Address Chemical Degradation of your Drug Product on Stability

PhaRxmon Consulting LLC provides a deep technical understanding of oxidative degradation processes, and how your formulation can impact oxidative degradation rates. New perspectives on nitrosamine impurity growth offer possible mitigation scenarios. Drawing on our years of education, industry experience, and as reflected in our scientific publications, we offer customized consulting services that address your specific drug degradation problems and concerns during the drug development process.

Oxidative Degradation

One common drug degradation pathway is oxidation. However, oxidative degradation is often difficult to mechanistically rationalize. We have extensive understanding of oxidation degradation mechanisms which allow us to suggest how to minimize it in your formulation. Excipients can play a large role and need to be considered carefully. After studying degradation in hundreds of compounds in development, we are able to tweak the theory vs the reality and put it into pragmatic perspective, so you can get your drug to market with a clean degradation profile. Review the scientific papers related to oxidative degradation and excipients published by Dr. Harmon in the field below.

Green Pills

Combination of Different Pills

Nitrosamine Formation

Recently, much attention has been drawn to nitrosamine impurity formation in drug substances and drug products. Drawing on previously established chemistry, Dr. Harmon has highlighted that trace levels of formaldehyde, common in oral dosage form excipients, may be able to promote nitrosation of secondary amines at neutral “tablet” pH values of pH 6-7. This perspective may bring with it new control strategies. Dr. Harmon has also proposed the first detailed chemical rationale for the formation of the nitrosamine NDMA in the well-known case of ranitidine solid oral dosage forms. With this proposed rationale, a simple control strategy is implicated. Review the scientific manuscripts describing the details of these ideas below by clicking on the links in the Nitrosamine Formation field.