6. EXCIPIENT PROFILE
Polyplasdone XL :
Synonyms: Crospovidone, Cross-linked povidone, PVPP, polyvinylpolypyrrolidone.
Functional Category: Tablet disintegrant.
Applications: It is a water insoluble tablet disintegrant used at 2-5 % concentration in tablets prepared by direct compression or wet & dry granulation method.
Description: White to creamy-white, finely divided, free- flowing, practically tasteless, odorless or nearly odorless, hygroscopic powder.
Solubility: Practically insoluble in water and most organic solvents.
Stability: Crospovidone is stable.
Storage conditions: Since it is hygroscopic it should be stored in an airtight container in a cool, dry, place.
Incompatibilities: When exposed to a high water level it may form molecular
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Deliberate abuse of formulations containing cellulose, either by inhalation or by injection, has resulted in the formation of cellulose granulomas.
Magnesium Stearate:
Synonyms: Dibasic magnesium stearate, magnesium distearate, Magnesia, stearas, Magnesium octadecanoate, Octadecanoic acid, magnesium salt, Stearic acid, magnesium salt.
Structural formula : [CH3 (CH2)16COO] 2Mg
Chemical name : Octa decanoic acid magnesium salt [557-04-0].
Empirical formula : C36H70MgO
Molecular weight : 591.24 daltons.
Description: Magnesium stearate is a very fine, light white, precipitated or milled, impalpable powder of low bulk density, having a faint odour of stearic acid and a characteristic taste. The powder is greasy to the touch and readily adheres to the skin.
Functional category: Tablet and capsule lubricant.
Physicochemical properties:
Solubility: Practically insoluble in ethanol (95%), slightly soluble in water and ether.
Melting point : 117-150°C (commercial samples).
Flow ability : Poorly flowing, cohesive