FIELD: medicine, pharmacology, pharmaceutical technology, pharmacy.
SUBSTANCE: invention relates to a solid pharmaceutical composition used in treatment of cyclooxygenase-2-dependent disorder or state that comprises from 200 mg to 400 mg of 5-methyl-2-(2'-chloro-6'-fluoroaniline)-phenylacetic acid and excipients wherein level of residual moisture in composition is from 1.5% to 5%. Also, invention relates to a method for stabilization of 5-methyl-2-(2'-chloro-6'-fluoroaniline)-phenylacetic acid as a component of the solid pharmaceutical composition that involves preparing the solid pharmaceutical composition comprising 5-methyl-2-(2'-chloro-6'-fluoroaniline)-phenylacetic acid wherein the composition comprises the level of residual moisture from 1.5% to 5%. The dried granulated preparation comprises 5-methyl-2-(2'-chloro-6'-fluoroaniline)-phenylacetic acid, microcrystalline cellulose, lactose monohydrate, croscarmellosa sodium wherein the level of residual moisture in the granulated preparation is from 2.5% to 4.5%. Solid pharmaceutical compositions comprise indicated dried granulated preparation. Invention provides enhancing stability of 5-methyl-2-(2'-chloro-6'-fluoroaniline)-phenylacetic acid as component of compositions and preparations.
EFFECT: improved and valuable properties of pharmaceutical compositions.
31 cl, 3 tbl, 1 ex
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Authors
Dates
2008-03-10—Published
2003-03-06—Filed