Formulation and Evaluation of Extended Release Matrix Tablets of Trimetazidine Dihydrochloride.

The present study was to formulate and evaluate once daily extended release matrix tablets of Trimetazidine Dihydrochloride using hydrophilic polymers Hydroxypropylmethylcellulose, Polyox, and natural polymer Xanthan gum. Trimetazidine has a half life 6 hrs and usual oral dosage regimen 0.5 mg and 60 mg daily. To reduce the frequency of administration and to improve patient compliance, a once-daily extended release formulation of Trimetazidine is desirable. The most commonly used method of modulating the drug release is to include it in a matrix system. Hydrophilic polymer matrix systems were widely used in oral controlled drug delivery because they make it easier to achieve a desirable drugrelease profile, they are cost effective and they have broad US Food and Drug Administration acceptance. Hence, in present work, an attempt has been mmade to develop once daily sustained release matrix tablets of Trimetazidine using putative hydrophilic matrix materials. The drug release for extended duration using a hydrophilic matrix system is restricted because of rapid diffusion of dissolved drug through the hydrophilic gel network. For such circumstances, hydrophobic polymers are suitable, along with a hydrophilic matrix for developing sustained release dosage forms.The present study was carried out to develop Trimetazidine dihydrochloride modified release matrix tablets in combination of three hydrophilic polymers for safe and effective action. Matrix tablets with HPMC K 200, Xanthan gum, Povidone were prepared by direct compression method and evaluated. Matrix is also done in order to achieve the release of drug as per expectation. The FT-IR spectroscopy study was carried out to know the preformulation and Compatibility of the excipients with Trimetazidine dihydrochloride, the active constituent of the formulation. Results were found no significance changes in characteristic peaks of drug in the recorded IR spectrum. These preformulation and compatibility study were confirmed the drug and other excipients in the formulation are compatible with each other.The Matrix tablets were prepared by Direct Compression Method. The angle of repose of the powder mixture was found to have 25 to 32. The flow property of the powder was excellent that was confirmed by the determination of angle of repose which indicates better uniformity of weight. Compressibility index (%) of formulations was observed between 12.782% to 18.252% that showed excellent compresibility.