Stabilized 1,25-dihydroxyvitamin d2 and method of making same

Details Stabilized 1,25-dihydroxyvitamin d2 and method of making same Stabilized 1,25-dihydroxyvitamin d2 and method of making same

A - Human Necessities

61

K

A61K 31/592 (2006.01) C07C 401/00 (2006.01)

Patent

CA 2718238

A stabilized 1,25 -dihydroxy vitamin D2 composition, free of methyl formate, which is particularly well suited for pharmaceutical formulations, pharmaceutical formulations of the 1,25 - dihydroxyvitamin D2 composition, and a method of making the purified composition by purifying a crude 1,25 -dihydroxy vitamin D2 from acetone/water, are disclosed. The stabilized 1,25 -dihydroxy vitamin D2 is characterized by a reduced rate of degradation on heat challenge and during prolonged storage and exhibits excellent storage stability when formulated in a pharmaceutical dosage form, e.g., a soft gelatin capsule.

L'invention porte sur une composition de 1,25-dihydroxyvitamine D2 stabilisée, exempte de formiate de méthyle, qui est particulièrement bien appropriée pour des formulations pharmaceutiques, sur des formulations pharmaceutiques de la composition de 1,25-dihydroxyvitamine D2 et sur un procédé de production de la composition purifiée par purification d'une 1,25-dihydroxyvitamine D2 brute à partir d'acétone/eau. La 1,25-dihydroxyvitamine D2 stabilisée est caractérisée par une vitesse de dégradation réduite lors d'une provocation par la chaleur et durant un stockage prolongé et présente une stabilité au stockage excellente lorsqu'elle est formulée dans une forme posologique pharmaceutique, par exemple une capsule de gélatine molle.

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