Researchers at Indian Institute of Technology, Hyderabad (IIT-H) have developed oral solution, which could be mass-produced now, to treat ‘black fungs’ providing huge relief to patients affected with it and doctors finding it hard to treat the patients due to the poor availability of the present medicine.
After two years of advancement of examination, the researchers are now confident that the technology can be transferred to suitable pharma partners for large-scale production.
At present, the Kala-Azar treatment is being used as a treatment for Black and other Fungus in the country and its availability and affordability make it need to allow emergency and immediate trial of this oral drug, argues a team of Prof. Saptarshi Majumdar and Dr. Chandra Shekhar Sharma and their PhD scholars Mrunalini Gaydhane and Anindita Laha, who have been working on the oral solution for the last two years.
The IIT-H in a statement here said that in 2019 Prof. Saptarshi Majumdar Dr. Chandra Shekhar Sharma from the Department of Chemical Engineering made a proven study about oral nanofibrous AMB to be effective for Kala Azar. “This is a first-ever attempt to fabricate nanofibrous oral tablets of Amphotericin B for the potential cure of Leishmaniasis or Kala Azar.
The institute further said the research funded by DST-Nanomission intended to deliver Amphotericin B (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 has selected gelatin an FDA-approved polymer as an excipient for drug molecules.
Explaining the reason for oral administration not preferred 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.
The main concern with high drug loading was it imposes nephrotoxicity. To ensure this, 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 as well as a minute amount of Glutaraldehyde crosslinker, the institute said.
Citing the importance of solution in given circumstances, Dr. Chandra Shekhar Sharma, Associate Professor, Department of Chemical Engineering said, “As 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.
The 60 mg AmB tablet is easily affordable at ₹200 and is patient-friendly ensuring the slow and steady release of the medicine thus reducing nephrotoxicity. The research team has also briefed the concept in a video on their YouTube channel.