Pharma-Mould - In just three minutes to a finished tablet
Innovative active ingredients pose a growing challenge to the pharmaceutical industry: 40 percent of the ingredients currently being developed are not readily soluble, and in future this fraction will grow to 90 percent. However, active pharmaceutical ingredients (APIs) are only bioavailable in soluble form to be absorbed via the membranes of the gastrointestinal tract to reach systemic circulation. Processing bioavailable medicines on the basis of poorly-soluble ingredients is a tedious process.
It is not unusual for the production of a single pharmaceutical, from the raw material through to the tablet in a box, to take 200 days or more. One possibility to transform poorly-soluble ingredients into bioavailable medicines is to integrate active ingredients in a polymer matrix by means of hot melt extrusion. After extrusion, however, many more production steps are often required - for example grinding, sifting, and pressing - before the final, desired dosage form is achieved.
An alternative processing technique is injection moulding, which combines the advantages of hot melt extrusion with direct shaping. Pharmaceuticals can therefore be processed in one step, and, equally important, in different shapes and sizes, too.
Direct processing in a single step
The Pharma-Mould project investigated injection moulding currently established in the plastics industry with respect to its applicability in processing pharmaceuticals. By optimizing the injection moulding equipment and the tools, the researchers succeeded in establishing a single-step process for producing the final dosage form.
In addition to achieving increased solubility, they were also able to modify the release behavior of the ingredients, depending on the materials used. This process allows now for the production of both fast release medication such as painkillers, and retarded-release systems (where the active ingredient is released over several hours).
A big innovation, indeed. The final dosage form can be processed in just three minutes, directly from the primary raw materials. With the assistance of nearinfrared spectroscopy, a fully automated, 100 percent, end-to-end quality control procedure was demonstrated on the manufactured tablets.
Other Consortium Partners
- ENGEL AUSTRIA GmbH
- Karl-Franzens University Graz, Institute of
- Pharmaceutical Sciences (IPW)
- Johannes Kepler University Linz, Institute of Polymer Injection Molding Technology and Process Automation (IPIM)
- FH Joanneum Gesellschaft mbH