Özet:

The present study was carried out with the objective of formulation and evaluation of a multi particulate drug delivery system of Tolterodine Tartrate microsponges by Quashi emulsion solvent diffusion method. The response surface methodology (RSM) with central composite design (CCD) was employed to study the effect of 5 independent variables including amount of rate retardant polymers (mg), internal phase volume (ml), emulsifier (W/V%) and Rotational speed (RPM) on the dependant variables production yield, drug entrapment, particle size, and % drug release at time interval of 1 st , 2 nd , 4 th and 8 th h . The results showed that the optimized quantities of formulation components for extraction of microsponges included rate retardants (Eudragit RSPO : 209.55 mg, HPMCK4M: 121.07 mg), internal phase volume( in equal ratio) that is(Dichloromethane : ethanol = 9.21 ml), emulsifier(Dibutyl phthalate:1.44 w/v%) and the process variable rotations per minute ( RPM): 750. In vitro release data obtained from the optimized formulation was fitted into various kinetic models. The optimized formulation showed desired % yield (94.90%), Drug entrapment (97.56%),Particle size(194.00 μm), cumulative % drug release at 1st, 2 nd, 4th and 8 th hr with 20.74%, 40.85%, 71.02%, and 91.02% respectively. Tolterodine Tartrate microsponge Tablets showed first order rate kinetics with Higuchi mechanism of diffusion process. Conclusion: Extended release tablets of Tolterodine tartrate microsponges were successfully developed by employing Quasi emulsion solvent diffusion technique. The response surface method with central composite design facilitated the formulation and optimization of modified oral drug delivery system of Tolterodine tartrate.

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