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Influence of Kollidon SR on Ondansetron HCl pH Independent Drug Release from Hydroxypropyl Methyl Cellulose Matrix Tablets
Abstract
The Polymers are tools used in novel drug delivery system to modify the drug release of pharmaceutical dosage form. Ondansetron HCl is a weakly basic drug belongs to BCS class-II; it is showing distinct pH dependent solubility. The major intention of the current study was to develop a pH independent controlled released system for pH dependent poorly soluble Ondansetron HCl. The effect of combination of polymers on parameters like release pattern, release mechanism of the drug were studied. A 32 full factorial design was used to study the effect of Kollidon SR on Ondansetron HCl Drug Release from Hydroxypropyl Methyl Cellulose Matrix Tablets. The release rate from formulated matrix tablets was studied at both SGF (pH 1.2) and SIF (pH 6.8). Drug release from Kollidon SR and Methocel (1:1) based matrix system based tablets was found to pH independent controlled drug release up to 24h with >90% drug release. Kollidon SR has a distinctive character of maintaining tablets geometric shape until the end of dissolution test, this is mainly due to the water insoluble content, polyvinyl acetate, forming 80% (w/w) of Kollidon SR, while the remaining content 20% (w/w) is the water soluble, polyvinylpyrrolidone, responsible for pore formation causing a diffusion controlled release The similarities in Release profiles were evaluated by applying the model independent (f2) similarity factor. The Optimized formulation characterized by DSE, X-RD and FT-IR studies was found not having any interaction with polymer and drug. The Optimized Formulation followed zero order with non-Fickian diffusion method. In conclusion, Kollidon SR and Methocel k100 were found to be novel potential candidates for the development of pH independent controlled delivery system of Ondansetron HCl.
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