During the development of pharmaceutical spray-dried formulations, many samples must be prepared for physico-chemical characterisation and dissolution testing by systematically varying parameters such as drug loading or the grades and…

Abstract The onset of the N-nitrosamine (NA) saga in 2018 was chiefly related to certain small dialkyl N-nitrosamines originating from the synthesis of the active pharmaceutical ingredient (API). However, the subsequent comprehensive…

Abstract The detection of N-nitrosamine impurities in medicines and the recent emergence of nitrosamine drug substance related impurities (NDSRIs) has posed a great challenge to manufacturers of drug products and regulators alike. NDSRIs…

1. Introduction The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical industry and health authorities. In June 2018, the FDA was notified of the presence of…

In mid-2018, N-nitroso-dimethylamine (NDMA) was unexpectedly detected in a valsartan active pharmaceutical ingredient (API). NDMA, like many other nitrosamines, is mutagenic and a probable human carcinogen. In contrast to many other newly…

The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be assessed for the potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper…

This work proposes a methodology for the design, development, and characterization of tablets prepared by the direct compression method of olmesartan medoxomil. The main objective was to ensure a high dissolution rate of the active…

Nitrosamine risk mitigation is front of mind for many drug formulators following the discovery of N-nitrosodimethylamine (NDMA) in valsartan – a commonly used drug in the treatment of high blood pressure and heart failure. To learn…

What are nitrosamines? Nitrosamines are chemical compounds that can be formed from secondary amines with a nitrosating agent. Those nitrosating agents can be nitrous acid, nitrites or NOX. Nitrosamines may be found in drinking water and…

Most of the promising drugs in development channels are poorly water-soluble drugs which limit formulation approaches, clinical application because of their low dissolution and bioavailability. And the major current challenges of the…