Process Development and Industrial Manufacturing of Nanotechnology-Based Pharmaceuticals
E. Hassan, S. Gumudavelli
Pharmaceutics International Inc. (Pii), US
Keywords: nanoparticles, pharmaceutical process development, dissolution, manufacturing
Abstract:Process design and development of oral, topical and parentral nanotechnology-based pharmaceuticals are presented. Factors affecting process output and scale-up choices for various dosage forms are discussed with emphasis on critical parameter control and optimization. For example, effect of process variables on nanoparticles crystal form, shape, size, as well as nanoparticles stabilization, purification and yield are elaborated. Quality control testing and design of accelerated stability studies for nanoparticles-containing pharmaceuticals are detailed. Finally, integrating nanoparticles manufacturing equipment into conventional equipment trains used for large scale production of tablets, capsules as well as parentral and topical suspensions are demonstrated using selected model drugs.