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|Title:||Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment|
|Abstract:||The present invention relates to carvedilol phosphate salts, which include novel crystalline forms of carvedilol dihydrogen phosphate (i.e., dihydrogen phosphate salt of 1-(carbazol-4-yloxy-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol) and/or carvedilol hydrogen phosphate, etc.), and/or solvates thereof, compositions containing the aforementioned salts and/or solvates, and methods of using the aforementioned salts and/or solvates to treat hypertension, congestive heart failure and angina, etc.|
|Inventor(s):||Brook; Christopher S. (King of Prussia, PA), Chen; Wei (Woodbury, MN), Spoors; Paul G. (King of Prussia, PA)|
|Assignee:||SB Pharmco Puerto Rico Inc. (Hato Rey, PR)|
1. A compound which is crystalline carvedilol dihydrogen phosphate hemihydrate.
2. The compound according to claim 1 having an x-ray diffraction pattern which comprises characteristic peaks in degrees two-theta as shown in FIG. 1.
3. The compound according to claim 2 having characteristic peaks from 0.degree. degrees 2-theta (2.theta.) to 35.degree. degrees 2-theta (2.theta.) at about 7.0.+-.0.2 (2.theta.), 11.4.+-.0.2 (2.theta.), 15.9.+-.0.2 (2.theta.), 18.8.+-.0.2 (2.theta.), 20.6.+-.0.2 (2.theta.), 22.8.+-.0.2 (2.theta.), and 25.4.+-.0.2 (2.theta.).
4. The compound according to claim 1 having an infrared spectrum which comprises characteristic absorption bands expressed in wave numbers as shown in FIG. 6.
5. The compound according to claim 1 having a Raman spectrum which comprises characteristic peaks as shown in FIG. 3.
6. A pharmaceutical composition comprising the compound according to claim 1 and a pharmaceutically acceptable carrier.
7. A method of treating hypertension, congestive heart failure or angina which comprises administering to a subject in need thereof an effective amount of the compound according to claim 1.
8. A method of treating hypertension, congestive heart failure or angina which comprises administering to a subject in need thereof an effective amount of the composition according to claim 6.
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