The growing regulatory focus on life-threatening impurities and the evolving role of excipients in formulation took centre stage during a partner session by Sigachi Industries at the FDD Conclave 2025, held on June 13–14, 2025, in Hyderabad.
The session, titled, ‘Impurities and Excipients’, was conducted on Day 1 by Dr Abhijit Gothoskar, Technical Expert at Sigachi Industries. The presentation opened with a discussion on impurities, particularly nitrosamines.
Referencing pivotal 1956 research, it was noted that dimethyl nitrosamine was found to cause liver tumours in rats—a discovery that has since shaped global regulatory standards. Subsequent studies confirmed that nearly 90 per cent of the 300 nitrosamines tested were carcinogenic in various animal models.
This has prompted regulatory agencies to closely monitor and mitigate nitrosamine contamination in pharmaceutical products. Dr Gothoskar explained that nitrosamine formation depends on several conditions, and approximately 40 per cent of active pharma ingredients (APIs) contain amines that are at risk.
Addressing these risks requires not just process control but a strong understanding of excipient behaviour. The presentation then moved to the role of excipients in formulations, with particular emphasis on their often-underestimated impact. As major components in most oral solid dosages, excipients, especially diluents, play a key role in controlling tablet compression characteristics.
Their physico-mechanical properties influence critical factors such as compressibility, tabletability, and compactibility. Dr Gothoskar presented Microcrystalline cellulose (MCC), specifically HiCel MCC by Sigachi, as a proven multifunctional excipient. His session highlighted MCC’s plastic deformation behaviour, hydrogen bond formation, and fibrous particle interlocking, which together enhance tablet strength at low compression forces.
Considerations such as blending speed, lubricant interaction, and addition of brittle excipients were also addressed in the context of maintaining optimal tensile strength and performance. He reinforced Sigachi’s position as a dependable formulation partner through this session.