Stable pharmaceutical formulation for a dpp-iv inhibitor
AssigneePhenomix Corporation
InventorsZhen-Ping Wu, Richard Alexander Moore, JR.
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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.
Claims46
A tablet dosage form for an active pharmaceutical ingredient comprising a compound of formula (I)
- as a tartarate salt, including a solvate, hydrate, tautomer, stereoisomer, or prodrug thereof, comprising:
- a diluent comprising microcrystalline cellulose;
- a disintegrant comprising crospovidone;
- a binder comprising copolyvidone;
- a lubricant comprising magnesium stearate;
- and
- a glidant comprising colloidal silicon dioxide;
- wherein the dosage form is free of calcium phosphate.
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Dependencies are inferred from the claim text.