Applying the science of advanced dissolution testing to accelerate product approval

Applying the science of advanced dissolution testing to accelerate product approval

Case study

Drug repurposing has become a rich source of safe and effective new therapeutic options against unmet medical needs.  With the appearance of SARS CoV2 and the pandemic spread of severe Covid-19, drug repurposing has intensively being used to identify potential new drug candidates. One of the potential drug candidates was a small molecule prodrug with poor solubility in ethanol, practically insoluble in water and rapid hydrolyzation in aqueous media.  The drug was marketed as an immediate release tablet for short term acute treatment. Since the drug showed efficacy against viruses including promising results to be effective against SARS CoV2 reformulation was required to achieve sufficient plasma level over the duration of 12 hours for a twice daily oral dosing regimen.

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