| US 7,588,779 B2 | ||
| Pharmaceutical formulation containing a biguanide and an angiotensin antagonist | ||
| Elliot F. Hahn, North Miami Beach, Fla. (US) | ||
| Assigned to Andrx Labs, LLC, Davie, Fla. (US) | ||
| Appl. No. 11/628,066 PCT Filed May 27, 2005, PCT No. PCT/US2005/018939 § 371(c)(1), (2), (4) Date Nov. 28, 2006, PCT Pub. No. WO2005/117591, PCT Pub. Date Dec. 15, 2005. |
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| Prior Publication US 2007/0231386 A1, Oct. 04, 2007 | ||
| Int. Cl. A61K 9/20 (2006.01); A61K 31/44 (2006.01); A61K 31/155 (2006.01) | ||
| U.S. Cl. 424—464 [514/342; 514/635] | 34 Claims |
| 1. A once a day pharmaceutical dosage form having a first and second active drug, said dosage form comprising:
(a) an antihyperglycemic drug which is metformin or a pharmaceutically acceptable salt thereof and
at least one pharmaceutically acceptable controlled release excipient;
and (b) an angiotensin antagonist selected from the group consisting of valsartan, losartan, candesartan, eprosartan, irbesartan,
olmesartan, tasosartan, and telmisartan or the like, and pharmaceutically acceptable salts, isomers or derivatives thereof,
wherein said metformin or a pharmaceutically acceptable salt thereof is released in a controlled release manner, and
wherein said dosage form exhibits the following dissolution profile when tested in a USP type 2 apparatus at 75 rpm in 900
mL of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 370° C.:
after 0.5 hours not less than 75% of the angiotensin antagonist drug is released;
after 2 hours 0-25% of the antihyperglycemic drug is released;
after 4 hours 10 -45% of the antihyperglycemic drug is released;
after 8 hours 30-90% of the antihyperglycemic drug is released;
after 12 hours not less than 50% of the antihyperglycemic drug is released;
after 16 hours not less than 60% of the antihyperglycemic drug is released; and
after 20 hours not less than 70% of the antihyperglycemic drug is released.
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