Umesh Barabde

Background

About Umesh Barabde

Professional with rich experience in drug product development and CMC for NCE phase-1/2/3, ANDA (P1/2/3/4), 505b2, which includes solid oral controlled release multiparticulate systems using Wurster coating process, sustained release reservoir and matrix tablets and immediate release dosage forms.>Development of products based on lyophilisation technology >Leading a group of scientists developing Novel Drug Delivery Systems for regulated markets.>Scale-up, technology transfer and execution of pivotal batches.>Trouble shooting in formulation and process at commercial scale >Patent analysis for non-infringement in product development >Understanding of polymorphism with respect to drug delivery development, solubility enhancement of water-insoluble drugs and relationship of physicochemical characteristics of pharmaceutical solids with respect to their drug delivery application. Specialities: Conceptualization and Development of following oral dosage forms using QbD approach:>Matrix based (Tablets and Pellets)>Multiparticulate systems based on Extrusion-Merumerization technique, Rotory granulation/coating and Wuster Coating.>Good understanding of crucial aspects in multiparticulate coating and its application in scale-up.>Design and development of non-infringing formulation strategies for FTF.