Potential Pyrrolizidine Alkaloid Contamination in Homoeopathic and Anthroposophic Medicinal Products of Herbal Origin

Rubrik: Originale

(Treffer aus pharmind, Nr. 02, Seite 235 (2019))

Busch J | Kammerer D | Linek M | Steinhoff B | Zeller J

Potential Pyrrolizidine Alkaloid Contamination in Homoeopathic and Anthroposophic Medicinal Products of Herbal Origin / Risk Evaluation Strategy: A Concept from Industry · Busch J, Kammerer D, Linek M, Steinhoff B, Zeller J · ¹DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und WALA Heilmittel GmbH, Bad Boll/Eckwälden und Weleda AG, Schwäbisch Gmünd und Bundesverband der Arzneimittel-Hersteller e. V. (BAH), Bonn und Biologische Heilmittel Heel GmbH, Baden-Baden
pyrrolizidine alkaloids (PA) homoeopathic medicinal products anthroposophic medicinal products risk evaluation strategy Since the beginning of the debate about a potential contamination of raw materials used for the production of herbal medicinal products caused by weeds containing pyrrolizidine alkaloids (PA) [ 1 , 2 ], the risk of PA contamination for homoeopathic and anthroposophic preparations has also been discussed. Recent data on the potential occurrence of PA in homoeopathic mother tinctures from not genuinely PA-producing plants and critical animal material showed only a low number of positive findings (1.7 % of 577 analyzed samples) [ 3 ]. In these few cases ...

Implementation of ICH Q3D for Homoeopathic and Anthroposophic Medicinal Products

Rubrik: europharm

(Treffer aus pharmind, Nr. 06, Seite 808 (2017))

Linek M | Busch J | Lipinski A | Knödler M | Kühn M | Wollersen H | Noetel A | Steinhoff B

Implementation of ICH Q3D for Homoeopathic and Anthroposophic Medicinal Products / A Concept from Industry · Linek M, Busch J, Lipinski A, Knödler M, Kühn M, Wollersen H, Noetel A, Steinhoff B · ¹Weleda AG, Schwäbisch Gmünd und ²DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und ³Homöopathisches Laboratorium A. Pflüger GmbH & Co. KG, Rheda-Wiedenbrück und ⁴WALA Heilmittel GmbH, Eckwälden/Bad Boll und ⁵Biologische Heilmittel Heel GmbH, Baden-Baden und ⁶Bundesverband der Arzneimittel-Hersteller e. V., Bonn
The new “ICH Guideline for Elemental Impurities” (ICH Q3D) [ 1 ] reached Step 4 of the ICH process in Dec 2014 and was recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada (ICH = International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). After final adoption by the Committee for Medicinal Products for Human Use (CHMP) in Dec 2014, the EMA published information on the transition periods in the European Union: New marketing authorisations for products containing new or established active substances should comply with the Guideline from ...

Evaluation of Pyrrolizidine Alkaloid Data in Homoeopathic Mother Tinctures

Rubrik: Originale

(Treffer aus pharmind, Nr. 05, Seite 701 (2017))

Busch J | Bauer S | Linek M | Zeller J | Criswell M | Noetel A | Steinhoff B

Evaluation of Pyrrolizidine Alkaloid Data in Homoeopathic Mother Tinctures / Busch et al. • Evaluation of Pyrrolizidine Alkaloid Data · Busch J, Bauer S, Linek M, Zeller J, Criswell M, Noetel A, Steinhoff B · ¹DHU-Arzneimittel GmbH & Co. KG, Karlsruhe und ²Kattwiga Arzneimittel GmbH, Nordhorn und ³Weleda AG, Schwäbisch Gmünd und ⁴Biologische Heilmittel Heel GmbH, Baden-Baden und ⁵Bundesverband der Pharmazeutischen Industrie e. V. (BPI), Berlin und ⁶Bundesverband der Arzneimittel-Hersteller e. V. (BAH), Bonn
pyrrolizidine alkaloids homoeopathic medicinal products homoeopathic mother tinctures anthroposophic medicinal products Since the German Federal Institute for Risk Assessment (BfR) published analysis results on the occurrence of pyrrolizidine alkaloids (PA) in herbal teas including some medicinal teas, the issue of potential contamination of herbal material with PA has received extensive attention [ 1 ]. PA are known to be natural constituents of a number of plants used for medicinal purposes or as part of the food or feed chain [ 2 , 3 ]. In the past years, it was further discussed in publications that PA-containing weeds may contaminate botanical ...