CSIR-NCL develops new, stable tuberculosis drug
Council of Scientific and Industrial Research - National Chemical Laboratory (CSIR-NCL), has developed a new drug with improved stability to treat tuberculosis (TB).
The team at CSIR-NCL, led by AK Nangia, developed the drug in association with the school of chemistry, University of Hyderabad.
The research was done in order to ensure a clear way of developing a stable formulation of 4-FDC (4 drugs fixed dose combination) for treating tuberculosis.
The study, published in the Journal of Pharmaceutical Sciences studied the cause for the instability of the 4-FDC drug and discovered a new cocrystal (solid substances which consist of few components mixed together) that addresses the issue.
“The stable cocrystal drug with its longer shelf life will improve the prospects of transport logistics and inventory management of TB drugs,” said Nangia .
Tuberculosis (TB), an airborne infectious disease, is caused by a species of pathogenic bacteria Mycobacterium Tuberculosis. It is one of the top ten leading causes of death worldwide. According to the World Health Organisation (WHO) in the year 2015, an estimated 10.4 million people developed TB and 1.8 million died from the disease, including 0.4 million deaths among HIV-positive people.
The team included Suryanarayana Cherukuvada, Devarapaga Maddileti, Swapna Battini, and MK Chaitanya Mannava. They studied the cause for the instability of the 4-FDC drug chemical structures and discovered a pharmaceutically-stable cocrystal. This was done by the application of crystal engineering principles to improve the stability, so that the drug inhibits the cross-reaction between Isoniazid (INH) and Rifampicin and overcomes the formation of inactive by-products.
The pharmaceutical cocrystals of INH namely, INH-Caffeic acid and INH-Vanillic acid, were used to improve the stability of 4-FDC. As per the findings of the team, the pharmaceutically stable cocrystal of INH is able to improve the stability by greater than 5 times the current stability of 4-FDC drugs. This was followed by a number of stability studies carried out under accelerated conditions of 40 degrees Celsius temperature and 75 per cent relative humidity.