by Korinde van den Heuvel, Senior Product Developer, DFE Pharma
3D printing offers huge potential benefits in pharmaceutical manufacturing, like creating fast and reliable wide dosed dosage forms for clinical use and ability to tailor dose in dosage forms for specific user groups. In order to embrace this new world of opportunities, there is a need for thorough understanding of the powder physics of the materials, processes and techniques involved. Powder bed printing, which has been used to develop Spritam, is arguably the best method for pharmaceutical manufacturing.
Powder physics like, flowability, wettability and consolidation of the blend are critical material attributes for powder bed printing and will impact the tablet functionality like hardness, disintegration and friability. Limited information is available on excipient selection in relationship to functionality in the dosage form in literature.
In this presentation we investigate the benefits of powder based 3D printing by utilizing a base formulation of lactose monohydrate and pregelatinized starch. Working with TNO (The Netherlands), DFE Pharma tested over 20 lactose grades in order to create a formulation which can be used effectively in the powder bed 3D printing.
The primary objective of this research was developing lactose blends with sufficient flow, wetting and binding. The obtained lactose blends were further challenged with a hydrophilic or hydrophobic drug.
This study will show both the powder characterization (such as FFCs of the blend) as well as the impact of print settings and formulations on tablet properties (such as hardness and dissolution).
What drives you?
Understanding of innovative technologies such as 3D printing and transferring this knowledge to formulators in order to enable them to make printed tablets.
Why should the delegate attend your presentation?
Currently there is limited literature available to guide formulators in excipient selection for powder bed printing. DFE pharma have successfully printed a tablet with model compound based on a lactose/starch blend. This presentation will give insights on the topic of excipient selection and print settings for powder bed printing.
What emerging technologies/trends do you see as having the greatest potential in the short and long run?
3D printing has proven benefits, such as high dose flexibility, early phase drug development and enabling personalized medicine. I believe that powder bed printing will play a role in the 3D printing field by means of clinical trials or special formulation production.
What kind of impact do you expect them to have?
Within the field of 3D printing will powder bed printing technology contribute in reducing the development time of new drug compounds and enable the development of more functional formulations.
What are the barriers that might stand in the way?
3D printing is a new production technique for the pharmaceutical industry and new technologies are in general rather expensive and have limited GMP equipment available; this holds also true for 3D printing.
Let’s redesign the future together.
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.
DFE Pharma is the global leader in excipient solutions. We develop, produce and market excipients for oral solid dose and dry powder inhalation. Our portfolio consists of filler/binders (Lactose, Microcrystalline Cellulose, Starches), superdisintegrants (Croscarmellose Sodium and Sodium Starch Glycolate) and carriers for inhalation (Lactose). Please visit dfepharma.com