QbD-based Formulation Optimization and Characterization of Polymeric Nanoparticles of Cinacalcet Hydrochloride with Improved Biopharmaceutical Attributes
Debashish Ghose, Chinam Niranjan Patra, Bera Varaha Venkata Ravi Kumar, Suryakanta Swain, Bikash Ranjan Jena, Punam CHOUDHURY, Dipthi Shree
Abstract
Objectives: The aim of the present work was to prepare QbD enabled optimization, and to improve the oral bioavailability of freeze-dried polymeric nanoparticles of cinacalcet hydrochloride manufactured by nanoprecipitation and ultrasonication methods using polymers PLGA, and poloxamer-188. Materials and Methods: drug release study. Results: drug release. The pharmacokinetic parameters of AUC and Cmax data for the optimized formulation increased 3- and 2.9-folds compared to the pure-drug suspension. Conclusion: The prepared polymeric nanoparticles formulation is an alternative delivery system for enhanced therapeutic efficacy and bioavailability potential of a model drug to manage long-term normocalcemia in patients with preliminary hyperparathyroidism.