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EXCIPIENT PROFILE
MAGNESIUM STEARATE
Synonyms : Magnesium octadecanoate; Octadecanoic acid, magnesium salt;
Stearic acid, magnesium salt.
Functional Category : Tablet and capsule lubricant.
Description : It 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 adheres to the skin.
Flowability : Poorly flowing, cohesive powder.
Melting range : 117150C (commercial samples);
126130C (high purity magnesium stearate).
Solubility : Practically insoluble in ethanol, ethanol (95%), ether and
water; slightly soluble in warm benzene and warm ethanol (95%).
Stability and Storage : It is stable and should be stored in a well-closed container
in a cool, dry place.
Incompatibilities : Incompatible with strong acids, alkalis, and iron salts. Avoid
mixing with strong oxidizing materials. It cannot be used in products containing
aspirin, some vitamins, and most alkaloidal salts.
Safety : Nontoxic following oral administration. However, oral consumption of
large quantities may produce a laxative effect or mucosal irritation.
CROSS POVIDONE
Nonproprietary Names
BP: Crospovidone
PhEur: Crospovidone
USP-NF: Crospovidone
Synonyms
Crospovidonum; Crospopharm; crosslinked povidone; E1202; Kollidon CL;
Kollidon CL-M; Polyplasdone XL; Polyplasdone XL-10;
polyvinylpolypyrrolidone; PVPP; 1-vinyl-2-pyrrolidinone homopolymer.
Chemical Name
1-Ethenyl-2-pyrrolidinone homopolymer [9003-39-8]
Empirical Formula and Molecular Weight
(C6H9NO)n >1 000 000
The USP32NF27 describes crospovidone as a water-insoluble synthetic
crosslinked homopolymer ofN-vinyl-2-pyrrolidinone. An exact determination of
the molecular weight has not been established because of the insolubility of the
material.
Structural Formula
Functional Category
Tablet disintegrant.
Applications in Pharmaceutical Formulation or Technology
Crospovidone is a water-insoluble tablet disintegrant and dissolution agent used at
25% concentration in tablets prepared by directcompression or wet- and dry-
granulation methods.
It rapidly exhibits high capillary activity and pronounced hydration capacity,with
little tendency to form gels. Studies suggest that the particle size of crospovidone
strongly influences disintegration of analgesic tablets.
Larger particles provide a faster disintegration than smaller particles. Crospovidone
can also be used as a solubilityenhancer. With the technique of co-evaporation,
crospovidone can be used to enhance the solubility of poorly soluble drugs. The
drug is adsorbed on to crospovidone in the presence of a suitable solvent and the
solvent is then evaporated. This technique results in faster dissolution rate.
Description
Crospovidone is a white to creamy-white, finely divided, freeflowing, practically
tasteless, odorless or nearly odorless, hygroscopic powder.
Typical Properties
Acidity/alkalinity pH = 5.08.0 (1% w/v aqueous slurry)
Density 1.22 g/cm3
Density (bulk) seeTable II.
Density (tapped)
1. Synonyms:
Explotab; Primogel; Vivastar. Carboxymethyl starch, sodium salt.
2. Chemical Name:
Sodium carboxymethyl starch.
3. Description:
It is a white or almost white free-flowing very hygroscopic powder. The PhEur
states that when examined under a microscope it is seen to consist of: granules
irregularly shaped, ovoid or pear-shaped, 30100 mm in size, or rounded,1035
mm in size; compoundgranules consisting of 24 components occur occasionally;
the granules have an eccentric hilum and clearly visible concentric striations.
Between crossed nicol prisms, the granules show a distinct black cross intersecting
at the hilum; small crystals are visible at the surface of the granules. The granules
how considerable swelling in contact with water.
4. Functional Category:
Tablet and capsule disintegrant.
5. Solubility:
Practically insoluble in water and insoluble in most organic solvents.
6. Incompatibilities:
Sodium starch glycolate is incompatible with ascorbic acid.
7. Stability and Storage Conditions:
Tablets prepared with sodium starch glycolate have good storage
properties.Sodium starch glycolate is stable although very hygroscopic, and should
be stored in a well-closed container in order to protect it from wide variations of
humidity and temperature, which may cause caking. The physical properties of
sodium starch glycolate remain changed for up to 3 years if it is stored at moderate
temperatures and humidity
CROSCARMELLOSE SODIUM
9. Applications:
Microcrystalline cellulose
MENTHOL
Nonproprietary Names
BP: Racementhol
PhEur: Mentholum racemicum
USP: Menthol
Synonyms
Hexahydrothymol; 2-isopropyl-5-methylcyclohexanol; 4-isopropyl-1-
methylcyclohexan-3- ol; 3-p-menthanol; p-menthan-3-ol; dl-menthol; peppermint
camphor; racemic menthol.
Structural Formula
Solubility:Very soluble in ethanol (95%), chloroform, ether, fatty oils and liquid
paraffin; soluble in acetone and benzene; very slightly soluble in glycerin;
practically insoluble in water.
Description
Racemic menthol is a mixture of equal parts of the (1R,2S,5R)- and (1S,2R,5S)-
isomers of menthol. It is a free-flowing or agglomerated crystalline powder, or
colorless, prismatic, or acicular shiny crystals, or hexagonal or fused masses with a
strong characteristic odor and taste. The crystalline form may change with time
owing to sublimation within a closed vessel. The USP 28 specifies that menthol
may be either naturally occurring l-menthol or synthetically prepared racemic or
dl-menthol. However, the JP 2001 and PhEur 2005, along with other
pharmacopeias, include two separate monographs for racemic and l-menthol.
Typical Properties
Boiling point: 212C
Flash point: 91C
Melting point: 34C
Refractive index: n20D = 1.4615
Incompatibilities
Applications:
CAMPHOR
Synonyms:
1,7,7-trimethyl bicyclo (2,2,1)-heptan-2-one, 2-bornanone, 2-camphanone, 2-keto-
1,7, 7-trimethylnorcamphane, 2-oxo-bornane, alcanfor, camfora, camphor-natural,
camphor-synthetic, formasa-camphor, Gum camphor, Japan camphor, l,7,7-
trimethy1norcamphor, laurel camphor, matricaria camphor, root bark oil, spirit of
camphor, tramfer.
Physical properties