Liquid pharmaceutical composition for oral administration comprising fexofenadine
View Patent ↗The present invention relates to a liquid pharmaceutical composition for oral administration comprising fexofenadine and/or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable carrier which is either polyethylene glycol or a propylene glycol-based solvent, or a mixture thereof, from 35 to 90% wt. of a pharmaceutical excipient stabilizing fexofenadine and/or a pharmaceutically acceptable salt thereof, said pharmaceutical excipient consisting of glycerol with optionally sorbitol. The invention also relates to the uses of these compositions as a medicament and to the process for preparing said compositions.
1. A liquid pharmaceutical composition for oral administration comprising:
a pharmaceutically effective amount of fexofenadine or a pharmaceutically acceptable salt thereof;
0.05% wt. to 2% wt. of polyethylene glycol;
1.3% wt. 3.5% wt. of propylene glycol;
25% wt. to 50% wt. of glycerol;
20% wt. to 50% wt. sorbitol; and
less than 5% wt. of extra water, and wherein the composition is substantially free of glucose or sucrose;
wherein the weight percentage is relative to the total weight of the composition.
2. The liquid pharmaceutical composition of claim 1 , further comprising a sugar substitute, a chelating agent, a flavouring agent, or a combination of any of the foregoing.
3. A method of treating an allergy and/or urticaria in a patient in need thereof comprising administering the liquid pharmaceutical composition of claim 1 to the patient in need thereof.
4. A process for preparing the liquid pharmaceutical composition of claim 1 , comprising the steps:
mixing the fexofenadine or pharmaceutically acceptable salt thereof with the polyethylene glycol and the propylene glycol to prepare a drug solution;
adding the glycerol and sorbitol to the drug solution; and
adding the extra water to the resulting drug solution; and wherein the polyethylene glycol, propylene glycol, glycerol, sorbitol, and extra water are added within the weight percent ranges of claim 1 .
5. The liquid pharmaceutical composition of claim 1 , comprising 0.2% wt. to 1.5% wt. of polyethylene glycol.
6. The liquid pharmaceutical composition of claim 1 , comprising 1.5% wt. to 2.5% wt. of propylene glycol.
7. The liquid pharmaceutical composition of claim 1 , comprising 30% wt. to 45% wt. of glycerol.
8. The liquid pharmaceutical composition of claim 1 , comprising 25% wt. to 40% wt. of sorbitol.
9. The liquid pharmaceutical composition of claim 1 , having a pH of about 4.0 to about 5.0.
10. The liquid pharmaceutical composition of claim 1 , comprising 0.05% wt. to 2% wt. of fexofenadine or a pharmaceutically acceptable salt thereof.