US2022040093A1PendingUtilityA1

Composition for use in the treatment of lesions in the mucosa by means of endoscopic resection

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Assignee: AGENCIA PUBLICA EMPRESARIAL SANITARIA HOSPITAL DE PONIENTEPriority: Jan 4, 2016Filed: Sep 7, 2021Published: Feb 10, 2022
Est. expiryJan 4, 2036(~9.4 yrs left)· nominal 20-yr term from priority
Inventors:José Antonio Morales MolinaPedro Acosta RoblesFrancisco Javier Gallego RojoBeatriz Clares Naveros
A61K 31/717A61K 31/728A61P 41/00A61K 31/137A61B 17/00234A61K 47/38A61K 47/36A61B 2017/00269A61K 47/26A61K 9/0024A61K 9/0019A61B 2017/00818A61P 9/00
42
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Claims

Abstract

The present invention relates to a composition, preferably an aqueous pharmaceutical solution, comprising a water-soluble polymer derived from cellulose and hyaluronic acid, preferably comprising carboxymethylcellulose and hyaluronic acid. More specifically, the invention relates to a composition, preferably an aqueous pharmaceutical solution, comprising 0.0001%-5% hyaluronic acid and 0.005%-2% carboxymethylcellulose. The invention also relates to the use of said composition, preferably an aqueous pharmaceutical solution, in the manufacturing of a medicament for the treatment of lesions in the mucosa by means of endoscopic resection, for example, the resection of polyps and/or tumors of the gastrointestinal mucosa.

Claims

exact text as granted — not AI-modified
1 . A composition comprising:
 a. a water-soluble polymer derived from cellulose at a concentration from 0.005% to 2%; and   b. hyaluronic acid at a concentration from 0.0001% to 0.5%;   wherein the viscosity of said composition is from 5 to 100 millipascal-seconds.   
     
     
         2 . The composition according to  claim 1 , wherein the concentration of the water-soluble polymer derived from cellulose is from 0.005% to 1%. 
     
     
         3 . The composition according to  claim 1 , wherein the concentration of hyaluronic acid is from 0.0001% to 0.3%. 
     
     
         4 . A composition comprising:
 a. a water-soluble polymer derived from cellulose at a concentration from 0.005% to 0.4%; and   b. hyaluronic acid at a concentration from 0.001% to 0.1%.   
     
     
         5 . The composition according to  claim 4 , wherein the viscosity of said composition is from 5 to 100 millipascal-seconds. 
     
     
         6 . The composition according to  claim 4 , wherein said water-soluble polymer derived from cellulose is selected from methylcellulose, hydroxypropylcellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, and combinations thereof. 
     
     
         7 . The composition according to  claim 1 , wherein said hyaluronic acid has a molecular weight of less than 1,000 kDa. 
     
     
         8 . The composition according to  claim 1 , wherein said hyaluronic acid has a viscosity in a 1% aqueous solution from 100 to 300 millipascal-seconds. 
     
     
         9 . The composition according to  claim 1 , wherein said hyaluronic acid is the hyaluronic acid sodium salt. 
     
     
         10 . The composition according to  claim 1 , wherein the concentration of hyaluronic acid is from 0.001% to 0.012%. 
     
     
         11 . The composition according to  claim 1 , wherein the concentration of the water-soluble polymer derived from cellulose is from 0.1% to 0.4%. 
     
     
         12 . The composition according to  claim 1 , wherein said water-soluble polymer derived from cellulose is carboxymethylcellulose. 
     
     
         13 . The composition according to  claim 1 , wherein said carboxymethylcellulose has a molecular weight of more than 500 kDa. 
     
     
         14 . The composition according to  claim 1 , wherein said carboxymethylcellulose has a viscosity from 500 to 4500 millipascal-seconds in a 1% aqueous solution. 
     
     
         15 . (canceled) 
     
     
         16 . The composition according to  claim 1 , further comprising a regulating agent at a concentration comprised between 1% and 30%, wherein the regulating agent is selected from the group consisting of a sugar, a polyalcohol, a salt, and combinations thereof. 
     
     
         17 - 18 . (canceled) 
     
     
         19 . The composition according to  claim 1 , wherein said composition is an aqueous composition. 
     
     
         20 . The composition according to  claim 1 , wherein said composition has a pH from  5  to  8 . 
     
     
         21 . (canceled) 
     
     
         22 . The composition according to  claim 1 , further comprising a dye. 
     
     
         23 - 24 . (canceled) 
     
     
         25 . The composition according to  claim 1 , wherein said composition comprises:
 hyaluronic acid, at a concentration from 0.001% to 0.1%   sodium carboxymethylcellulose, at a concentration from 0.005% to 0.4%   fructose or inulin q.s.f. pH from 5 to 6   physiological saline q.s.f.   
     
     
         26 - 28 . (canceled) 
     
     
         29 . A method for obtaining a composition according to  claim 1  comprising the following steps:
 a. mixing a gel of a water-soluble polymer derived from cellulose having a viscosity from 3,000 to 5,000 millipascal-seconds in a 2% aqueous solution with an aqueous solvent; and 
 b. mixing the solution obtained in step a) with hyaluronic acid 
 wherein said mixing process is carried out until achieving a solution with a viscosity from 5 to 100 millipascal-seconds. 
 
     
     
         30 - 39 . (canceled) 
     
     
         40 . The composition according to  claim 1 , wherein said composition is a pharmaceutical composition. 
     
     
         41 . (canceled) 
     
     
         42 . A method for the treatment of mucosal lesions, wherein said method comprises administration of a composition by means of injection in the submucosal layer, and wherein said composition comprises:
 a. a water-soluble polymer derived from cellulose at a concentration from 0.005% to 0.4%; and   b. hyaluronic acid at a concentration from 0.0001% to 0.3%.   
     
     
         43 . The method according to  claim 42 , wherein said composition is administered by means of endoscopic injection. 
     
     
         44 . The method according to  claim 42 , wherein said method comprises the resection of a portion of the mucosa. 
     
     
         45 . (canceled) 
     
     
         46 . The method according to  claim 42 , wherein said method of treatment is an endoscopic resection of the mucosa. 
     
     
         47 . (canceled) 
     
     
         48 . The method according to  claim 42 , wherein the retention time of the composition is at least 45 minutes. 
     
     
         49 . The method according to  claim 42 , wherein the mean height of the protuberance in the retention time is at least 3 mm. 
     
     
         50 - 53 . (canceled) 
     
     
         54 . The method according to  claim 44 , wherein said mucosa is the mucosa of the gastrointestinal tract. 
     
     
         55 . The method according to  claim 46 , wherein said endoscopic resection of the mucosa is selected from the group consisting of i) endoscopic submucosal resection (EMR) and ii) endoscopic submucosal dissection (EDS). 
     
     
         56 . The method according to  claim 48 , wherein the retention time of the composition is of 60 minutes or more. 
     
     
         57 . The method according to  claim 49 , wherein the mean height of the protuberance is of 4 mm or more. 
     
     
         58 . The method according to  claim 42 , wherein said lesions of the gastrointestinal tract are tumors, polyps, or combinations thereof.

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