Chapter-6 polymer profile

MICROCRYSTALLINE CELLULOSE

Microcrystalline cellulose is partially depolymerised cellulose prepared

from alpha cellulose.

Category: - Pharmaceutical aid (suspending agent, tablet and capsule adjuvant)

Description: - White or almost white powder, odorless.

Solubility: -

Insoluble in water but swells producing a white opaque dispersion or gel,

slightly soluble in dilute sodium hydroxide solution.

Microcrystalline cellulose for direct compression tabletting comes in a number

of grades like PH 101 (original product) & PH 102 (more agglomerated, large
particle size with better fluidity). When compressed, the MCC particles are
deformed plastically due to the presence of slip planes & dislocation. A strong
compact is formed due to the extremely large number of clean surfaces brought in
contact during plastic deformation & the strength of hydrogen bonds formed.

Here Avicel 102 used as diluent cum disintegrant. The mechanism of Avicel 102
is interlocking .The particle size of Avicel 102 is small. The decrease in particle
size increases binding strength and decreases disintegration time so here we used
Avicel 102.

MCC is found in the concentration of 10-25% as a filler binder disintegrant

MCC can be used as a disintegrant at a level of 5-15%. The MCC is
effective as abinder in direct compression. Its binding advantages in granulation
decrease with an increase in water addition. MCC is useful as a disintegrant
when used in proportion ofat least 5-15%. The disintegration time of tablets of
cation exchange resin was reduced significantly in the presence of MCC.

Dept of pharmaceutics 29 gokula krishna college of pharmacy

 Chapter-6 polymer profile

PURIFIED TALC
Synonyms:

Altalc; E553b; hydrous magnesium calcium silicate; hydrous magnesium silicate; powdered
talc; purified French chalk; Purtalc; soapstone; steatite; Superiore.

Empirical formula and molecular weight:

Talc is a purified, hydrated, magnesium silicate, approximating to the formula

Mg6(Si2O5)4(OH)4. It may contain small, variable amounts of aluminum silicate and iron.

Functional category:

Anticaking agent; glidant; tablet and capsule diluent; tablet and capsule lubricant.

Applications:

Talc is also used as a lubricant in tablet formulations; in a novelpowder coating for

extended-release pellets; and as an adsorbant. In topical preparations, talc is used as a dusting
powder, although it should not be used to dust surgical gloves. Talc is additionally used to
clarify liquids and is also used in cosmetics and food products, mainly for its lubricant
properties. Talc was once widely used in oral solid dosage formulations as a lubricant and
diluent.

Stability and storage conditions:

Talc is a stable material and may be sterilized by heating at 160o C for not less than 1 hour. It
may also be sterilized by exposure to ethylene oxide or gamma irradiation. Talc should be
stored in a well-closed container in a cool, dry place.

Dept of pharmaceutics 30 gokula krishna college of pharmacy

 Chapter-6 polymer profile

MAGNESIUM STEARATE

Synonyms : Magnesium Octadecanoate, stearic acid magnesiumsalt,

Chemical name : Octadecanoic acid magnesium salt.

Structural formula : [CH3(CH2)16COO]2Mg.

Description :

It is a fine, white, precipitated or milled, impalatable powder of low bulk

density, having a faint odor of stearic acid and a characteristic taste. The powder is greasy to
touch and adhere to skin.

Functional categories:

Tablet and capsule lubricant.

Solubility :

Practically in soluble in ethanol, ether, water; slightly soluble in warmbenzene and

ethanol.

Stability and storage :

It is stable and should be stored in well- closed container in a cool, dryplace.

Incompatibilities :

Incompatible with strong acids, alkali and iron salts. most alkaloidal salts.

SODIUM STARCH GLYCOLATE

Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for

tablets and capsules. Sodium starch glycolate absorbs water rapidly, resulting in swelling which
leads to rapid disintegration of tablets and granules. It is used as a disintegrant, a suspending
agent and as a gelling agent.

Molecular Formula : C2H3NaO3

Synonyms : Sodium glycolate 2836-32-0 Sodium hydroxyacetate Sodium 2-

hydroxyacetateMonosodium glycolate

Molecular Weight : 98.03

Parent Compound : CID 757 (Glycolic Acid)

Dept of pharmaceutics 31 gokula krishna college of pharmacy

 Chapter-6 polymer profile

Melting point: >210℃

Solubility : practically insoluble in methylene chloride . It gives a translucent suspension in

water

Appearance:white

powder Colour : white to

off white

Applications:

Sodium starch glycolate is a commonly used super-disintegrant employed to promote

rapid disintegration and dissolution of IR solid dosage forms.

CROSPOVIDONE
Synonyms:

Crospovidone, Polyplasdone XL ,1-Ethenyl-2-Pyrrolidinone, Homopolymer1-vinyl-

2-pyrrolidinone Homopolymer , 2S7830E561 ,A07BC03 , CROSPOVIDONE (EP IMPURITY)

Molecular formula: (C6H9NO)n

Solubility: Insoluble in water ,ethanol and ether

PH: between 5.0 and 8.0

Density: 1.22g/cm

Applications:
It is medically used for the treatment of some intestinal disorders as
solubilizing excipients to improve the bioavailability of drugs (such as steroids) and as
germicides in wound treatment. It is also commonly used as a clarifier in alcoholic and
nonalcoholic beverages.
Safety:
Oral use of crospovidone is not usually associated with toxicity in normal use as a
pharmaceutical excipient.

Stability / Storage Conditions:

Crospovidone is highly hygroscopic and absorbs significant amounts of moisture (25%

water uptake at 75% RH). Storage conditions selected should prevent contact with the
atmosphere for prolonged periods of time. Crospovidone has an expected shelf life is 3 years.

Dept of pharmaceutics 32 gokula krishna college of pharmacy

 Chapter-6 polymer profile

CROSCARMELLOSE SODIUM

Synonyms:

Croscarmellose sodium, or sodium CMC, is a cross-linked polymer of

carboxymethyl cellulose sodium.

PH: less than 5,0 and not more than 7,0 (1 % solution)
Solubility:
White or grayish-white powder, practically insoluble in anhydrous ethanol.
Hygroscopic. Insoluble in water but rapidly swells in it to four to eight times the original
volume.

Density : In bulk 0.53 g/ml.

Storage conditions:
Keep container tightly closed in a dry and well-ventilated place. Store at room
temperature in the original container. Store away from incompatible materials.

MolecularFormula:C8H16O
Molecular Weight: 240.21.
Melting Point: 171℃.
Boiling Point: 223 ℃
Properties:
It appears as white, fibrous, free-flowing powder
Applications:
Croscarmellose sodium is a carboxymethylcellulose (CMC) that is widely used as an
additive in pharmaceutical and non-pharmaceutical industry; in particular, it is used in oral
pharmaceutical formulations as a disintegrant for capsules, tablets and granules.

Dept of pharmaceutics 33 gokula krishna college of pharmacy