Pharmaceutical Raman

This Wesnesday afternoon session will discuss Raman spectroscopy and the role it plays in pharmaceutical development, manufacturing, and characterization.

The first presentation in this session, “Application of Raman Spectroscopy to Solid-State Characterization of Active Pharmaceuticals during Early Drug Development,” will be presented by Sachin Lohani of Merck & Company. The presentation will focus on using Raman to monitor solid-state transformation when x-ray powder diffraction (XRPD) analysis fails.

Olof Svensson of Pharmaceutical & Analytical R&D will present “Rapid Development of Quantitative Calibrations for Pharmaceutical Formulations Using Transmission Raman and Multivariate Curve Resolution” next. In this presentation the use of excipient reference spectra and libraries in combination with multivariate curve resolution (MCR) will be shown and compared with PLS for quantitative analysis of API in tablets. The possibility to use transmission Raman spectroscopy for quantitative measurements in early phase formulation development will also be discussed.

Following Svensson’s presentation will be “High-throughput Content Uniformity Measurements of a Dry Powder Inhaler Using Raman Spectroscopy,” given by Chanda Yonzon of Schering-Plough Research Institute. In this work, Yonzon will describe a Raman spectroscopic technique to measure content uniformity at a unit dose level of 1-3 mg scale of two intermediate products of a dry powder inhaler (DPI). This Raman spectroscopic method is complimentary to USP, allowing for analysis of hundreds of samples that would otherwise require days worth of analyst time using the conventional methodology.

Sarah Vallance of GlaxoSmithKline will present the next discussion titled, “The Role of Raman Microscopy in Polymorph Screening.” The talk will describe a particular case study, in which Raman microscopy was fully utilized to characterize a number of different anhydrous, hydrated, and solvated forms. The study enabled selection of the most suitable solid-state form for further development as well as mitigating the risk of hydrate formation during primary and secondary processing.

” The Role of Raman Spectroscopy in Productivity Enhancement,” will be the next presentation given by Ming-Hsing Huang of Bristol-Myers Squibb Co. Huang’s talk will focus on Raman spectroscopy as an analytical tool suitable for substitution of numerous GC methods developed for the purpose of following solvent exchanges. It will outline the development process, method transfer, collaborative efforts during the validation, as well as the degree of productivity improvement, and future plans for this method.

The final presentation in this session will be given by Sean Gilliam of Kaiser Optical Systems, Inc. and is titled, “Advances in the use of Raman Spectroscopy with Pharmaceutical Secondary Manufacturing.” Gilliam will discuss the use of Raman as an at-line, in-line, and on-line analysis and monitoring tool with secondary pharmaceutical manufacturing, as well as several relevant applications.