The process of creating new medication may involve a vast number of steps. As new research seem to discover novel compounds or more efficient pathways, scientists typically use animal testing to improve the understand the effects of the drug on an organism. Following from such experimentation, clinical studies are able to commence, usually enrolling a small number of volunteers or patients in order to undergo a pilot study, assessing various parameters and variables.
Should these small-scale studies show positive or beneficial results, the drug undergoes successively larger trials, with further experimentation and analysis. This means, certain drugs may take years and millions of pounds to create.
However, a breakthrough drug-testing device has been developed. This device, created by Dr. Hamid Merchant, a lecturer from the University of Huddersfield, accurately mirrors how the gut absorbs and interacts with medication. The working prototype of the device is presently housed in London’s own UCL.
The study by the team form the university was published in the scientific journal European Journal of Pharmaceutics and Biopharmaceutics. Dr. Merchant is particularly qualified in the mechanisms of drug delivery into the body, as well as how to create compounds which include an active drug component. Seeing as pre-clinical tests require animal testing in order to be approved for further trials in human models, Dr. Merchant and his team were looking for a way to get around this phase of the study. This was notably due to the animal and human gastrointestinal tracts differ in a number of ways, especially in the capacity to absorb compounds, as well as the pH and varying levels of gut bacteria, for example.
As a result, pre-clinical tests sometimes produce results which leave scientists still attempting accurately work out the reliability of the results produced in the animal models, particularly the rate and amount of medication absorption using differing concentrations of the compounds. This sort of investigation often requires further funding in order to fully understand variables such as correct dosage, for example.
As a result, Dr. Merchant and his team created a novel device which looked to mimic the way a human intestinal system might absorb orally administered drugs, and now the device is currently being applied for a patent with several companies looking to acquire it. The device itself simulates the differences in pH across the gastrointestinal tract using a bicarbonate buffer system, with the acidity or alkalinity of a certain area often key to the way a drug is broken down and absorbed by the gut wall.
Buffers are solutions made up of an acid (reduced pH) and its conjugate base (high pH) which is capable of keeping the pH of a solution stable, even in the presence of a strong acidic or alkaline compound, allowing a constant state. What makes this device special may be the way scientists are able to skip the animal testing phase of clinical trials. This might be seen as a major success for animal rights campaigners, for example, as well as companies who pride themselves in selling ethical goods. Importantly, the device also means which the costs of a pre-clinical animal trial may be reduced, allowing more money down the production line and in theory creating affordable medication for patients and customers.
“By minimising human trials we [may] reduce the cost of development, which is then charged to patients when the drug comes to the market – if the development costs are [reduced], then we [may] make new drugs more affordable,” said Dr. Merchant during the news release by the University of Huddersfield.
Dr. Merchant and his team are now looking to develop a second prototype of this manmade intestinal tract while he waits the outcome of the pending patent application, with the aim his model allows for more time efficient, accurate and in a sense, ethical testing procedure.
How might researchers make medical sciences even more cost-effective?