Excipients

151
Chapter 4 Pharmaceutical and Formulation Considerations
Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS

Ingredient Type
Definition
Examples
Acidifying agent
Used in liquid preparations to provide acidic

medium for product stability
Citric acid
Acetic acid
Fumaric acid
Hydrochloric acid
Nitric acid
Alkalinizing
agent
Used in liquid preparations to provide alkaline

medium for product stability
Ammonia solution
Ammonium carbonate
Diethanolamine
Monoethanolamine
Potassium hydroxide
Sodium bicarbonate
Sodium borate
Sodium carbonate
Sodium hydroxide
Trolamine
Adsorbent
An agent capable of holding other molecules onto

its surface by physical or chemical (chemisorption)
means
Powdered cellulose
Activated charcoal
Aerosol
propellant
Agent responsible for developing the pressure

within an aerosol container and expelling the
product when the valve is opened
Carbon dioxide
Dichlorodifluoromethane
Dichlorotetrafluoroethane
Trichloromonofluoromethane
Air displacement
Agent employed to displace air in a hermetically

sealed container to enhance product stability
Nitrogen
Carbon dioxide
Antifungal
preservative
Used in liquid and semisolid preparations to prevent

growth of fungi. Effectiveness of parabens is usually
enhanced by use in combination
Butylparaben
Ethylparaben
Methylparaben
Benzoic acid
Propylparaben
Sodium benzoate
Sodium propionate
Antimicrobial
preservative
Used in liquid and semisolid preparations to prevent

growth of microorganisms
Benzalkonium chloride
Antioxidant
Used to prevent deterioration of preparations by

oxidation
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
Potassium metaphosphate
Potassium phosphate,
monobasic
Sodium acetate
Sodium citrate, anhydrous and
dihydrate
(Continued)
0002035883.INDD 151
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152
SECTION II Drug Dosage Form and Drug Delivery System Design
Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS (Continued)

Ingredient Type
Definition
Examples
Chelating agent
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
Edetic acid
Edetate disodium
Colorant
Used to impart color to liquid and solid (e.g., tablets

and capsules) preparations
FD&C Red No. 3

FD&C Red No. 20
FD&C Yellow No. 6
FD&C Blue 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 a filtering aid for its adsorbent qualities
Bentonite
Emulsifying
agent
Used to promote and maintain dispersion of finely

subdivided particles of liquid in a vehicle in which it
is immiscible. End product may be a liquid emulsion
or semisolid emulsion (e.g., a cream)
Acacia
Cetomacrogol
Cetyl alcohol
Glyceryl monostearate
Sorbitan monooleate
Polyoxyethylene 50 stearate
Encapsulating
agent
Used to form thin shells to enclose a drug for ease

of administration
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
Anise oil
Cinnamon oil
Cocoa
Menthol
Orange oil
Peppermint oil
Vanillin
Humectant
Used to prevent drying of preparations, particularly

ointments and creams
Glycerin
Propylene glycol
Sorbitol
Levigating agent
Liquid used as an intervening agent to reduce the

particle size of a powder by grinding, usually in a
mortar
Mineral oil
Glycerin
Propylene glycol
Ointment base
Semisolid vehicle for medicated ointments
Lanolin
Hydrophilic ointment
Polyethylene glycol ointment
Petrolatum
Hydrophilic petrolatum
White ointment
Yellow ointment
Rose water ointment
Plasticizer
Component of film-coating solutions to make film

more pliable, enhance spread of coat over tablets,
beads, and granules
Diethyl phthalate
Glycerin
0002035883.INDD 152
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153

Ingredient Type
Definition
Examples
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)
Alcohol
Corn oil
Cottonseed oil
Glycerin
Isopropyl 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 thickness or hardness of a

preparation, usually an ointment
Cetyl alcohol
Cetyl esters wax
Microcrystalline wax
Paraffin
Stearyl alcohol
White wax
Yellow wax
Suppository base
Vehicle for suppositories
Cocoa butter
Polyethylene glycols (mixtures)
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
Benzalkonium chloride
Nonoxynol 10
Octoxynol 9
Polysorbate 80
Sodium lauryl sulfate
Sorbitan monopalmitate
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
Agar
Bentonite
Carbomer (e.g., Carbopol)
Carboxymethylcellulose
sodium
Hydroxyethyl cellulose
Hydroxypropyl cellulose
Hydroxypropyl
methylcellulose
Kaolin
Methylcellulose
Tragacanth
Veegum
Sweetening
agent
Used to impart sweetness to a preparation
Aspartame
Dextrose
Glycerin
Mannitol
Saccharin sodium
Sorbitol
Sucrose
Tablet
antiadherents
Prevent tablet ingredients from sticking to punches

and dies during production
Magnesium stearate
0002035883.INDD 153
(Continued)
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154
SECTION II Drug Dosage Form and Drug Delivery System Design

