FORMULATIONS DEVELOPMENT OF NON STEROIDAL ANTIENFLAMATUAR DRUGS IN THE BIOPHARMACEUTICAL CLASSIFICATION THAT WERE DETERMINED AS CLASS II FOR INCREASING THE SOLUBILITY
Project no. 1099 · Status: Kapanmış · 2017
Summary
In the development of a pharmaceutical dosage form, which have been continue both in industry and academia, development of new formulations in the biopharmaceutical classification system and in connection with this system. The biopharmaceutical classification system is based on the solubility in water of drug substances affect and intestinal permeability. This study aimed to compared the permeability and in vitro release properties of the commercial formulation of developing innovative formulations will increase the solubility of the ibuprofen active substance, identified as class II in biopharmaceutical classifications. The reason for was preferred the soft gelatin capsule dosage form using the microemulsion method, microemulsions are thermodynamically stable, increase the bioavailability of the active ingredients, have a transparent and very small droplet size, the soft gelatin capsule dosage forms are easy to swallow, haven’t taste, resistant to puncture and have a wide variety of colors and sizes. The purpose, methods was developed and validated in selected active ingredients by HPLC. İbuprofen’s solubility studies were done in various oil phases, surfactans, cosurfactans and buffers. After working with the solubility studies, triagle phase diagrams were drawn with specified compounds and formulation were decided. Thermodynamic stability studies of study results was determined stable formulation was not observed phase separation and examined physicochemical properties of this formulation. The amount of ingredients of the microemulsion formulation was preformed by HPLC. The active ingredient of ibuprofen, developed soft gelatin capsule dosage form using the microemulsion method was studied similarity (f1) and difference (f2) in-vitro release studies and compared with the commercial formulation. In-vitro permeation studies were carried out with the Caco-2 cells for absorption studies of active ingredient of ibuprofen, the microemulsion formulation and commercial formulation. Key words: İbuprofen, emulsion, microemulsion, in-vitro permeability, in-vitro release, f1 and f2 test.