Industrial applications of 3D powder bed printed lactose tablets: From laboratory scale to production.

Since the approval of Spritam in 2015, various proof of concepts on 3D printed tablets have been published by the academic world. They proofed that 3D printing is a versatile technique capable of printing tablets in line with pharmaceutical standards. The next step for this technique is to convert the academic proof into industrial applications.

In previous publications, we showed that known excipients like lactose and starch can be successfully used to create drug-based powder bed printed tablets. This presentation will focus on how these formulations can be applied in an industrial setting in order to manufacture 3D printed tablets. Two different kind of applications will be highlighted. First the scalability of 3D tablet printing from laboratory R&D equipment to (Aprecia) production equipment scale will be shown. Secondly, a showcase of formulation development for powder bed printed tablets for use in Phase 1 and 2a clinical trial formulations will be discussed.

A presentation by Korinde van den Heuvel, Senior Product Developer at DFE Pharma.

Interview

Question 1: What drives you?
I am driven by gaining more understanding of innovative technologies such as 3D printing, and by transferring this knowledge to formulators in order to enable them to make printed tablets.

Question 2: Why should the delegate attend your presentation?
DFE Pharma is at the centre of 3D-printing innovation. We believe that by pooling our resources and knowledge, industry, innovators and academia can build the common evidence base we need to produce the medicines of the future. We believe there is a need to thoroughly understand the processes involved in order to further utilize this technology.

DFE Pharma has successfully printed tablets with model compounds based on a lactose/starch blend. The next step is to use these tablets in industrial applications. This presentation will give insights in 2 different types of applications, being scalability to production scale and applying these formulations in clinical trial phase 1 and 2a testing.

Question 3: What emerging technologies / trends do you see as having the greatest potential in the short and long run?
This innovation is opening up a world of new opportunities. As the applications of 3D printing in the pharmaceutical industry are numerous – ranging from clinical trial preparations and orphan drugs to personalized medicine and polypills. Among these various applications of 3D printing, clinical trial preparations present a huge potential benefit. 3D printing offers high flexibility in drug loading and small batch sizes – required in phase 1 and 2a clinical studies. This results in a costs-savings due to a reduction of the required amount of the active pharmaceutical ingredient (API) and a shorter development time. On-demand printing could further reduce the need for stability-improving measures and enable formulators to easily access features such as excipient inclusion.

Question 4: What kind of impact do you expect them to have?
Powder bed printing provides several benefits that make them suitable for drug production, of which scalability is one of the most important ones. Additional it is a technique which does not require high temperatures or laser light to agglomerate the particles together. Therefore it creates tablets which can provide fast and complete release even for thermosensitive APIs.

Within the field of 3D printing, the powder bed printing technology could contribute in shortening the development time of new drug compounds and enable the development of more functional formulations.

Question 5: What are the barriers that might stand in the way?
As the use of 3D printing in pharma is still relatively new, regulatory bodies are still defining guidelines for 3D printing causing uncertainty for pharmaceutical companies. That said, 3D powder bed printing is the only 3D-technique with an approved drug product on the market, Spritam®. It is therefore proven to be scalable and acceptable for the authorities.

About Korinde van den Heuvel
Korinde van den Heuvel is senior product developer at DFE pharma since April 2014. In this role she contributed on multiple OSD projects but currently mainly focusing on 3D printing of pharmaceutical tablets. Prior to working at DFE pharma she worked for 10 years at Synthon in formulation development developing various generic plus OSD forms such as ODT, IR and MR tablets and capsules. Korinde holds a master degree of Organic chemistry from the Radboud University in Nijmegen, The Netherlands.

About DFE Pharma
DFE Pharma is a global leader in pharma- and nutraceutical excipient solutions. We strive to develop, produce and supply the highest quality functional excipients for use in the pharmaceutical, biopharmaceutical and nutraceutical industries for respiratory, oral solid dose (OSD), ophthalmic and parenteral formulations.

Our excipients play an essential role as fillers, binders, disintegrants, and in stabilizing active ingredients for release in a predictable and effective manner into the patient’s system. With more than a century of experience and around 450 people worldwide, we are serving over 5,000 customers in 100+ countries worldwide. Headquartered in Goch, Germany, DFE Pharma is committed to supporting (bio)pharmaceutical and nutraceutical companies in their journey to improve patients’ lives, driven by our purpose your medicines, our solutions. Moving to a healthier world.

Korinde van den Heuvel is speaker at the 2022 edition of the 3D Pharma Printing Conference.

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