Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, India
Research Article
Development and Evaluation of Aerodynamic Particle Size Distribution of Inhalable Spray Dried Rifampicin Loaded Steric Acid-Chitosan Nanomicellar Micro-Composites Dry Powder Inhaler by Qbd Approach with Dual Analysis by TSI/ACI Deposition Study
Author(s): Ashwin J Mali*, Nirav J Javiya and Atmaram P Pawar
The present work deals with the development of spray-dried Rifampicin-Loaded Nanomicellar Micro Composites (RFP-NMC) by Quality by Design (QbD) approach. The RFP-NMC was prepared by oil in water emulsion solvent evaporation technique and optimized by the 3 full factorial designs. The stearic acid (X1) and chitosan (X2) were selected as Critical Quality Attributes (CQA’s) while particle size (Y1) and % drug content (Y2) as dependent factors. The data was represented by QbD Minitab software. The in vitro lung deposition of RFP-NMC was evaluated by Twin Stage Impinger (TSI) and by Andersen Cascade Impactor (ACI). Further, in vitro release was carried out by dialysis method in Simulated Lung Fluid (SLF) and cytotoxicity was assessed by MTT assay. The optimized formulation depicted a particle size of 5.85 µm ±.. View more»