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|Abstract:||Provided herein are stable enalapril powder compositions for oral liquid formulation. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.|
|Inventor(s):||Rajewski; Lian G. (Lawrence, KS), Rajewski; Roger A. (Lawrence, KS), Haslam; John L. (Lawrence, KS), Heppert; Kathleen (Lawrence, KS), Beckloff; Michael C. (Leawood, KS), Seagrave; Frank (Dublin, OH), Mauro; Robert (Miller Place, NY), Colabuono; Peter (Las Vegas, NV)|
|Assignee:||Silvergate Pharmaceuticals, Inc. (Dublin, OH) University of Kansas (Lawrence, KS)|
1. A pharmaceutical powder that is reconstituted into an oral liquid formulation, the powder consisting of: (a) about 14% (w/w) enalapril or a pharmaceutically acceptable
salt thereof, (b) about 85% (w/w) mannitol, and (c) about 1% (w/w) colloidal silicon dioxide, wherein, when the powder is reconstituted into an oral liquid, the liquid is homogenous and stable for at least 12 weeks at about 25.+-.5.degree. C. and
55.+-.10% relative humidity.
2. The pharmaceutical powder of claim 1, wherein the enalapril or pharmaceutically acceptable salt thereof is enalapril maleate.
3. The pharmaceutical powder of claim 1, wherein the powder is reconstituted in water for the oral liquid.
4. The pharmaceutical powder of claim 1, wherein the powder is reconstituted in syrup for the oral liquid.
5. The pharmaceutical powder of claim 1, wherein the powder is stable for at least six months at ambient, accelerated or refrigerated conditions.
6. The pharmaceutical powder of claim 1, wherein the powder is 150 mg enalapril, 890 mg mannitol and 10 mg colloidal silicon dioxide.