Drug solubility in the intravenous formulation of Solithromycin

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Development of the tri-amino acids-buffered solithromycin IV formulation was achieved using a dynamic in vitro precipitation model” Evans et al (2017).

Abstract:

Solithromycin is a fluoro-ketolide (a fourth-generation macrolide) antibiotic that has been undergoing clinical trials for the treatment of community-acquired bacterial pneumonia. In this study, development of the tri-amino acid-buffered solithromycin intravenous (IV) formulation was performed to minimize the occurrence of infusion-associated local adverse events (infusion-site pain or phlebitis) observed in patients who received the tartaric acid-buffered IV formulation with a lower buffered capacity during phase I clinical trials. Development of the tri-amino acids-buffered solithromycin IV formulation was achieved using a dynamic in vitro precipitation model. Computational modeling also supports the superiority of the amino acid-buffered formulation over the tartaric aid-buffered formulation.

Reference:

Evans, D., Yalkowsky, S., Wu, S., Pereira, D. and Fernandes, P. (2017) Overcoming the Challenges of Low Drug Solubility in the Intravenous Formulation of Solithromycin. Journal of Pharmaceutical Sciences. October 28th. [epub ahead of print].

doi: 10.1016/j.xphs.2017.10.030.

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