Antidiabetic formulation and method

• US 7,507,768 B2
• Filed: 01/30/2007
• Issued: 03/24/2009
• Est. Priority Date: 12/17/2001
• Status: Expired due to Fees

• Current Assignee: Bristol-Myers Squibb Company
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Li, Danping, Phusanti, Lawan, Desai, Divyakant S.
• Primary Examiner(s): KWON, YONG SOK
• Application Number:
  US11/668,536
• Publication Number:
  US 20070141154A1
• Time in Patent Office: 784 Days
• Field of Search: 514/635, 514/369
• US Class Current: 514/635
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 31/64 Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/2077 Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

Abstract

An antidiabetic pharmaceutical formulation is provided, especially adapted for treating Type II diabetes, which includes a combination of metformin and glipizide in a manner to control moisture in the formulation so that the glipizide does not hydrolyze, yet the metformin is compressible, if necessary. A method for treating diabetes is also provided employing the above formulation.

Claims

1. A method for treating type 2 diabetes which comprises administering to a patient in need of treatment a therapeutically effective amount of a pharmaceutical composition comprising a single dosage formulation of metformin and glipizide said formulation containing from 2 to 3% by weight moisture, said formulation being in the form of a tablet designed to control moisture so that the glipizide does not hydrolyze and said metformin is compressible, said tablet further including an outer protective coating or finishing layer surrounding said tablet, said composition being devoid of an enteric coating.

2. The method as defined in claim 1 wherein the amount of metformin and glipizide in the combination is that employed in generally accepted medical practice for treating diabetes.

3. The method as defined in claim 2 wherein the dosage of metformin administered is from about 250 mg to about 2500 mg/day.

4. The method as defined in claim 3 wherein the metformin is administered in 250 mg increments.

5. The method as defined in claim 2 wherein the dosage of glipizide administered is from about 1.25 to about 25 mg/day.

6. The method as defined in claim 5 wherein the glipizide is administered in about 2.25 mg increments.

7. The method as defined in claim 1 wherein the metformin is employed in a weight ratio to glipizide within the range from about 1000:

1 to about 100;

1.

8. The method as defined in claim 1 wherein the pharmaceutical composition comprises a dosage of metformin of from about 250 to about 2500 mg/day and a dosage of glipizide from about 1.25 to about 25 mg/day.

9. The method as defined in claim 1 wherein the metformin is employed in a weight ratio to the glipizide within the range from about 400:

1 to about 100;

1.

10. The method as defined in claim 1 wherein the dosage of metformin is 250 mg and the dosage of glipizide is 1.25 mg.

11. The method as defined in claim 1 wherein the dosage of metformin is 250 mg and the dosage of glipizide is 2.50 mg.

12. The method as defined in claim 1 wherein the dosage of metformin is 500 mg and the dosage of glipizide is 2.50 mg.

13. The method as defined in claim 1 wherein the dosage of metformin is 500 mg and the dosage of glipizide is 5.00 mg.