Screening pharmaceutical excipient powders for use in commercial 3D binder jetting printers
Binder jetting is an additive manufacturing technique that creates three-dimensional constructs from a powder feedstock. It is used by several industries, including pharmaceuticals. This additive approach to manufacture provides several functional benefits that are not easily achievable using conventional manufacturing methods. There is currently only limited publicly available knowledge that details the requirements of an effective binder jetting powder. Specifically in the pharmaceutical industry, since the 2015 release of Spritam®, a binder-jetted tablet containing levetiracetam, no new pharmaceutical tablets have been produced using such methods.
- • Screening of pharmaceutical excipient powders for use in Binder Jetting process.
- • Printable microcrystalline cellulose formulation developed.
- • Various dosage shapes printed using pharmaceutical excipients.
- • Particle engineering can tune flow and wetting properties to enhance printability.
There appears to be gap in powder technology expertise and the development of 3D printing processes. Our goal is to enhance our knowledge in terms of powder flow, powder wetting and powder binding to link particles with process and build the capability to create a greater range of powders suitable to be binder-jetted into new products. After initially screening several standard pharmaceutical excipient powders for their relevant properties, two candidates showed best fit potential for use in binder jetting, specifically microcrystalline cellulose (Pharmacel 101 and 102) and lactose (Lactohale 200). Using simple formulations of these pharmaceutical excipient powders as a model, we analysed for printability and powder performance using a range of quantitative parameters including dimensional accuracy, construct hardness, friability, porosity and surface finish. In general, formulations of these powders showed good printability, but some powder blends produced constructs with more obvious manufacturing imperfections. Several routes to improve the printability of these pharmaceutical powders are proposed for future works. Ultimately, this work provides a fundamental basis to start to quantitatively assess the potential of standard pharmaceutical excipient powders in binder jetting printers using powder characterisation techniques and print quality outcomes. Continue reading
Table 1. Candidate powders evaluated for binder jetting in a Projet CJP 460Plus printer.
|Powder Trade Name||Powder Generic Name||Manufacturer||Batch||d10||d50||d90|
|Calcium sulfate dihydrate||Set gypsum||Sigma Aldrich||BCBV1390||7||18||46|
|Calcium sulfate anhydrous||–||Sigma Aldrich||MKBW9429V||3||9||23|
|Calcium sulfate hemihydrate||Plaster of Paris||Sigma Aldrich||BCBV7581||5||17||62|
|β-tricalcium phosphate||–||Sigma Aldrich||BCBS4390V||3||7||17|
|Methocel E5||HPMC E5||Dow Chemical||VJ27012N23||24||51||107|
|Methocel E6||HPMC E6||Dow Chemical||QC27012402||24||49||127|
|Methocel K100||HPMC K100||Dow Chemical||TK06012N21||20||51||119|
|Methocel K4M||HPMC K4M||Dow Chemical||TD02012N12||23||62||186|
|Methocel K3||HPMC K3||Dow Chemical||TE18012N22||19||56||160|
|Salicylic Acid||–||Merck KGaA||F1591335||9||18||36|
|Croscarmellose sodium||–||DFE Pharma||Not available*||19||31||47|
|Sigmacell Cellulose||Cellulose||Sigma Aldrich||SLBN4490V||10||20||36|
|Avicel PH101||MCC 101||FMC Corp||BCBQ8403V||24||55||103|
|Pharmacel 101||MCC 101||DFE Pharma||765||25||60||120|
|Pharmacel 102||MCC 102||DFE Pharma||772||31||86||172|
|Lactopress anhydrous lactose||Lactose||DFE Pharma||956||3||20||70|
|Lactochem extra fine lactose||Lactose||DFE Pharma||974||3||20||50|
|Lactochem fine lactose||Lactose||DFE Pharma||752||3||15||40|
|Pharmatose 350 M||Lactose||DFE Pharma||689||4||30||80|
|Pharmatose 450 M||Lactose||DFE Pharma||105||3||20||50|
|Lactohale 200||Lactose||DFE Pharma||395||18||65||114|
|Pharmatose 130 M||Lactose||DFE Pharma||Not available*||16||85||196|
|20:80 VA64-Pharmacel 102||–||BASF-DFE Pharma||Not applicable**||27||73||150|
|20:80 VA64-Pharmacel 101||–||BASF-DFE Pharma||Not applicable**||21||54||105|
|20:80 VA64-Lactohale 200||–||BASF-DFE Pharma||Not applicable**||27||71||119|
|0.5:9.0:90.5 MgSt-VA64-Lactohale 200||–||Honeywell-BASF-DFE Pharma||Not applicable**||24||70||119|
by A. Antic, J. Zhang, N. Amini, D.A.V. Morton, K.P. Hapgood, Screening pharmaceutical excipient powders for use in commercial 3D binder jetting printers, Advanced Powder Technology, 2021,ISSN 0921-8831, https://doi.org/10.1016/j.apt.2021.05.014. (https://www.sciencedirect.com/science/article/pii/S0921883121002387)