Polyethylene glycol 3350 (PEG 3350) as a practical vehicle for rapid reconstitution of PARPi-FL formulations for clinical use Journal Article
| Authors: | de Souza França, P. D.; Viray, T.; Roberts, S.; Michel, A.; Abrahão, M.; Patel, S. G.; Ganly, I.; Schöder, H.; Brand, C.; Reiner, T.; Pillarsetty, N. V. K. |
| Article Title: | Polyethylene glycol 3350 (PEG 3350) as a practical vehicle for rapid reconstitution of PARPi-FL formulations for clinical use |
| Abstract: | PARPi-FL is a molecularly specific fluorescent agent that targets poly ADP-ribose polymerase 1, a DNA repair enzyme overexpressed in the nuclei of tumor cells. This imaging agent is being investigated in a clinical trial (NCT03085147) for the detection of oral cancer. The PARPi-FL mouthwash formulation currently being used in the phase I/II clinical trial comprises 1,000 nM of PARPi-FL dissolved first in 4.5 ml of polyethylene glycol (PEG) 300 and then in 9.5 ml of water. This formulation requires a 2-step process that can be cumbersome for routine clinical use. To minimize errors and simplify the formulation process, we have developed a new one-step formulation, which requires only the direct addition of water into a vial containing a mixture of the PARPi-FL and PEG 3350, which is also a powder. In a series of analytical and preclinical studies, we demonstrate that the new formulation of PARPi-FL is stable over 365 days, sustains its characteristics, and performs similar to the previous formulation. Moving forward, the new formulation of the PARPi-FL will be used for patients accrued in the phase II clinical trial. © 2022, The Author(s), under exclusive licence to World Molecular Imaging Society. |
| Keywords: | clinical trial; nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor; mouth neoplasms; macrogol; polyethylene glycols; mouth tumor; humans; human; parp1; poly(adp-ribose) polymerase inhibitors; macrogol 3350; parpi-fl; polyethylene glycol 300; new formulation |
| Journal Title: | Molecular Imaging and Biology |
| Volume: | 25 |
| Issue: | 2 |
| ISSN: | 1536-1632 |
| Publisher: | Springer |
| Date Published: | 2023-04-01 |
| Start Page: | 294 |
| End Page: | 302 |
| Language: | English |
| DOI: | 10.1007/s11307-022-01756-8 |
| PUBMED: | 35882728 |
| PROVIDER: | scopus |
| PMCID: | PMC11225571 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PDF and PubMed -- MSK corresponding authors are Paula de Souza França and Naga Vara Kishore Pillarsetty -- Source: Scopus |
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