The basis of the rational development of Phytotherapy

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1 Symposium 20 Years Cologne (Germany), 18th June 2009 The basis of the rational development of Phytotherapy NIVERSITAT DE ARCELONA Prof. Dr. Salvador Cañigueral nitat de Farmacologia i Farmacognòsia Facultat de Farmàcia arcelona 1 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

2 Rational development of Phytotherapy Aimed to: The appropriate use of herbal products in therapy and health care Foeniculum vulgare Salvador Cañigueral 2 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

3 How to use appropriately herbal products in health care and therapy? 3 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

4 Rational Phytotherapy Appropriate use of herbal remedies in therapy P r e m i s e s Natural does not mean safe There is a scientific evidence supporting the efficacy of many herbal remedies for certain indications The efficacy will only be achieved with the correct use of the herbal medicines. 4 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

5 Rational Phytotherapy Appropriate use of herbal remedies in therapy Evidence based products What is required? Information Education 5 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

6 Evidence based products Requirements to meet Quality Safety Efficacy 6 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

7 Quality Herbal Medicinal Products (HMP) Efficacy HMP Safety Quality is the basis for the reproducibility of safety and efficacy. 7 Quality (ased on auer, 1998) nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

8 8 The develop pment of new from plants medicines Plant used in traditional medicine Chemical research Production of plant material Galenic development nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral Discovery of an interesting pharmacological activity or an interesting clinical effect Extracts and bioactive molecules Marketing authorisation Marketed medicine Other plants Quality control development Preclinical pharmacology and toxicology studies Clinical trials NIVERSITAT DE ARCELONA

9 Complexity of herbal drugs and herbal drug preparations Inert substances (matrix) Potential antagonists Active principles Potentially allergenic or toxic substances Adjuvant substances 9 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

10 Variability of the herbal material Chemotypes in the oil from Thymus vulgaris 1. Thymol 2. Carvacrol 3. Linalool 4. Geraniol 5. Eucalyptol 6. α-terpineol 7. trans-thujan-4-ol / Terpinen-4-ol 10 NIVERSITAT DE ARCELONA

11 Variability of the herbal material Thyme esential oil Thymi aetheroleum Profile by GC: Thymol 36,0-55,0 % OH Carvacrol 1,0-4,0 % OH p-cymene 15,0-28,0 % γ-terpinene 5,0-10,0 % Thymol Carvacrol p-cymene Linalool 4,0-6,5 % OH ß-Mircene 1,0-3,0 % Terpinen-4-ol 0,2-2,5 % OH European Pharmacopoeia, 2008 γ-terpinene Linalool ß-Myrcene Terpinen-4-ol 11 NIVERSITAT DE ARCELONA

Variability of the herbal material During the vegetative cicle 1,4 Serpentine e (%) in roots 1,2 1 0,8 0,6 0,4 0,2 0 0 1 2 3 4 5 6 7 8 9 Age of the plants (months) 12

12 Variability of the herbal material During the vegetative cicle 1,4 Serpentine e (%) in roots 1,2 1 0,8 0,6 0,4 0, Age of the plants (months) 12 Evolution of the content of serpentine in the roots of Catharanthus roseus nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

II and III according to Vahlensieck Dose Drug: 4-6 g/day (infusion); dry extracts (MeOH 20%, EtOH 70%):

13 Influence of the extraction Species rtica dioica L.,. urens L. Active principles? Indication Symptomatic treatment of mictu- rition disorders in benign prostate hyperplasia (PH) at stages II and III according to Vahlensieck Dose Drug: 4-6 g/day (infusion); dry extracts (MeOH 20%, EtOH 70%): mg/day; fluid extract (EtOH 45%): ml; tinture (40% EtOH): 15 ml; etc Extracts of nettle root 13 NIVERSITAT DE ARCELONA

14 Influence of the extraction Extracts of nettle root Extract Inhibition of prostate grow (%) p vs. Control Cyclohexane Ethyl acetate n-utanol Methanol 20% Water Suramine Effect of nettle root extracts (. dioica) on experimentally induced prostate hyperplasia in mouse (Adapted from Lichius and Muth, 1997). 14 NIVERSITAT DE ARCELONA

15 Quality issues related to herbal products Complexity of the composition of herbal drugs and herbal preparations Variability of the biological materials (biodiversity, chemotypes, etc.). Influence of the collection and post-harvesting processes (drying, storage, etc) Influence of the extraction process The active principles are sometimes not identified or only partially known Possible contaminations (adulterations, heavy metals, pesticides, microbial, etc.) 15 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

16 Stability of herbal medicinal products Tea tree oil (Melaleuca alternifolia) OH OH Formed by oxidation of terpinen-4-ol OH Terpinen-4-ol ( 30%) OH 1,2,4-Trihydroxymenthane Responsible of contact dermatitis caused by 16 aged oxidized oils Harkenthal et al., Pharmazie 55: (2000) 16 NIVERSITAT DE ARCELONA

17 Quality control of herbal drugs and Objectives herbal preparations Identity Purity Contaminants Quantitative determi- nation of active principles and markers Stability 17 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

18 European Pharmacopoeia European Directorate for the Quality of Medicines (EDQM) Council of Europe 2007 Members: European states European nion Analytical methods and specifications for medicinal products Observers: European and non European states WHO 18 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

