Prevention of the conversion of pharmaceutical agents into toxic n-nitrosamine compounds

Abstract

A pharmaceutical composition, which is an oral solid dosage form, containing a pharmaceutical agent comprising a dialkylamino- or a trialkylamino-group and one or more pharmaceutically acceptable excipient(s), wherein over a period of 2 weeks at 60° C. under open exposure (at any humidity between 30 and 75% rH), or 6 months at 40° C./75% rH in the primary packaging, or 6 months at 25° C./60% rH in the primary packaging the concentration of the corresponding N-nitroso-derivative of the pharmaceutical agent remains below 50 ppm (relative to the weight of the free base of the pharmaceutical agent in the pharmaceutical composition).

Dependencies are inferred from the claim text.