Development and Evaluation of Diclofenac sodium Controlled Release Dosage Forms Using Natural, Hydrophilic and Hydrophobic Polymers and its Comparative Studies

Abstract:

The aim of the present study is to develop the controlled release dosage form of diclofenac using hydrophilic polymers (xanthan gum from natural origin, hydroxy propyl methyl cellulose K 100M from semisynthetic origin) and hydrophobic polymer (compritol 888 ATO from synthetic origin). Diclofenac sodium matrix tablets were prepared by xanthan gum and hydroxy propyl methyl cellulose by wet granulation method. Hot melt granulation method was used for compritol as it was insoluble polymer. Fourier transform infrared spectroscopy (FTIR) analysis, differential scanning calorimetry (DSC) and X-Ray diffraction (XRD) studies indicated that there was no interaction between drug and polymers. Matrix tablets were formulated according to formulae and evaluated the suitability for controlled release systems for 24 h. Tablets prepared with xanthan gum, hydroxy propyl methyl cellulose and compritol matrix tablets showed zero order drug release. The hardness for all the formulations found to be in the range of 4-5 kg/cm2. The friability values of all formulations were found to be less than 1 %. The drug content of each individual preparation was found to be within the specified limits of the stated amount of diclofenac sodium. XGD4, HPD4 and CD2 formulations were considered as optimum formulations for oral controlled release of diclofenac sodium.

Key words: Diclofenac sodium, Hydroxy propyl methyl cellulose K 100M, Xanthan gum, controlled release dosage forms, Compritol 888 ATO.