
Aerosol Agent responsible for developing the pressure Carbon dioxide
propellant within an aerosol container and expelling the Dichlorodifluoromethane
product when the valve is opened Dichlorodifluoromethane
Trichloromonofluoromethane
Air displacement Agent employed to displace air in a hermetically Nitrogen
sealed container to enhance product stability Carbon dioxide
Antifungal Used in liquid and semisolid preparations to prevent Butylparaben
preservative growth of fungi. Effectiveness of parabens is usually Ethylparaben
enhanced by use in combination Methylparaben
Benzoic acid
Propylparaben
Sodium benzoate
Sodium propionate
Antimicrobial Used in liquid and semisolid preparations to prevent Benzalkonium chloride
preservative growth of microorganisms
Antioxidant Used to prevent deterioration of preparations by Ascorbic acid
oxidation 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 Potassium metaphosphate
addition of acid or alkali Potassium phosphate.
monobasic
Sodium acetate
Sodium citrate, anhydrous and
dihydrate
{Continued)
 CHAPTER 4 • PHAMACEU7CAL AND FORMULATION CONSIDERATIONS 155

CPA EXAMP ES OF PHA MACEUT N ED EN S C ued)

INOREDIENT TYPE DEFINITION EXAMPLES

Tablet glidant Used in tablet and capsule formulations to improve Colloidal silica
flow properties of the powder mixture Cornstarch
Talc
Tablet lubricant Used in tablet formulations to reduce friction during Calcium stearate
tablet compression Magnesium stearate
Mineral oil
Stearic acid
Zinc stearate
Tablet or capsule Used to render a coating opaque. May be used Titanium dioxide
alone or with a colorant
Tablet polishing Used to impart an attractive sheen to coated tablets Carnauba wax
agent Used to render solution similar in osmotic dextrose White wax
Tonicify agent characteristics to physiologic fluids, for example, in Sodium chloride
ophthalmic, parenteral. and irrigation fluids
Carrying agent used in formulating a variety of
Vehicle 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

Flavored. Acacia syrup

sweetened Aromatic syrup
Aromatic elixir
Cherry syrup
Cocoa syrup
Orange syrup
Syrup
Oleaginous Com oil
Mineral oil
Peanut oil
Sesame oil
Sterile Bacteriostatic sodium chloride
Used to render preparations more resistant to flow. injection
Used in suspensions to deter sedimentation, in Alginic acid
ophthalmic solutions to enhance contact time (e.g.. Bentonite
methylcellulose), to thicken topical creams, etc. Carbomer
Carboxymethylcellulose
Sodium
Methylcellulose
Povidone
Sodium alginate
Tragacanth

may or may not be present, it should be
qualified by words such as “or” or “may also
contain.” If an ingredient is a trade secret, it
may be omitted from the list if the list states
“and other ingredients.” If an ingredient is
only present in a trace amount and has no
functional or technical effect on the product,
it does not need to be listed unless it has been
shown to cause sensitivity reactions or aller-
gic responses.
154 SECTION II • DRUG DOSAGE FORM AND DRUG DELIVERY SYSTEM DESIGN

CPA EXAMP ES OF PHA MACEU N E EN S (C n nued)

INGREDIENT TYPE DEFINITION EXAMPLES

Tablet binders Substances used to cause adhesion of powder Acacia

particles in tablet granulation. Alginic acid
Carboxymethylcellulose
sodium
Compressible sugar
(e.g., Nu-Tab)
Ethyl cellulose
Gelatin
Liquid glucose
Methylcellulose
Povidone
Pregelatinized starch
Tablet and Inert filler to create desired bulk, flow properties, Dibasic calcium phosphate
capsule diluent and compression characteristics of tablets and Kaolin
capsules Lactose
Mannitol
Microcrystalline cellulose
Powdered cellulose
Precipitated calcium
carbonate
Sorbitol
Starch
Tablet-coating Used to coat a tablet to protect against
agent decomposition by atmospheric oxygen or humidity,
to provide a desired release pattern, to mask taste
or odor, or for aesthetic purposes. Coating may be
sugar, film, or thick covering around a tablet. Sugar-
coated tablets generally start to break up in the
stomach. Film forms a thin cover around a formed
tablet or bead. Unless it is enteric, film dissolves in
the stomach. Enteric coating passes through the
stomach to break up in the intestines. Some water-
insoluble coatings (e.g., ethyl cellulose) are used to
slow the release of drug in the gastrointestinal tract
Sugar coating Liquid glucose
Sucrose
Film coating Hydroxyethyl cellulose
Hydroxypropyl cellulose
Hydroxypropyl methylcellulose
Methylcellulose (e.g.,
Methocel)
Ethyl cellulose (e.g., Ethocel)
Enteric coating Cellulose acetate phthalate
Shellac (M9â in alcohol,
pharmaceutical glaze)
Tablet direct Used in direct compression tablet formulations Dibasic calcium phosphate
compression (e.g., Ditab)
excipient
Tablet Used in solid forms to promote disruption of the Alginic acid
disintegrant mass into smaller particles more readily dispersed Polacrilin potassium (e.g.,
or dissolved Amberlite)
Sodium alginate
Sodium starch glycolate
Starch
 CHAPTER' 4 • PHAMACEU7 L AND FO 'MUTATION CONSIDERATIONS 153

