Researchers at the Indian Institute of Technology (Hyderabad) have developed a method to produce an oral solution to treat patients suffering from black fungus. A 60-mg tablet, which can be priced at about ₹200, ensures slow and sustained release of the drug. It also ensures reduced nephrotoxicity (adverse impact of medicines and chemicals on the kidney).

A technology developed to treat Kala Azar can be quickly repurposed to treat patients of black fungus in an affordable and convenient way.

“In 2019, Saptarshi Majumdar and Chandra Shekhar Sharma from the institute’s Department of Chemical Engineering made a proven study on oral nanofibrous AMB (Amphotericin B) to treat Kala Azar,” an IIT-H spokesperson said.

Also read: 14,872 cases of black fungus being treated across the country, says Centre

In Kala Azar, also called visceral leishmaniasis, the parasite infects internal organs such as liver.

“This is a first-ever attempt to fabricate nanofibrous oral tablets of Amphotericin B for the potential cure of Kala Azar. With the 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,” he said.

At present, the Kala-Azar treatment is being repurposed to treat patients infected by black fungus and other fungi in the country. The black fungus is seen in Covid-19 patients in the post-infection period.

Keeping in view the shortage of drugs to treat the disease, the institute feels that there is a need 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, thus causing nephrotoxicity,” the IIT-H researchers said.

Hence, oral administration is avoided, although it’s the most comfortable and effective method.

In the research funded by the Department of Science and Technology-Nanomission, a team led by Saptarshi Majumdar and Chandra Shekhar Sharma intended to deliver Amphotericin B orally at an extremely slow rate.

PhD scholars Mrunalini Gaydhane and Anindita Laha were part of the research team.

The research aimed at increasing the drug absorption and reducing aggregation in order 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 hydrolyze the polymers, the team has also checked and confirmed the enzymatic stability of the tablet in pepsin,” the researchers said.

The main concern with the high drug loading was the level of nephrotoxicity.

“The technology developed is free of IP which facilitates its mass-production, making it affordable and available to the public at large,” Chandra Shekhar Sharma, Associate Professor, Department of Chemical Engineering, said.