EXCIPIENTS PROFILE

EXCIPIENTS PROFILE

GUAR GUM
Nonproprietary names : BP : Guar galactomannan
PhEur : Guar galactomannan
USPNF: Guar gum
Synonyms : E412, galactosol, guar flour, meyprogat, meyprofin,
meyprodor, guar Galactomannanum
Chemical name : Galactomannan polysaccharide
Molecular formula : (C6H12O6)n
Functional category : Suspending agent, viscosity increasing agent, tablet
Binder and tablet disintegrant.
Description : It occurs as a white to yellowish- white color,
odourless, with bland taste.
Solubility : Practically insoluble in organic solvents. In cold or
warm water, guar gum dispersed and swells almost
to form highly viscous thixotropic solution.
Viscosity : 2000-2250 cps for 1% w/v dispersion.
Applications : In pharmaceuticals, guar gum is used in solid-
dosage forms a binder and disintegrant. In oral and
topical products as a suspending, thickening, and
stabilizing agent; and also as a controlled-release
carrier. Guar gum has also been examined for use
in colonic drug delivery.
Stability and storage : Aqueous guar gum dispersions have a buffering
action and are stable at pH 4-10.5 however
prolonged heating reduces the viscosity of the
dispersion. The bacteriological stability of guar gum
dispersions may be improved by the addition of
mixture of 0.15% methylparaben and 0.02% of
propylparaben as a preservative. Guar gum should
be stored in a well closed container in a cool or dry
place.

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CHITOSAN
Nonproprietary names : BP :Chitosan hydrochloride
PhEur :Chitosan hydrochloridum
Synonyms : 2-Amino-2-deoxy-(1,4)-β-D-glucopyranan;
deacetylated chitin; deacetylchtin;
β- 1, 4-poly-D-glucosamine.
Chemical name : Poly-β-(1, 4)-2-amino-deoxy-D-Glucose.
Functional category : Disintegrant; mucoadhesive; tablet binder,
Viscosity increasing agent.
Description : Chitosan occurs as odorless, white or
creamy-white powder or flakes.
Solubility : Sparingly soluble in water. Practically
insoluble in ethanol (95%), other
organic solvents, and neutral
or alkali solutions.
Applications : Used in controlled drug delivery
applications like, mucoadhesive
dosage forms, rapid release
dosage forms, improved peptide
delivery, colonic drug delivery
systems and used for gene delivery.
Stability and storage : Chitosan is a stable material at room
temperature, although it is
hygroscopic after drying.
Chitosan should be stored in tightly
closed container in a cool, dry place.

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Xanthan Gum
Nonproprietary Names:
 BP and USP/NF: Xanthan gum
 PhEur: Xanthani gummi

Chemical Name: Xanthan gum

Synonyms: Corn sugar gum, E415, Keltrol, polysaccharide B-1459, Rhodigel,
Vanzan, NF, Xantural.

Chemical structure:

Molecular formula: (C35H49O29) n

Molecular mass: 933(monomer)
Description:
Odour : Odourless
Colour : White to cream coloured free flowing powder
Taste : Tasteless

Functional Category:
 Stabilizing agent
 Suspending agent
 Viscosity-increasing agent.
Solubility: Practically insoluble in ethanol and ether, soluble in cold or warm water.
Melting point: Chars at 2700C.
Viscosity (dynamic): 1200–1600mPa s (1200–1600cP) for a 1%w/v aqueous solution at
250C.
Stability and Storage Conditions:

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Xanthan gum is a stable material. Aqueous solutions are stable over a wide pH
range (pH 3–12), although they demonstrate maximum stability at pH 4–10 and
temperatures of 10–600C. Xanthan gum solutions of less than 1%w/v concentration may
be adversely affected by higher than ambient temperatures, for example viscosity is
reduced. Solutions are also stable in the presence of enzymes, salts, acids and bases.
The bulk material should be stored in a well-closed container in a cool, dry place.
Applications:
 Xanthan gum is widely used in oral and topical pharmaceutical formulations,
cosmetics and foods as a suspending and stabilizing agent.
 It is also used as a thickening and emulsifying agent.
 Xanthan gum has also been used to prepare sustained-release matrix tablets.
 Controlled-release tablets of diltiazem hydrochloride prepared using xanthan gum
have been reported to sustain the drug release in a predictable manner.
 Xanthan gum has been incorporated in an ophthalmic liquid dosage form.
 Xanthan gum can be used to increase the bio adhesive strength in vaginal
formulations and as a binder in colon specific drug delivery systems.
 Xanthan gum is also used as a hydrocolloid in the food industry and in cosmetics
it has been used as a thickening agent in shampoo.

