Application of Response Surface Methodology and Central Composite Design to Study the Effect of Polymers on Floating and Bioadhesive Gastroretentive Matrix Tablet

Author(s)

Mathew, S. M., Menon, A., Nair, S. K.

Author's Affiliation

Abstract

The main objective of this study was to develop a gastroretentive dosage form of Atorvastatin calcium with bioadhesion and floating properties. Thirteen matrix tablets were formulated using different ratios of hydroxypropylmethylcellulose (HPMC K4M) and Moringa gum as release controlling agent. Also Sodium bicarbonate (NaHCO₃) was used as gas generating agent. The study discussed the application of Central composite design (CCD) as a design of experiment and response surface methodology (RSM) for the optimization of process parameters i.e. concentration of Moringa gum and HPMC K4M, affecting the drug release, floating and mucoadhesive properties. The range of values of the independent variable used in the design were, f_lag time of as minimum as possible, mucoadhesive strength of  >  20 g, drug release at 2 h of 15% to 20% and drug release at 8 h of 60% to 65%. The Predicted values were found to be in good agreement with experimental values (r² values of 0.9938, 0.9894, 0.9977 and 0.9939 for f_lag time, mucoadhesive strength, drug release at 2 h, drug release at 8 h respectively). Drug release profiles of all formulations followed zero order rate kinetics with non- fickian diffusion mechanism. The magnitude of the coefficient of correlation of the fitted quadratic equations revealed that both Moringa gum and HPMC K4M has negative effect on the floating lag time and drug release profile, and positive effect on mucoadhesive strength. Statistical analysis revealed that tablets containing HPMC K4M (50 mg), Moringa gum (75 mg) i.e. formulation F6 exhibits good floating properties, mucoadhesive strength and control release characteristics. From the study we can infer that the design of experiment and Response surface methodology could be used efficiently for the modelling of gastroretentive dosage form.

Keywords

Gastroretentive, Floating, mucoadhesion, central composite, Surface response methodology, Moringa gum, HPMC K4M, release kinetics

Cite This Article

Mathew, S. M., Menon, A., Nair, S. K. (2013). Application of Response Surface Methodology and Central Composite Design to Study the Effect of Polymers on Floating and Bioadhesive Gastroretentive Matrix Tablet. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(4), 254-265.