Topical composition for the treatment of mucosal lesions
Inventors
LORENZO-ZÚÑIGA GARCÍA, Vicente Maria • BARTOLÍ SOLÉ, Ramon • BOIX VALVERDE, Jaume
Assignees
Centro de Investigacion Biomedica en Red CIBER • Fundacio Institut dInvestigacio en Ciencies de la Salut Germans Trias i Pujol IGTP
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Publication Number
US-11234999-B2
Publication Date
2022-02-01
Expiration Date
Abstract
It relates to a topical composition comprising specific amounts of: a) a hyaluronic acid or a pharmaceutically or veterinary acceptable salt thereof, b) one or more adhesive agents, and c) a non-absorbable antibiotic; to delivery devices comprising it; and to its uses in medicine, in particular, in the treatment and/or prevention of mucosal lesions; in the prevention of postpolypectomy syndrome; as adjuvant therapy to mechanical treatments in gastrointestinal perforations, and as sealant treatment in surgical anastomoses and leaks or fistulas in gastrointestinal tract.
Core Innovation
The invention relates to a topical aqueous composition comprising hyaluronic acid or a pharmaceutically or veterinary acceptable salt thereof, one or more adhesive agents, and a non-absorbable antibiotic. The composition is characterized by a body-temperature gel consistency with defined adhesion and viscosity, and exhibits reverse thermogellation. The composition is formulated for local application to mucosal surfaces rather than systemic use.
The invention addresses mucosal lesions and post-endoscopic complications by using the locally applied reverse-thermogelling composition. The described targets include postpolypectomy syndrome, thermal-injury lesions, and reduced perforation risk associated with gastrointestinal therapeutic endoscopy. The described approach includes an endoscopic shielding technique and delivery concepts using an injection device and/or a catheter through an endoscope working channel.
The invention further provides sealant use for gastrointestinal surgical anastomoses and for leaks and fistulas. The document describes example compositions using hyaluronic acid sodium salt together with cellulose ether and/or a pluronic compound (including Pluronic F127/poloxamer 407), and the non-absorbable antibiotic rifaximin. Preclinical rat and pig studies are described as showing improved healing outcomes and reduced inflammatory marker TNF-α compared with hyaluronic acid alone.
Claims Coverage
The independent claim is directed to a topical composition defined by three component groups (hyaluronic acid, two specified adhesive agents, and a non-absorbable antibiotic) and a defined material behavior (reverse thermogellation). The main inventive features are centered on the specific combination and relative amounts of the components and the reverse thermogellation property.
Reverse-thermogelling topical composition with hyaluronic acid and non-absorbable antibiotic
A topical composition comprising 0.6 to 1.5 wt % of a hyaluronic acid or a pharmaceutically or veterinary acceptable salt thereof; two adhesive agents including a first adhesive agent selected from sodium alginate, starch, polyvinyl alcohol, and sodium silicate present at 0.75 to 3 wt % and a second adhesive agent comprising a pluronic compound present at 10 to 25 wt %; and 1.5 to 2.5 wt % of a non-absorbable antibiotic, wherein the topical composition exhibits reverse thermogellation.
Across the independent claim and its dependent refinements, the claim coverage centers on the reverse thermogellation behavior of the topical composition, the defined ranges and selection of hyaluronic acid, the specific pair of adhesive agents, and a defined non-absorbable antibiotic. Dependent claims further specify performance properties at body temperature and narrow to particular salt/antibiotic variants, as well as prevention or treatment contexts.
Stated Advantages
Improved healing outcomes versus hyaluronic acid alone in preclinical studies.
Reduced inflammatory marker TNF-α versus hyaluronic acid alone in preclinical studies.
Documented Applications
Prevention of postpolypectomy syndrome by topically applying a therapeutically effective amount of the topical composition to a subject in need thereof.
Topical treatment of mucosal lesions and post-endoscopic complications, including postpolypectomy syndrome, thermal-injury lesions, and reduced perforation risk.
Sealant use for gastrointestinal surgical anastomoses and for leaks and fistulas.
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