Hybrid Cooperative Complexes in the Treatment of Osteoarthritis
Intra-articular application of corticosteroids and hyaluronic acid is part of the treatment of osteoarthritis (OA) in patients for whom oral or topical treatment does not provide sufficient response. The following text addresses the lubricating and protective properties of synovial fluid and the related choice of appropriate intra-articular viscosupplementation, with emphasis on innovative molecules with high concentrations of hyaluronic acid and low viscosity.
COMMERCIAL STATEMENT
Current Recommendations for OA Treatment
According to current ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases) guidelines, the treatment of osteoarthritis (OA) can begin with oral monotherapy with glucosamine sulfate or chondroitin sulfate, or their combination, with the addition of paracetamol as needed. Treatment can be supported by topical non-steroidal anti-inflammatory drugs (NSAIDs) or capsaicin. If symptoms persist, the next step is intermittent or continuous oral NSAIDs. If symptoms continue to persist, intra-articular injection of corticosteroids or hyaluronic acid (HA) can be considered.
Properties of Synovial Fluid
Synovial fluid (SF) ensures joint nutrition, increases and maintains cartilage elasticity, and reduces friction on articulated surfaces. HA has a high molecular weight and is present in various chain lengths in the joint, but with age, the number of HA and chondroitin sulfate molecules decreases. This non-Newtonian fluid exhibits lubricating behavior with viscous response or protective behavior with elastic response depending on the movement frequency.
In osteoarthritis, the protective function of SF is always lower than its lubricating function, which worsens with age, resulting in cartilage damage due to insufficient protection. When there is a lesion in the joint, the properties of synovial fluid change significantly, with a decrease in HA concentration.
In patients suffering from osteoarthritis, up to 92% of the lubricating abilities of endogenous hyaluronic acid are lost. A significant drop in lubricating properties can be improved by viscosupplementation aimed at restoring the rheological homeostasis of the joint.
Choosing Appropriate Supplementation
To closely mimic endogenous HA, exogenous HA should have a high concentration and high molecular weight. However, at high HA concentrations, hydrophobic properties and hydrogen bonds within the chain between hyaluronic acid molecules come into play, resulting in highly viscous complex structures and gel-like solutions that are difficult to apply.
In 2012, a patent was issued for an invention that transformed HA and created stable cooperative hybrid molecules between low and high molecular weight hyaluronic acid. The result is a high concentration of HA with low viscosity, allowing easier injection.
Hybrid Cooperative Complexes
Another patented advancement in this field is the invention of hybrid cooperative complexes utilizing biotechnologically produced chondroitin (without sulfate groups), whose molecular shape allows further viscosity reduction. The result is the preservation of high HA concentration, the need for less force to apply the formulation, and physiological behavior closer to synovial fluid.
Clinical Evidence
A pilot study with a single application of this complex in patients with hip osteoarthritis confirmed a rapid and significant reduction in hip pain. An improvement of >50% in terms of pain reduction was noted. A statistically significant decrease in the VAS (visual analog scale of pain) value was observed within 7 days (decrease from 67.5 to 29.3; p < 0.0001) and persisted at the end of the 6-month observation period (22.8; p < 0.0001).
After 30 days, there was also a significant improvement in the Lequesne index – a reduction of >50% (from 10.4 to 5.1; p < 0.0001). The treatment was well tolerated, with most adverse events related to injection site pain and localized arthralgia.
This product is now coming to the Czech market under the name Sinogel.
New Viscosupplementation Agent Enters the Czech Market
Sinogel contains a unique hybrid cooperative complex of highly purified sodium hyaluronate (2.4%) with high molecular weight and sodium chondroitin (1.6%) obtained using NAHYCO technology. The product not only possesses exceptional rheological properties and the highest glycosaminoglycan (GAG) content (4%) on the market but is also suitable for viscosupplementation of large joints in case of pain or reduced joint mobility due to degenerative diseases, post-traumatic conditions, or joint and tendon damage, given its 3 ml volume.
Sinogel works locally at the injected joint level, restoring the viscoelastic properties of synovial fluid, reducing pain, and restoring joint and tendon mobility. It is intended for single-dose administration in each treatment cycle.
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Source: Guerrasio S. Hybrid cooperative complexes of hyaluronic acid alone or in combination with chondroitin sodium in the treatment of musculoskeletal disorders. Current Trends in the Treatment of Musculoskeletal Disorders in Practice. 44th Symposium of the Orthopedic Clinic 1st Faculty of Medicine UK and IPVZ and FN Bulovka in Prague, November 30 – December 1, 2023.
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