Challenges in natural health product research: The importance of standardization

Before there can be acceptance of natural health products (NHPs) or "phytomedicines" by the Western medical community, questions related to active ingredients, mechanisms of action, toxicology, and drug interactions will need to be satisfactorily addressed. Since NHPs are generally manufactured from highly variable raw materials, identifying the therapeutically active ingredients can be challenging. Standardization according to all known bioactive components is critical to ensure consistent pharmacological and clinical results. CV Technologies, Inc. has made great strides in resolving these challenges through the patented technology, ChemBioPrint. During early ChemBioPrint product development, the optimal active components of a natural extract are identified and characterized chemically (chemical fingerprinting) and pharmacologically through a variety of activity assays (biological fingerprinting). Subsequent manufacturing steps ensure each batch is standardized accordingly and has consistent composition and efficacy. Case studies will be presented on two commercially available ChemBioPrint products: COLD-fX (an immune-modulator) and REMEMBER-fX (a neuro-modulator). Unique and important structure-function relationships exist between the major classes of bioactive molecules from the shared source material of these two products, Panax quinquefolius. Through numerous published and ongoing clinical trials and pharmacological studies, these ChemBioPrint products have been shown to be consistent, safe and effective. The future directions of NHP research will be discussed, including the requirements for accurate reporting of study results related to ingredient and standardization descriptions.