Drug Development

Articles

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

FDA Releases Draft Guidance for Cell-Based Vaccine Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Paris (Oct. 3)-In gearing up for opportunities in the generic drug market, Codexis, which specializes in biocatalysis for pharmaceutical chemical development, is expanding into direct sale of pharmaceutical intermediates with the receipt of its first commercial orders from generic drug manufacturers for ATS-8, a chemical intermediate in atorvastatin, the API in Pfizer's top-selling drug ?Lipitor.?

Codexis targets sale of intermediate in atorvastatin

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

Ramesh Panchagnula, PhD, is a professor in the department of pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector-67, Ph-X, SAS Nagar-160 062, Punjab, India, tel. -91 172 214 682 or 214 687, fax -91 172 214 692.

Mefenamic acid has variable bioavailability and tabletting issues because of its hydrophobic nature and poor material characteristics. Recrystallization of mefenamic acid was performed from three different solvent–solvent mixtures under differing conditions. The crystals obtained were screened for the existence of new crystal properties or polymorphic forms, then characterized further.

Mefenamic acid: new polymorph or crystal defect?

Evaluating disintegrant properties and consistency in performance is an essential part of tablet formulation.

A Comparative Study of Current Superdisintegrants

The presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.

Carriers for DPIs: formulation and regulatory challenges

Formulations containing a novel soluble dextrin fiber have been shown to exhibit several advantages in processibility and clinical response over those containing existing fibers.

New Dextrins: Supplementing Fiber with Innovation

The market potential for high-potency active ingredients will be influenced by growth patterns in the cytotoxic drug market. Strong growth is projected for cytotoxics through 2009, but the market then will see generic drug erosion, according to Sarah Terry Johnston, vice-president, healthcare, Datamonitor PLC.

Ingredients