After two years of research, a team from the Indian Institute of Technology - Hyderabad has developed an oral form of Amphotericin B (AmB), which is used to treat black fungus in post-covid patients, along with kala azar or leishmaniasis.
At present, the treatment for patients affected with black fungus post-COVID-19 includes administering injections of Amphotericin B (AmB). This drug was earlier developed to treat a deadly fungal infection named Kala Azar, also known as Leishmaniasis or Black Fever.
However, AmB is available only for intravenous administration, owing to its high toxicity.
“AmB has poor aqueous solubility which makes it nephrotoxic. This means that improper dosage or overdosage could lead to kidney failure or cardiac arrests. That is why it needs to be administered under medical supervision and in controlled doses,” says Dr Chandra Shekar Sharma, a professor at the Chemical Engineering Department, at the Indian Institute of Technology (IIT) – Hyderabad. He adds that this is also why researchers could not find an appropriate method to prepare an oral solution.
However, after two years of research and conducting several advanced lab-level tests, a team — led by Dr Saptarshi Majumdar and Dr Chandra Shekhar Sharma along with their PhD scholars — has developed an oral form of AmB using nanofibers.
The team is confident that this can be used for the treatment of black fungus. They are also requesting pharma companies to come forward, use their intellectual property for free, and manufacture the same for large scale distribution.
In an interview with The Better India, Dr Chandra Shekhar explains how this will be a relief for doctors and patients fighting black fungus.
A low-cost solution
The current administration of AmB, i.e, through injections, is an expensive process. Each vial costs over Rs 3,000 and the treatment is done over the course of 30 days.
“A patient requires up to 70 vials, depending on the severity of their condition. Apart from this, they would need to stay in the hospital for all 30 days so that doctors can administer the medicine and monitor any complications,” Dr Shekhar explains.
The oral medicine of AmB developed now is made using gelatin, an FDA-approved polymer. This allows slow release of the drug, within the therapeutic window.
Dr Raja Selvarajan, a general physician at Corona Health Care Clinic in Bengaluru, says there is currently a massive demand and supply gap for the Injectable AmB. Additionally, an oral drug might ease the burden for doctors and patients. However, he warns against its unmonitored usage.
He says the drug is highly nephrotoxic and unmonitored admission can lead to severe complications including renal dysfunctions. “While the drug has shown promising results during the lab-level tests, it is important to conduct clinical trials to demonstrate its efficacy and safety profile,” he adds.
To ensure there is no toxic loading, the team conducted a series of lab-level experiments against human kidney fibroblast cells.
“Tests were also conducted to understand how the medication reacts to various PH levels to check for any adverse reactions before approval,” says Dr Shekhar, adding that a 60 mg tablet would cost Rs 200.
After two days of launching the medicine, the team has received enquiries from 20 pharma companies to replicate the medication for widespread distribution.
Edited by Divya Sethu