FORMULATION AND EVALUATION OF CEFDITOREN PIVOXIL GRANULES FOR ORAL USE

Cefditoren pivoxil is used in the treatment of various bacterial infections. It exhibits a strong bitter taste on oral administration. Thus, there is a need that the bitter taste of cefditoren pivoxil should be minimized to such an extent that the oral administration of cefditoren pivoxil would be palatable to patients. The study reported here aimed to develop cefditoren pivoxil granules by dry granulation technique, characterize them for micromeritic properties, to mask the bitterness of the drug and undertake in vitro drug release studies. The pre-formulation studies were carried out using High Performance Liquid Chromatography method. This involved subjecting drug-excipient mixture to high temperature and humidity for a predetermined time. After the stress test the drug content was determined by using HPLC. The prepared granules were subjected to various evaluating parameters of dry its suspension. The optimized formulation showed satisfactory results, including micromeritic properties, taste masking effect and drug release. The dry syrup formulation developed using dry granulation technique, employing various flavouring and sweetening agents could effectively mask the unpleasant taste of the drug in comparison with marketed syrup formulation, while showing similar drug release profile to the marketed formulation.