Controlled release metformin formulations

• US 20070154548A1
• Filed: 03/02/2007
• Published: 07/05/2007
• Est. Priority Date: 03/20/1998
• Status: Active Grant

• Current Assignee: Andrx Labs LLC (Abbvie Incorporated)
• Original Assignee: Andrx Labs LLC (Abbvie Incorporated)
• Inventors: Chen, Chih-Ming, Chou, Joseph, Jan, Steve, Cheng, Xiu
• Granted Patent: US 7,919,116 B2
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/282 Organic compounds, e.g. fats
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

Sustained release pharmaceutical formulations comprising an antihyperglycemic drug or a pharmaceutically acceptable salt thereof are disclosed. The formulations provide therapeutic plasma levels of the antihyperglycemic drug to a human patient over a 24 hour period after administration.

Claims

1-29. -29. (canceled)

30. A sustained release pharmaceutical formulation comprising (i) an active agent consisting of metformin or a pharmaceutically acceptable salt thereof, and (ii) a sustained release material, wherein said formulation provides therapeutic plasma levels of said metformin to a human patient over a 24 hour period after administration to said patient;

and said formulation providing an AUC which is increased by the presence of food as compared with administration in the fasting state.

31. The sustained release pharmaceutical formulation of claim 30 wherein said formulation provides a time to peak plasma concentration (T_max) of the metformin which occurs at a time from about 8 hours to about 12 hours after administration to said human patient.

32. A method of treating a human diabetic patient with an oral solid dosage form of metformin, comprising:

swallowing on a once a day basis in the presence of food an intact controlled release oral dosage form containing (i) an active agent consisting of an effective amount of metformin or a pharmaceutically acceptable salt thereof and one or more materials controlling the release of metformin from the dosage form such that therapeutic levels of said metformin are attained in said human for 12 to 24 hours and a decrease in the bioavailability of metformin is not exhibited.