ABSTRACT

Objective: The objective of the current research work was to prepare a taste-masked Orodispersible tablet of Nateglinide which improve patient compliance. Method: Taste Masked ion exchange resins were selected based on the preliminary studies and the process parameters of the Solvent evaporation method were also finalized by the same. 32 full factorial design was used for optimization. A mole of Kyron T-114 and % of Aspartame was taken as independent variables X1 & X2 respectively. % Drug release at 15 minutes, wetting time, Disintegration time, Water absorption ratio and Ability of taste masking were taken as dependent variables. Short term accelerated stability studies were performed for tablets prepared using optimized Orodispersible Tablet. Results and Discussion: Optimized batch composition had 1 Mole (49 mg) of Kyron T-114, 60 mg of Nateglinide and 3.31%(9.9 mg) Aspartame was prepared based on the values of the dependent variable of the design batches. All the evaluation parameters of the optimized batch met the acceptance criteria. The taste was improved as compared to pure Nateglinide. % In-vitro Drug release was found to be 94.40% at 15 minutes, In-vitro Disintegration Time 29 second and Taste masking as per taste panel gives the very slightly bitter for Optimized Orodispersible tablet. Stability data were also in the range of acceptance. Conclusion: A Taste masked Orodispersible tablet was developed successfully by the Solvent evaporation method. This method proved as a successful method for the development of Masking the bitter Taste of Nateglinide by using the ion exchange resin. Keywords: Nateglinide; Orodispersible Tablet; Solvent Evaporation Method; 32 Full factorial Design; Diabetes mellitus
Publication date: 01/02/2023

https://ijbpas.com/pdf/2023/February/MS_IJBPAS_2023_6837.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.2.6837