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AssigneeUnison Pharmaceuticals Pvt. Ltd.
InventorsBalvir Singh, Ramesh Shingala, Milap Patel, Ritesh Patel
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The present invention relates to a stable pharmaceutical composition comprising a fixed dose combination of a therapeutically effective amount of DPP-IV inhibitor and a therapeutically effective amount of SGLT2 inhibitor for reducing blood glucose level in patients with diabetes. The present invention specifically relates to a stable pharmaceutical composition comprising Sitagliptin or a pharmaceutically acceptable salts or solvate or hydrate or premix thereof and Empagliflozin or a pharmaceutically acceptable salt or solvate or hydrate or premix thereof in the presence of one or more pharmaceutically acceptable excipients. Moreover, the present invention relates to a stable pharmaceutical composition comprising Sitagliptin Phosphate Monohydrate, Empagliflozin and one or more pharmaceutically acceptable excipients with high content uniformity, reduced degradation impurities and optimum dissolution.
A stable pharmaceutical composition comprising a combination of Sitagliptin or pharmaceutically acceptable salt or solvate thereof with Empagliflozin or pharmaceutically acceptable salt or solvate thereof and at least one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition comprises a first portion and a second portion, wherein the first portion comprises Sitagliptin or pharmaceutically acceptable salt or solvate thereof in the form of powder or granules along with one or more pharmaceutically acceptable excipients, and the second portion comprises Empagliflozin or pharmaceutically acceptable salt or solvate thereof in the form of powder or granules along with one or more pharmaceutically acceptable excipients.
Dependencies are inferred from the claim text.