Formulation and Process Development Articles

The US Food and Drug Administration launched the Chemistry, Manufacturing, and Controls (CMC) Pilot Program in the Federal Register in 2005 (1), as part of its Pharmaceutical CGMPs for the 21st Century initiative (2).

The US Food and Drug Adminstration released its Pharmaceutical Quality for the 21st Century: A Risk-Based Approach report in 2004. Since that time, the concepts around quality by design (QbD) have been discussed in multiple meetings and regulatory guidances, including in three finalized guidelines by the International Conference on Harmonization (ICH) (1–3).

Pharmaceutical manufacturers are seeking ways to maintain and improve product quality while reducing manufacturing costs, including in the analytical testing of raw materials. Movement toward 100% inspection of raw materials as well as increased production volumes and the desire for lean manufacturing are additional motivations to find more cost-effective testing technologies.

Famotidine is a histamine H2-receptor antagonist. It is widely prescribed in the treatment of gastric ulcers, duodenal ulcers, Zollinger-Ellison syndrome, and gastroesophageal reflux disease in doses ranging from 10 to 80 mg (1).

Leaders from Brazil, Russia, India, and China, also known as the BRIC nations, met in Yekaterinburg, Russia, this past June at the first formal emerging economies summit. The group of nations is expected to surpass the current leading economies by 2050 (1), and the pharmaceutical industry is paying attention.

Solid dosage formulators rely on dissolution testing to mechanically model the biological conditions of drug release in the body. For quality control, analysts use dissolution studies to ensure product and process consistency. Although the objectives of these two groups are different, both are developing means to improve testing methodologies and ensure results are reliable.

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

Across the global pharmaceutical industry, there is a sense of urgency when looking at the pharmerging markets, says David Campbell, senior principal at IMS Consulting. "We're starting to see a lot of movement and interest from companies wanting to enter pharmerging markets or, for those companies already in the pharmerging markets, to expand their opportunities in those markets," he says.

Contract research organizations (CROs) such as Covance (Princeton, NJ) are heading further east through Europe. The company opened new clinical development offices in February 2009, in Kiev, Ukraine, and Bratislava, Slovakia (a third office opened in Tel Aviv, Israel) (1).

One of the timeless principles of commerce is caveat emptor (Latin for, "let the buyer beware"). Under the principle of caveat emptor, the buyer takes the responsibility for the condition of the items or quality of the services that he or she purchases. Prior to the current consumer protection laws, buyers had no warranties for the goods or services that they purchased.