Solid pharmaceutical composition containing benzofuran derivatives
The present invention relates to a solid pharmaceutical composition for oral administration characterized in that it comprises a benzofuran derivative with antiarrhythmic activity, or one of the pharmaceutically acceptable salts thereof, as an active principle, and a pharmaceutically acceptable nonionic hydrophilic surfactant optionally in combination with one or more pharmaceutical excipients.
1. A solid pharmaceutical composition in tablet form for oral administration comprising a benzofuran derivative with antiarrhythmic activity selected from the group consisting of dronedarone and amiodarone, or a pharmaceutically acceptable salt thereof, as an active principle, and a pharmaceutically acceptable nonionic hydrophilic surfactant selected from poloxamers, optionally in combination with one or more pharmaceutical excipients, said nonionic hydrophilic surfactant being present in a proportion of from 5% to 15% by weight of the active principle in base form, provided that the pharmaceutical composition does not contain a polysorbate surfactant.
2. A pharmaceutical composition according to claim 1 wherein the pharmaceutically acceptable salt is the hydrochloride.
3. A pharmaceutical composition according to claim 2 , wherein the benzofuran derivative is dronedarone hydrochloride.
4. A pharmaceutical composition according to claim 2 , wherein the benzofuran derivative is amiodarone hydrochloride.
5. A pharmaceutical composition according to claim 1 wherein the nonionic hydrophilic surfactant is selected from the group consisting of poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338, and poloxamer 407.
6. A pharmaceutical composition according to claim 5 wherein the nonionic hydrophilic surfactant is poloxamer 407.
7. A pharmaceutical composition according to claim 6 wherein the benzofuran derivative is dronedarone hydrochloride.
8. A pharmaceutical composition according to claim 6 wherein the benzofuran derivative is amiodarone hydrochloride.
9. A pharmaceutical composition according to claim 5 containing from 50 to 500 mg of active principle.
10. A pharmaceutical composition according to claim 9 , containing from 200 to 400 mg of active principle.
11. A pharmaceutical composition according to claim 10 , containing from 200 to 400 mg of active principle, calculated in base form, and 10% by weight of nonionic hydrophilic surfactant relative to the active principle in base form.
12. A pharmaceutical composition according to claim 11 wherein the active principle is selected from the group consisting of amiodarone hydrochloride and dronedarone hydrochloride or a pharmaceutically acceptable salt thereof.
13. A pharmaceutical composition according to claim 12 wherein the nonionic hydrophilic surfactant is poloxamer 407.
14. A pharmaceutical composition according to claim 13 wherein the active principle is dronedarone hydrochloride.