Formulation, evaluation and in vitro characterization of gastroretentive floating tablet of diclofenac sodium

Pak J Pharm Sci. 2019 Nov;32(6):2573-2578.

Abstract

Currently a variety of tools and techniques are used to deliver complex medicines. Whereas, certain advanced methods assure the safety and usefulness by regulating the pharmacokinetic and pharmacodynamic. Thus, we aimed this study to develop a novel gastro retentive floating tablets. The formulation was designed to provide the desired controlled and complete release of drug for prolonged period of time. The formulations were evaluated for physical characterization. The obtained results of hardness (4.6-5.1), friability (0.20-0.43%), weight variation (350 ±2 - 350±5) and in vitro buoyancy were found within official limits of United Stated Pharmacopoeia (USP). Whereas, the F-7 showed most optimized intra gastric floating characteristics and exhibited 93.87% release of diclofenac sodium in 9 hours. The Floating Lag Time of 8 minutes and Total Floating Time >12 hours were recorded. In-vitro drug release kinetics evaluated using the linear regression method was found to follow the Zero Order and Peppas model for the release of both the drugs. DSC thermograph and FTIR spectra depicted that there was no chemical incompatibility between drugs and polymers. In conclusion the desgined tablet can be use in clinical practice as model drug. Because, the pre-compression and post-compression parameters were satisfactory and within desired limits.

MeSH terms

  • Delayed-Action Preparations / administration & dosage
  • Delayed-Action Preparations / pharmacokinetics
  • Diclofenac / administration & dosage*
  • Diclofenac / pharmacokinetics
  • Drug Compounding / methods*
  • Drug Liberation
  • Humans
  • Spectroscopy, Fourier Transform Infrared
  • Tablets

Substances

  • Delayed-Action Preparations
  • Tablets
  • Diclofenac