Stable pharmaceutical compositions of 2-aza-bicyclo(3.3.0)-octane-3-carboxylic acid derivatives
First Claim
1. A stable pharmaceutical composition comprising from about 2.5% to about 20% of a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative by weight of the composition and at least one pharmaceutically acceptable excipient, wherein the composition has a total weight of less than 100 mg.
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Abstract
Provided are stable pharmaceutical compositions comprising from about 2.5% to about 20% of a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative by weight of the composition and at least one pharmaceutically acceptable excipient, wherein the composition preferably has a total weight of less than 100 mg. Also provided are stable pharmaceutical compositions comprising a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative in a stabilizing-effective concentration and at least one pharmaceutically acceptable excipient. Further provided are methods for improving the stability of a pharmaceutical composition and methods for treating hypertension by administering a therapeutically effective amount of the stable pharmaceutical compositions of the invention.
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Citations
45 Claims
- 1. A stable pharmaceutical composition comprising from about 2.5% to about 20% of a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative by weight of the composition and at least one pharmaceutically acceptable excipient, wherein the composition has a total weight of less than 100 mg.
- 24. A method for improving the stability of a pharmaceutical composition comprising combining a stabilizing-effective concentration of a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative with at least one pharmaceutically acceptable excipient, wherein the composition has a total weight of less than 100 mg.
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37. A stable pharmaceutical composition comprising a 2-aza-bicyclo[3.3.0]-octane-3-carboxylic acid derivative in a stabilizing-effective concentration and at least one pharmaceutically acceptable excipient, wherein:
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(a) less than about 2% of a diketopiperazine by weight of the derivative before degradation is present after storage at 40°
C. under 75% relative humidity for one month;
(b) less than about 3% of a diketopiperazine by weight of the derivative before degradation is present after storage at 40°
C. under 75% relative humidity for two months; and
(c) less than about 3.5% of a diketopiperazine by weight of the derivative before degradation is present after storage at 40°
C. under 75% relative humidity for three months. - View Dependent Claims (38, 39, 40)
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41. A stable pharmaceutical composition comprising about 1.25 mg of ramipril, wherein the composition has a total weight of about 50 mg.
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42. A stable pharmaceutical composition comprising about 2.5 mg of ramipril, wherein the composition has a total weight of about 50 mg.
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43. A stable pharmaceutical composition comprising about 5 mg of ramipril, wherein the composition has a total weight of about 50 mg.
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44. A stable pharmaceutical composition comprising about 10 mg of ramipril, wherein the composition has a total weight of about 50 mg.
Specification