October 18 - 20, 2005, EUM 2005, Obernai, France

ACD/Labs Solution for the Preformulation Laboratory: Applications to Accelerating Salt and Polymorph Analysis

Michael Boruta, Michel Hachey, Karim Kassam

Abstract

Salt screening and polymorph analysis are performed both to find the most appropriate form of a drug and to extensively document possible forms for legal/patent protection issues. The goal of the analysis is to make timely decisions on which form to pursue development efforts on. This analysis ideally takes place early in the development cycle, and should quickly fail any inappropriate forms and minimize problems during clinical trials or the development process. On the other hand, this speed must be counter-balanced with sufficient thoroughness to provide a complete polymorphic profile with attention toward future formulation, manufacturing, and patent issues.

High Throughput Screening is often used to explore as much of the salt-form chemical space as possible in the briefest amount of time. Managing the various data types produced by automated dispensers and HT instruments and their associated metadata is a challenge to most preformulation labs. This challenge includes the need to automate as much as possible the processing and analysis of data generated by the HT instruments. Furthermore, efficient laboratories must have a means of reviewing accumulated data from related experiments in a coordinated way, so the decision can be made in view of all necessary information. A single report can then be produced that summarize all relevant findings in a concise way. Last but not least, the challenge is to allow different groups within an organization to have real time access to the project data throughout its lifespan - from the early stages, to the working, completion, and finally legacy stages.

This talk will look at some of the challenges and issues faced by today's preformulation laboratories and where ACD/Labs can offer solutions to enhance the decision making processes.

Download the presentation in MS PowerPoint (2.8 Mb ZIP file) or Adobe Acrobat format (1.37 Mb PDF file).

Relevant Products/Product Lines: Curve, UV-IR, Web Librarian, Automation Server

Relevant Solution: Preformulation