Formulation and assesement of domperidone fast dissolving tablets using natural superdisintegrants

Abstract

Current research is focused on development and optimization of fast dissolving tablets of Domperidone by applying 32
factorial
designs. Direct compression method was used. Two factors as independent variables (X1-amount of β-cyclodextrin and X2-
amount of Lepidium Sativum mucilage) were taken with three levels (+1,0,-1). The levels of two factors were selected on the
basis of preliminary experiments conducted and their effect on three dependent variables (disintegration time, wetting time and in
vitro drug release) was estimated. All the active blends were evaluated for precompression parameters (angle of repose, bulk
density, carr’s index, hausner’s ratio) and formulated tablets were evaluated for post compression parameters (hardness, friability,
weight variation, wetting time, disintegration time, water absorption ratio) and In vitro drug release studies. The software Design
Expert (8.0.7.1) was used for generating experimental design, modeling the response surface and calculating the statistical
evaluation. The optimized batch was further evaluated for SEM and accelerated stability studies. Tablet parametric tests of
formulations (F1-F9) were observed within prescribed limits. DT was observed in the range from 15±2 to 42±4 sec and WT from
19±2 to 44±3 sec for formulation batches (F1-F9). Batch F6 was observed as promising batch with DT values of 15 sec and in
vitro drug release (94%) in 15 min. No remarkable changes were observed in batch F6 (physicochemical properties and in vitro
release profile) when kept for 3 months at 40ºC and 75% RH conditions. This indicates good stability of the formulation even
after stressed conditions. Polynomial mathematical models, generated for various response variables using multiple regression
analysis were found to be statistically significant (p<0.05). Conclusion: An optimized combination of Lepidium Sativum mucilage
with β-cyclodextrin leads to successful development of fast dissolving tablets of Domperidone.