Formulation, Optimization And Evaluation Of Novel Biomaterial As A Sustained Release Excipient

Abstract:

Natural materials have been gaining lot of interest in the field of drug delivery because they are readily available, cost effective, eco-friendly, capable of multitude of chemical modifications, potentially degradable and compatible due to their natural origin. The present study was an attempt to evaluate the natural Samanea saman seed gum (SSSG) as a novel persistent release excipient in tablet dosage form. The gum powder was evaluated for different physicochemical properties as per Indian Pharmacopoeia standards. The water uptake study was performed by capillary method, surface morphology and crystallinity of gum was studied by using scanning electron microscopy (SEM) and X-Ray diffraction (XRD) respectively and drug-excipient interaction was studied by FTIR. Matrix tablets of Valsartan, as model drug, were formulated by wet granulation method. PEG 4000 was used as pore former in combination with SSSG for the controlling drug release profile. A 32 full factorial design was applied with SSSG and PEG 4000 as independent variables while the percent drug released in 12 hrs and the time required for a given 50% of drug to be released (t50%) were selected as dependent variables. The developed matrix tablets were evaluated for post compression and in-vitro drug release kinetics and all results passed as per IP standards. All the formulations developed were found to follow zero order drug release kinetics. The drug release retardation was observed with an increase in the SSSG concentration and decreased concentration of PEG 4000. The similarity factor (f2) was calculated for optimized batch considering mean in vitro drug release data of marketed Valsartan SR tablet as a reference standard. It is concluded that the desired drug release pattern can be obtained by using optimized combination of SSSG and PEG 4000.Keywords: Valsartan, Matrix Tablet, Samanea Saman Seed Gum, Sustained Release, Optimization, Factorial Design.

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