29. April 2017

Abstract Thoughtfully designed early clinical formulations not only meet the needs of the study at hand and inform the development of the commercial product, but can influence the direction of the clinical program as well as provide further guidance to potential backups still in exploratory stages. This chapter focuses on the various types of early clinical formulations, why they are developed, and how the preclinical formulation space helps to guide initial clinical formulation selection....

14. December 2016

Purpose: To validate a new and simple method for cleaning a manufacturing line for creams and ointments. Methods: The worst case product of the line chosen was a cream containing three practically insoluble ingredients: betamethasone, tolnaftate and cliquinol. The cleaning method utilized hot water and a commercial detergent, followed by rinsing. Validation methods included the visual inspection of the machine surface, swab sampling, microbial bioburden determination and testing the final rinse...

29. February 2016

The relevance of solid form in drug development has been well established over time. In order to fully understand drug properties, attention has been paid to solid state structure of drug molecules and their relationship to the drug formulation. While each drug developer has had their own strategies and workflows for screening and choosing solid forms of drug molecules, the industry is aware of instances where “the best laid plans” often go awry. This manuscript has summarized several case...