Ashland Pharmaceuticals

Ashland webinar:
control strategies for reduction of nitrosamine formation in pharmaceutical products: focus on excipients


EMEA/APAC: Wednesday, 11:00 a.m. CET – 15 May 2024
NA/LATAM: Thursday, 10:00 a.m. ET – 16 May 2024

The pharmaceutical industry is focused on strategies to reduce the risk of nitrosamines in oral solid dosage products, and it is essential that drug product manufacturers work closely with excipient manufacturers to control and mitigate the risk of these nitrosamine related impurities.

Ashland is collaborating through IPEC Americas on the presence of nitrite, a potential nitrosamine precursor, in an excipient and its impact on nitrosamine formation in the drug products. Per the most recent IPEC position paper (Feb 2024), it is recommended that drug manufacturers develop control strategies based on risk assessment. If a risk is present for nitrosamine formation due to the presence of nitrites in an excipient, the risk should be mitigated in cooperation with the excipient supplier. 

In this webinar, we will discuss the mechanisms and factors that affect nitrosamine formation in drug products. We will share strategies to reduce the risk of formation and describe the efforts and actions that we have taken to counteract that risk. We will share the analytical challenges faced in the methodologies we use for the detection of nitrites and nitrosamines.

key learning objectives:

  • nitrosamines baseline, industry challenges, and regulatory updates
  • formulation strategies to mitigate the formation of nitrosamines in oral solid dosage pharmaceuticals
  • impact of excipient selection
  • factors that affect the percent conversion of nitrites into nitrosamines
  • processes to reduce nitrite levels in excipients 
  • typical nitrite level in Ashland’s excipients 
  • analytical challenges
  • fundamentals, chemical principles, and detection method (limit of quantification, limit of detection, robustness)
  • regulatory landscape for the near future and the importance of collaboration between drug product manufacturers and excipient suppliers

presenter information:

Kapish Karan, M.Sc. 
Global OSD Leader Pharmaceutical R&D, Ashland 

Kapish Karan possesses more than 10 years of experience with film coatings applications, the design of immediate and modified release coating products, unit operations associated with the preparation of oral solid dosage forms, and oral drug delivery; his recent interests have expanded into continuous processing as it relates to the manufacture of oral solid dosage forms. Kapish has authored and co-authored over 15 research papers, posters, and patents. He has published and presented on coating technology and taste masking at various technical conferences.
 

Fernando Mucelin
Senior Manager, Life Science Regulatory Affairs - Americas 

Fernando Mucelin is an accomplished regulatory and quality professional with more than 20 years of experience at Ashland, having expertise in pharmaceutical excipients and chemicals. Fernando is the chair of IPEC – Americas Latin America Working Group with a mission to educate, innovate, and develop best practices for pharmaceutical excipients in the region while prioritizing patients’ safety and drug product efficacy. He holds a degree in environmental engineering from Pontifical Catholic University of Campinas, Brazil. Prior to joining Ashland, Fernando was a lab analyst with Nutron.

 

Fan Wu, Ph.D.
Technical Director of Global Measurement Science, Ashland 

Dr. Fan Wu is responsible, through comprehensive analytical characterizations and fundamental understanding of structure/property relationships, for enabling the creation of innovative and sustainable Ashland platform technologies to drive and accelerate profitable growth. Dr. Wu is a member of the United States Pharmacopeia (USP) Povidone expert panel, excipient monograph expert committee and complex excipient expert committee. He received a Ph.D. in organometallic chemistry from the University of Chicago, followed by a postdoctoral fellowship at Brookhaven National Laboratory. Prior to joining Ashland in 2010, Dr. Wu was with Ciba Specialty Chemicals followed by BASF.


 

 

 

register for webinar

Fill out the form below to register for this webinar. You will receive follow up emails as reminders before the event. 

By checking the subscribe box and submitting this form, I agree to my email address being stored and used to receive promotional emails from Ashland, and I acknowledge that I have read and understand the Ashland privacy policy.