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Novel stable oral pharmaceutical compositions of dabigatran etexilate

机译:达比加群酯的新型稳定口服药物组合物

摘要

A pharmaceutical compositions of Dabigatran etexilate in the form of the free base or in the form of pharmaceutically acceptable salts, polymorphs, solvates or hydrates thereof containing mixture of two different physical forms selected from powder, granules, pellets, beads, mini-tablets and tablets with at least one pharmaceutically acceptable excipient and processes for the preparation of said pharmaceutical compositions which are bioequivalent to FDA approved Pradaxa® (Dabigatran etexilate) capsules 150 mg.
机译:达比加群酯的游离碱形式或其药学上可接受的盐,多晶型物,溶剂化物或水合物形式的药物组合物,其包含选自粉末,颗粒,丸剂,小珠,小片和片剂的两种不同物理形式的混合物具有至少一种药学上可接受的赋形剂的制剂和制备所述药物组合物的方法,所述药物组合物与FDA批准的150mg(Dabigatran etexilate)胶囊具有生物等效性。

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