Dissolution testing is a method of analyzing the physical properties of solid drugs. An imperative step in drug development and QC, it is required to understand the physical changes in any pharmaceutical ingredient. The tests are performed on all solid and semisolid forms of drugs, such as capsules, tablets, ointments and creams. Hygroscopicity, dissolution and solubility are measured during dissolution testing. By setting different parameters, dissolution testing can help determine release rates, shelf life and stability. In fact, dissolution testing gives critical information on the efficacy of a drug’s in vivo performance without the use of clinical studies that involve humans.

Dissolution testing is performed using vessels in which conditions are customized. The vessels are typically controlled by an external source. Samples in the vessels can be monitored by HPLC or other relevant technologies. Most dissolution testing systems are automated so users can set custom times, temperatures and even aliquot size of samples.

Traditional dissolution systems require users to manually sample the vessel with syringes, which can be time-consuming and error prone. To alleviate this, many vendors have developed automated systems. Systems are now designed to directly inject samples into an HPLC or UV-Vis spectrophotometer, decreasing downtime and increasing efficiency. Fiber optic probes can be used for in situ monitoring.

Not only are systems becoming multifunctional and integrated, online systems can meet high-throughput demands. Moreover, the hydrodynamics associated with various dissolution apparatuses have become more standardized in order to provide consistency in fluid dynamics. This can help discriminate changes in product performance as well as increase reproducibility.

Dissolution testing is predominantly used in the pharmaceutical industry, whether it be in the early stages of drug development or ADME testing for clinical studies. In particular, researchers can study the dissolution of pharmaceutical ingredients to optimize the rate at which a drug is released.

Automated systems make up the largest portion of the market, and this segment will continue to grow in the future. Additionally, as developing countries improve their infrastructures, and receive outsourced contracts from global pharmaceutical companies, demand for these systems will also grow.

Agilent Technologies and SOTAX are the market leaders. Other major vendors include Distek, Hanson Research, ERWEKA, Pharma Test and Logan Instruments. This year, Distek released a new sample probe and filter. The two-piece sample probe design features a “twist n’ lock” probe housing.

The total market for dissolution testing was about $200 million in 2015 and is growing at a rate of around 4% annually.
Dissolution Testing at a Glance:

Leading Suppliers

• Agilent Technologies
• SOTAX
• Distek

Largest Markets

• Pharmaceuticals
• CROs
• Clinical

Instrument Cost

• $5,000–$70,000