Ingredients

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.?

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.

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

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

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.

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

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.

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

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.

Albemarle Corporation signed an agreement with DSM Pharmaceutical Products to buy the assets and the fine chemistry services and pharma chemicals business associated with DSM's South Haven, Michigan facility.

I recently embarked on a quest: to investigate industry's use of the words, "generic" and "biosimilar" when describing a biologic molecule. An English major at heart, I was wrapped up in a news story that was partly about science, partly about words.

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:

Potent-compound awareness training for operators is important to understand why the containment and controls are in place.

Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).

Novozymes (Bagsvaerd, Denmark) made an offer to acquire the the biotechnology company GropPep Ltd (Adelaide, Australia) for DKK 375 million ($65 million) to build its position in supplying ingredients to the biopharmaceutical industry. Novozymes is a major producer of enzymes, including biocatalysts used in pharmaceutical synthesis.

Combinatorial catalysis in asymmetric synthesis and asymmetric biaryl Suzuki coupling highlight recent advances in chiral chemistry. Plus the marriage of green and chiral chemistry.

Examples of genuine strategic partnership agreements between end users and vendors are relatively rare in custom synthesis.

Select large custom manufacturers expand capacity, private equity firms buy companies in transition, and players from India and China build their positions.

China is on the rise as a center for pharmaceutical R&D, but companies are still getting their footing for operating in China and the services industry has some maturing to do.

The hydrophilic matrix system continues to be the most popular and widely used strategy to achieve extended drug release. Hypromellose (hydroxypropylmethylcellulose [HPMC]) is typically the polymer of choice for the rate-controlling carrier in these systems.

Degussa AG (D?sseldorf, Germany) and Lynchem Co., Ltd. (Dalian, Liaoning Province, China) signed a contract to establish a custom manufacturing joint venture.

Gilead Sciences, Inc. (Foster City, CA) signed a definitive agreement to acquire the Canadian subsidiary Raylo Chemicals and most of its assets from Degussa AG (D?sseldorf, Germany) for 115.2 million euros ($147 million).

CMOs account for 20–30% of biopharm production. Big Pharma also is filling the biologics supply chain.

Bioequivalence with the reference product is the only reliable measure of demonstrating the therapeutic equivalence of a generic product to the innovator product. Systematic and comprehensive innovator product characterization can be used to make generic product development easier. This involves characterization of API and quantification of the critical excipients. The latter contributes towards performance of the final dosage form. This article describes the capsule formulation of a poorly water-soluble drug, celecoxib, which contains sodium lauryl sulphate as a critical excipient. The importance of a decoding process aimed at developing a generic product that matches the innovator formulation in a discriminating dissolution method is demonstrated.

AstraZeneca PLC (London, England) has agreed to acquire the biopharmaceutical company Cambridge Antibody Technology Group PLC (CAT, Cambridge, England).