Patent ID: 8580298
Filing Date: 2013-11-12
Classification: A61K,A61P

Abstract:
1. A unit dosage form for weight loss for oral administration to a patient having a body mass index of at least 30 kg/m 2 and a condition associated with obesity, comprising a combination of: an immediate release phentermine formulation containing a unit dosage of phentermine in the range of 2 mg to 8 mg; and a controlled release topiramate formulation containing a unit dosage of topiramate in the range of 15 mg to 50 mg, wherein the dosage of phentermine in mg/day is about 16% of the dosage of topiramate in mg/day, and wherein the controlled release topiramate formulation reaches a maximum plasma concentration (Cmax) at about 6 to about 10 hours (Tmax) after administration and exhibits a lower Cmax, than non-controlled release topiramate, without decreasing total drug exposure defined by the area under the concentration-time curve (AUC), thereby enabling reduction of concentration-dependent side effects without a decrease in efficacy.