Technology will be transferred to pharmaceutical firms
Researchers at the Indian Institute of Technology, Hyderabad (IIT-H), have approved the mass production of an oral solution to treat black fungus, providing huge relief to patients.
After two years of study, the researchers are now confident that the technology can be transferred to suitable pharma partners for large-scale production.
The oral solution will ensure easy medicare for patients and also affordable with a 60 mg tablet likely to cost ₹200 only.
At present, Kala Azar (visceral leishmaniasis) treatment is being used for black fungus and other fungus in the country but its availability, affordability and the procedures involved make it imperative to allow emergency and immediate trial of this oral drug, feels the team of Prof. Saptarshi Majumdar and Dr. Chandra Shekhar Sharma and their Ph.D scholars Mrunalini Gaydhane and Anindita Laha, who have been working on the oral solution for the last two years.
According to IIT-H, Prof. Saptarshi Majumdar and Dr. Chandra Shekhar Sharma from the Department of Chemical Engineering made a proven study in 2019 about oral nanofibrous Amphotericin B (AmB) to be effective for Kala Azar.
This was the first attempt to fabricate nanofibrous oral tablets of Amphotericin B (AmB) for the potential cure of Leishmaniasis or Kala Azar.
The institute further said the research funded by DST-Nanomission intended to deliver AmB orally at an extremely slow rate 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. They explaining the reason for oral administration not preferred earlier despite the comfortable and effective route.
The researchers said that due to its amphiphilic nature, the AmB has poor aqueous solubility and forms aggregates in the system, which stresses renal filtration and thus causing nephrotoxicity (adverse impact of medicines on the kidney).
Since the main concern with high drug loading was nephrotoxicity, the team has carried out a cell viability assay (MTT assay) against human kidney fibroblast cells which illustrated no evidence of cell toxicity caused by AmB, the institute said.
Dr. Chandra Shekhar Sharma, Associate Professor, Department of Chemical Engineering Sharma said that since the idea behind the research was to find a solution to serve society, the oral solution developed is made free from intellectual property so that it can be mass produced and is made affordable and available to all.
The 60 mg AmB tablet will be affordable at ₹200 and is patient-friendly ensuring its slow and steady release thus reducing nephrotoxicity.
The research team has also explained the concept in a video on YouTube.
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