Sunday, July 4, 2021

IIT Hyderabad develops oral amphotericin B to treat black fungus

The Indian Institute of Technology-Hyderabad has developed nanofibre-based, controlled-release oral tablets of amphotericin B (AmB) to treat post-Covid fungal infections.Researchers have kept the technology free of intellectual property rights and are looking for pharmaceutical partners who can take up mass-scale production. Currently, AmB is an injectable drug.

In 2019, faculty members Saptarshi Majumdar and Chandra Shekhar Sharma from the department of chemical engineering had released a study about oral nanofibrous AmB to be effective for kala azar, a parasitic ailment that can cause fever, weight loss and swelling of the liver or the spleen. This is a first-ever attempt to fabricate nanofibrous oral tablets of amphotericin B for the potential cure of leishmaniasis or kala azar.

With two years of advancement of examination, the researchers say they are confident the technology can be transferred to suitable pharma partners for large-scale production. At present, kala azar treatment is being used to treat black and other fungi in the country and its availability and affordability make it necessary to allow emergency and immediate trial of this oral drug.

“Due to its amphiphilic nature, the AmB has poor aqueous solubility and forms aggregates in the system, which stresses renal filtration and thus causes nephrotoxicity. This is the reason the oral administration has abstained, despite being the most comfortable and effective route,” said professor Majumdar.

Stressing on the need for pharma companies to come forward, Sharma said, “The main idea behind our research is to find a solution to serve society. The technology developed is made free from IP, so that it can be mass-produced and is affordable and available to the public at large. We can be reached via our public & corporate relations.”

In the present research funded by DST-Nanomission, a team led by Majumdar and Sharma along with their PhD scholars Mrunalini Gaydhane and Anindita Laha intended to deliver AmB orally at an extremely slow rate, albeit within the therapeutic window. The purpose was to increase the drug absorption and reduce aggregation, to lower the drug toxicity. For this, the team selected gelatin, an FDA-approved polymer as an excipient for drug molecules.

Further, as the gastrointestinal tract contains different enzymes which hydrolyse the polymers, the team checked and confirmed the enzymatic stability of the tablet in pepsin. The main concern with high drug loading was if it imposes nephrotoxicity. To ensure this, the team has carried out a cell viability assay (MTT assay) against human kidney fibroblast cells which showed no evidence of cell toxicity caused by AmB as well as a minute amount of Glutaraldehyde crosslinker.


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