Dissolution testing is a process where pharmaceutical products such as oral drugs are tested for quality control purposes, to help determine how quickly the drug is released, and aid multiple other aspects of its development. Without this form of testing, a drug’s efficacy would be much harder to gauge.
Knowing how to test solid oral dosage forms and evaluate their performance is a great skill to learn for anyone pursuing a career in food and pharmaceutical research and development.
But how has this process come to be? And how do oral drug products such as capsules and tablets go through its different phases before reaching their final form?
Here’s what you need to know about the history of dissolution testing.
The Rise of Dissolution Testing in Pharmaceuticals
The development of pharmaceutical tablets has been going on for decades. In fact, the first studies on dissolution can be traced as far back as 1897. However, it took until well into the 20th century for dissolution testing to arrive, after unsatisfactory results with tablets became increasingly common.
Eventually, disintegration tests started to be administered in the United States and United Kingdom in the mid-1940s and early 1950s, despite the process not being considered a definitive, complete testing process.
It took several other instances of products failing during the late ‘50s for dissolution testing’s reliability to be taken more seriously. After this, other analytical methods with drugs would come to exist. In particular, the advent of the Rotating Basket in 1970 helped pave the way for dissolution testing to officially begin.
The Purpose of Dissolution Testing Explained for Pharmaceutical School Students
Arguably the biggest advantage of dissolution testing is how it assists in quality control, namely its evaluation of the drug’s consistency. Those attending pharmaceutical school may already be aware that the dissolution process involves tablets and capsules being composed of both active ingredients and dormant binding agents.
During dissolution, the active ingredients present create a solution after going into a solvent. Once the dosage form enters a human host’s body, it dissolves within their stomach before reaching the small intestine, in which the host’s bloodstream absorbs the ingredient and carries it to where the effects will be felt.
This testing also helps to expedite certain processes in the development of pharmaceutical products, such as comparing the dissolution profiles of an original product and their generic equivalents, determining the product’s release given the dissolution test results, and the perfecting of its formulation.
How Dissolution Testing Has Continued to Evolve in Recent Years
In spite of initial skepticism over its capabilities, students in pharmaceutical training should know that dissolution testing has since evolved into as a complete test for oral dosage forms, thanks to regular fine-tuning of its processes over the years.
With proper conditions now in place, dissolution testing can be done to definitively assess the characteristics of capsules and tablets, as well as other products such as:
- Contact lenses
Dissolution testing can now be used for other products like ointments
Furthermore, developments in the 1970s and beyond would lead to other apparatuses being adopted for dissolution testing purposes. In 1997, the Food and Drug Administration (FDA) released guidelines for dissolution testing as well as in vitro dissolution, helping to provide recommendations for testing processes as well as methods for dissolution profile comparisons.
Today, this testing method essentially stands in for human testing and bioavailability, producing results that can help us better understand how effective and safe these drugs are for human use.
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