Colon targeted tablets were prepared in two steps. Initially core tablets were prepared and then the tablets were coated by using different pH dependent polymers. Ethyl cellulose, Eudragit L100 and S100 were used as coating polymers. FT-IR studies were carried out to find out the possible interaction between the selected drugs and polymer. FT-IR studies revealed that there was no interaction between the selected drug and excipients. The pre-compression blend of all formulations was subjected to various flow property tests and all the formulations passed the tests. The tablets were coated by using polymers and the coated tablets were subjected to various evaluation techniques. The tablets passed all the tests. Among all the formulations F3 formulation was found to be optimized as it was retarded the drug release up to 12 hours and showed maximum of 97.57% drug release. It followed zero order kinetics mechanism. The ideal formulation was subjected to stability studies at 40°C/75%RH. The stability studies indicated that the formulation was stable and retained its pharmaceutical properties at 40°C/75%RH over a period of 1 month.
Keywords: Colon target, Ethyl cellulose, Eudragit L100 and S100, pH dependent polymers.
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/cm 2 .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.
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