Composition and method for raising blood glucose level

1 . A glucose composition for delivering glucose across oral mucosa to raise the blood glucose level of an individual, the composition comprising:

a. an effective amount of glucose;

b. an effective amount of sodium glycocholate, and

c. an effective amount of a pharmaceutically acceptable carrier, wherein the composition is free of any additional active pharmaceutical agents.

2 . The composition of claim 1 , wherein the oral mucosa is the buccal mucosa.

3 . The composition of claim 1 , wherein the glucose is present in a concentration of from 10 to 80 w/w %.

4 . The composition of claim 1 , wherein the glucose is present in a concentration of from 20 to 70 w/w %.

5 . The composition of claim 1 , wherein the glucose is present in a concentration of from 30 to 60 w/w %.

6 . The composition of claim 1 , wherein each absorption enhancer is present in a concentration of from 0.01 to 5 w/w %.

7 . The composition of claim 6 , wherein each absorption enhancer is present in a concentration of from 0.01 to 3 w/w %.

8 . The composition of claim 7 , wherein each absorption enhancer is present in a concentration of from 0.01 to 1 w/w %.

9 . The composition of claim 1 , wherein the total concentration of absorption enhancer is less than 10 w/w %.

10 . The composition of claim 9 , wherein the total concentration of absorption enhancer is less than 5 w/w %.

11 . (canceled)

12 . The composition of claim 1 , comprising glycerin.

13 . The composition of claim 1 , comprising sodium lauryl sulfate.

14 . The composition of claim 1 , comprising polyoxyethylene sorbitan monooleate.

15 . The composition of claim 1 , wherein the carrier is an aqueous solvent.

16 . The composition of claim 1 , further comprising at least one additional ingredient chosen from flavouring agents, colouring agents, preservatives and antimicrobial agents.

17 . The composition of claim 16 , comprising sodium benzoate as a preservative or antimicrobial agent.

18 . The composition of claim 1 , wherein the carrier is a chewing gum base.

19 . A non-aerosol dispenser containing the composition of claim 1 .

20 . The non-aerosol dispenser of claim 19 , wherein the dispenser is a metered dose dispenser.

21 . The non-aerosol dispenser of claim 19 , wherein the dispenser is adapted to deliver the composition as droplets having a size between 1 and 200 μm.

22 . The dispenser of claim 21 , wherein the dispenser is adapted to deliver the composition as droplets having a size between 1 and 20 μm.

23 . The dispenser of claim 19 , wherein the dispenser is adapted to dispense between 0.05 and 0.5 mL of the glucose composition per actuation.

24 . The dispenser of claim 23 , wherein the dispenser is adapted to dispense between 0.05 and 0.3 mL of the glucose composition per actuation.

25 . The dispenser of claim 24 , wherein the dispenser is adapted to dispense between 0.05 and 0.1 mL of the glucose composition per actuation.

26 . A method of raising the blood glucose level of an individual comprising administering an effective amount of the composition of claim 1 to an oral mucosa of the individual.

27 . The method of claim 26 , wherein the administration is to the buccal mucosa.

28 . The method of claim 26 , wherein the administration comprises spraying the composition into the mouth of the individual using a non-aerosol dispenser.

29 . The method of claim 28 , wherein the non-aerosol dispenser is a metered dose dispenser.

30 . The method of claim 26 , wherein 30 to 50 mg of glucose is administered per actuation of the dispenser.

31 . The method of claim 26 , wherein the total amount of glucose administered per dose is from 150 to 300 mg.

32 . The method of claim 31 , wherein the total amount of glucose administered per dose is from 175 to 200 mg.

33 . The method of any claim 28 , wherein three to eight spray actuations are administered per dosing session.

34 . The method of any claim 28 , wherein between 0.05 and 0.5 mL of the glucose composition is sprayed per actuation.

35 . The method of claim 34 wherein between 0.05 and 0.3 mL of the glucose composition is sprayed per actuation.

36 . The method of claim 35 wherein between 0.05 and 0.1 mL of the glucose composition is sprayed per actuation.

37 .- 40 . (canceled)

41 . The composition of claim 1 , comprising glycerin.

42 . The composition of claim 41 , comprising sodium lauryl sulfate.

43 . The composition of claim 42 , comprising polyoxyethylene sorbitan monooleate.

44 . The composition of claim 1 , comprising an effective amount of at least one additional absorption enhancer chosen from glycerin, sodium lauryl sulfate, polyoxyethylene sorbitan monooleate, lecithin, hyaluronic acid, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linoleic acid, linolenic acid, monoolein, monooleates, monolaurates, borage oil, evening primrose oil, menthol, trihydroxy oxo cholanyl glycine, polyglycerin, lysine, polylysine, triolein, polyoxyethylene ethers, polidocanol alkyl ethers, chenodeoxycholate, deoxycholate, alkali metal salicylate, pharmaceutically acceptable edetate, and pharmaceutically acceptable salts and analogues thereof

45 . The composition of claim 44 , further comprising at least one additional ingredient chosen from flavouring agents, colouring agents, preservatives and antimicrobial agents.

46 . The composition of claim 45 , comprising sodium benzoate as a preservative or antimicrobial agent.