PHARMACEUTICAL FORMULATIONS
New and improved antihistaminic syrups are disclosed.
1 . An antihistaminic syrup formulation comprising desloratadine or a pharmaceutically acceptable salt thereof that is storage stable, at least one pharmaceutically acceptable artificial sweetening agent, at least one pharmaceutically acceptable carrier, wherein the syrup formulation has a pH of greater than about 4.5.
2 . The antihistaminic syrup formulation according to claim 1 further comprising a buffering system, wherein the buffering system comprises sodium citrate and citric acid.
3 . The antihistaminic syrup formulation according to claim 2 , wherein the buffering system comprises sodium citrate and citric acid and wherein the sodium citrate is present in a concentration of about at least 0.1 mg/mL and the citric acid is present in a concentration of about at least 0.1 mg/mL.
4 . The antihistaminic syrup formulation according to claim 1 , wherein the desloratadine is present in a concentration of about 0.1 to about 10 mg/L.
5 . The antihistaminic syrup formulation according to claim 4 , wherein the desloratadine is present in a concentration of about 0.5 mg/mL.
6 . The antihistaminic syrup formulation according to claim 1 , wherein there is at least one pharmaceutically acceptable sweetening agent selected from the group consisting of sucralose, saccharin, a fluourinated sucrose derivative, acesulfame potassium and aspartame.
7 . The antihistaminic syrup formulation according to claim 1 , wherein the at least one pharmaceutically acceptable carrier is selected from the group consisting of water, propylene glycol, polyethylene glycol, sorbitol and glycerin and combinations of two or more thereof.
8 . The antihistaminic syrup formulation according to claim 1 further comprising at least one pharmaceutically acceptable viscosity increasing agent.
9 . The antihistaminic syrup formulation according to claim 1 , wherein the at least one pharmaceutically acceptable viscosity increasing agent is selected format least one of the group consisting of guar gum, gelatin, locust bean gum, tara gum, xanthan gum, tamarind gum, tragacanth gum, karaya gum, konjac mannan, water-soluble carboxyvinyl polymer, sodium carboxymethylcellulose, sodium alginate, pectin, azotobacter vinelandii gum, carrageenan, polyethylene glycol, modified starch, cassia gum, psyllium seed gum, carboxymethylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, methyl cellulose and microcrystalline cellulose.
10 . The antihistaminic syrup formulation according to claim 1 , wherein the liquid formulation is storage stable for at least 15 months.
11 . The antihistaminic syrup formulation according to claim 1 further comprising about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof.
12 . An antihistaminic syrup formulation comprising desloratadine or a chemically related antihistamine, including any pharmaceutically acceptable salt thereof that is storage stable, at least one pharmaceutically acceptable artificial sweetening agent, at least one pharmaceutically acceptable carrier, wherein the syrup formulation has a pH of about 4.5 to about 6.5.
13 . The antihistaminic syrup formulation according to claim 12 further comprising a buffering system.
14 . The antihistaminic syrup formulation according to claim 13 , wherein the buffering system comprises sodium citrate and citric acid and wherein the sodium citrate is present in a concentration of about at least 0.1 mg/mL and the citric acid is present in a concentration of about at least 0.1 mg/mL.
15 . The antihistaminic syrup formulation according to claim 12 , wherein the desloratadine is present in a concentration of about 0.1 to about 10 mg/mL.
16 . The antihistaminic syrup formulation according to claim 15 , wherein the desloratadine is present in a concentration of about 0.5 mg/mL.
17 . The antihistaminic syrup formulation according to claim 13 , wherein there is at least one pharmaceutically acceptable sweetening agent selected from the group consisting of sucralose, a fluourinated sucrose derivative, dextrose, acesulfame potassium, saccharin and aspartame.
18 . The antihistaminic syrup formulation according to claim 12 , wherein the at least one pharmaceutically acceptable carrier is selected from the group consisting of water, propylene glycol, polyethylene glycol, sorbitol and glycerin and any combinations of two or more thereof.
19 . The antihistaminic syrup formulation according to claim 12 further comprising at least one pharmaceutically acceptable viscosity increasing agent.
20 . The antihistaminic syrup formulation according to claim 19 , wherein the at least one pharmaceutically acceptable viscosity increasing agent is selected from at least one of the group consisting of guar gum, gelatin, locust bean gum, tara gum, xanthan gum, tamarind gum, tragacanth gum, karaya gum, konjac mannan, water-soluble carboxyvinyl polymer, sodium carboxymethylcellulose, sodium alginate, pectin, azotobacter vinelandii gum, carrageenan, polyethylene glycol, modified starch, cassia gum, psyllium seed gum, carboxymethylcellulose, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, methyl cellulose and microcrystalline cellulose.
21 . The antihistaminic syrup formulation according to claim 12 , wherein the liquid formulation is storage stable for at least 15 months.
22 . The antihistaminic syrup formulation according to claim 12 further comprising about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof.