Proof of Concept

The author of this report spent over 20 years in the pharmaceutical industry directing R&D activities into the development and eventual commercialization of both OTC and pharmaceutical drug products. These activities were conducted in the laboratories of both generic and brand drug companies. For the most part, the abovementioned products fell under the category of the label slogan “for the symptomatic relief of…” with little attention paid to the possible underlying cause of the disease for which the product was intended to treat. One classical example is the multi-drug approach to treating digestive disorders. Various OTC antacid products containing bicarbonates and magnesium & aluminum hydroxides with and without simethicone for the relief of gastric upset; gastric acid inhibitors cimetidine and ranitidine for heartburn/abdominal pain; milk of magnesia & bisacodyl for constipation; loperamide for diarrhea; monoclonal antibodies for targeting of pain-inducing proinflammatories such as TNFα; antibiotics (rifaximin) for bacterial imbalances, etc.

Our concept from the beginning was to formulate a single product with all-natural ingredients possessing activities that would encompass the majority of treatment modalities cited above and test our formulation on candidates experiencing GI disorders who harbour certain identifiable factors responsible for these diseased conditions. The summaries of their feedback through numerous email updates are presented herein and the combined results provide evidence that our product has the capability to positively impact most major factors involved in digestive disorders.

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