To discern the wise use of botanicals, one should understand the important factors that determine whether a botanical product has a high probability of being safe, effective and reproducible. To do no harm, we should only use botanical products that have a significant time and extent of human use, are consumed at the proper dose and for the correct duration, do not contain significant levels of toxic compounds, are low in heavy metals, are free of toxic microbes, have little or no pesticides, and have minimal or no potentially toxic solvent residues. As the list of potential toxicity's shows most of the safety issues can be prevented by the selection of plants with extensive human use over a long time, are moderate in their physiological activity and adhere to rigorous good manufacturing practices. Safe, effective botanical products that are reproducible for the desired physiological activity require standards and systematic protocols for the plant material and the manufacturing process of the botanical product. To determine if a specific herbal product can be a safe, effective, and reproducible product, a manufacturer must conduct a thorough evaluation of the traditional, commercial and scientific literature on the plant. In addition, botanical products should be manufactured according to a standardized process that includes standards for Good Plant Practices and Good Manufacturing Practices.
Learning Objectives: Participants will be able to identify what makes a botanical product reproducible for the desired physiological activity; what are the important factors in Good Plant Practices; what are the important factors in Good Manufacturing Practices; and what is the impact of excipients and the dosage form on efficacy of botanicals.
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: Dr. Croom is the Scientific and Regulatory Affairs Director for Indena, USA East.