title: 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 (R(2)(adjusted) > 0.99). The results suggest the need to establish an adequate dissolution method to evaluate the release kinetics of ketoprofen from suppositories.
authors.affiliation: Departamento Sistemas Biologicos, Universidad Autónoma Metropolitana-Xochimilco, Mexico.
authors.forename: José Raúl
authors.initials: JR
authors.lastname: Medina
authors.affiliation: Departamento Sistemas Biologicos, Universidad Autónoma Metropolitana-Xochimilco, Mexico.
authors.forename: Adrián Roberto
authors.initials: AR
authors.lastname: Padilla
authors.affiliation: Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico.
authors.forename: Marcela
authors.initials: M
authors.lastname: Hurtado
authors.affiliation: Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico.
authors.forename: Alma Rosa
authors.initials: AR
authors.lastname: Cortés
authors.affiliation: Departamento Sistemas Biologicos, Universidad Autonoma Metropolitana-Xochimilco, Mexico.
authors.forename: Adriana Miriam
authors.initials: AM
authors.lastname: Domínguez-Ramírez
mesh_terms: D007660:Ketoprofen / Q000737:chemistry*; D010602:Pharmacopoeias as Topic; D012995:Solubility; D013488:Suppositories
chemical_list: D013488:Suppositories; D007660:Ketoprofen