| Stabilitätsuntersuchungen von pflanzlichen Wirkstoffen und Fertigarzneimitteln bei erhöhter Temperatur Eine erste Bestandsaufnahme Teil 1 Sebastian Hosea, d, Frank Poetschb, d und Barbara Steinhoffc, d aKneipp-Werke GmbH & Co. KG, Würzburg, bSalus-Haus GmbH & Co. KG, Bruckmühl, cBundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn (Korrespondenzanschrift), und im Namen der dArbeitsgruppe „Stabilität von Drogen mit kritischen Inhaltsstoffen“
Stability Testing of Active Substances of Herbal Origin and Related Finished Products at Higher Temperatures / A first stocktaking
For the manufacturers of herbal substances and herbal drugs, the ICH guideline “Stability Testing of Existing Active Substances and Related Finished Products” (CPMP/QWP/556/96) and its revised version CPMP/QWP/122/02 imply a substantial extension of their testing programme, when applied consistently. Many active substances of herbal origin and also finished medicinal products fail when tested at elevated temperature. For this reason, a working group of the German Medicines Manufacturers’ Association (BAH, Bundesverband der Arzneimittel-Hersteller) in agreement with the German Federal Institute for Drugs and Medical Devices (BfArM) occupied with pragmatic ways of implementing this guideline and assessed and summarised published literature including theses from universities as well as data from the companies involved. The data presented in the following paper can principally be used for the preparation-related argumentation of the companies if testing at higher temperatures is to be waived according to the guideline. Thus, this document is of vital importance for manufacturers of herbal substances and herbal medicinal products.
Key words Accelerated Testing • Ätherische Öle • Langzeittest • Pflanzliche Arzneimittel • Pflanzliche Wirkstoffe • Stabilitätsprüfung |