CPA EXAMP ES OF PHA MACEU N ED EN S (C n nued)

INGREDIENT TYPE DEFINITION EXAMPLES

Solvent Used to dissolve another substance in preparation Alcohol

of a solution: may be aqueous or not (e.g., Com oil
oleaginous). Cosolvents, such as water and alcohol Cottonseed oil
(hydroalcoholic) and water and glycerin, may be Glycerin
used when needed. Sterile solvents are used in isopropyl alcohol
certain preparations (e.g., injections) Mineral oil
Oleic acid
Peanut oil
Purified water
Water for injection
Sterile water for injection
Sterile water for irrigation
Stiffening agent Used to increase thickness or hardness of a Cetyl alcohol
preparation, usually an ointment Cetyl esters wax
Microcrystalline wax
Paraffin
Stearyl alcohol
White wax
Yellow wax
Suppository 6ose Vehicle for suppositories Cocoa butter
Polyethylene glycols (mixtures)
PEG 3350
Surfactant Substances that absorb to surfaces or interfaces to Benzalkonium chloride
surface active reduce surface or interfacial tension. May be used Nonoxynol 10
agent) as wetting agents, detergents, or emulsifying agents Octoxynol 9
Polysorbate 80
Sodium lauryl sulfate
Sorbitan monopalmitate
Suspending Viscosity-increasing agent used to reduce Agar
agent sedimentation rate of particles in a vehicle in which Bentonite
they are not soluble: suspension may be formulated Carbomer (e.g., Carbopol)
for oral, parenteral, ophthalmic, topical, or other Carboxymethylcellulose
route sodium
Hydroxyethyl cellulose
Hydroxypropyl cellulose
Hydroxypropyl
methylcellulose
Kaolin
Methylcellulose
Tragacanth
Veegum
Sweetening Used to import sweetness to a preparation Aspartame
agent Dextrose
Glycerin
Mannitol
Saccharin sodium
Sorbitol
Sucrose
Tablet Prevent tablet ingredients from sticking to punches Magnesium stearate
antiadherents and dies during production
(Continued)
152 SECTION II - DRUG DOSAGE FORM AND DRUG DELIVERY SYSTEM DESIGN

CPA EXAMP ES OF PHA MACEU N E EN S (C n nued)

INGREDIENT TYPE DEFINITION EXAMPLES
Chelating agent Substance that forms stable water-soluble Edetic acid
complexes (chelates) with metals: used in some Edetate disodium
liquid pharmaceuticals as stabilizers to complex
heavy metals that might promote instability. In such
use, they ore also called sequestering agents
colorant Used to import color to liquid and solid (e.g., tablets FD&C heel No. 3
and capsules) preparations FD&C heel No. 20
FD&C Yellow No. 6
FD&C Blue No. 2
D&C Green No. 5
D&C Orange No. 5
D&C bed No. 8
Caramel
Ferric oxide, red
Clarifying agent Use as a filtering aid for its adsorbent qualities Bentonite
Emulsifying Used to promote and maintain dispersion of finely Acocio
agent subdivided particles of liquid in a vehicle in which it Cetomocrogol
is immiscible. End product may be a liquid emulsion Ce1yl alcohol
or semisolid emulsion (e.g., a cream) Glyceryl monosteorote
Sorbitan monooleate
Polyoxyelhylene 50 steorote
Encapsulating Used to form thin shells to enclose a drug for ease Gelcrtin
agent of administration
Flavorant Used to import a pleasant flavor and often odor to Anise oil
a preparation. In addition to the natural flavorant Cinnamon oil
listed, many synthetic ones are used Cocoa
Menthol
Orange oil
Peppermint oil
Vanillin
Humectant Used to prevent drying of preparations, particularly Glycerin
ointments and creams Propylene glycol
Sorbitol
Levigating agent Liquid used as on intervening agent to reduce Ihe Mineral oil
particle size of a powder by grinding, usually in a Glycerin
mortar Propylene glycol
Ointment Dose Semisolid vehicle for medicated ointments Lanolin
Hydrophilic ointment
Polyethylene glycol ointment

Hydrophilic petrolatum
White ointment
Yellow ointment
Rose water ointment
Plasticizer Component of film-coating solutions to make film Diethyl phthalate
more pliable, enhance spread of coat over tablets, Glycerin
beads, and granules