Company insight
3D printing: The future of pharmaceuticals
Despite still being a small segment of pharmaceutical manufacturing, 3D printing is becoming a reality, with one drug approved by the FDA already on the market produced with this technology. In the case of 3D powder bed tablet printing, the powder’s properties are critical, which aligns with DFE Pharma’s core expertise: mechanistic understanding of powder behaviour.
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ow becoming a more established approach for tablet production,
3D printing brings great potential to meet several of the current challenges of the pharmaceutical industry. Among other advantages, when compared with traditional processes, 3D printing can help to accelerate the scaling up of drug manufacturing. Unlike the most common approach – high volume batch manufacturing – 3D printing allows the small-scale production needed for orphan drugs, designer tablets for personalised medicine, and even clinical trials.
With 3D powder bed tablet printing, the drug’s powder properties are critical
It enables opportunities for tablet shape modifications, dose flexibility, solubility enhancement and multiple pills with several active pharmaceutical ingredients (APIs), also known as polypills. And since the Covid-19 pandemic, this technology has also grasped attention as a possible way to secure supply through local 3D printers, which could meet the production needs of life-saving medicines in specific areas. Among the different 3D printing techniques applied in the pharmaceutical landscape, powder bed or drop-on solid printing (DOS) has already proved its viability. It is currently used by a product in the market (ZipDose from Aprecia), it is scalable and suitable for thermosensitive APIs as well as providing fast and complete API release. It also allows using a large choice of excipients. Indeed, choosing the right excipient is an essential step for powder bed printing, as the resulting tablets can have high friability. The flowability, wettability and consolidation of the powder used to print tablets will determine the resulting tablet’s hardness, friability and
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disintegration. But, although currently used in the commercial set, the information on pharmaceutical powder bed printing is still limited. To overcome this lack of knowledge, DFE Pharma is using its more than a century of expertise in formulation, to further research and develop suitable excipients for 3D printing, conducting several studies to explore the most suitable solutions for this technique.
Solutions lab
Lactose is a well-known, commonly established and widely used pharmaceutical excipient, but its application in the 3D printing of pharmaceuticals needed further research. As a key leader in lactose-based excipients, DFE Pharma has focused on this area to apply on 3D printing opportunities, demonstrating that specific grades of lactose monohydrate can be utilised effectively for DOS tablet printing and can be a preferred filler for powder bed printing once formulated with a binder.
One of these case studies by DFE Pharma looked into formulating with a hydrophilic model drug compound, concluding that lactose/starch base formulation is suitable for formulating a 10% w/w hydrophilic model compound via power bed printing. It also
shows that optimising print settings and formulation has to be in conjunction to achieve a successful result. Other research by DFE Pharma focused on lactose/starch platform formulation for clinical trials application. It showed that it was possible to vary both percentage API load and tablet mass in order to obtain different tablet doses required for clinical studies. Even though the lactose/starch platform
formulation was very suitable for printing clinical trial formulations, it has to be taken into mind that each formulation approach has its own considerations on tablet mass, tensile strength and dissolution speed.
The way forward
DFE Pharma is at the centre of 3D-printing innovation and keeps studying the most innovative ways to apply this technology, to build with industry partners, innovators and academia, the common evidence base to produce the medicines of the future. The company has screened over 20 different lactose grades to be able to advise pharmaceutical companies on the optimal lactose binder blends for 3D printing applications. DFE Pharma can produce customised lactose-binder blends and provide a mechanistic understanding of those excipient blends, adding value to the formulation and speeding up the development time. This expertise and knowledge in 3D printing allow DFE Pharma to better support and work with pharmaceutical companies that are starting their journey in this promising technology. ●
www.dfepharma.com World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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