Generated: May 25, 2017
|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)|
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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.