Pharmaceutical Technology-01-02-2008

The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.

Ireland seeks to maintain a leading position in pharmaceutical and biopharmaceutical manufacturing as it also builds its base in research.

Singapore moves forward with a plan to diversify its life science investment with projects in biologics and drug discovery.

The most significant early-stage discovery to hit the journals in late 2007 were the dual announcements from two independent research groups that they turned adult human skin cells into cells with properties that are seemingly identical with human embryonic stem (hES) cells.

There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.

With 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.

The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.

FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.

Puerto Rico seeks to build its standing in biopharmaceutical manufacturing and research as it retains its role in bulk pharmaceutical and dosage manufacturing for small molecules.

Researchers and process chemists share approaches in synthesis of active ingredients and pharmaceutical intermediates.

Fixing FDA lies in the hands of the government, but is the president-to-be paying attention?

The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.

Brief pharmaceutical news items for January 2008.

What should contractors and their clients bear in mind when they collaborate on a project?

The traditional pharmaceutical business model is disintegrating, but the new model is not much different.

Natural gums and mucilage are biocompatible, cheap, readily available, and represent a potential source of excipients. The authors examine the functionality of mucilage extracted from the leaves of Hibiscus rosa-sinensis Linn as an excipient in a sustained-release tablet formulation.

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

Process efficiency is measured not only by what is kept, but also by what is thrown away.

Editors' Picks of Pharmaceutical Science & Technology Innovations

News, world briefs, facility roundup, events and other items for January 2008.

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.