Antidiabetic formulation and method

• US 20030139461A1
• Filed: 12/17/2001
• Published: 07/24/2003
• Est. Priority Date: 12/17/2001
• Status: Active Grant

• Current Assignee: Bristol-Myers Squibb Company
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Desai, Divyakant S., Li, Danping, Phusanti, Lawan
• Granted Patent: US 7,183,321 B2
• Time in Patent Office: Days
• US Class Current: 514/369
• 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 pharmaceutical composition comprising a single dosage formulation of metformin and glipizide, said formulation designed to control moisture so that the glipizide does not hydrolyze.

2. The pharmaceutical composition as defined in claim 1 wherein the single dosage formulation is a tablet.

3. The pharmaceutical composition as defined in claim 2 further including an outer protective coating or finishing layer surrounding said tablet.

11. The pharmaceutical formulation as defined in claim 2 which includes 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.

12. The pharmaceutical formulation as defined in claim 2 wherein the metformin is employed in a weight ratio to the glipizide within the range from about 1000:

1 to about 100;

1.

13. The pharmaceutical formulation as defined in claim 2 wherein the dosage of metformin is 250 mg and the dosage of glipizide is 1.25 mg.

14. The pharmaceutical formulation as defined in claim 2 wherein the dosage of metformin is 250 mg and the dosage of glipizide is 2.50 mg.

15. The pharmaceutical formulation as defined in claim 2 wherein the dosage of metformin is 500 mg and the dosage of glipizide is 2.50 mg.

16. The pharmaceutical formulation as defined in claim 2 wherein the dosage of metformin is 500 mg and the dosage of glipizide is 5.00 mg.

4. 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 combination of metformin and glipizide in a single dosage form, which dosage form controls moisture so that the glipizide does not hydrolyze.

5. The method as defined in claim 4 wherein the amount of metformin and glipizide in the combination is that employed in generally accepted medical practice for treating diabetes.

6. The method as defined in claim 5 wherein the dosage of metformin administered is from about 250 mg to about 2500 mg/day.

7. The method as defined in claim 6 wherein the metformin is administered in 250 mg increments.

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

9. The method as defined in claim 8 wherein the glipizide is administered in about 2.25 mg increments.

10. The method as defined in claim 4 wherein the metformin is employed in a weight ratio to glipizide within the range from about 1000:

1 to about 100;

1.