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MICROCRYSTALLINE CELLULOSE
Non proprietary names : BP : Microcrystalline Cellulose
PhEur: Cellulosum microcristallinum
USPNF: Microcrystalline cellulose
Synonyms : Avicel PH; celex; cellulose gel; Celphere;
Ceolus KG; crystalline cellulose; E460;
Emocel; fibrocel; pharmacel; tabulose.
Chemical name : Cellulose
Chemical formula : (C6H10O5)n
Functional category : Adsorbent; suspending agent; tablet and capsule
diluents and tablet disintegrant.
Description : Purified, partially depolymerized cellulose that
occurs as a white, odorless, tasteless, crystalline
powder composed of porous particles.
Solubility : Slightly soluble in 5% w/v sodium hydroxide
solution. Practically insoluble in water, dilute
acids, and most organic solvents.
Applications : Microcrystalline cellulose is widely used in
pharmaceuticals, primarily as a binder/diluent in
oral tablet and capsule formulations where it is
used in both wet - granulation and direct
compression processes In addition to its use as a
binder/diluent, microcrystalline cellulose also
has some lubricant and disintegrant properties
that make it useful in tableting.
Stability and storage conditions: Microcrystalline cellulose is a stable though
hygroscopic material. The bulk material should
be stored in a well-closed container in a cool, dry
place.

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MAGNESIUM STEARATE
Nonproprietary names : BP: Magnesium stearate
PhEur: Magnesium stearas
USP: Magnesium stearate
Synonyms : Magnesium octadecanpate; octadecanoic acid;
magnesium salt; stearic acid, magnesium salt.
Chemical name : Octadecanoic acid magnesium salt
Molecular formula : C16H70MgO4
Functional category : Tablet and capsule lubricant.
Description : Magnesium stearate is a very fine, light white,
precipitated or milled, impalpable powder of
low bulk density, having a faint odor of stearic
acid and a characteristic taste. The powder is
greasy to the touch and readily adhere to the
skin.
Solubility : Practically insoluble in ethanol, ether and water,
slightly soluble in warm benzene and warm
ethanol (95%).
Applications : Magnesium stearate is widely used in cosmetics,
foods, and pharmaceutical formulations. It is
primarily used as a lubricant in capsule and
tablet manufacture at concentrations between
0.25% and 5.0% w/w. It is also used in barrier
creams.
Stability and storage : Magnesium stearate is stable and should be
stored in a well closed container in a cool dry
place.

TALC

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Nonproprietary names : BP : Purified talc

PhEur: Talcum
USP : Talc
Synonyms : Altalc, ESS3b, hydrous magnesium
calcium silicate; hydrous magnesium
silicate; Luzenac pharma; magnesium
Hydrogen metasilicate, magsil
Oamanthus
Chemical name : Talc
Molecular formula : Mg6(Si2O5)4(OH)4
Functional category : Anti caking agent; tablet and capsule diluent;
tablet and capsule lubricant.
Description : Talc is a very fine, white to Grayish-white,
odorless, impalpable, unctuous, crystalline
powder.
Solubility : Practically insoluble in dilute acids and alkali,
organic solvents and water.
Applications : It is widely used as a dissolution retardant in the
development of controlled - release products.
Talc is also used as a lubricant in tablet
formulations. In a novel powder coating for
extended - release pellets; and as an adsorbant.
In topical preparations, talc is used as a dusting
powder,
Stability and storage : Talc is a stable mineral. Should be stored in a
well- closed container in a cool, dry place.

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