Amphotericin B is the most potent and broad-spectrum antifungal of all the drugs discovered in more than a century of global efforts. Amphotericin B has been in clinical use for half a century and has not shown any drug resistance. The drug, however, has a paradoxical reputation emanating from the experience of half a century of its clinical use. On one hand owing to its merits it earned the status of a Gold Standard while on the other hand the dose limiting and frequently fatal toxicities predominantly nephrotoxicity labeled it as Ampho-the-Terrible. Despite the nephrotoxicity in two thirds of the patients using Amphotericin B, hitherto no better drug could be discovered to replace its broad-spectrum and drug sensitivity - in fact the only antifungal free of drug resistance.
Amphotericin B –The only broad-spectrum Antifungal
The first dosage form of Amphotericin B that could be formulated is an intravenous infusion presently known as “Conventional Amphotericin B” is a Sodium Deoxycholate- Amphotericin B colloidal suspension in 5% Dextrose. Decades of studies unraveled the ironic fact that each of the three constituents of the formulation contribute to the range of adverse effects including potentially fatal nephro-, cardio-, and neuro-toxicities.
Extremely limited solubility of Amphotericin B that prevented deviation from the conventional Amphotericin B recipe could be addressed to by the advent of Liposome Technology in mid 1960s. Through the decade of 1980s a novel Liposomal formulation was developed by replacing Deoxycholate of conventional Amphotericin B with a strategic mix of lipids that formed the matrix of the drug carrier Liposomes. The shift from conventional to Liposomal formulation helped improve efficacy from 33% to 76% and bring down nephrotoxicity from 60% to 20%. However, both efficacy and safety levels needed further improvement. In the decade of 1990s two other Liposomal/Lipid formulations with different lipid combinations and compositions were developed but remained short of expectations on efficacy and toxicity.
FUNGISOME® i.v. has the highest efficacy against all pathogenic Fungi
- Sanath SS, Gogtay NJ, Khirsagar NA, Journal of Postgraduate Medicine, 2005; 51(supplement): 58-63.
- John R. Perfect., Oncology, 2004; Vol. 18, No. 13: 1-13
- Aoun M., Medical Mycology, 2006; 44: s363-s366.
- Reboli A C et al., The New Eng. J. Med., 2007; 356: 247-82.
- Isidro Jarque., Rev Iberiam Micol, 2009; 26(1): 75-77
- Dena M. Behm Dillon et al., P&T, May 2002; 27(5): 256-263
FUNGISOME® i.v. : The most nephrosafe formulation of the only broad spectrum
potent antifungal – Amphotericin B. It is the most economical too!
i.v. developed in India by combining Liposome- and Nano-Technologies along with strategic changes in composition have given a Nanosomal Amphotericin B i.e. most broad-spectrum, potent at lower dose and yet nephrosafe at high dose making it the best antifungal ever developed anywhere in the world for the treatment of systemic as well as superficial fungal infections and visceral leishmaniasis – a vector borne parasitic disease commonly known in Indian sub-continent as Kala-Azar.
The merits of FUNGISOME®
i.v. have been well recognized with three national awards in India and India winner award from the Welsh Assembly Government of UK. More recently FUNGISOME®
i.v. has been cited amongst top ten innovations of the decade.