Formulation and Optimization of Doxofylline Controlled Porosity Osmotic Pump Tablets by Fractional Factorial Design

Author(s): B. Bhagya and Shayeda*

Abstract: Objective: The objective of this study was formulation and optimization of doxofylline Controlled Porosity Osmotic Pump Tablets by using Fractional Factorial design with an aim to achieve zero-order release and to reduce dosage frequency. Methods: Doxofylline core tablets were formulated with Hydroxy Propyl Methyl Cellulose K100M, Polyvinyl Pyrrolidone K30 and Potassium chloride, sodium chloride as Osmogens. Core tablets were coated with Cellulose Acetate as Semi-permeable membrane, Sorbitol and Polyethylene Glycol 400 as pore-forming agents. Formulations were optimized by using Fractional Factorial design, with the effect of formulation variables like a different ratio’s of osmogens and polymer concentration in the core tablet. Eight formulations were developed and evaluated for physicochemical Parameters and in-vitro drug release. Results: From the in-vitro dissolution data formulation DF1 batch was optimized showing 100.0± 0.64 % drug release in 24 hrs and exhibited zero order kinetics. The release was independent of the pH and agitational intensity. SEM studies showed the formation of pores in Semi-permeable membrane. Conclusion: Optimized Doxofylline Controlled Porosity Osmotic Pump Tablets were formulated, and zero order release rate was obtained. From the studies we can conclude that increase in polymer concentration drug release was decreased and with increase in concentration of osmotic agent increased drug release rate was observed which indicates the mechanism of drug release was due to osmotic pressure created by osmotic agent.

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