New Delhi: Availability of injectable insulin formulation has been a major breakthrough in diabetes management. However, insulin needs to be kept in a refrigerator, which, otherwise, after some hours, becomes unfit for use due to fibrillation (some kind of 'solidification'). Its prolonged storage, even in the normal refrigerator, is also not good. Therefore, its thermal instability and fibrillation at non-refrigerated temperatures demand cold chain storage and maintenance, making it expensive. Further, the problem is more acute for diabetes patients who are staying at remote locations with no refrigerator facility or those who are travelling for long hours.
Worldwide efforts are being made to invent new formulations for Thermo-stable, nontoxic and bioactive insulin.
Researchers from Bose Institute, CSIR-Indian Institute of Chemical Biology (CSIR-IICB), Kolkata, in collaboration with CSIR-Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, have shown that a small peptide molecule consists of four amino acids, named as "Insulock" prevents both heat and storage induced insulin fibrillation and thereby loss of an effective quantum of insulin. They found that the "Insulock" is non-toxic, non-immunogenic and heat-stable and can maintain insulin in the active form at room temperature with no loss for months. The "Insulock" has been tested in mice models. This research work has been published in iScience, a reputed international journal of Cell Press.
The work involves two major contributions (1) identification of an appropriate small peptide to inhibit the insulin from fibrillation, which has been accomplished by Dr. Subhrangsu Chatterjee, Associate Professor of Bose Institute and Dr. Partha Chakrabarti (Principal Investigators) and (2) Determination of the 3-dimensional (3D) structure of the Insulock-insulin complex and its thermal stability by using high-resolution Nuclear Magnetic Resonance (NMR) Spectroscopy, which has been accomplished by Dr B. Jagadeesh, Chief Scientist, and Dr Jithender Reddy, Scientist from NMR Centre of CSIR-IICT.
Dr. Jagadeesh of CSIR-IICT said that "gaining the structural insights about the "Insulock" and establishing its 3D-structural similarity with respect to the native insulin injection are crucial steps, which have been carried out at the NMR centre of CSIR-IICT. This NMR centre has world-class facilities with USFDA-audited and National accreditations best suited for drug molecule regulatory studies.
The Kolkata-Hyderabad scientists' team hopes that, upon successful completion of trials in humans, the novel Insulock formulation can give a rich scope for producing cost-effective insulin injection and will be extremely useful in delivering it to the patients even in resource-limited areas. Further, the team is planning to participate in the developmental activity of human trials by collaborating with the Indian pharmaceutical industries. This discovery is expected to attract pharma giants with a vested interest in Thermo-stale insulin production.
Courtesy: India Science Wire