In vitro release of ketoprofen suppositories using the USP basket and the flow-through cell dissolution methods

ABSTRACT

In order to study the release characteristics of ketoprofen suppositories under the hydrodynamic environment generated by USP Apparatus 1 and 4, the dissolution profiles of the Mexican reference product [100 mg] were determined. Phosphate buffer pH 8 and 1% sodium lauryl sulfate [SLS] aqueous solutions were proved as dissolution mediums. Baskets were rotated at 100 rpm with USP Apparatus 1 and different flow rates from 16-32 mL/min with USP Apparatus 4 were used. Drug samples were taken and quantified during 60 min by UV analysis at 260 nm. Mean dissolution time [MDT] and dissolution efficiency [DE] were calculated by model-independent methods. Data were also fitted to several kinetic models. Poor dissolution was found in both dissolution mediums when USP basket method was used [< 10% dissolved] while better results were obtained with USP Apparatus 4 when 1% SLS at 24 mL/min was used [43.6% dissolved, MDT of 25.5 min and DE of 25.0%]. Kinetics showed a great variability when the USP Apparatus 1 was used, and Gompertz fitted well for data of 1% SLS at 24 mL/min [R2 adjusted > 0.99]. The results suggest the need to establish an adequate dissolution method to evaluate the release kinetics of ketoprofen from suppositories.