Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Multi-pharm Co Ltd, 24, Apollonos Str., 1046, Nicosia, Cyprus
Pharmacotherapeutic group: Other drugs for disorders of the musculoskeletal system
ATC Code: M09AX01
Hyaluronic acid, a natural polymer belonging to the glycosaminoglycan family (acidic mucopolysaccharides), is an important component of all extracellular matrices and is present in particularly high concentrations in the cartilage and synovial fluid. The active ingredient of the medicinal specialty HYALGAN is a high-molecular-weight hyaluronic acid fraction with a high degree of purity and molecular definition, and special biochemical, physico-chemical and pharmacological properties.
The administration of HYALGAN into arthritic joints leads to a normalisation of the viscoelasticity of the synovial fluid and to an activation of tissue repair processes in the joint cartilage.
Evidence has emerged from various experimental models that hyaluronic acid has an anti-inflammatory and analgesic activity. This property translates into an improvement in joint function and means that the objective and subjective symptomatology related to arthritis can be kept in check.
Exogenous hyaluronic acid, being widely present in the organism, is physiologically metabolised after parenteral administration through the usual hexose metabolic pathways.
The results of studies carried out in dogs and rabbits after single and repeated intra-articular administration have shown that hyaluronic acid is rapidly distributed in the joint tissues and persists for a long period of time. The labelled product can be found in the synovial membrane within 2 hours of administration and persists for 7 days; the maximum concentration of labelled product is seen mainly in the synovial fluid and then in decreasing concentrations in the joint capsule, ligaments and adjacent muscle. With regard to organ distribution, radioactivity has been found in the liver, kidneys, bone marrow and lymph nodes; the product is excreted mainly through the kidneys.
A study carried out in pregnant rats, through i.v. administration, showed radioactivity in the placenta and in various organs of the foetus.
The results from conventional preclinical studies on pharmacological safety, toxicity after repeated administrations, genotoxicity, carcinogenic potential and reproductive toxicity revealed no risk to humans.
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