Inlex Mechanism of Action

Pharmacology: Pharmacodynamics: Carnitine orotate is the pharmacologically active salt of carnitine and orotic acid. These two compounds act synergistically for histological restoration and lipotropic effect in the liver. Carnitine, an indispensable biostimulant for the metabolism of fat, promotes ß-oxidation of free fatty acids in the hepatocytes. Orotic acid is a precursor in nucleic acid (i.e., DNA and RNA) biosynthesis which is essential in the synthesis of proteins. Orotic acid prohibits the necrosis of injured liver cells by normalizing cell proliferation and the enzymatic system in the liver.
Hepatic extract antitoxic fraction (i.e., purified liver extract hydrolysate) detoxifies intrinsic and extrinsic hepatotoxic substances. Pyridoxine, cyanocobalamin and adenine act through amino acid metabolism, thereby augmenting the treatment of hepatic disease.
The combined substances result in marked improvement on various histological profiles (i.e., SGOT, SGPT, bilirubin, biopsy) and vital signs (i.e., weight loss, nausea).
Pharmacokinetics: Peak plasma concentrations are observed about 30 minutes after dosing.
Absorption and Distribution: Carnitine orotate is non-hygroscopic and less deliquescent than L-carnitine. The ionic complex salt is also more soluble and more easily absorbed by the injured cells compared to the administration of carnitine individually.
Adenine combines with the sugar ribose to form adenosine, which in turn can be bonded with from one to three phosphoric acid units, yielding AMP, ADP and ATP. These adenine derivatives perform important functions in cellular metabolism. Adenine is one of four nitrogenous bases utilized in the synthesis of nucleic acids.
Pyridoxine hydrochloride (vitamin B6) is readily absorbed from the gastrointestinal tract, mainly in the jejunum and is converted to pyridoxal phosphate which is totally bound to plasma proteins.
Riboflavin (vitamin B2) is an easily absorbed, water-soluble micronutrient with a key role in maintaining human health. Like the other B vitamins, it supports energy production by aiding in the metabolizing of fats, carbohydrates, and proteins. Vitamin B2 is also required for red blood cell formation and respiration, antibody production, and for regulating human growth and reproduction. It is essential for healthy skin, nails, hair growth and general good health, including regulating thyroid activity.
Cyanocobalamin (vitamin B12) has a cobalt content of 4.34%. Vitamin B12 is bound to intrinsic factor during transit through the stomach. Separation occurs in the terminal ileum in the presence of calcium and vitamin B12 enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins.
Hepatic extract antitoxic fraction is a specifically hydrolysed 17 amino acid complex, which is prepared by enzymatic hydrolysis from the liver. It is readily absorbed from the gastrointestinal tract.
Elimination: Carnitine Orotate + Hepatic Extract Antitoxic Fraction + Adenine HCl + Pyridoxine HCl + Riboflavin + Cyanocobalamin (Inlex) is predominantly metabolized in the liver and excreted via urine.
Carnitine orotate is metabolized in the liver. When metabolized, it leaves its free carnitine content. A different behavior was observed in the elimination of exogenous carnitine via urine. In a test in healthy humans, the moderate ingestion of carnitine orotate does not produce increased carnitine elimination in the urine. This retention of carnitine in the body tissues means a better utilization of the substance in the body.
Pyridoxine is stored mainly in the liver, with lesser amounts stored in muscle and brain. Biotransformation is hepatic and almost entirely as metabolites excreted in the urine. Excess beyond daily needs is excreted, largely unchanged, in the urine. In dialysis, it is removed.
After a single oral dose, the biologic half-life of riboflavin is about 66 to 84 minutes in healthy people. Riboflavin is metabolized to FMN in erythrocytes, GI mucosal cells, and the liver. FMN is converted to FAD in the liver. About 9% of the drug is excreted unchanged in urine after normal ingestion. Excretion involves tubular secretion and glomerular filtration. Amount renally excreted unchanged is directly proportional to the dose. Drug removal by hemodialysis is slower than by natural renal excretion.
Within 48 hours after injection of 100 or 1,000 mcg of cyanocobalamin, 50-98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage.