Focusing on Wellness with the Highest Quality Nutritional Supplements available By Helen Granado-Boesel PD, MEd, BA Chem cepharmacyservices Understanding the effect of categorization of nutritional supplements as ‘dietary’ Unfortunately in the US today, nutritional supplements are regulated as ‘dietary’ rather than as pharmaceutical. This opens a Pandora‘s Box to the acceptance of grave diversity and inconsistency of manufacturing processes within this industry. Manufacturers set their own standards and develop their own processes. Standards and recommendations made for updated, state-of-the art procedures to be taken in manufacturing are not always utilized and too many patients find themselves in a compromised situation either (i) not seeing any results (ii) getting ill after ingesting the product (iii) becoming more distressed in their disease state by having caused more damage through stressing the systems that detoxify and support immunity. To be confident that nutritional supplements are ‘medicinally fit’, one has to ensure that manufacturers have been consistent in delivering the highest quality products during their manufacturing processes and that these products will offer only overall positive outcomes in patient health. Understanding Bioavailability and where it starts in nutritional supplements FDA (21 Code of Federal Regulations 320) defines bioavailability as “the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action”. However, in more common use in the pharmacy profession is “bioavailability is the rate and extent that the active drug is absorbed from a dosage form and becomes available in the systemic circulation.” It is thus clear that in this process,’ micro-particles’ are allowed to ‘enter’ the human body systems and become available for use in some systemic function for a healthy outcome! However, there are some basic elements that must be discussed which facilitate the easy and correct entrance and movement to the site and system of action. It is here that the connection is linked to the quality of the nutritional supplement being ingested. A product has to have been carefully manufactured i.e.: -carefully sourced to include the appropriateness and quality of material used and the formulation; properties (salt form, crystalline structure, formation of solvates and solubility) -carefully formulated (presence or absence of excipients and special coatings & manufacturing variables to include tablet compression force, particle size of excipients, processing variables) -comparative studies for absolute and relative bioavailability and for bio- equivalency. If not, then the bioavailability is not optimal. It is thus appropriate to mention that effectiveness and efficacy of any nutritional supplement is based on Sourcing, Extraction, Formulation, Production Processes, and Purity (elimination of unnecessary packages and artificial ingredients) of the Active ingredients, Additives and fillers. Hence, it is extremely important that when dealing with nutritional supplements one should be extremely careful to: 1. research the usefulness and outcomes effected by a specific manufacturer 2. checks should be specifically address formulation and sourcing 3. carefully research length of time in existence, and country of manufacture. Quality, Potency and Purity of Nutritional Supplements Adequate/Suggested Nutritional Amounts – this refers to the fact that the amount stated on the label is in fact correct. If the manufacturer is Good Manufacturing Practices (GMP) certified, we would prefer to trust that manufacturer over one that is not. Seek out pharmaceutical grade supplements. This indicates that the manufacturer has taken the time to raise the standards of manufacturing to the level of that accepted by the FDA as pharmaceutical. This infers that “dissolution and absorption meet the highest regulatory standards verified by 3rd party testing”. Usually Biopharmaceutics Classification Systems (BCS) would apply to the product. When a product manufacturer states that production is done in an FDA registered/licensed facility, it is another criterion that GMP policies are applied. Good Manufacturing Practices internationally assures that products have the quality and purity that appears on the label. Other factors which play a role in lack of standardization of Nutritional Supplements Because there is great disparity in translating physiological requirements into actual RDA, based on culture, environment, body functions etc., the end result is disparity and diversity in the quantities of micro-nutrients that are actually available from different supplements, based on where and how that supplement was manufactured. The European Union like the US FDA, has tried to place certain parameters in an effort to begin to establish some standardized assessment methodologies. Hence, it could be fair to say that in the not too distant future, supplements manufactured by trustworthy houses in Europe and the USA, with GMP credentials, ‘should’ have bioavailability that is close to optimal! Today, in the USA, we have merely a handful of manufacturers who produce nutritional supplements which can be considered within this category. Wellness International (WIN) produces one such line of nutritional supplements. The WIN line of micro nutrients is GMP and BCS certified and are produced in an FDA regulated environment in the USA. WIN has been in existence for the past 30 years. References Retrieved on 09/28/2014 from: hwif/naturalmedicinepdts Agget, P.J.(2010). Population reference intakes and micronutrient bioavailability: A European perspective. American Journal of Clinical Nutrition 91(suppl):1433S. Gourley, D. R., and Eoff, J. C.(10th Edition). The APhA Complete Review for Pharmacy. District of Columbia: Washington. American Pharmacists Association. Holst, B., Williamson, G. (2008). Nutrients and phytochemicals: from bioavailability to bioefficacy beyond antioxidants. Current Opinion in Biotechnology 19:73-82.
Posted on: Mon, 29 Dec 2014 23:16:10 +0000
Trending Topics
Recently Viewed Topics
© 2015