Dissolution Testing

E-Separation Solutions

E-Separation Solutions-11-11-2010, Volume 0, Issue 0

Dissolution testing is a mandatory test for the physical evaluation of solid dosage forms, such as capsules, tablets, ointments, and creams.

Dissolution testing is a mandatory test for the physical evaluation of solid dosage forms, such as capsules, tablets, ointments, and creams. The most basic form of testing measures the rate of dissolution or solubility of a drug tablet. Dissolution testing can also be used in ADME and bioavailability studies, release rates of a drug substance under different conditions, as well as provide information as to the efficacy of in-vivo performance.

2009 dissolution testing demand by industry.

It is a common practice to link a dissolution tester with an HPLC system. This is perhaps one of the fastest growing areas in dissolution testing market. When the samples are introduced into the vessel, researchers remove small aliquots at regular intervals that will later be analyzed via high performance liquid chromatography (HPLC). Furthermore, fully automated online systems directly inject the sample into an HPLC and offer in-situ reaction monitoring capabilities.

Dissolution testing systems are used in a variety of laboratory settings including R and D, quality control, and production steps of pharmaceutical development. The systems must be durable and provide quality information to meet regulatory requirements. In addition, because dissolution testing is so important to drug development, it is an essential tool for pharmaceutical companies.

The pharmaceutical industry accounts for an overwhelming majority of the market. However, this industry is not the only consumer of dissolution testing instruments. Other industries like contract research organizations (CROs) and biotechnology, in addition to agriculture/food and academic labs account for the remaining share of the market. China continues to experience the largest growth rate primarily due to the region’s fast growing pharmaceutical market.

The foregoing data was extracted from SDi’s Global Assessment Report, 11th Edition. For more information, contact Glenn Cudiamat, VP of Research Services, Strategic Directions International, Inc., 6242 Westchester Parkway, Suite 100, Los Angeles, CA 90045, tel. (310) 641-4982, fax (310) 641-8851, e-mail:cudiamat@strategic-directions.com