Sustained release pharmaceutical composition containing glipizide and method for producing same

A process of producing a sustained release glipizide composition that releases glipizide in conformity to a zero-order kinetics and results in a serum plasma glipizide concentration of at least 50 ng/ml twenty-four hours after administration of a single dose of said composition, comprising the steps of:

• a. mixing glipizide with at least one hydrophilic polymer selected from a group consisting of hydroxypropylmethylcellulose having a molecular weight of 26,000-86,000, a methoxy degree of substitution of 1.36-1.90, and a hydroxypropyl molar substitution of 0.18-0.25, and hydroxypropylcellulose having a molecular weight of 80,000-115,000, and at least one other excipient, to form a mixture;
• b. granulating the mixture with a diluent selected from a group consisting of polyvinylpyrrolidone, microcrystalline cellulose and gum arabic, and an alcohol;
• c. drying the granulated mixture;
• d. sizing the dried granulated mixture through a 2.4 mm screen to form sized granules;
• e. blending the sized granules with at least one flow regulating agent selected from a group consisting of colloidal silicon dioxide, talc and starch, and a lubricant selected from a group consisting of magnesium stearate and zinc stearate;
• and
• f. compressing the blended sized granules into a plurality of oral dosage forms, each form containing glipizide in an amount from 2.5-20 mg.

A process of producing a sustained release glipizide composition that releases glipizide in conformity to a zero-order kinetics and results in a serum plasma glipizide concentration of at least 50 ng/ml twenty-four hours after administration of a single dose of said composition, comprising the steps of:

• a. mixing glipizide with at least one hydrophilic polymer selected from a group consisting of hydroxypropylmethylcellulose having a molecular weight of 26,000-86,000, a methoxy degree of substitution of 1.36-1.90, and a hydroxypropyl molar substitution of 0.18-0.25, and hydroxypropylcellulose having a molecular weight of 80,000-115,000;
• a diluent selected from a group consisting of polyvinylpyrrolidone, microcrystalline cellulose and gum arabic;
• at least one flow regulating agent selected from a group consisting of colloidal silicon dioxide, talc and starch;
• a lubricant selected from a group consisting of magnesium stearate and zinc stearate;
• and at least one other excipient;
• and
• b. compressing the mixture into a plurality of oral dosage forms, each form containing glipizide in an amount from 2.5-20 mg.