The use of deuteration in medicinal chemistry has exploded in the last few years. Deuteration refers to the selective replacement of protium hydrogen isotope atoms in small-molecule drugs with deuterium hydrogen isotope atoms. A carbon-deuterium (C-D) bond is more stable in the body than a carbon-hydrogen (C-H) bond. If the deuterium is strategically located in a drug’s chemical structure, the extra stability of the bond will be more resistant to metabolic breakdown, and the duration of drug action will be prolonged.
Neuland Laboratories for over a decade now has developed expertise in developing deuterated drug substances. Our core process development team works towards phase-appropriate process development of deuterium molecules which are in the drug development stage. We work towards addressing the key element of route scouting, process optimization, DoE studies, function group modification or insertion of deuterium functionality at appropriate stage into the core moiety, process safety evaluation, and scalability, to deliver processes that are robust, safe, reliable and scalable.
Our R&D team is also well-versed with catalyst-based methodologies to produce the deuterated molecule in an exchange approach and polymorph evaluation in the very early stages of process development. Besides, a QbD approach ensures the potential process impurities are controlled diligently in the drug substances. It is also ensured that the APIs are free from potential genotoxic and carcinogenic (including nitrosamine) impurities. Extensive analytical tools and techniques such as 1H NMR, 13C NMR, 2D NMR, HRMS, DSC, TGA. IR, SEM and PXRD have been used to elucidate the API structure, compare the different solid forms, and demonstrate the chemical and physical attributes of the API. We leverage our technical strength, analytical expertise and regulatory knowledge, to design and execute development strategies. These interventions at the API stage facilitate flawless drug substance development.
Our state of the art R&D facility, skilled scientific team and manufacturing capabilities is equipped to manufacturing Deuterated building blocks for the scale-up of deuterated building blocks in gram scale to metric tons scale. The manufacturing facilities comply with all Regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and are successfully inspected/approved by US FDA, EDQM, BfArM (Germany), TGA (Australia), PMDA (Japan), AFSSAPS (France), ANVISA (Brazil) and Cofepris (Mexico).
Neuland is licensed to:
Connect with us to discuss a deuteration project – Contact us