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Comparative Study on Effect of Natural and Synthetic Superdisintegrants in the Formulation of Fast Dissolving Tablets containing Promethazine Hydrochloride

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Upendra Prajapati, Akash Yadav*, Dinesh Kumar Jain
» doi: 10.48047/ecb/2023.12.si12.004

Abstract

Objective: To formulate promethazine HCl as fast dissolving tablets (FDTs) by using different natural and synthetic superdisintegrant. Methods: An attempt was made to extract the Plantago ovata (ispaghula) mucilage, Aegle marmelos (bael) mucilage, dehydrated banana powder and evaluated it for various physicochemical characterizations. The swelling index, melting point, moisture absorption, loss of drying, stability, pH was determined respectively. FDTs of promethazine hydrochloride was formulated by direct compression technique using different concentration (5-15%) of Plantago ovata (ispaghula) mucilage, Aegle marmelos (bael) mucilage, dehydrated banana powder as natural superdisintegrant, and compared with renowned and sodium starch glycolate as synthetic superdisintegrant. The formulated tablets were evaluated for post-compression parameters like thickness, hardness, friability, weight variation, wetting time, content of active ingredient (%), in-vitro disintegration, in-vitro dispersion, and in-vitro dissolution. Result: The formulated tablets were evaluated for various physical tests like weight variation, friability, hardness, thickness and results complied with the limits. Among all the formulations F3 containing Plantago Ovata with a concentration of 15% produce the least disintegrating time 18.80 sec and dispersion time 29.32 resulting in higher drug release rate 95.43% in 12 minutes. Hence it is considered an optimized formulation. The present study revealed that the Plantago ovata as a natural superdisintegrant showed better disintegrating properties than the most widely used synthetic superdisintegrant like sodium starch glycolate in the formulation of FDTs. Conclusion: The result suggested that the Plantago ovata act as a good super disintegrating agent.

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