Development, Optimization and Evaluation of Fast Dissolving Repaglinide Tablet Using Synthetic and Natural Superdisintegrants.

Abstract

The main objective of this research was to formulate and evaluate Repaglinide mouth-dissolving tablets for the treatment of type 2 diabetes utilising both synthetic and natural superdisintegrants. Methods: In this study, we prepared the mouth-dissolving tablet Repaglinide (Prandin) using direct compression with synthetic and natural superdisintegrants. The tablets were tested for friability, hardness, disintegration, wetting time, in vitro drug release, and drug content. Crospovidone was used to make formulas S1, S2, and S3, while fenugreek seed mucilage was used to prepare formulas N1, N2, and N3. The batches (formulations F1 to F6) of the combination of crospovidone and fenugreek seed mucilage were prepared. Assessment parameters such as friability, hardness, disintegration, wetting time, in vitro drug release, and drug content were evaluated. Results: The calibration curve of a pure drug was plotted, and the values of the precompression parameter evaluated were within the prescribed limit. All the prepared formulations were subjected to various assessment parameters, and the findings obtained were within the prescribed limit. The disintegration times for formulations N1, N2, and N3 were longer than those for formulations S1, S2, and S3, indicating that using a natural superdisintegrant alone may not be enough to provide a quicker release of the medication from the tablet. The effect of fenugreek seed mucilage at 5 mg (formulation N1) was insignificant on disintegration time. Trial batches (formulations F1 to F6) of the combination of crospovidone and fenugreek seed mucilage were prepared using fenugreek seed mucilage at two levels (10 mg and 15 mg). The S3 formulation's dissolution profile was compared to that of the F3 and F6 formulations to compare the effects of the superdisintegrant (crospovidone, 10 mg) with the combination of crospovidone and fenugreek seed mucilage on drug release. The addition of fenugreek seed mucilage reduced the requirements of crospovidone to achieve similar drug release in batches F3 and F6. Conclusion: The results obtained in the research work clearly showed that the formulation (F3) showed that the addition of natural disintegrants (fenugreek seed mucilage) reduced the requirements of synthetic superdisintegrants (crospovidone) to achieve similar drug release.