Tablet to be sucked and/or dissolved in the mouth based on hyaluronic acid and chondroitin sulphate and their salts

Abstract

The present invention relates to a chewable and/or suckable and/or melt-in-mouth tablet based on hyaluronic acid and chondroitin sulphate and/or salts thereof.

1 . A composition for oral use in the solid form of a chewable and/or suckable and/or melt-in-mouth tablet, comprising a mixture which comprises a hyaluronic acid, or a salt thereof, and a chondroitin, or a salt thereof and, optionally, at least one food or pharmaceutical grade excipient or additive; said composition being for use:
 i) in the treatment of subjects with disorders or symptoms caused or provoked by gastroesophageal reflux (GERD), or   ii) in the treatment of subjects with extraesophageal disorders or symptoms caused by the upflow of gastric contents and/or gastric vapours from the stomach along the oral cavity, or refluxate, which comprises pepsin, acid and/or mildly acidic or non-acidic but irritating contents), or   iii) in the treatment of subjects with ulcers or lacerations provoked in the gastric mucosa (stomach lining), in the esophageal and laryngopharyngeal mucosa or the tissues lining the oral cavity, so as to protect the mucosa and the tissues of the various anatomical regions from the damage provoked thereto.   
     
     
         2 . The composition for use according to  claim 1 , wherein both of said hyaluronic acid, or a salt thereof, and said chondroitin, or a salt thereof, have an average molecular weight comprised from greater than about  1  KDa to less than about 1,000 KDa. 
     
     
         3 . The composition for use according to  claim 1 , wherein said hyaluronic acid is a linear, branched, cross-linked or substituted hyaluronic acid having an average molecular weight comprised from about 200 KDa to about 800 KDa. 
     
     
         4 . The composition for use according to  claim 3 , wherein said hyaluronic acid is preferably the hyaluronic acid CAS no. 9004-61-9. 
     
     
         5 . The composition for use according to  claim 1 , wherein said hyaluronic acid is in the form of a hyaluronate salt of an alkali metal or an alkaline earth metal. 
     
     
         6 . The composition for use according to  claim 5 , wherein said salt is preferably sodium hyaluronate; more preferably, it is sodium hyaluronate having CAS no. 9067-32-7. 
     
     
         7 . The composition for use according to  claim 1 , wherein said chondroitin, or a salt thereof, is chondroitin or a chondroitin sulphate or a chondroitin sulphate sodium derived from chondroitin of animal origin. 
     
     
         8 . The composition for use according to  claim 7 , wherein said chondroitin, or a salt thereof, has an average molecular weight comprised from about 200 KDa to about 800 KDa. 
     
     
         9 . The composition for use according to  claim 1 , wherein said chondroitin is preferably a chondroitin sulphate. wherein said mixture may further comprise a basic substance with antacid properties, wherein said basic substance with antacid properties is a substance selected from the group consisting of a salt in the form of an oxide, a hydroxide, a carbonate, a bicarbonate, a silicate, a trisilicate, a sulphate or a citrate of a cation, the cation being an alkali metal cation, an alkaline earth metal cation or a metal (III) cation. 
     
     
         11 . The composition for use according to claim  10 , wherein said cation is selected from the group consisting of:
 sodium cation, potassium cation, calcium cation, magnesium cation or aluminum cation.   
     
     
         12 . The composition for use according to claim  10 , wherein said salt is selected from the group consisting of aluminum hydroxide, magnesium hydroxide, or magnesium trisilicate, magnesium trisilicate hydrate, or mixtures thereof. 
     
     
         13 . The composition for use according to  claim 1 , wherein said mixture may also further comprise a proton pump inhibitor (PRI) compound selected from the group consisting of: omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole sodium, ilaprazole and tenatoprazole. 
     
     
         14 . The composition according to  claim 3  wherein said linear, branched, cross-linked or substituted hyaluronic acid has an average molecular weight comprised from about 400 KDa to about 600 KDa. 
     
     
         15 . The composition according to  claim 5  wherein said hyaluronate salt is selected from the group consisting of sodium hyaluronate, potassium hyaluronate, calcium hyaluronate and magnesium hyaluronate. 
     
     
         16 . The composition according to  claim 7  wherein the chondroitin of animal origin is extracted from chickens, bovines, swine, fish and shells of crustaceans including crabs, lobsters or prawn shells. 
     
     
         17 . The composition according to  claim 8  wherein said chondroitin, or a salt thereof, has an average molecular weight comprised from about 400 KDa to about 600 KDa. 
     
     
         18 . The composition according to  claim 12  wherein said salt is a mixture of aluminum hydroxide and sodium bicarbonate in a 2:1 ratio by weight; or a mixture of magnesium hydroxide and sodium bicarbonate in a 2:1 ratio by weight; or a mixture of magnesium trisilicate and sodium bicarbonate in a 2:1 ratio by weight. 
     
     
         19 . A method for alleviating symptoms or preventing damage caused by gastric, extraesophageal, or gastroesophageal disorders in a subject in need thereof, the method comprising orally administering the composition of  claim 1 . 
     
     
         20 . The method of  claim 19  wherein the subject has (1) GERD, or (2) extraesophageal disorders or symptoms caused by the upflow of gastric contents and/or gastric vapours from the stomach along the oral cavity or refluxate comprising pepsin, acid and/or mildly acidic or non-acidic but irritating contents, or (3) ulcers or lacerations provoked in the gastric mucosa (stomach lining), in the esophageal and laryngopharyngeal mucosa or the tissues lining the oral cavity.