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Development and Evaluation of Ketoprofen Mini-Matrices as Sustained Release formulation

M. Najmuddin, Razvi Fayaz Hafiz, M. Nizamuddin and M. S. Khalid

Mini-matrices (multiple unit dosage forms) with release sustaining properties were developed by simple extrusion (die cavity of 3 mm) using ketoprofen a NSAID as a model drug and hydrophilic (HPMC and xanthan gum), hydrophobic (ethyl cellulose) as a sustained release agents and 5% propylene glycol was selected as plasticizer with 10% lactose as channeling agent. In vitro drug release study was calculated for all the formulations and showed maximum drug release of 93.81% for mini-matrices (F15) having HPMC as polymer in a ratio of 1 : 2 with respect to drug along with plasticizer and channeling agent. The drug release has shown first order kinetics with diffusion release systems followed by erosion mechanism. The physico-chemical chracterization of mini-matrices were carried out by performing drug content, weight variation test, friability and uniformity of size. The FT-IR studies have showed no chemical interaction and drug was in an intact form. The SEM studies were carried out to confirm the plasticizing efficiency of propylene glycol. Short term stability studies of all the parameters were done at a temperature of 30 ± 2ºC and 65 ± 5% RH and these were stable upto 3 months.