This work explores the use of cyrene as a green solvent to improve the cleaning performance on Islatravir, Doravirine and Olanzapine, which are challenging drugs to clean. Cyrene addition showed an improvement in aqueous and methanolic solubility, and ternary cyrene blends showed high solubility at high cyrene concentration, which did not directly translate into a reduction in cleaning time. The presence of cyrene and its geminal diol form reduced the API surface concen?tration after cleaning, thus improving the dissolution of the bound API layer. Cyrene was effi?ciently removed by water and left low residues. Higher cyrene concentrations (>20% vol) must be assessed for API solubility and suitability for CIP applications.
History
Publication
Sustainable Chemistry and Pharmacy, 2023, 33, 101149
Publisher
Elsevier
Other Funding information
This work was supported supported by Enterprise Ireland (https://www.enterprise-ireland.com/en/) through the PMTC (https://pmtc.ie/) core cleaning project "SPOTLESS" (Grant number: TC-2018-0026). The authors thank the PMTC members and collaborators Eli Lilly (Kinsale, Ireland) and MSD (Ballydine, Ireland) for their in-kind contributions of (Olanzapine) and (Islatravir, Doravirine) used in this work.