Exploring Excipient Functionality - Pharmaceutical Technology

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PharmTech Europe

Exploring Excipient Functionality
This technical forum is part of a special issue on Solid Dosage and Excipients.

Pharmaceutical Technology
Volume 35, pp. s6-s11

Film coating section references

1. Z. Ayenew et al., Recent Patents on Drug Deliv. & Formul. 3 (1), 26–39 (2009).

2. BASF SE, Kollicoat Smartseal Technical Information (Ludwigshafen, Germany), Jan. 2011.

3. K. Kolter, F. Guth, and M. Angel, "Physiochemical Characteristics of a New Aqueous Polymer Designed for Taste-Masking and Moisture Protection," presented by BASF at AAPS Annual Meeting and Exposition, New Orleans, Nov, 14–18, 2010.

Formulation development and manufacturing

Despite the intensification of biologic-based drug development, solid dosage forms are the mainstay in the pharmaceutical industry. Changing regulatory requirements, increased cost pressures, and the need to innovate for better product life-cycle management and product differentiation, are leading pharmaceutical companies to seek ways to improve development and manufacturing.

Pharmaceutical Technology recently held an webcast to more fully examine the current and future direction in formulation development, dosage forms, and manufacturing of solid-dosage products, including the role of continuous processing and FDA's quality by design (QbD) initiative. Participating in the webcast, which was held Mar. 1, 2011, was Robin H. Bogner, R.Ph., Ph.D., associate professor of pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut, to discuss technical advances in solid-dosage formulations and dosage forms. John Groskoph, senior director of new products CMC, global chemistry manufacturing and controls at Pfizer, discussed QbD in solid-dosage manufacturing.

External development and manufacturing also are becoming more important in a pharmaceutical company's strategy. In another webcast, Pharmaceutical Technology examined how to optimize outsourcing CMC development and manufacturing. The webcast, which was broadcast on Mar. 8, 2011, featured Clive V. Bennett, nonexecutive chairman of Halo Pharmaceutical, Gregg Brandyberry, CEO of Wildfire Commerce and senior advisor of A.T. Kearney Procurement and Analytic Solutions, and former vice-president of procurement of global systems and operations at GlaxoSmithKline, and George Bobotas, PhD, and chief scientific officer at Halo Pharmaceutical. On-demand viewing on both webcasts are available in the multimedia section at http://PharmTech.com/.


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