FORMULATION AND EVALUATION OF SUSTAINED RELEASE DICLOFENAC SODIUM MATRIX TABLETS USING NATURAL POLYMER
Mohammed Salman Khaleel
Department of Pharmaceutics, Azad College of Pharmacy, Moinabad, Rangareddy, Andhra Pradesh, India.
Syed M. Faizi
Department of Pharmaceutics, Azad College of Pharmacy, Moinabad, Rangareddy, Andhra Pradesh, India.
The aim of this research was to investigate the technique for preparation and maximize the therapeutic efficacy, reduce frequency of administration, and improve patient compliance of Diclofenac Sodium sustained -release matrix tablet using different Natural Polymers. Diclofenac Sodium, being NSAID, its oral administration restricted due to its inherent pro blems. Hence in the present study, attempt has been made to design oral sustained release matrix tablets of Diclofenac Sodium using Polymers such as Metolose SR, Sodium Carboxy Methyl Cellulose (SCMC), Sodium Alginate and Combination of these polymers. And to study the effect of various process and formulation variables like polymer properties and polymer viscosity on in-vitro release of drug. Diclofenac sodium dose ranges from 100-200 mg twice or thrice daily. So there is a commercial utility of controlled release once daily tablets of Diclofenac sodium for better therapeutic efficacy, patient compliance and other advantages. The tablets were evaluated for preformulation studies like angle of repose, bulk density, compressibility index. Physical characteristics of the fabricated tablet like hardness, weight variation, friability and drug content were found to be within the acceptable limits. The diclofenac sodium matrix tablet were prepared by wet granulation method, with a solvent such as Isopropyl alcohol, lactose was used as diluents, Magnesium Stearate was used as lubricant and PVP K-30 was used as Binder. In-vitro release of drug was performed in Simulated Gastric Fluid (SGF) pH-1.2 for two hours and Simulated Intestinal Fluid (SIF) pH-7.4 for subsequent 10 hours by USP-I dissolution apparatus, in 900 ml at 37.5±0.5 o C (stirring speed was 70 rpm). SCMC and Sodium alginate exhibited greater drug content than Metolose SR. A better sustained drug release (98.53) was obtained with the matrix tablet (F-12) made-up of the SCMC and Sodium Alginate than with Metolose SR and Sodium Alginate. It is cleared through the dissolution profile of Diclofenac sodium from matrix tablets prepared using different polymers were indicated an increase in the polymer ratio retarded the drug release to a greater extent.
4 , 2 , 2014
99 - 107