Drug Development

Articles

High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.

Multimodal HPLC screening of polysaccharide-based chiral stationary phases

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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 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 US 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

The authors consider the advantages of using rapidly dissolving films to accurately and effectively deliver pharmaceutical ingredients, with an emphasis on the importance of controlling moisture content and drug loading during formulation development.

Quick API delivery

To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.

Calorimetry — the fully scalable PAT tool

Company and People Notes: Evotec and Renovis enter agreement, Amgen to lay off 675 workers, more.

Company and People Notes: Evotec and Renovis Enter Agreement, Amgen to Lay Off 675 Workers, More

The US Food and Drug Administration has denied shipments of active pharmaceutical ingredients manufactured at a production facility of Kunshan Chemical and Pharmaceutical Co. for violation of good manufacturing practices, according to an FDA warning letter issued Sept. 6, 2007.

FDA Denies Entry of APIs from Chinese Supplier

Company and People Notes: Catalent expands Bolton, UK, warehouse; Biotica appoints Edward E. Hodgkin as CEO and director; more.

Company and People Notes: Catalent Expands Bolton, UK, Warehouse; Biotica Appoints Edward E. Hodgkin as CEO and Director; More

Pfizer plans to cease all remaining manufacturing operations at its facility in Sandwich, Kent, United Kingdom. The closure will result in the loss of approximately 420 jobs, phased over the next two years, according to a company release

Pfizer Plans to End Manufacturing at Sandwich, UK, Facility

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More.

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More

Angie Drakulich was editorial director of Pharmaceutical Technology.

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

Ingredients