Product Formulation

Most ALA products currently sold utilize ALA that is a racemic mixture of S and R forms (enantiomers or structural mirror images). The ALA raw material is supplied to manufacturers as a powder, that is extremely insoluble in water, and even less soluble at acidic pH. The easiest and least expensive way to put the powdered ALA into a pharmaceutical dosage form is to either make ALA tablets or fill the ALA powder into gelatin capsules. Most manufacturers formulate their products with ALA powder. Because ALA is insoluble in water and less soluble at an acid pH, the absorption of powdered ALA from the GI tract is both hindered and highly variable.

KemTek Pharmaceuticals (EAP) has developed a proprietary procedure to dissolve (solubilize) the powdered ALA. The solubilized ALA (ThioGel) is then filled into softgel capsules, using sophisticated equipment that forms a gelatin envelope around a measured amount of the liquid ALA. The liquid form ALA is more easily absorbed (higher bio-availability), with correspondingly less variability in the amounts being absorbed and entering the circulation.

In addition to the difference in the physical state of the ALA, many manufacturers have started using a substantially cheaper ALA made in China versus the long-standing industry premium ALA made in Europe. Since the source of the raw material ALA is not specified in product labeling, there is no way to know which source is used in a given product. Generally, the products made with China-sourced ALA are substantially less expensive than products made with European-source ALA. The China-source ALA meets analytical laboratory specifications that are similar to those established for European-source ALA, but lacks the long history of successful clinical use recorded by the European-source ALA.The lower cost of the China-source ALA is enticing, but the risk, albeit small, of non-uniformity of continuing production supplies, unknown impurities, unknown absorption profiles, or the possibility of impaired clinical performance, offset the cost benefit.

These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.