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US 9,750,735 B2Granted
Pharmaceutical composition containing palonosetron
AssigneeSamyang Biopharmaceuticals Corporation
InventorsHye-Jeong Yoon, Sang-Jun Lee
Life of this patent
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Abstract
Provided are a pharmaceutical composition with improved stability including palonosetron, a preparation method thereof, and a pharmaceutical package including the pharmaceutical composition.
Claims5
A pharmaceutical package, comprising:
- a pharmaceutically acceptable container, and
- a pharmaceutical composition comprising:
- palonosetron or pharmaceutically acceptable salts thereof in the container as an active ingredient at a concentration of 0.01 to 0.5 mg/ml;
- a pharmaceutically acceptable aqueous carrier;
- a buffering agent, an isotonic agent, or a mixture thereof,
- wherein the pharmaceutically acceptable container is a transparent borosilicate glass container, and the glass is a low-expansion borosilicate glass, satisfying ASTM type 1, class A, USP type 1 Powdered Glass, USP Arsenic, EP type 1 Glass Grains (Test B) and EP Arsenic conditions, and
- wherein the pH of the pharmaceutical composition is 4 to 6,
- wherein the pharmaceutical composition is free of EDTA or a salt thereof,
- wherein a total content of heavy metals is maintained to be equal to or less than 50 ppm during a storage period, and
- wherein the pharmaceutical composition has storage stability of maintaining the content of palonosetron or a pharmaceutically acceptable salt thereof at 95% by weight to 100% by weight based on the initial content thereof when the pharmaceutical composition is stored at 25 ° C. for 24 months.
7 more elements
Dependencies are inferred from the claim text.