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Claims for Patent: 4,499,108

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Claims for Patent: 4,499,108

Title: Stable pleasant-tasting albuterol sulfate pharmaceutical formulations
Abstract:Albuterol sulfate syrups that are pleasant-tasting and stable upon prolonged storage.
Inventor(s): Sequeira; Joel A. (New York, NY), Zupon; Michael A. (Madison, NJ)
Assignee: Schering Corporation (Madison, NJ)
Application Number:06/502,427
Patent Claims: 1. A stable, pleasant-tasting pharmaceutical formulation comprising per ml of the formulation:

(a) 0.2 to 6.0 mg albuterol sulfate,

(b) sufficient buffer to control the pH of the formulation to 2 to 5,

(c) sufficient preservative to prevent microbial growth,

(d) 0.1 to 2.0 mg saccharin,

(e) sufficient viscosity imparting agent to cause the viscosity of the formulation to be higher than that of water at room temperature, and

(f) water q.s. for 1 ml.

2. The formulation of claim 1 wherein elements (b), (c), and (e) comprise per ml of the formulation:

(b) 1.4 to 11.2 mg citric acid and 0.8 to 6.4 mg sodium citrate dihydrate,

(c) 0.5 to 3 mg sodium benzoate,

(e) 2 to 8 mg hydroxypropyl methyl cellulose.

3. The formulation of claim 2 comprising per ml of the formulation:

(a) 0.45 to 0.55 mg albuterol sulfate,

(b) 2.5 to 3.5 mg citric acid and 1.3 to 2.3 mg sodium citrate dihydrate,

(c) 0.5 to 1.5 mg sodium benzoate,

(d) 0.1 to 0.4 mg saccharin,

(e) 4 to 5 mg hydroxypropyl methylcellulose, and

(f) water q.s. for 1 ml.

4. The formulation of claim 3 comprising per ml of the formulation:

(a) 0.482 mg albuterol sulfate,

(b) 2.8 mg citric acid and 1.59 mg sodium citrate,

(c) 1 mg sodium benzoate,

(d) 0.2 mg saccharin,

(e) 4.5 mg hydroxypropyl methylcellulose,

(f) water q.s. for 1 ml,

(g) sufficient coloring agent to impart a pleasant color, and

(h) sufficient flavor to a impart a pleasant flavor.

5. The formulation of claim 4 wherein said coloring agent is FD&C Yellow No. 6, and said flavor is artificial strawberry flavor.

6. The formulation of claim 5 wherein the amount of FD&C Yellow No. 6 is 0.015 mg/ml of the formulation and the about of artifical strawberry flavor is 0.0005 ml/ml of the formulation.
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