Combination of glycosaminoglycans and an antacid agent and compositions thereof
The present invention refers to a combination of hyaluronic acid, chondroitin sulfate in combination with at least one antacid agent, in particular magaldrate, for the prevention or treatment of gastric hyperacidity and gastroesophageal reflux and related pathologies thereof. More particularly, the combination is used for the preparation of oral compositions with at least one pharmaceutical carrier and advantageously that comprise a bioadhesive agent as well.
1. A liquid pharmaceutical composition consisting of
hyaluronic acid or a pharmaceutically acceptable salt thereof,
chondroitin sulfate or a pharmaceutically acceptable salt thereof,
magaldrate,
a bioadhesive agent, and
at least one pharmaceutically acceptable carrier or excipient wherein said liquid pharmaceutical composition is in unit doses consisting of 30 to 100 mg of sodium hyaluronate and 80 to 200 mg of sodium chondroitin sulfate, 400 to 600 mg of magaldrate and 100 to 400 mg of bioadhesive agent.
2. The liquid pharmaceutical composition according to claim 1 , in the form of unit doses, each consisting of:
a. sodium hyaluronate in an amount of 35 to 45 mg;
b. sodium chondroitin sulfate in an amount of 90 to 110 mg;
c. magaldrate in an amount of 450 to 550 mg; and
d. at least one bioadhesive polymer in a total amount of 250 to 350 mg.
3. The liquid pharmaceutical composition according to claim 1 wherein said bioadhesive polymer is selected from the group consisting of poloxamers, copolymers of ethylene and propylene oxide, vinylpyrrolidone polymers, and cellulose derivatives.
4. The liquid pharmaceutical composition according to claim 1 wherein said bioadhesive polymer is the copolymer of ethylene and propylene oxide named poloxamer 407.
5. A method for prevention and treatment of gastric hyperacidity and gastroesophageal reflux and related diseases, said method comprising administering a therapeutically effective amount of the pharmaceutical composition according to claim 1 , to a subject in need thereof.
6. The method according to claim 5 , wherein said pharmaceutical composition is liquid and in the form of unit doses, each consisting of
a. sodium hyaluronate in an amount of 30 to 100 mg;
b. sodium chondroitin sulfate in an amount of 80 to 200 mg;
c. magaldrate in an amount of 400 to 600 mg; and
d. at least one bioadhesive polymer in a total amount of 100 to 400 mg.
7. A liquid composition in single-dose of 10 ml each, which consists of
mg/10 ml
sodium hyaluronate 46.719
sodium chondroitin sulfate 116.798
xylitol powder 1262.315
poloxamer 407 303.000
polyvinylpyrrolidone 280.517
sodium benzoate 10.523
potassium sorbate 21.035
flavor 2.336
magaldrate 20% suspension 2500.000
sucralose 1.685
xanthan gum 17.969
water 667.660.
8. The method according to claim 5 , wherein said pharmaceutical composition is in single-dose of 10 ml each consisting of
mg/10 ml
sodium hyaluronate 46.719
sodium chondroitin sulfate 116.798
xylitol powder 1262.315
poloxamer 407 303.000
polyvinylpyrrolidone 280.517
sodium benzoate 10.523
potassium sorbate 21.035
flavor 2.336
magaldrate 20% suspension 2500.000
sucralose 1.685
xanthan gum 17.969
water 667.660.
9. The pharmaceutical composition according to claim 1 , wherein the viscosity is 6,000-7,000 centipoises.
10. The pharmaceutical composition according to claim 1 , wherein the pH is 7.9 to 8.4.
11. The pharmaceutical composition according to claim 1 , wherein hyaluronic acid or a pharmaceutically acceptable salt thereof has an average molecular weight not lower than 10 5 Da.