In order to give boost to research and development in pharma institutions across the country, experts advocate that dissolution science should be taught as an applied science across institutions in the country. Dissolution science as an applied science is not only required for development and evaluation of a pharma product but to demonstrate the quality of drug to meet regulatory requirements.

Dissolution testing is required for all solid oral pharmacopoeial dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect.

Says Dr Umesh Banakar, president, Banakar Consultancy Services, USA, "There is a need for training pharmacists on dissolution science as the industry takes around 6 months to train a fresh graduate on dissolution testing. Dissolution science became a part of US Pharmacopeia with emphasis on safety, efficacy and quality of drugs in accordance with the calibration standards for quality control and apparatuses for research and development."

Almost two decades old in India, dissolution testing is also gradually becoming a core competency requirement for clinical efficacy of the product, in vitro development of the product, analysis of quality and regulatory competency for Indian pharma companies. Informs Dr Vinod Shah, Ex. US FDA, Pharmaceutical Consultant, USA,"Dissolution testing is principally useful as a quality control test for solid dosage forms like tablets and capsules and complements the GMP requirements."  

Echoing similar views, Prof. Dr. Sompol Prakongpan, Professor of Pharmacy, Burapha University, Thailand says, "Apart from applications in bioequivalence testing, solid dosage forms, bio therapeutic products, sustained release products, transdermal delivery, dissolution is an important component of in vitro development for the product and to fulfill quality and regulatory requirements."

"Traditionally developed for solid oral dosage forms, use of dissolution testing has been widened to a variety of dosage forms such as semi solid, liposomes, nano particles, parenteral preparations in the last few years," explains Dr L Ramaswamy, managing director, Sotax India.   

Disintegration was originally thought to be this characteristic. The United States Pharmacopeia (USP) introduced its disintegration test in 1950. With advances in methodology, the disintegration test was found to be too insensitive, and dissolution test methods were introduced in the USP in 1968.