PREVENTION OF THE CONVERSION OF PHARMACEUTICAL AGENTS INTO TOXIC N-NITROSAMINE COMPOUNDS

PREVENTION OF THE CONVERSION OF PHARMACEUTICAL AGENTS INTO TOXIC N-NITROSAMINE COMPOUNDS

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 of2 weeks at 60° C. under open exposure (at any humidity between 30 a...

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Bibliographische Detailangaben
Hauptverfasser: GUJJAR, Chaitanya Yogananda, FITZNER, Ansgar, RALLABANDI, Bala Ramesha Chary, SAGILI, Manohar Reddy, MANKALA, Santhosh Kumar, DÖBBER, Alexander, KALAMATA, Venkatasimhadri Naidu, MADALLAPALLI, Kiran Kumar
Format: Patent
Sprache:eng
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung: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 of2 weeks at 60° C. under open exposure (at any humidity between 30 and 75% rH), or6 months at 40° C./75% rH in the primary packaging, or6 months at 25° C./60% rH in the primary packagingthe 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).