Using computer-aided design (CAD) software, formulation scientists can design and the test prototype medicines on the computer and provide significant savings in both time and costs, according to the team from the Institute for Innovation in Industrial Pharmacy (IFIIP) in Pfeffingen.
In a review article published in the European Journal of Pharmaceutical Sciences, the scientists describehow they used a software package called F-CAD (Formulation-Computer Aided Design) - developed by Swiss company CINCAP GmbH to develop prototypes of capsule and tablet formulations on a computer.
By setting up the software to accommodate variables such as the particle size distribution of the active pharmaceutical ingredients(APIs) and excipients in a tablet and the processes that would be used to produce it, they claim to be able to accelerate the process of designing robust formulations with optimal bioavailability and reduced side effects.
A key advantage of using CAD is that it avoids the use of a simple capsule formulation for early clinical trials – an approach still common in the industry – that is not suitable for later development and has to be discarded and re-designed. CAD enables a “right first time” process that also fits with quality by design principles laid out in ICH Q8.
Combined with other technologies such as novel excipients and high-throughput stability screening, F-CAD could help drugmakers reduce time to market for new medicines, reduce the rate of attrition and achieve higher quality commercial dosage forms.
According to the authors of the paper – Hans Leuenberger and Michael Leuenberger – the approach can help industrial pharmacists improve formulations even though “the technology to manufacture tablets and capsules [has] not changed fundamentally since its introduction.”
There is a clear need for improvement, they suggest, citing a 2004 analysis which estimated that as much as $91bn a year was lost by the pharma industry worldwide because of a product quality deficiencies.
"The ongoing digital revolution is no longer limited to the application of apps on the smart phone for daily needs but starts to affect also our professional life in formulation science," they write.
"It is the job of the industrial pharmacists to develop an optimal formulation which shows the beauty and covers the ugly parts of an API.”
The approach can be applied to new product design, existing product optimization, rapid prototyping and tooling design and root cause analysis, amongst other applications.
In future, it may also be possible to rent access to F-CAD at low cost over the cloud, according to the researchers.