ThioGel-L 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 form 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.

TRIPLE ANTIOXIDANT LIVER FORMULA: While each of the active ingredients included in the ThioGel-L formula are potent antioxidants, their respective mechanisms of action are both overlapping and complementary. The triple antioxidant formula provides a greater level of protection of liver function due to a combined antioxidant effect, that is coupled with a broader range of biological activity. The principle behind this triple antioxidant approach is not unlike the use of multiple drug products to treat difficult conditions that are only partially responsive to individual drugs.

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.

The damage that occurs in many liver diseases is often linked to the production of free radicals. The membranes that surround cells and organelles are composed of long chain fatty acids (lipids), that are subject to the process of lipid peroxidation. Free radicals play a major role in cell membrane damage, cause proteins and DNA to cross-link, and interfere with ribosomal protein production.

Since oxidative stress is observed in peripheral blood mononuclear cells from hepatitis C patients, it is hypothesized that oxidative stress might alter lymphocyte function and facilitate the chronicity of the infection. It also appears that the hepatitis C virus codes for a selenium-dependent glutathione peroxidase enzyme, by linking viral replication and pathogenesis to the selenium status and dietary oxidant/antioxidant balance of the host. This phenomenon could help explain why hepatitis C disease progression is accelerated by oxidant stresses such as alcoholism and iron overload.

Primary among the many biological actions of alpha lipoic acid are the chelation of heavy metals, the quenching of various free radical species, and the recycling of vitamins E, vitamin C and glutathione, making it a uniquely important compound in counteracting oxidative stress associated with various liver conditions.

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

Uses & Doses

The antioxidants used in Thiogel-L have been used for a variety of conditions that affect liver function. Prominent among these conditions are various forms of liver intoxication, infection, inflammation, and hepatic cell damage. A clinical study performed by Dr. Burton Berkson found that the triple antioxidant approach was effective in treating patients with Hepatitis C, as evidenced by their clinical recovery and remarkably improved laboratory values.

Numerous well-designed clinical trials have been conducted in Europe, primarily Germany, on the therapeutic efficacy of silymarin in the treatment of metabolic liver damage, chronic hepatitis, and bile duct inflammation, often induced by alcohol, drugs (psycopharmaceuticals), and chronic liver disease including certain forms of hepatitis. The hepatoprotective effects of silymarin have been demonstrated in accelerating normalization of impaired liver function.

There is a great deal of evidence indicating that selenium supplementation at high levels reduces the incidence of cancer in animals. More than two-thirds of over 100 published studies in 20 different animal models of spontaneous, viral, and chemically induced cancers found that selenium supplementation significantly reduced tumor incidence.

There is no established dose of ThioGel-L for the 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 reported for use in Hepatitis C. When more than 200 mg. is taken per day, the dosage should be divided over the day to maintain blood levels over a longer period of time. 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

There have been no adverse reactions reported, no known contraindications, and no known reports of ALA over-dosage. Silymarin preparations have been used for the treatment of liver disease since antiquity. At one time or another, virtually all parts of the plant have been used as both food and medicine with virtually no reports of toxicity, aside from a mild laxative effect in some patients. The Food and Nutrition Board recently set the tolerable upper level for selenium at 400 mcg/day in adults. Selenium obtained from food averages about 100 mcg/day for adults in the U.S. Each ThioGel-L softgel contains 70 mcg of selenium.

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.