Enhanced Hyaluronate Compositions and Soft Tissue Fillers with Improved Particle Size Control and Reduced Post-Injection Swelling

A novel system and method for preparing modified hyaluronate compositions with improved particle size control and reduced post-injection swelling, resulting in enhanced dermal filler performance and patient outcomes.

The original patent disclosed hyaluronate compositions and soft tissue fillers with various limitations, including uncontrolled particle size and post-injection swelling. The new inventive concept addresses these limitations by introducing a particle size control module and optimizing the crosslinking process to minimize swelling.

The new system comprises a mixing chamber for combining uncrosslinked hyaluronic acid or uncrosslinked sodium hyaluronate with a crosslinking agent in unbuffered 135 mM to 200 mM NaCl, and a particle size control module for maintaining an average particle size of less than about 1.5 μm. The method involves controlling the weight percent of the soluble HA fraction to less than 10% and maximizing crosslinking to achieve a swelling ratio of less than 200%. The resulting modified hyaluronate composition exhibits a reduced soluble HA fraction and a high degree of crosslinking, resulting in a swelling ratio of less than 150%. Additionally, the process involves ultrafiltration and diafiltration steps to remove low molecular weight HA fractions, producing a composition with less than 5% of HA fractions below 250 kDa.

The new inventive concept introduces a novel particle size control module and an optimized crosslinking process, which are not disclosed in the original patent. The combination of these features enables the production of modified hyaluronate compositions with improved performance and reduced post-injection swelling.

Alternative embodiments of the inventive concept may include varying the type and concentration of crosslinking agents, adjusting the pH and ionic strength of the solution, or incorporating additional components to enhance the composition's performance. Variations of the process may involve different filtration techniques or purification steps to optimize the composition's properties.

The enhanced hyaluronate compositions and soft tissue fillers have significant commercial potential in the cosmetic and medical industries, particularly in the areas of dermal fillers, tissue engineering, and wound healing. The target market includes manufacturers of dermal fillers, pharmaceutical companies, and research institutions focused on tissue engineering and regenerative medicine.