Wholistic Approach to Herbal Products Quality Case Study: Thyme Adnan Badwan, Hashim Taha and Nadia Abu Nimeh Delass Natural Products Company, Naor-Jordan The First International Conference on Natural Products and Drug Discovery Venue The University of Jordan September 8 10, 2015
This Presentation is a Concept Paper Describing the transfer of a plant to a plant material and product
The natural products never left world arena The whole plant use versus its constituents The reproducibility challenges in herbal preparations Content Thyme as an example Good Agriculture Practice and its application in thyme production Standardization of herbal material and product Rationale in markers selection Conclusion
Dominant Use Alternative Use
Herbal Personalized Treatment in Modern Medicine Societies is Delicate treatment Consumed mostly by females and children
Traditional Usage was Based on a Philosophical Point of View not Clinical Based Evidence Two Main Schools Focus on the whole Body Balance with Nature Focus on Parts of the Body Which Needs Treatment
COMPLEMENTARY and ALTERNATIVE MEDICINE (CMA) Chinese Medicine Ayurvedic Medicine Bush Medicine Yunâni Arabic Medicine
Terms Used to Describe Herbal Product Herbal Drugs Phytomedicines Phytopharmaceuticals Nutraceuticals
Herbal material was influenced by the advancement in separation science Extraction includes supercritical fluids, distillation and molecular fractionation Freeze drying Various separation techniques were used to identify plant constituents
This raised a question?
Whole Plant Vs Constituents
Which of the constituents is the pharmacologically active part? Does the whole plant work collectively? Traditional treatment utilizes the whole plant
Thyme, Orange Plants Over 300 Thyme Species are Identified Thyme, Lime Plants Thyme, White Creeping Thyme Thyme, Bressingham Plants Thyme, Wine and Roses
Good Agriculture Practice (GAP) for Herbal Material Production 1. Working environment 2. Hygiene 3. Careful use of water for irrigation 4. Monitor E Coli in water
1. Fumigation of the soil and irrigation 2. Harvesting maturity of the plant 3. Preservation following harvesting 4. Drying herbal material Critical Steps to Control
Thyme Post harvesting handling Genetic makeup of plant material Heavy metals for irrigation Cultivation Practices Preparation of soil-planting Control of weeds, pests and diseases
Effect of Harvesting Stages on Studied Traits in 2 Thymus Species Source:Intl J Agri Crop Sci. Vol., 7 (13), 1346-1351, 2014, The effect of harvesting stages on quantitative and qualitative characters of essential oil and Phenolic yield composition in two thyme species (Thymus daenensis Celak & T. vulgaris L.) in Iran
Adaptation of GAP: Adoption of GPA leads to : Adoption of GPA leads to : 1. Ensures safety and quality in herbal products chain 2. Offers a novel chance to create new markets 3. Improves the added value in specialized agriculture crops
Thyme intended for medicinal use, must be of the same species
An Example Illustrating the Use of Solvents to Extract Thymol (It is not encouraged to use this in Nutraceutical products) (Concentration of Thymol (%) contained in the extracts) Source: III Ibero American Conference on Supercritical Fluids, Cartagena de Indias (Colombia) 2013, Extraction of Thymol from Different Varieties of Thyme Plants Using Green Solvents
Markers are Tools for Standardization Where Does the process Start?
Markers must be selected to allow the manufacturer to reproduce its (Thyme) material This marker can be used in the finished herbal product or its combination.
Different terms are used Standard Marker Reference
Selection of the Marker 1. Ideal markers must be the therapeutic component of the herbal material 2. Simple to analyse and can be easily separated from other constitutes 3. Usually, the higher concentration constituent is used 4. It is preferable to use a constituent as it can be used as stability indicating material 5. Ideal situation when the marker can be analysed in finished formulation
Which of Which To Select as Marker Compendial (Minimum Requirement) In house requirement (Trade Secrets)
Thyme, Orange Plants Over 300 Thyme Species are Identified Thyme, Lime Plants Thyme, White Creeping Thyme Thyme, Bressingham Plants Thyme, Wine and Roses
Adulteration can take place by placing other non-compendial species in extraction or distillation processes.
Thymus Vulgaris L. Zygis L.
Thyme Constituents Essential Oil : Thymol Carvacrol Terpenoid Glycosides Phenolic Monoterpenoids Eugenol Aliphatic alcohols Acetophenones Flavonoids: Thymonin Cirisilineol 8-Methoxy-Cirsilineol Biphenyl compound: Monoterpenoid Origin Saponin Long chain saturated Hydrocarbon Aliphatic Aldehydes Arabinogalacton
Compendial Monographs Thyme Definition of species : Two Species can be a mixture Character: Strong aromatic odour (Thymol) Identification: - Plant description leaf and leaf powder (microscopy) - Thin layer chromatography - Chromatograms for Thymol and Carvacrol (Retention time compared with reference) Other tests: Foreign Matter Adulteration Water content Total Ash- Ash insoluble in Acid Assay : Thymol and Carvacrol by Gas Chromatography (markers)
What about other Constituents As a rule: Pharmacopeial Monograph is the minimum requirement Manufacturers: Must have additional tests which can be classified under trade secrets
Thyme Extract Broncare Syrup
Thank You