Continuous manufacturing of cocrystals using 3D-printed microfluidic chips coupled with spray coating
Kara, Aytug and Kumar, Dinesh and Healy, Anne Marie and Lalatsa, Katerina and Serrano, Dolores R. (2023) Continuous manufacturing of cocrystals using 3D-printed microfluidic chips coupled with spray coating. Pharmaceuticals, 16 (8). 1064. ISSN 1424-8247 (https://doi.org/10.3390/ph16081064)
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Abstract
Using cocrystals has emerged as a promising strategy to improve the physicochemical properties of active pharmaceutical ingredients (APIs) by forming a new crystalline phase from two or more components. Particle size and morphology control are key quality attributes for cocrystal medicinal products. The needle-shaped morphology is often considered high-risk and complex in the manufacture of solid dosage forms. Cocrystal particle engineering requires advanced methodologies to ensure high-purity cocrystals with improved solubility and bioavailability and with optimal crystal habit for industrial manufacturing. In this study, 3D-printed microfluidic chips were used to control the cocrystal habit and polymorphism of the sulfadimidine (SDM): 4-aminosalicylic acid (4ASA) cocrystal. The addition of PVP in the aqueous phase during mixing resulted in a high-purity cocrystal (with no traces of the individual components), while it also inhibited the growth of needle-shaped crystals. When mixtures were prepared at the macroscale, PVP was not able to control the crystal habit and impurities of individual mixture components remained, indicating that the microfluidic device allowed for a more homogenous and rapid mixing process controlled by the flow rate and the high surface-to-volume ratios of the microchannels. Continuous manufacturing of SDM:4ASA cocrystals coated on beads was successfully implemented when the microfluidic chip was connected in line to a fluidized bed, allowing cocrystal formulation generation by mixing, coating, and drying in a single step.
ORCID iDs
Kara, Aytug, Kumar, Dinesh, Healy, Anne Marie, Lalatsa, Katerina ORCID: https://orcid.org/0000-0003-4791-7468 and Serrano, Dolores R.;-
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Item type: Article ID code: 86386 Dates: DateEvent27 July 2023Published23 July 2023Accepted9 July 2023SubmittedSubjects: Medicine > Pharmacy and materia medica > Pharmaceutical technology Department: Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences Depositing user: Pure Administrator Date deposited: 03 Aug 2023 14:55 Last modified: 01 Sep 2024 01:41 URI: https://strathprints.strath.ac.uk/id/eprint/86386