Topical composition for the treatment of mucosal lesions
Inventors
LORENZO-ZÚÑIGA GARCÍA, Vicente María • 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-10561680-B2
Publication Date
2020-02-18
Expiration Date
Abstract
Topical composition for the treatment of mucosal lesions 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 composition for the treatment and/or prevention of mucosal lesions and complications derived from mucosal lesions, including in therapeutic endoscopy contexts. The topical composition comprises hyaluronic acid or a pharmaceutically or veterinary acceptable salt thereof, methyl cellulose as a first adhesive agent, a pluronic compound as a second adhesive agent, and a non-absorbable antibiotic.
The composition parameters are defined by wt% ranges expressed with respect to the total weight of the composition, with the requirement that the sum of the amounts of the components is equal to or less than 100%. The formulation is described in a way that supports performance at body temperature using quantitative properties such as viscosity at body temperature and adhesion at body temperature.
In addition to the composition, the invention also relates to an injection device comprising the topical composition with the same defined component ranges and wt% constraints. The document also describes methods for topically applying a therapeutically effective amount of the topical composition to a subject in need, including humans.
Claims Coverage
The document contains four independent claims covering a defined topical composition, an injection device, and topical therapeutic methods. Across the independent claims, there are four main inventive features focused on the defined formulation and its topical uses.
Topical composition with hyaluronic acid, methyl cellulose, pluronic compound, and non-absorbable antibiotic
A topical composition comprising hyaluronic acid or a pharmaceutically or veterinary acceptable salt thereof, methyl cellulose as a first adhesive agent, a pluronic compound as a second adhesive agent, and a non-absorbable antibiotic, with wt% ranges and a component-sum constraint.
Injection device comprising the defined topical composition
An injection device comprising the defined topical composition with the same component ranges and wt% constraints.
Topical treatment and/or prevention of mucosal lesions and complications derived from mucosal lesions
A method for the treatment of mucosal lesions and/or for the prevention of complications derived from mucosal lesions by topically applying a therapeutically effective amount of the topical composition to a subject in need thereof, including a human.
Topical prevention and sealant uses
Methods for the prevention of postpolypectomy syndrome and for sealant treatment in surgical anastomoses and leaks or fistulas in the gastrointestinal tract by topically applying a therapeutically effective amount of the topical composition to a subject in need thereof, including a human.
Across the independent claims, the coverage centers on a narrowly defined topical composition including hyaluronic acid or an acceptable salt, methyl cellulose, a pluronic compound, and a non-absorbable antibiotic, with wt% ranges and a component-sum constraint. The same defined composition is then used in an injection device context and in topically applied therapeutic methods for mucosal lesions, postpolypectomy syndrome, and sealant treatment for surgical anastomoses and gastrointestinal leaks or fistulas.
Stated Advantages
Improved mucosal healing compared with saline and hyaluronic acid alone.
Reduced perforation risk compared with saline and hyaluronic acid alone.
Prolonged adherence as supported by CT evidence.
Documented Applications
Treatment of mucosal lesions and/or prevention of complications derived from mucosal lesions by topically applying a therapeutically effective amount of the topical composition to a subject in need, including a human.
Prevention of postpolypectomy syndrome by topically applying a therapeutically effective amount of the topical composition to a subject in need, including a human.
Sealant treatment in surgical anastomoses and leaks or fistulas in the gastrointestinal tract by topically applying a therapeutically effective amount of the topical composition to a subject in need, including a human.
Adjuvant therapy for gastrointestinal perforations by applying a therapeutically effective amount of the topical composition.
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