Formulation Development and Evaluation of Doxofylline Sustained Release Tablets

Raghavendra KUMAR GUNDA*º, Jujjuru Naga Suresh KUMAR*

* Department of Pharmaceutics, Narasaraopeta Institute of Pharmaceutical Sciences, Narasaraopet, Guntur (Dt), Andhra Pradesh, India-522601

° Corresponding Author;
M.Pharm.,(Ph.D), Assistant Professor, Department of Pharmaceutics,
Narasaraopeta Institute of Pharmaceutical Sciences,
Narasaraopet, Guntur (D.t), A.P. India-522601.
E-mail: raghav.gunda@gmail.com,
Mob: +91-9666705894

Summary

The main objective of present research investigation is to formulate the sustained release tablet of Doxofylline using 32 factorial design. Doxofylline, an anti-Asthmatic agent, belongs BCS class-III agent. The SR tablets of Doxofylline were prepared employing different concentrations of HPMC K100M and Chitosan in different combinations by Direct Compression technique using 32 factorial design. The concentration of Polymers, HPMC K100M and Chitosan required to achieve the desired drug release was selected as independent variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables. Totally nine formulations were designed, Formulated and are evaluated for hardness, friability, thickness, % drug content, In-vitro drug release. From the Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept, slope & regression coefficient were calculated. Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F4) containing combination of 10% HPMC K100M and 15% Chitosan, is the most similar formulation (similarity factor f2= 64.501, dissimilarity factor f1= 6.862 & No significant difference, t= 0.23001) to marketed product (DOXOLIN). The selected formulation (F4) follows Zero order, Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion anomalous Super Case-II Transport (n= 0.963).

Key Words :
Doxofylline, 32 Factorial Design, Sustained Release Tablet, HPMC K100M ,Chitosan, SUPAC,