Abstract

VALIDATION OF DEVELOPED ANALYTICAL METHODS FOR THE DETERMINATION OF ISAVUCONAZOLE IN PHARMACEUTICAL DOSAGE FORMS -AN UPDATED REVIEW

Tabassum Wasim Ahmad*, Dr. Madhuri Channawar, A. V. Chandewar, Nitin Kochar, Deepak Mohale, Deepika Devnani and Santosh Rahate

ABSTRACT

Isavuconazole is a broad spectrum triazole antifungal with that was recently licenced for the treatment of invasive aspergillosis and mucormycosis. Aspergillus and Mucorales-caused invasive fungal infections are treated with a restricted arsenal. The morbidity and mortality associated with these diseases remain elevated. Recently, the US Food and Drug Administration and the European Medicines Agency approved the triazole antifungal isavuconazole for the treatment of invasive aspergillosis and mucormycosis. Isavuconazole was shown to be noninferior to voriconazole in a randomised, double-blind study for the treatment of invasive aspergillosis. A separate, open-label research investigating the effectiveness of isavuconazole in the treatment of mucormycosis reported response rates equivalent to historical controls treated with amphotericin B and posaconazole. The prodrug isavuconazonium sulphate is available commercially in both oral and intravenous formulations and is typically well tolerated. The broad breadth of efficacy, low adverse effect profile, and excellent pharmacokinetics of isavuconazole will likely consolidate its position as a therapeutic agent.

Keywords: Isavuconazonium, triazole drug, antifungal, mucormycosis, mould infection, Solid –Phase extraction, HPLC-UV, therapeutic drug monitoring, pharmacokinetics, pharmacodynamics, clinical efficacy, therapy.