Pharmaceutical Non-Sterile Liquid Dosage Form Development, Scale-up & Manufacture

This 2-day intensive course is designed to provide a set of theoretical and practical tools for those interested in working with non-sterile pharmaceutical Liquid formulation development either for prescription or OTC drugs such as cough syrups, elixirs, expectorants, mouth washes, irrigation fluids for external use, nasal inhalation solutions, ear drops, eye drops, rectal preparations (Enemas), emulsions, creams, gels and solutions. The participant will learn how to determine and evaluate the criteria for the selection of right raw materials and manufacturing processes needed to create stable liquid Dosage Forms products, and to effectively solve problems arising during development. Troubleshooting existing commercial product problems will be emphasized. The theoretical underpinnings of various types of liquid aqueous, organic, micellar and suspension behavior will be described to provide a backdrop for discussions of specific emulsifying and suspending systems. Current methods to analyze the behavior of dispersed phases will be described, as will methods to measure and predict stability of the products. Processing and scale-up issues specific to the type of equipment needed to create uniform, homogenous liquids, dispersed phases will also be discussed. Key emphasis will be placed on application of recent (QbD) principles and (PAT) in the formulation, development and scale up. Risk analysis tools will be discussed along with key principles of process validation, technology transfers and clinical manufacturing.