Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Facing still-sluggish market conditions and a changing world order in fine chemicals, the large Western custom manufacturers are responding by building their toolboxes in specialized technologies in chiral chemistry, catalysis, and biosciences and by adjusting their manufacturing networks via streamlining or investment in Asia. 

Custom Manufacturers Target Chiral Chemistry, Catalysis, and Biosciences

This is a year of change for the Synthetic Organic Chemical Manufacturers Association (SOCMA), the Washington, DC-based trade association representing chemical batch and custom manufacturers. Following the sale of Informex, its flagship trade show, last fall, the association is advancing key programs, most notably its new ChemStewards program, an environmental, health, safety, and security initiative (EHS&S) that its members began implementing last month.

SOCMA Launches ChemStewards Program

Palatinit's "galenIQ" is line of multifunctional excipients that offer the combined advantages of other bulk excipients.

Multifunctional Excipients

Cormac Smyth is a product manager and Breda O’Driscoll is managing director at Ultrasonic Scientific Ltd, 1 Richview Office Park, Clonskeagh, Dublin 14, Ireland. Tel. +353 1 218 0600 Fax +353 1 218 0601 info@ultrasonic-scientific.com www.ultrasonic-scientific.com

HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

Analysing Raw Materials and Formulations Using High Resolution Ultrasonic Spectroscopy

New Excipient Guidance Doesn?t Fill Regulatory Gap

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients

Pharmaceutical Science & Technology Innovations

In the Spotlight-December 2004

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.

Specifications of chemical substances for pharmaceutical use

Ashish A. Joshi, PhD, is a project coordinator at Roquette America Inc., 1417 Exchange Street, Keokuk, IA 52632, tel. 319.526.2219, ashish.joshi@roquette.com

Added functionality excipients facilitate the development of novel drug delivery methods and improve processing techniques.

Added Functionality Excipients: An Answer to Challenging Formulations

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

The author suggests that an excipient's functionality can only be determined in the context of a specific formulation and manufacturing process.

APIs and Excipients