Ingredient Type
Definition
Examples
Tablet binders
Substances used to cause adhesion of powder

particles in tablet granulations
Acacia
Alginic acid
sodium
Compressible sugar
(e.g., Nu-Tab)
Ethylcellulose
Gelatin
Liquid glucose
Methylcellulose
Povidone
Pregelatinized starch
Tablet and
capsule diluent
Inert filler to create desired bulk, flow properties,

and compression characteristics of tablets and
capsules
Dibasic calcium phosphate

Kaolin
Lactose
Mannitol
Microcrystalline cellulose
Powdered cellulose
Precipitated calcium
carbonate
Sorbitol
Starch
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. Coating may be
sugar, film, or thick covering around a tablet. Sugarcoated 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 waterinsoluble coatings (e.g., ethylcellulose) 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)
Ethylcellulose (e.g., Ethocel)
Enteric coating
Cellulose acetate phthalate

Shellac (35% in alcohol,
pharmaceutical glaze)
Tablet direct
compression
excipient
Used in direct compression tablet formulations
Dibasic 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
Alginic acid
Polacrilin potassium (e.g.,
Amberlite)
Sodium alginate
Sodium starch glycolate
Starch
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155

Ingredient Type
Definition
Examples
Tablet glidant
Used in tablet and capsule formulations to improve

flow properties of the powder mixture
Colloidal silica
Cornstarch
Talc
Tablet lubricant
Used in tablet formulations to reduce friction during

tablet compression
Calcium stearate
Magnesium stearate
Mineral oil
Stearic acid
Zinc stearate
Tablet or capsule
opaquant
Used to render a coating opaque. May be used

alone or with a colorant
Titanium dioxide
Tablet polishing
agent
Used to impart an attractive sheen to coated

tablets
Carnauba wax
White wax
Tonicity agent
Used to render solution similar in osmotic-dextrose

characteristics to physiologic fluids, for example, in
ophthalmic, parenteral, and irrigation fluids
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
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
Viscosityincreasing 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.
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
0002035883.INDD 155
Alginic acid
Bentonite
Carbomer
Sodium
Methylcellulose
Povidone
Sodium alginate
Tragacanth
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 allergic responses.
11/29/2013 9:43:22 PM

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151

Chapter 4 Pharmaceutical and Formulation Considerations

Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS

Used in liquid preparations to provide acidic

Used in liquid preparations to provide alkaline

An agent capable of holding other molecules onto

Agent responsible for developing the pressure

Agent employed to displace air in a hermetically

Used in liquid and semisolid preparations to prevent

Used in liquid and semisolid preparations to prevent

Used to prevent deterioration of preparations by

Used to resist change in pH upon dilution or

SECTION II Drug Dosage Form and Drug Delivery System Design

Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS (Continued)

Substance that forms stable water-soluble

Used to impart color to liquid and solid (e.g., tablets

FD&C Red No. 3

Used as a filtering aid for its adsorbent qualities

Used to promote and maintain dispersion of finely

Used to form thin shells to enclose a drug for ease

Used to impart a pleasant flavor and often odor to

Used to prevent drying of preparations, particularly

Liquid used as an intervening agent to reduce the

Semisolid vehicle for medicated ointments

Component of film-coating solutions to make film

Chapter 4 Pharmaceutical and Formulation Considerations

Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS (Continued)

Used to dissolve another substance in preparation

Used to increase thickness or hardness of a

Vehicle for suppositories

Substances that absorb to surfaces or interfaces to

Viscosity-increasing agent used to reduce

Used to impart sweetness to a preparation

Prevent tablet ingredients from sticking to punches

SECTION II Drug Dosage Form and Drug Delivery System Design

Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS (Continued)

Substances used to cause adhesion of powder

Inert filler to create desired bulk, flow properties,

Dibasic calcium phosphate

Used to coat a tablet to protect against

Cellulose acetate phthalate

Used in direct compression tablet formulations

Dibasic calcium phosphate

Used in solid forms to promote disruption of the

Chapter 4 Pharmaceutical and Formulation Considerations

Table 4.3 EXAMPLES OF PHARMACEUTICAL INGREDIENTS (Continued)

Used in tablet and capsule formulations to improve

Used in tablet formulations to reduce friction during

Used to render a coating opaque. May be used

Used to impart an attractive sheen to coated

Used to render solution similar in osmotic-dextrose

Carrying agent used in formulating a variety of

Bacteriostatic sodium chloride

Used to render preparations more resistant to flow.

may or may not be present, it should be

only present in a trace amount and has no

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Chapter 4 Pharmaceutical and Formulation Considerations

Chapter 4 Pharmaceutical and Formulation Considerations

Chapter 4 Pharmaceutical and Formulation Considerations