ANTIARRHYTHMIC AGENT PREPARATIONS HAVING A PH-INDEPENDENT DISSOLUTION PROFILE

摘要

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.