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OPTIMIZATION OF FORMULATION PARAMETERS FOR LEUPROLIDE ACETATE LOADED DRUG DELIVERY SYSTEM

Sandhya Pittala, Dr. Vedula Girija Sastry, Dr.N.Selvasudha*, Dr.K.Ruckmani

Leuprolide acetate is peptide indicated for many cancers especially prostate cancer. It has disadvantages like higher solubility, instability and low drug loading during formulation. The objective of this study was to evaluate the effect of process (homogenization speed and evaporation type and time, temperature) and formulation (surfactant type and concentrations) variables on the preparation of leuprolide acetate loaded PLA microparticles using double emulsion solvent evaporation technique. The best formulation was selected on the basis of particle size and drug loading. The final formulation was also characterized for its morphology and interaction pattern through FT-IR and DSC. It was observed that the formulation consists of 0.15% of Poloxamer 188( minimal surfactant concentration), cooled below 15°C with high external phase volume, high stirring speed with extended time of stirring with overhead evaporation was effective. The lyoprotectant mannitol with 0.1 and 0.15% concentration had good dispersability with no aggregates. Thus, it was concluded that the particle size of the microparticles could be reduced further and the leuprolide loaded microspheres could be adjusted to nanosize using above optimized conditions. Keywords: Leuprolide acetate, microparticles, poloxamer 188, lyoprotectant.

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