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    • 3. 发明申请
    • ANTIARRHYTHMIC AGENT PREPARATIONS HAVING A PH-INDEPENDENT DISSOLUTION PROFILE
    • 具有PH独立溶解度特征的抗菌药物制剂
    • WO2012105767A3
    • 2012-10-26
    • PCT/KR2012000658
    • 2012-01-30
    • DONG A PHARM CO LTDKIM JEONG-HOONJANG SUN-WOOHAN SANG-DUGJUNG SANG-WON
    • KIM JEONG-HOONJANG SUN-WOOHAN SANG-DUGJUNG SANG-WON
    • A61K31/343A61K9/16A61K9/20A61K9/48
    • A61K31/343A61K9/146A61K9/1641A61K9/2031
    • The present invention relates to preparations containing dronedarone, which is an antiarrhythmic agent, and more particularly, to coprecipitated solid dispersions, or solids or liquids containing dronedarone, which enables a pH-independent dissolution profile, or the pharmaceutically acceptable salts thereof, and to preparations comprising the solid dispersions or solids or liquids. The solid dispersions or solids or liquids containing dronedarone according to the present invention maximize the dissolution of a main component in an acidic environment to improve dissolution in the event of fasting when the pH level is low, and maintain dronedarone in an extremely small particle or dissolved state when the environment is changed from the acidic environment into an alkaline environment, to thereby improve the low bioavailability of dronedarone or the salts thereof, or reduce the effects of food in terms of varying bioavailability depending on whether drugs are taken before or after a meal. Accordingly, the dronedarone preparations containing solid dispersions or solids or liquids according to the present invention may enable a patient to easily take drugs at any time before or after a meal, and may reduce the size of drugs to improve drug compliance.
    • 本发明涉及含有决奈罗隆的制剂,其是抗心律失常剂,更具体地说,涉及共沉淀的固体分散体,或含有决奈达隆的固体或液体,其使得不依赖于pH的溶出曲线,或其药学上可接受的盐和制剂 包括固体分散体或固体或液体。 根据本发明的含有决奈罗隆的固体分散体或固体或液体在酸性环境中使主要组分的溶解最大化,以在pH水平低时在禁食的情况下改善溶解,并且将决奈达隆保持在极小的颗粒中或溶解 当环境从酸性环境变为碱性环境时,从而提高决奈达隆或其盐的低生物利用度,或者根据是否在饭前或服食后服用药物来降低食物在不同生物利用度方面的影响 。 因此,根据本发明的含有固体分散体或固体或液体的决奈达隆制剂可以使得患者能够在饭前或饭后容易地服用药物,并且可以减小药物的大小以改善药物依从性。