Phenylephrine-containing liquid formulations
An oral, aqueous-based, liquid pharmaceutical composition is provided. The composition comprises up to about 45% glycerin and up to about 10% sorbitol wherein the glycerin to sorbitol ratio is about 2:1 to 10:1.
1. An aqueous oral pharmaceutical composition comprising:
a) one or more pharmaceutical actives, wherein at least one of the one or more pharmaceutical actives is phenylephrine;
b) artificial sweetener;
c) 18% w/v to about 30% w/v glycerin; and
d) up to about 10% w/v of sorbitol,
wherein the glycerin to sorbitol ratio as a weight % of the composition is about 2:1 to about 10:1,
wherein each of the one or more pharmaceutical actives is a water-soluble pharmaceutical active,
wherein the composition is free from high fructose corn syrup, and
wherein the composition is substantially free of phenylephrine degradants as measured under conditions of 40° C. and 75% relative humidity for 1 month.
2. The composition of claim 1 , further including at least one second pharmaceutical active ingredient, wherein the second pharmaceutical active ingredient is acetaminophen, dextromethorphan, diphenhydramine, guaifenesin, doxylamine, brompheniramine, or a combination thereof.
3. A method of treating at least one of cough, cold, fever, headache, pain, body ache, migraine and allergy in a patient comprising the administration of an aqueous oral pharmaceutical composition comprising:
a) phenylephrine;
b) artificial sweetener;
c) 18% to about 30% glycerin; and
d) up to about 10% sorbitol;
wherein the glycerin to sorbitol ratio is about 2:1 to about 10:1,
wherein the composition is not a suspension,
wherein the composition is free from high fructose corn syrup, and
wherein the composition is substantially free of phenylephrine degradants as measured under conditions of 40° C. and 75% relative humidity for 1 month.
4. The composition of claim 1 , wherein the glycerin to sorbitol ratio as a weight % of the composition is about 2.5:1.
5. The composition of claim 3 , wherein the glycerin to sorbitol ratio as a weight % of the composition is about 2.5:1.
6. The composition of claim 1 , wherein phenylephrine is the only pharmaceutical active.
7. The method of claim 3 , wherein the composition comprises one or more pharmaceutical actives, wherein at least one of the one or more pharmaceutical actives is the phenylephrine.
8. The method of claim 7 , wherein the phenylephrine is the only pharmaceutical active.