Bioadhesive-floating matrix tablet of salbutamol sulphate using response surface methodology: optimization and in vitro evaluation


Bioadhesive-floating matrix tablet of salbutamol sulphate using
response surface methodology:
optimization and in vitro evaluation
Girish S. Sonar*, M. R. P. Rao, R. R. Mandsaurwale, Vishal K. Gogad, Swapnila D. Vanshiv.
AISSMS College of Pharmacy, Department of Pharmaceutics, Kennedy Road, Near RTO, Pune - 411 001, India.
Received on: 12-09-2008; Accepted on: 05-03-2009

ABSTRACT

The purpose of this research was to develop and optimize Bioadhesive-Floating Drug Delivery system (BFDDS) for salbutamol sulphate, which is absorbed from the upper part of GIT. A 23 full factorial design was applied to systematically optimize the drug release profile and bioadhesive force, with total polymer-to-drug ratio (X1), polymer-to-polymer (X2) and polymer grade (X3) as independent variables. The percentage drug release after 8 h, time required for 50 % drug dissolution (t50%) and bioadhesive force (f) were kept as dependent variables. Hydroxypropyl methyl cellulose (HPMC) of different viscosity grades and Carbopol 940P (CP940) were used in formulating the gastroretentive bioadhesive-floating drug delivery system. Response surface plots were drawn, and optimum formulations were selected by grid search method. Regression analysis and numerical optimization were preformed to identify the best formulation. It was found  that HPMC, Carbopol and their interaction had significant impact on the release and bioadhesive properties of the delivery system. The decrease in the release rate was observed with an increase in the viscosity of the polymeric system but at higher concentration HPMC; different grades of HPMC (K4M and K100M CR) did not significantly affect the release profile. Kinetic treatment of dissolution profiles revealed that drug release ranges from anomalous transport to super case (II) type. The observed difference in the drug release and the bioadhesive properties of BFDDS could be attributed to the difference in the basic properties of three  polymers (HPMC K4M, K100M CR and CP940) due to their water uptake potential and functional group substitution. The predicted values agreed well with the experimental values, and the results demonstrate the feasibility of the model in the development of bioadhesive-floating drug delivery system.

Keywords: Salbutamol sulphate, bioadhesive-floating, ex-vivo bioadhesive studies, response surface methodology

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