Dilute filtration sterilization process for viscoelastic...

C - Chemistry – Metallurgy – 08 – B

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C08B 37/00 (2006.01) C12P 19/26 (2006.01)

Patent

CA 2705850

Manufactured hyaluronic acid products are used in numerous surgical applications including viscoelastic supplementation for the treatment of osteoarthritis, however, traditional sterilization techniques result in the breakdown of such high molecular weight viscoelastic biopolymers and are thus unsuitable. Disclosed are processes for obtaining concentrated sterile solutions of high molecular weight biopolymers such as hyaluronic acid. The processes include filter sterilization with a dilute preparation of the biopolymer, and concentration of the dilute filter sterilized biopolymer by ultrafiltration to a desired concentration.

Les produits manufacturés d'acide hyaluronique sont utilisés dans de nombreuses applications chirurgicales comprenant une supplémentation viscoélastique pour le traitement de l'ostéoarthrite; cependant, les techniques traditionnelles de stérilisation conduisent à la dégradation de tels biopolymères viscoélastiques de masse moléculaire élevée et sont ainsi non appropriées. L'invention porte sur des procédés pour obtenir des solutions stériles concentrées de biopolymères de masse moléculaire élevée, tels que de l'acide hyaluronique. Les procédés comprennent la stérilisation par filtration avec une préparation diluée du biopolymère, et la concentration du biopolymère stérilisé par filtration dilué par ultrafiltration à une concentration désirée.

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