Formulation and Evaluation of Fast Dissolving Tablets of Trimetazidine Dihydrochloride Using Natural and Synthetic Superdisintegrants

Plant products serve as an alternative to synthetic products because of local accessibility, eco friendly nature and lower price compared to imported synthetic products. Natural gums and mucilage have been widely explored as pharmaceutical excipients. Tablet disintegration has received considerable attention as an essential step in obtaining fast drug release. The present work was carried out to study the disintegration properties of Plantago Ovata mucilage powder by formulating orally disintegrating tablets of Trimetazidine hydrochloride by direct compression method. Disintegrant property of above disintegrants was evaluated by comparing their formulations with the formulations of various superdisintegrants extracted Mucilage was subjected to toxicity studies for its safety and preformulation studies for its suitability as a disintegrating agent. The extracted mucilage is devoid of toxicity. No chemical interaction between drug and excipients was confirmed by FTIR and DSC studies. Mouth dissolving tablets of Trimetazidine hydrochloride were prepared and compared with different concentrations viz; 0.5, 1, 1.5, 2.0 and 2.5% (w/w) of Plantago Ovata mucilage powder, cross carmellose sodium and sodium starch glycolate. Thirty six formulations were prepared by using different diluents and evaluated for physical parameters such as thickness, hardness, friability, weight variation, drug content, disintegration time and drug dissolution. The formulated tablets had good appearance and better drug release properties. The study revealed that Plantago Ovata mucilage powder was effective as disintegrant in low concentrations (1%). The mucilage was found to be a superior disintegrating agent than sodium starch glycolate and cross carmellose sodium. Studies indicate that the extracted mucilage may be a good source of pharmaceutical adjuvant, specifically a disintegrating agent.