Formulation development and Optimization of Diclofenac Sodium Extended release Matrix tablets as per USP standards.

Authors

  • S Edavalath Pharmaceutics Research Laboratory. Nehru College of Pharmacy (India)
  • M Shan Pharmaceutics Research Laboratory. Nehru College of Pharmacy (India)

Keywords:

Diclofenac sodium, Extended release matrix tablet, Optimization, Drug release kinetics

Abstract

Aim: To formulate Diclofenac sodium extended release tablets as per the standards given for extended release tablets of Diclofenac sodium in USP.

Materials and Methods: The extended release tablets of Diclofenac sodium was prepared by using different concentration of polymers such as hydroxyl propyl methyl cellulose sodium K4M (HPMC K4M) and hydroxyl propyl methyl cellulose sodium K15M (HPMC K15M). The drug polymer interactions were studied by using Fourier transform infrared (FT-IR) spectroscopy. The in vitro drug release and drug release kinetic studies of all the formulations were performed and compared with the marketed product Fenac SR. The optimization done by considering the factors such as drug release limit given as per USP standard, t50% and release exponent (‘n’ value as per Korsmeyer Peppas).

Results and Conclusions: The FT-IR spectroscopy studies revealed that there was no interaction between drug and excipients. The drug release observed that it depends on the concentration and nature of the rate controlling polymers used. The ANOVA studies revealed that the formulations show significant effect in drug release. The optimization studies proved that the formulation containing drug, polymer (HPMC K4M) ratio of 1:1.5 (Formulation M3) is the most satisfactory formulation. The stability studies proved that the formulation is stable.

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Published

2012-03-20

How to Cite

1.
Edavalath S, Shan M. Formulation development and Optimization of Diclofenac Sodium Extended release Matrix tablets as per USP standards. Ars Pharm [Internet]. 2012 Mar. 20 [cited 2025 Jan. 5];53(1):05-10. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/4656

Issue

Vol. 53 No. 1 (2012)

Section

Original Articles

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