Saccharin-Enabled Oral Formulation, Biopharmaceutics and Early Genotoxicity Assessment of the PPARγ Antagonist T0070907
Background/Objectives: T0070907 is a potent PPARγ antagonist with emerging antitumour activity in osteosarcoma; however, its very low aqueous solubility, uncertain systemic exposure, and nitroaromatic structure raise significant developability concerns. This work aimed to convert T0070907 into a pharmaceutically tractable oral entity and generate an integrated early developability and genotoxicity snapshot. Methods: The physicochemical properties of T0070907 were characterised, solubility-enhancing strategies were evaluated, and saccharin was identified as a supramolecular excipient enabling high-dose oral delivery. A 20 mg/mL oral liquid formulation was developed and monitored using a validated, stability-indicating UHPLC/LC–MS method. In vivo systemic and tissue exposure was assessed in rats using LC–MS/MS; hepatic metabolism was explored in human liver microsomes; and genotoxicity risk was evaluated both in silico (ICH M7) and in a GLP-compliant Ames test. Results: Saccharin markedly enhanced solubility and enabled a 20 mg/mL oral formulation that remained stable for 90 days, with pyridin-4-amine identified as the dominant degradation product. In rats, T0070907 was below the limit of quantification in plasma after oral dosing at 5, 10 and 100 mg/kg, including in a solubilising vehicle. In contrast, T0070907 was clearly mutagenic in the Ames test. Conclusions: These findings support saccharin-based supramolecular formulations as a practical strategy for poorly soluble nitrobenzamides, while positioning T0070907 primarily as a pharmacological tool.
Authors
- Bernard Do (ORCID: https://orcid.org/0000-0002-1131-2080)
- Antonin Marchais (ORCID: https://orcid.org/0000-0003-0954-8294)
- François‐Xavier Legrand (ORCID: https://orcid.org/0000-0002-7271-7284)
- Maxime Annereau (ORCID: https://orcid.org/0000-0001-9594-2516)
- Nathalie Gaspar (ORCID: https://orcid.org/0000-0002-1827-8903)
- Maria Eugénia Marques Da Costa (ORCID: https://orcid.org/0000-0002-1498-603X)
- Charlotte Devant (ORCID: https://orcid.org/0009-0005-5274-1294)
- Lilia Sehad
Institutions
- Centre National de la Recherche Scientifique (FR)
- Inserm (FR)
- Université Paris-Saclay (FR)
- Institut Gustave Roussy (FR)
- Institut Galien Paris-Saclay (FR)
- Institut des Sciences Moléculaires d'Orsay (FR)
Publication Details
- Journal
- Pharmaceutics
- Published
- 2026-10-05
- DOI
- https://doi.org/10.3390/pharmaceutics18101258
- Primary Topic
- Drug Solubulity and Delivery Systems
- Type
- article
- Field-Weighted Citation Impact
- 0.00