Patent ID: 8425937
Filing Date: 2013-04-23
Classification: A61K,A61P

Abstract:
1. A coated tablet dosage form for delivery of glucocorticoid replacement therapy, comprising: (a) an extended release tablet core and an immediate release coating surrounding said tablet core, (b) said extended release tablet core comprising hydrocortisone and an extended release excipient composition consisting of (i) a combination of hydroxypropylmethylcellulose, microcrystalline cellulose and pregelatinized starch (ii) colloidal silicon dioxide, and (iii) magnesium stearate, the amount of hydrocortisone present in said extended release core being 60% to 80% of the total amount of hydrocortisone present in said dosage form; (c) said immediate release coating comprising hydrocortisone and at least one coating material selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, polyvinylalcohol, sodium carboxymethylcellulose, gelatin, polyethylene glycol, said immediate release coating further comprising at least one of titanium dioxide and talc, with the amount of hydrocortisone present in said immediate release coating material being 20% to 40% of the total amount of hydrocortisone present in said dosage form; and (d) said dosage form being effective to deliver a daily dose of from about 5 to about 40 mg of hydrocortisone.