While availability of injectable insulin formulation has been a major breakthrough in diabetes management, insulin needs to be kept in a refrigerator or it will become unfit for use due to fibrillation (‘solidification’) after a few hours. Plus, its prolonged storage even in a normal refrigerator is also not good. Hence, its thermal instability and fibrillation at non-refrigerated temperatures demands storage and maintenance of the cold chain, making it expensive. The problem becomes acute for diabetes patients staying at remote locations with no refrigerator facility or those travelling for long hours.
Scientists from the CSIR-Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, in collaboration with Bose Institute, CSIR-Indian Institute of Chemical Biology (CSIR-IICB), Kolkata, have announced the discovery of a novel formulation of cost effective thermostable insulin injection on Wednesday.
Their joint research helped in identification of a small peptide molecule ‘Insulock’ which inhibits insulin from fibrillation with the first part done by principal investigators from Bose Institute - Subhrangsu Chatterjee and Partha Chakrabarti whereas determination of 3D structure of ‘Insulock-insulin’ complex and thermal stability by using high-resolution Nuclear Magnetic Resonance (NMR) spectroscopy, was taken up IICT’s B. Jagadeesh (chief scientist) and Jithender Reddy (scientist).
They had shown that “Insulock” prevents both heat and storage induced insulin fibrillation and thereby loss of effective quantum of insulin. “Insulock” is non-toxic, non-immunogenic, heat-stable and can maintain insulin in the active form at room temperature without any loss for months. It has been tested successfully in mice models.
“Gaining structural insights about “Insulock” and establishing structural similarity with respect to the native insulin injection are crucial steps and these were carried out at our NMR which is USFDA-audited, has national accreditations, best suited for regulatory studies of drug molecules,” said Dr. Jagadeesh. IICB scientists stated that once the trials in humans are completed, the novel ‘Insulock’ formulation can provide cost-effective insulin to remote patients.
The research teams are planning to take up the clinical trials in humans by collaborating with Indian pharmaceutical industries. This research work has been published in iScience, an international reputed journal of Cell press.