Patent ID: 7985422
Filing Date: 2011-07-26
Classification: A61K

Abstract:
1. A pharmaceutical dosage form of a combination of a high dose high solubility active ingredient, in the form of a modified release formulation and a low dose active ingredient selected from the group consisting of glibenclamide (glyburide),glipizide, gliclazide, glimepiride, tolazamide, tolbutamide, clorpropamide, gliquidone, nateglinide, mitiglinide, glyburide, glisoxepid, glibornuride, phenbutamide, tolcyclamide, repaglinide, troglitazone, ciglitazone, rosiglitazone, pioglitazone, englitazone, acarbose, voglibose, emiglitate, miglitol, farglitazar, (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl} ethoxy) phenyl] propanoic acid, 3-{4-[2-4-tert-butoxycarbonyl aminophenyl)ethoxy]phenyl}-(S)-2-ethoxy propanoic acid and pharmaceutically acceptable salts thereof as an immediate release formulation suitable for swallowing; said dosage formulation comprising an inner portion having the low dose active ingredient as an immediate release formulation and an outer portion having the high dose, high solubility active ingredient as modified release, wherein said inner portion is covered by the outer portion from all the sides except a top surface that remains uncovered; wherein said outer portion is prepared by using dual retard technique to control the release of the high dose high solubility activity active ingredient, wherein the said dual retard technique is a combination of a matrix formulation and a reservoir formulation and comprises a) micro matrix particles consisting of a high dose, high solubility active ingredient and one or more hydrophobic release controlling agents wherein the weight ratio of high dose, high solubility active ingredient and hydrophobic release controlling agent is in the range of 100:2.5 to 100:30 and said high dose, high solubility active ingredient is selected from the group consisting of metformin hydrochloride, phenformin and buformin and, b) a coating of one or more hydrophobic release controlling agents on said micro matrix particles, wherein the weight ratio of micromatrix particles and hydrophobic release controlling agent is in the range of 100:2.5 to 100:30.