FORMULATION EVALUATION AND OPTIMIZATION OF EXTENDED-RELEASE CORE OSMOTIC PELLETS OF GALANTAMINE HYDROBROMIDE

Extended-release systems provide drug release in an amount sufficient to maintain the therapeutic drug level over an extended period, with the release profiles predominantly controlled by the special technological construction and design of the system itself NACL is most commonly used as an osmotic agent in the osmotic drug delivery systems, thus was selected. The batches of core pellets were taken with different sodium chloride concentration range. Pellets without sodium chloride were prepared in the same way with sodium chloride being replaced by lactose

After analysis of reference product release profile, it was decided that the drug release should be controlled in the pH 4.5 buffer. Few important attributes from the reference product were to release the drug at zero order release kinetics in pH 5.8 phosphate buffer. Optimized formulation as well as reference product had a split- release profile having mixed type of release kinetics. The formulation was studied for the effect of medium osmolality on drug release by varying the concentration of osmotic agent in dissolution medium. It was found that drug release was decreased linearly with an increase in the medium osmolality

The surface of the optimized formulation was studied before and after dissolution study by scanning electron microscopy. Pores were not seen in the membrane before exposure to the release medium, but several pores or voids were found in the membrane after drug release. suggests that the membrane became porous after exposure to the medium due to the leaching of plasticizers from the membrane. Kinetics of drug release of optimized.

Keywords: Extended-release systems, Galantamine Hydrobromide Core Osmotic Pellets.