Company insight
How 3D printing is revolutionising pharma
3D printing is well positioned to optimise the manufacturing of everything from clinical trial preparations and orphan drugs to personalised medicine and polypills, and DFE Pharma is at the centre of innovation in the space. Senior product developer Korinde van den Heuvel explains how the company’s work with lactose-based excipient blends is helping create the medicines of the future.
What are some of the most interesting and important applications for 3D printing in pharma?
Korinde van den Heuvel: This innovation is opening up a world of new opportunities but, to take one example, clinical trial preparations present a huge potential benefit. 3D printing combines the high flexibility in drug loading and the small batch sizes needed for phase I and IIa clinical studies, which results in cost savings due to a reduction of the required amount of the active pharmaceutical ingredient (API) and a shorter development time. On-demand printing could also reduce the need for stability-improving measures and enable formulators to easily access features such as excipient inclusion.
How can the industry determine the best materials and processes for 3D printing pharmaceuticals? What are the most promising directions? We at DFE Pharma believe that all stakeholders should join forces to fill the gaps in 3D printing knowledge, as there is a need to thoroughly understand the processes involved to further utilise the technique. By pooling the knowledge and expertise of industry, innovators and academia, we can truly move the dial on 3D printing in pharmaceuticals and, in doing so, take huge strides towards delivering the person-centred clinical trials and medicines of the future.
For the moment, as the use of 3D printing in pharma is still relatively new, regulatory bodies are still defining guidelines for its
“By pooling the knowledge and expertise of industry, innovators and academia, we can truly move the dial on 3D printing in pharmaceuticals.”
Other advantages are clear from the success of Aprecia’s Spritam (levetiracetam), which became the first – and, so far, only – 3D-printed medication to receive FDA approval in 2015. The epilepsy drug delivers a high dose via a tablet that dissolves on the tongue with a small amount of water, which isn’t possible to manufacture with conventional techniques.
Producing clinical trial formulations will presumably be the next step on the 3D printing pathway, and it will help further accustom industry and regulatory bodies to the technique. From that point onwards, 3D printing in pharma will grow to become an economical production option for commercial formulations for products that have a smaller batch size.
use, making it difficult for pharma companies to make the most of the technology. That said, 3D powder bed printing is the only technique that has an approved drug product on the market. It has proven highly scalable and acceptable for the authorities, and it is a technique that does not require high temperatures or laser light to agglomerate the particles together. Therefore, it creates tablets that can provide fast and complete release even for thermosensitive APIs.
How is DFE Pharma using 3D printing to improve pharmaceutical development and manufacturing? Understanding critical (raw) material attributes for 3D powder bed printing is essential to create a tablet that meets the
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Ph Eur and USP specifications. The difficulty is that excipients suited for direct compression and wet granulation do not always reproduce the same functionalities when they are 3D printed. Unfortunately, there is limited information available in the public domain on the relationship between excipient selection and functionality for different dosage forms.
As a leading excipient supplier, we play a valuable role in advising clients about the right excipients and producing them for specific applications. Working with the Netherlands Organisation for Applied Scientific Research (TNO), we tested 20 lactose grades with the primary objective of developing a lactose with sufficient flow, wetting and binding to be used effectively in the powder bed 3D printing of pharmaceuticals. Ultimately, the tests proved that lactose works in this context, approaching the industry standard for hardness and friability. Our ability to both produce and provide mechanistic understanding of customised lactose blends brings added value to formulators and speeds up development time, making us a perfect match for a new technology such as 3D powder bed printing. Nevertheless, there’s a long way to go to realise the potential of 3D printed pharmaceuticals. To start, more collaborations between print specialists, academics and the pharmaceutical industry will be needed to accelerate the development of 3D printing for clinical trial formulations. We would like to invite other organisations to work with us to further develop our mechanistic knowledge of lactose-based 3D printing blends and our ability to customise lactose to suit each use case. ●
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