19 European Pharmacopoeia Working groups Working groups on herbal drugs and herbal drug preparations (2008) Permanent groups 13A 13 13H Phytochemistry Phytochemistry Fatty oils and derivatives Groups ad hoc MQH Microbiological quality of herbal drugs and herbal drug preparations PST TCM WXT Pesticide residues TCM herbal drugs Water for extraction 19 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia NIVERSITAT DE ARCELONA

20 Edition: 2nd 3rd 4th 5th *6th Year: N umber of monographs ographs *) Including supplements 6.1 to 6.4 European Pharmacopoeia Monographs of herbal drugs and herbal drug preparations 20 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

21 Soy isoflavones and menopause Soy isoflavons are obtained from the seeds of Glycine max (= G. soja) Glycosides of HO O O OH Genistein OH HO O O Daidzein OH Soy beans 21 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

22 Soy isoflavones and menopause Isoflavones are phytoestrogens They bind the estrogenic receptors (ER). Higher affinity for ERβ than for ERα. Higher transcriptional activity on ERβ than on ERα. Preferential activity on CNS, bone and vascular wall. Genistein has the higher affinity for ER. 22 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

Reduction of the postmenopause vascular risk.

23 Soy isoflavones and menopause Clinical interest in menopause Menopause symptoms, mainly hot flushes. Reduction of the postmenopause vascular risk. Reduction of the risk of ostheoporosis. 23 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

24 Soy isoflavones and menopause Why the clinical trials are contradictory? Williamson-Hughes et al. Menopause 2006; 13 (5): Genistein <10 mg/day nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral Genistein >15 mg/day NIVERSITAT DE ARCELONA

25 The European market of Phytotherapy Prescription of herbal medicinal products by medical doctors 25 Europe Italy Poland Austria Spain elgium Hungary Germany K France 0% 20% 40% 60% 80% 100% Self-medication Prescription nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral 41% 7% 9% 9% 13% 18% 18% 38% 43% 73% Prescription quota (in percentage) Source: IMS International 2002 NIVERSITAT DE ARCELONA

26 Rational Phytotherapy Appropiate use of herbal remedies in Therapy Evidence based products Information Education 26 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

27 Rational Phytotherapy Information and education Good and reliable information tools for health professionals Solid education oportunities for health professionals. 27 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

28 Rational Phytotherapy Information and education ooks Journals Internet Pregraduate education Postgraduate and continued education Education for the general population Congresses, symposia, workshops 28 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

29 Phytotherapy: information and education ooks 29 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

30 Phytotherapy: Journals Revista de Fitoterapia 30 NIVERSITAT DE ARCELONA nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral

31 Phytotherapy: Journals Revista de Fitoterapia 2009: 10 years New look The journal of the Phyto- therapy Societies of: Spain Chile Mexico Portugal 31 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

32 Phytotherapy: Internet Electronic version of the Revista de Fitoterapia Phytotherapy data base Vade mecum of herbal products in Spain Activity alerts ook reviews Links 32 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

33 Rational Phytotherapy Information and education ooks Journals Internet Pregraduate education Postgraduate and continued education Education for the general population Congresses, symposia, workshops 33 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

Phytotherapy Postgraduate education: distance learning IL3 (niversity of arcelona) Master on Phytotherapy (2 years) Postgraduate courses on: Fundamentals on Phytotherapy:

34 Phytotherapy Postgraduate education: distance learning IL3 (niversity of arcelona) Master on Phytotherapy (2 years) Postgraduate courses on: Fundamentals on Phytotherapy: quality, safety and efficacy (1 year) Clinical Phytotherapy (1 year) 34 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

Phytotherapy Postgraduate education: presential learning niversidad de arcelona niversidad Autónoma de arcelona Colegio de Farmacéuticos de arcelona Postgraduate Diploma on Medicinal Plants and

35 Phytotherapy Postgraduate education: presential learning niversidad de arcelona niversidad Autónoma de arcelona Colegio de Farmacéuticos de arcelona Postgraduate Diploma on Medicinal Plants and Phytotherapy (1 year) Master on Medicinal Plants and Phytotherapy (2 years) 35 NIVERSITAT DE ARCELONA nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral C O L L E G I D E FARM ACÈ TICS D E LA PR O V IN C IA D E AR CE LO N A NIVERSITAT DE ARCELONA

36 Sociedad Española de Fitoterapia 36 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

37 Iberoamerican Council of Phytotherapy Consejo Iberoamericano de Fitoterapia Argentina C I A F rasil Chile México Portugal España Founded in Sevilla (18th October 2007) 37 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

38 2 nd Iberoamerican Congress of Phytotherapy Lisbon (Portugal) 8 th -10 th October nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

39 Symposium 20 Years Cologne (Germany), 18th June 2009 Thank you very much for your attention NIVERSITAT DE ARCELONA The basis of the rational development of Phytotherapy Prof. Dr. Salvador Cañigueral 39 nitat de Farmacologia i Farmacognòsia - Facultat de Farmàcia - S. Cañigueral NIVERSITAT DE ARCELONA

QUALITY OF HERBAL REMEDIES

QUALITY OF HERBAL REMEDIES Guideline Title Quality of Herbal Remedies Legislative basis Directive 75/318/EEC as amended Date of first adoption November 1988 Date of entry into May 1989 force Status Last