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Pharma industry eyes 3D printing technology for manufacture in the future as it allows easy fabrication of tablets with multiple APIs (active pharmaceutical ingredients). The key reasons for the pharma industry to take up 3D printing technology are that it is suitable for orphan drugs and personalized medicine, said Korinde van den Heuvel, senior product developer, DFE Pharma.
At a recent webinar on ‘3D printing: Future of pharma manufacturing’ conducted by the International Pharma Excipients Council of India (IPEC India), Heuvel highlighted the benefits of technology in drug development.
“3D printing technology accelerates FIH (first in human trials). It is an excellent fit for clinical trials, allowing high dose flexibility in dose escalation studies. There is adequate bioavailability, easy to administer with no issues around drug solubility and stability like for liquid formulations. It helps in the production of several product iterations for testing, reduces the length of storage, transportation and prevents the need for stability-improving measures,” she stated.
US FDA has approved two such products. One was Spritama 3D printed tablet from Aprecia Pharmaceuticals in 2015. Here the
3D powder bed printing technology was selected to solve the drug loading problem in ODTs (oral disintegration tablets).
The second is early this year, when Triastekhas received an Investigational New Drug (IND) approval for its second 3D
printed drug product, T20 was produced via the Melt Extrusion Deposition (MED) technology platform which is novel design, Heuvel said.
Delving into the technique further, she said that for 3D printing in pharma a powder bed or drop on solid printing (DOS) is used.
There are also methods like Selective Laser Sintering (SLS) and Fused Deposition Modeling (FDM).
While elaborating on advantages and disadvantages of 3D printing, Hevuel mentioned that for Powder bed printing the benefits are that it is suitable for thermosensitive APIs like for example: Spritam by Aprecia. But the disadvantage is that tablets with higher porosity could break into smaller pieces. Another benefit is its high drug loading and adjustable drug release profiles.
But the disadvantage is that it is not suitable for thermosensitive APIs. In the case of semi solid extrusion, the advantage is high drug loading and it is also suitable for thermosensitive APIs. The disadvantage is the risk of cracking tablets. The selection of proper excipients plays an important role in taking care of the issues.
Kaushik Desai, secretary general, International Pharmaceutical Excipient Council of India and moderator of the event said that from an Indian stand point there is no chance at least in near future to utilise 3D printing for manufacture, even though some exploratory work may have begun by big pharma companies in the country.
The 3D printing manufacture is more applicable for personalised medicines or orphan drugs reaching out to the small pool of patients. However it is very important and cannot be ignored in a phase where technology is an integral part of pharma operations, stated Desai.
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