Compositions and methods useful for treatment of respiratory illness
Disclosed are compositions including phenylephrine, its free and addition salt forms, and mixtures thereof, alone, or in combination with other pharmaceutical actives. The compositions have a pH of about 2 to about 5 and are substantially free of aldehydes. Also disclosed are methods of treating respiratory illness through administration of a composition comprising phenylephrine, its free and addition salt forms, and mixtures thereof alone, or in combination with other pharmaceutical actives, wherein the composition has a pH of from about 2 to about 5 and is substantially free of aldehydes.
1. A liquid composition comprising:
(a) from about 0.01 mg to about 15 mg of a phenylephrine active, per dose of the liquid composition, selected from the group consisting of phenylephrine, its free and addition salt forms, and mixtures thereof;
(b) a flavor which comprises one or more non-aldehydic aesthetic agents;
(c) a sugar alcohol selected from the group consisting of glycerin, sorbitol, maltitol, mannitol, and mixtures thereof; and
(d) a solvent selected from the group consisting of water, ethanol, propylene glycol, and mixtures thereof;
wherein the liquid composition is a solution;
wherein the liquid composition has a pH of from about 2 to about 5; wherein the liquid composition comprises a ratio of propylene glycol to sorbitol of about 0.5:1 to 5:1; and wherein the liquid composition comprises less than about 0.1% of total aldehydes, by weight of the liquid composition.
2. The liquid composition according to claim 1 wherein the phenylephrine active is phenylephrine hydrochloride.
3. The liquid composition according to claim 2 which comprises less than about 0.05% of total aldehydes, by weight of the liquid composition.
4. The liquid composition according to claim 3 which comprises from about 0.0001% to about 5% of total non-aldehydic aesthetic agents, by weight of the liquid composition.
5. The liquid composition according to claim 4 wherein at least one of the non-aldehydic aesthetic agents is an ester.
6. The liquid composition according to claim 4 wherein at least one of the non-aldehydic aesthetic agents is a ketone.
7. The liquid composition according to claim 4 wherein at least one of the non-aldehydic aesthetic agents is an alcohol.
8. The liquid composition according to claim 4 which comprises less than about 0.01% of total aldehydes, by weight of the liquid composition.
9. The liquid composition according to claim 8 comprising from about 10% to about 25% of total sugar alcohol solution, by weight of the liquid composition.
10. The liquid composition according to claim 9 comprising from about 60% to about 80% of total sugar alcohol, by weight of the sugar alcohol solution.
11. The liquid composition according to claim 1 further comprising an artificial sweetener selected from the group consisting of sodium saccharine, acesulfame potassium, sucralose, aspartame, monoammonium glycyrrhizinate, neohesperidin dihydrochalcone, thaumatin, neotame, cyclamates, and mixtures thereof.
12. The liquid composition according to claim 11 wherein the phenylephrine active is phenylephrine hydrochloride.
13. The liquid composition according to claim 12 which comprises less than about 0.05% of total aldehydes, by weight of the liquid composition.
14. The liquid composition according to claim 13 which comprises from about 0.0001% to about 5% of total non-aldehydic aesthetic agents, by weight of the liquid composition.
15. The liquid composition according to claim 14 wherein at least one of the non-aldehydic aesthetic agents is an ester.
16. The liquid composition according to claim 14 wherein at least one of the non-aldehydic aesthetic agents is a ketone.
17. The liquid composition according to claim 14 wherein at least one of the non-aldehydic aesthetic agents is an alcohol.
18. The liquid composition according to claim 14 which comprises less than about 0.01% of total aldehydes, by weight of the liquid composition.
19. The liquid composition according to claim 18 comprising from about 0.0001% to about 5% of total artificial sweetener, by weight of the liquid composition.
20. The liquid composition according to claim 19 comprising from about 0.0425% to about 3.5% of total artificial sweetener, by weight of the liquid composition.
21. The liquid composition according to claim 19 comprising from about 0.05% to about 2.0% of total artificial sweetener, by weight of the liquid composition.
22. The liquid composition according to claim 8 further comprising an artificial sweetener selected from the group consisting of sodium saccharine, acesulfame potassium, sucralose, aspartame, monoammonium glycyrrhizinate, neohesperidin dihydrochalcone, thaumatin, neotame, cyclamates, and mixtures thereof.
23. The liquid composition according to claim 22 further comprising a chelating agent.
24. The liquid composition according to claim 23 further comprising a reducing agent.
25. The liquid composition according to claim 23 wherein the chelating agent is selected from the group consisting of disodium and calcium salts of ethylene diamine tetraacetic acid (EDTA), terasodium EDTA, sodium hexametaphosphate (SHMP), citric acid, phosphoric acid, di(hydroxyethyl)glycine, 8-hydroxyquinoline, and mixtures thereof.
26. The liquid composition according to claim 24 wherein the chelating agent is disodium EDTA.
27. The liquid composition according to claim 1 wherein the liquid composition comprises a ratio of propylene glycol to glycerin of 1:1 to 3:1.