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.

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Journal
Pharmaceutics
Published
2026-10-05
DOI
https://doi.org/10.3390/pharmaceutics18101258
Primary Topic
Drug Solubulity and Delivery Systems
Type
article
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article

Saccharin-Enabled Oral Formulation, Biopharmaceutics and Early Genotoxicity Assessment of the PPARγ Antagonist T0070907

Bernard Do, Antonin Marchais, François‐Xavier Legrand, Maxime Annereau et al.
Pharmaceutics
Drug Solubulity and Delivery Systems
article

Saccharin-Enabled Oral Formulation, Biopharmaceutics and Early Genotoxicity Assessment of the PPARγ Antagonist T0070907

Bernard Do, Antonin Marchais, François‐Xavier Legrand, Maxime Annereau, Nathalie Gaspar, Maria Eugénia Marques Da Costa, Charlotte Devant, Lilia Sehad
article en

Abstract

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.

PharmaceuticsVol. 18(10)
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)
Openalex Percentile: Top 13%
Drug Solubulity and Delivery Systems
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