Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

As custom manufacturers gather for InformexUSA this month, strategies in asymmetric synthesis and catalysis prevail.

Innovations in API Synthesis

In 2007, the global pharmaceutical market is expected to grow moderately while biologics, generic drugs, and specialty-initiated drugs are projected to increase at double-digit rates. These trends for finished pharmaceuticals are reflected in the global market for active pharmaceutical ingredients (APIs), where the merchant generic API market is expected to see strong demand. On a production basis, India and China are forecast to raise their shares of the global generic API market against industry strongholds Italy and Spain. Meanwhile, the United States is expected to hold its its position as the leading producer of biotechnology-based APIs in an area traditionally dominated by captive production. And biogenerics or biosimilars gradually reshape the market.

The Changing Fortunes of APIs

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for dealing with genotoxic impurities in new active substances.

Excipient Manufacturers and Pharmaceutical Companies Raise Concerns Over Guidelines for Genotoxic Impurities

AstraZeneca's purchase of Cambridge Antibody Technology and Merck's acquisitions of GlycoFi and Abmaxis are the latest efforts by pharmaceutical majors to build critical mass in biologics capabilities.

Pharmaceutical Majors Build Positions in Monoclonal Antibodies

The specialty excipients market in the United States, Western Europe, and China is valued at nearly $800 million. The authors discuss the opportunities and challenges in these markets by examining the product mix, supply base, and preferred production methods.

China Emerges as the Next Frontier For Specialty Excipients

The authors investigated the influence of various particle size fractions of Tamarind seed polyose (TSP) on indomethacin (IND) release from matrix tablets. They assessed the TSP fractions for swelling, density, and flow properties and the IND matrix tablets for tensile strength, friability, and release profile. Release kinetics was evaluated using Higuchi and Peppas equations. The density and flow properties showed that the size fraction affects the suitability of TSP as an entrapment polymer. The release profile showed that the release of IND from TSP matrix is swelling dependent, thereby affecting the kinetics of release.

Polymer Particle Size Influence on Indomethacin Release from Tamarind Seed Polyose: A Potential Sustained-Release Excipient

As custom manufacturers and pharmaceutical ingredient suppliers gather for CPhI Worldwide in Paris, Oct. 3–Oct. 5, industry observers point to a mixed outlook for pharmaceutical custom synthesis. While industry performance for 2006 is better than 2005, the critical question remains the improvement in drug output. The slow rate of approvals of new molecular entities (NMEs) continues in 2006 as Big Pharma seeks to build pipelines of active pharmaceutical ingredients (APIs) through acquisitions, including capabilities in biologics.

The Outlook for New Molecular Entities

This article provides an overview of functionality, functionality-related characteristics, and excipients performance.

Functionality and Performance of Excipients

Facing cost pressures and regulatory changes, pharmaceutical companies address the need for increased functionality by looking to excipients.

Current Trends and Challenges in the Excipients Market

The Product Quality Research Institute (PQRI) conducted an open, publicly available, electronic survey of current excipient-control strategies among pharmaceutical excipient manufacturers, excipient distributors, and drug-product manufacturers (excipient users). Among the major findings are:

PQRI Survey of Pharmaceutical Excipient Testing and Control Strategies Used by Excipient Manufacturers, Excipient Distributors, and Drug-Product Manufacturers

APIs and Excipients