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AssigneeSun Pharmaceutical Industries Limited
InventorsRomi Barat SINGH, Ashish KUMAR, Rajesh Srikrishan SHEAR, Satish Kumar JAIN, Paras P. JAIN
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The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.
A stable extended release liquid composition of metformin characterized by a Tmax in a range from about 3 hours to about 12 hours after a single dose administration under fed conditions, wherein the composition comprises:
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A stable extended release liquid composition of metformin characterized by a pharmacokinetic profile having one or more features of:
A stable extended release liquid composition of metformin characterized in that the liquid composition is bioequivalent to a marketed extended release tablet of metformin, wherein the composition comprises:
A stable extended release liquid composition of metformin comprising metformin hydrochloride in a concentration from about 25 mg/mL to about 500 mg/mL of the composition, wherein the composition comprises:
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Dependencies are inferred from the claim text.