STABLE PHARMACEUTICAL FORMULATION FOR A DPP-IV INHIBITOR
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United States of America Patent
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Issued Date -
Sep 30, 2010
app pub date -
May 21, 2008
filing date -
May 21, 2007
priority date (Note) -
Abandoned
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Abstract
A dosage form is provided for an anti-diabetic DPP-IV inhibitor of formula (I) as its tartarate salt, wherein the purity of the active pharmaceutical ingredient is maintained over a prolonged storage period under conditions similar to those likely encountered in home storage of the medication by a diabetic patient. A formulation free of calcium salts such as calcium phosphate, but including microcrystalline cellulose, copovidone, crospovidone, colloidal silicon dioxide, and magnesium stearate, when compacted into a tablet with the active pharmaceutical ingredient, was shown to be stable for at least six months at 40° C. and 75% relative humidity. Methods for preparation of the dosage form are also provided.
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