Stable pharmaceutical formulation for a dpp-iv inhibitor

Details Stable pharmaceutical formulation for a dpp-iv inhibitor Stable pharmaceutical formulation for a dpp-iv inhibitor

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61J 3/10 (2006.01) A61K 31/69 (2006.01)

Patent

CA 2688721

A dosage form is provided for an anti-diabetic DPP-TV 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.

L'invention concerne une forme de dosage pour un inhibiteur de DPP-IV antidiabétique de formule (I) sous forme de son sel de tartrate, la pureté de l'ingrédient pharmaceutique actif y étant maintenue pendant une période de stockage prolongée dans des conditions similaires à celles généralement rencontrées dans un stockage domestique de la médication par un patient diabétique. Une formulation exempte de sels de calcium tels que le phosphate de calcium, mais comprenant la cellulose microcristalline, la copovidone, la crospovidone, le dioxyde de silicium colloïdal et le stéarate de magnésium, lorsqu'elle est compactée en un comprimé avec l'ingrédient pharmaceutique actif, s'est avérée être stable pendant au moins six mois à 40°C et à une humidité relative de 75%. L'invention concerne également des procédés de préparation de la forme pharmaceutique.

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