FORMULATION AND PREPARATION OF OMEPRAZOL AND KETOPROFEN BI-LAYER TABLETS BY DIRECT COMPRESSION METHOD

The aim of the study was to prepare and characterize bi-layer tablets containing ketoprofen and omeprazole in order to reduce the side effects of ketoprofen and to improve the therapeutic benefits and patients’ compliance to treatment. Bi-layer tablets of ketoprofen 100 mg and 20 mg omeprazole (in form of enteric pellets) were prepared by direct compression technique using carbopol, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, Kollidon ® as matrix-forming agents. These polymers have the ability to hydrate in digestive fluids and form a gel on the surface of the tablets undergoing erosion processes in time, in order to control the release of active drugs from compressed matrix tablets. Hardness, friability and release studies were performed on bi-layer tablets. The results have shown the influence of polymers over the physicochemical properties and the release profile of the active drugs. Rezumat Obiectivul studiului a fost prepararea si caracterizarea unor comprimate dublu strat conţinând ketoprofen si omeprazol cu scopul de a reduce reacţiile adverse la nivel gastrointestinal ale ketoprofenului si de a imbunătăţi beneficiile terapeutice si complianţa pacientului la tratament. S-au preparat comprimate dublu strat ce conţin 100 mg ketoprofen si 20 mg omeprazol (sub formă de pelete) prin metoda comprimării directe, utilizând ca polimeri formatori de matriţă carbopol, carboximetilceluloză sodică, hidroxipropilmetilceluloză, Kollidon ® care au capacitatea de a se hidrata in lichidele digestive si de a forma la suprafaţa comprimatelor un gel care suferă procese de erodare in timp, astfel incât vor controla eliberarea din matriţă a substanţelor medicamentoase. S-a determinat duritatea si friabilitatea si s-a efectuat testul de dizolvare pe comprimatele dublu strat. Rezultatele obţinute au arăt influenţa polimerilor asupra proprietăţilor fizico-chimice si a profilului de eliberare a principiilor active.