The Various Facets Of Drug Dissolution

Drug dissolution, a key attribute for determining the bioavailability of a drug, first became official in the United States Pharmacopeia in 1975 for just 12 dosage forms. But now, there are thousands of products which have the dissolution requirement. Further, efficacy is important for any dosage form, and dissolution provides the quality performance phenomena for these. Considered one of the crucial aspects during the drug development process, dissolution comes with a number of challenges, the biggest being simulating in-vivo conditions in toto in an in-vitro dissolution test. Experts suggest we will never be able to simulate it 100 per cent. However, technologies like 3-D printing and automisation, among others, have helped the stalwarts in the industry to cope up to some extent with artificial intelligence (AI) also creating a space for itself. While a lot has been done so far, yet there is scope for more!

- Akanki Sharma

Understanding the science of drug dissolution is a must

Drug dissolution is a key attribute for determining the bioavailability of a drug. It’s the one which is least understood, and can affect the quality of the product. Taking the popular dosage form, hard capsules, for instance, when swallowed, it first disintegrates, which is always predictable within a few minutes. After that comes the process of dissolution which can be extremely variable depending on a number of factors.

The failures and problems of some Indian companies with the US FDA authorities are being caused partly due to dissolution failures and variability. This has been serious enough to result in a recall of products from the market. This is not only expensive, but affects the reputation of the company as well. So, the science of dissolution needs to be studied and understood thoroughly. One solution is to consider the use of robotic equipment which are now available, wherein results are recorded online. This brings more accuracy and integrity, and is an effective way to give the inspectors the assurance they look for. Another important trend is the use of artificial intelligence (AI) which is already appearing in the pharma industry. In due course, robotics systems tend to become inevitable. Such work handled by human beings is subject to variability and skill levels.