ThioGel Softgels

Label Info

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.

Biological Properties

Alpha lipoic acid (ALA) is one of the most potent biological antioxidants known. Referred to as the “universal” antioxidant, ALA is unique among anti-oxidants, demonstrating anti-oxidant activity in aqueous, as well as in lipophilic regions, and in extracellular and intracellular environments. Also unique among anti-oxidants, ALA participates in the recycling of other important endogenous anti-oxidants such as vitamins E and C, ubiquinone and glutathione.

The primary role of antioxidants is to act as scavengers of free radical molecules, inactivating various reactive oxygen species (hydroxyl radicals, nitric oxide radical, peroxynitrite, hydrogen peroxide, hypochlorite, singlet oxygen, and peroxyl radicals). Oxygen-derived free radicals can damage DNA, proteins and lipids, resulting in inflammation and acute and delayed cell death. The body protects itself from the harmful effects of free radicals and other oxidants through multiple anti-oxidant enzyme systems such as superoxide dismutases (SOD), peroxidases, and through natural antioxidant molecules such as glutathione. When too many free radicals are produced for the body’s normal defenses to convert, “oxidative stress” occurs with a cumulative result of reduced cellular function, and ultimately, disease.

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

Uses & Doses

Individuals suffering from high levels of oxidative stress can benefit from the use of ALA. Oxidative stress has been correlated with a wide range of disease states, and even the aging process itself. An abundance of evidence exists that diabetic complications, renal failure, viral infections and other disorders are linked to excess levels of free radicals and the damage they cause to DNA, lipid membranes, and enzyme systems. There is strong clinical evidence that ALA is useful in diabetic neuropathy, a reasonable body of evidence that it is useful in pre-diabetic (Syndrome X) states, reasonable evidence that it protects the liver and is useful as a general liver detoxifier, and limited human data on its use to delay aging.

There is little doubt that ALA relieves oxidative stress, but less scientific evidence exists regarding beneficial effects in specific conditions. The Physicians Desk Reference for Nutritional Supplements states that "it may be protective against atherosclerosis, ischemia-reperfusion injury and various radiologic and chemical toxins. There is less evidence that it may be useful in some neurodegenerative disorders. There is preliminary evidence that it may have some immune-modulating effects, and it has been suggested that ALA may slow aging of the brain and that it may be an anti-aging substance, in general".

There is no established dose of ALA for the many different areas of use. A 200 mg daily dose is typically used for general anti-oxidant protection. Doses up to 600 mg per day have been used for diabetic neuropathy and Hepatitis C. When more than 200 mg. is taken per day, the dosage should be divided over the day to maintain blood levels of ALA over a longer period of time. Because peak levels of ALA are reached at about 30 minutes after ingestion, and the material also has a half-life in the circulation of about 30 minutes, divided dosing is recommended. If taking 400 mg. per day, a typical dosing schedule would be 200 mg. in the morning and 200 mg. in the afternoon. If taking 600 mg. per day, a typical schedule might be 200 mg. in the morning, 200 mg. in the afternoon, and 200 mg. in the evening.

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

Product Safety

Alpha lipoic acid has an excellent safety record over decades of use. There have been no adverse reactions reported, no known contraindications, and no known reports of ALA over-dosage. ALA is regulated as a prescription drug in Germany and dosages of 600 mg per day have been well-tolerated in long-term treatment of diabetic neuropathy. The only precaution is that ALA may lower blood glucose levels and individuals with diabetes should monitor blood glucose levels for possible adjustment of anti-diabetic medications. Individuals with glucose tolerance problems should also be aware of possible hypoglycemia with ALA use. Dr. Peter Dyck, renowned diabetologist at the Mayo Clinic, recently reported on a clinical study of ALA and indicated that the compound is “very safe”. “There have been no known complications”. It is also recommended that a daily multivitamin be taken when using ALA supplements, as ALA has been reported to deplete B complex vitamins due to its effect upon metabolism.

These statements are not intended as medical advice. They are intended as solely instructional and educational. Please consult a medical or health professional before undertaking any changes in your health treatment.