FORMULATION AND EVALUATION OF CONTROLLED RELEASE MATRIX TABLETS OF FINASTERIDE
Journal Title: International Journal of Pharmaceutical Development & Technology - Year 2014, Vol 4, Issue 1
Abstract
The aim of the present investigation was to develop oral controlled release matrix tablet formulations of Finasteride using Eudragit and Hydroxypropyl methylcellulose (HPMC) as a hydrophilic release retardant polymer and to study the influence of various formulation factors like proportion of the polymer, polymer viscosity grade, compression force, and release media on the in vitro release characteristics of the drug. The formulations were developed using dry granulation technology. The in vitro release studies were performed using US Pharmacopoeia type 1 apparatus (basket method) in 900 mL of pH 6.8 phosphate buffer at 100 rpm. The release kinetics was analyzed using Korsmeyer–Peppas model. The release profiles found to follow Higuchi’s square root kinetics model irrespective of the polymer ratio and the viscosity grade used. The results in the present investigation confirm that the release rate of the drug from the Eudragit matrices is highly influenced by the drug/Eudragit ratio and viscosity grade of the Eudragit. Also, the effect of compression force and release media was found to be significant on the release profiles of Finasteride from Eudragit matrix tablets. The release mechanism was found to be anomalous non-Fickian diffusion in all the cases. In the present investigation, a series of controlled release formulations of Finasteride were developed with different release rates and duration so that these formulations could further is assessed from the in vivo bioavailability studies. The formulations were found to be stable and reproducible. The results of dissolution studies indicated that the formulation F9 (containing Eudragit as polymer) is the most successful of the study. On increasing polymer ratio a decrease in release rate of the drug was observed after lag time. The optimized formula F9 was best fitted formulation.
Authors and Affiliations
Nagalaxmi V , Mahipal Reddy L , Manikanta Kumar A , Manjunath Shetty KS
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