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US 2009/0292016 A1Published application
Stable Pharmaceutical Compositions Containing Pravastatin
OwnerBoyong Li, Avinash Nangia +2inventors
InventorsBoyong Li, Avinash Nangia, Aaron Dely, David Wong
Life of this patent
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Abstract
Stabilized pharmaceutical preparations containing a drug which is sensitive to a low pH environment, such as pravastatin are disclosed in which pravastatin degradations is prevented with a buffering agent. The basic excipient enhances storage stability.
Claims10
1-22. (canceled)
A stable pravastatin sodium tablet comprising:
- pravastatin sodium granules and a tablet filler wherein the granules exhibit a pH less than 9 as determined by dissolving the tablet in 900 ml of deionized water and are prepared by granulating a mixture comprising pravastatin sodium and a granulation filler with a granulating solution comprising water and a buffering agent and wherein the tablet retains 90 to 110 percent of an original pravastatin assay value after storage for 3 months at about 40° C. and 75% relative humidity;
- and comprises 2-6 weight percent based upon the total weight of the tablet of buffering agent.
Dependencies are inferred from the claim text.