(566g) A New Approach Towards the Production of a Personalizable Dry Solid Dosage Form for Biologics: In-Vial Direct Dosing and Drying By Inkjet Printing
AIChE Annual Meeting
Wednesday, November 16, 2022 - 4:54pm to 5:15pm
To this end, we developed a new personalizable concept of directly dosing the protein solution (i.e., ink) via inkjet printing into the final vial, followed by a gentle drying step to end up in a stable dosage form. In our study, Human Serum Albumin (HSA, approx. 66kDa) stabilized in phosphate buffered saline was used as a model protein. Dispensing a single (personalizable) dose of protein into its final vial was achieved via an industrial inkjet printer. Subsequently, vacuum drying at ambient temperature and 50 mbar was applied.
All investigated DoE formulations were printable fluids, but within the satellite droplets regime (Oh<0.10, 40<Re<125) (Derby, 2010). Thereby, we found PS80 to be crucial for reducing the jetted drop angle to allow for precise drop deposition at the vial bottom. Further, the residual moisture of the dried doses revealed acceptable water content (<10wt%) to maintain the protein flexibility and long-term stability. Therefore, the two optimized formulations were consistently printable and no increase in protein aggregation was detected when printing over prolonged time period. Further, 93% of a targeted dose were successfully dispensed into the final vial and reconstitution volumes down to 100Âµl resulted in no significant loss in reconstituted dose. To conclude, the developed concept is a promising approach to broaden the available processes for (personalizable) flexible production of solid dosage forms, allowing for fast adaption of production scales.
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