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Description
As we approach the first anniversary of the launch of the FDA’s Novel Excipient Review Pilot Program, join us for an exciting two-part event focused on excipient innovation. Part two is described below. For information on part one (and registration bundling options) visit our event page: Modernizing Excipient Technology - Need for excipients designed for purpose
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Characteristics and Requirements of Excipients Designed Specifically for 3D Printing
Presented by: Anna Worsley
Pharmaceutical 3D printing is a rapidly growing field, with more and more pharmaceutical research groups in academia and industry investing time and resources to investigate its use to personalise medicine. The additive manufacturing technology provides the ability to fabricate small batches of precise structures rapidly, allowing for the personalisation of medication with varying dosage, colour, flavour, shape and drug combinations (polypills). Transitioning 3D printing to the pharmacy will require the development of novel formulations aligning with the high-quality standards demanded and regulated by the pharmaceutical industry. This is leading to new challenges and opportunities in research. This presentation will provide an overview of the different 3D printing technologies and materials that are being used in the field.
3D Printing – The future of Pharmaceutical Manufacturing
Presented by: Korinde van den Heuval
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 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.
DFE pharma aims to provide a starting point for clinical trial formulation development for both hydrophobic or hydrophilic drug compounds. In this presentation, we will show case the 3D powder bed printing technology by utilizing a base formulation of lactose monohydrate/pregelatinized starch at various print settings. It was found that formulation and print settings have to be in conjunction as they are closely related (van den Heuvel et al).
van den Heuvel et al, Evaluation of lactose based 3D powder bed printed pharmaceutical drug product tablets, powder technology (390), 2021, 97-102
Quality Considerations of 3D Printing of Drug Products: ETT Collaborative Approach for Fostering Innovation
Presented by: Ahmed Zidan
Precision medicine is an emerging healthcare delivery approach that considers variability between patients, such as genetic makeups, in contrast to the current one-size-fits-all approach that are designed to treat the average patient. The White House launched the Precision Medicine Initiative in 2015, starting an endeavor to reshape healthcare delivery. To translate the concept of precision medicine from the bench to practice, advanced manufacturing plays an integral part, including 3D printing of personalized drugs and drug delivery devices, and drug screening platforms. These 3D printed products are highly customized and require robust yet flexible manufacturing systems. This presentation will highlight the current status of the development of regulatory submission and quality control considerations of 3D printed drug products.
3D Printing of Microparticles Using Light: Direct Laser Writing
Presented by: Stephen Hoag
During this presentation we will explore the advantages and limitations of 3D printing using direct laser writing (DLW). We will take a look at how microstructures can be created and loaded with drug using this early-stage technology, as well as the excipient requirements for such a process. In addition, we will discuss what happens once particles are made and how the release rate can be controlled using DLW.