Formulation Evaluation and Optimization of Orodispersible Tablets of Pantoprazole Sodium by the using of Different Superdisintigrants

Abstract

The objective of this study was to formulate and optimize an orodispersible formulation of pantoprazole sodium using a 32 factorial design for optimized the superdisintigrant concentration. Various concentration (2%,4%,6%) of superdisintegrants (SSG, CP) were added in formulation, all processing steps are carried out at temperature below 250C and relative humidity less than 35%. Procedure to manufacture orodispersible tablets by direct compression was established. The results show that the presence of a superdisintegrants is desirable for orodispersion. The best optimized batch found was the batch having amount of crosspovidone 4.37 mg and SSG 10.59 mg. All the formulations satisfied the limits of orodispersion with a dispersion time of less than 30 sec. Best formulation showed a disintegration time of 30 sec, % friability is 0.82%, drug content of 96 to 99.4 and fast drug release rate of 80% of drug release within 10 min. The optimized batch was evaluated for thickness, weight variation, hardness, friability, disintegration time dissolution and accelerated stability study for period of 3 months. The similarity factor was calculated for comparison of dissolution profile before and after stability studies. The f2 value was found more than 50 that indicate a good similarity between both the dissolution profiles. Hence, the results of stability studies reveal that the developed formulation has good stability.

Keywords: Pantoprazole sodium, Orodispersion, Crosspovidone, SSG, Factorial design

Cite this Article Chundawat Lokendra Singh, Wadhwa Shailendra. Formulation Evaluation and Optimization of Orodispersible Tablets of Pantoprazole Sodium by the using of Different Superdisintigrants. Research & Reviews: A Journal of Pharmacology. 2017; 7(3): 11–20p.