Pharmaceutical composition
Provided is a pharmaceutical composition which contains pemafibrate, a salt thereof or a solvate thereof and has excellent stability. A pharmaceutical composition is provided containing pemafibrate, a salt thereof or a solvate thereof and having a moisture content of 2.4 mass % or less.
1. A pharmaceutical composition comprising pemafibrate, a salt thereof or a solvate thereof and having a moisture content of 0.3 to 2.4 mass %.
2. The pharmaceutical composition according to claim 1 , wherein the moisture content is 0.8 to 1.5 mass %.
3. The pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition is a solid preparation.
4. The pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition is a tablet, a capsule, a granule, a powder or a pill.
5. A pharmaceutical preparation obtained by storing the pharmaceutical composition according to claim 1 in a tight package.
6. A pharmaceutical preparation according to claim 5 , wherein the tight package is one or more selected from the group consisting of a bottle package, an SP package, a PTP package, a pillow package and a stick package.
7. A method for stabilizing pemafibrate, a salt thereof or a solvate thereof in a pharmaceutical composition, the method comprising setting a moisture content in a pharmaceutical composition comprising pemafibrate, a salt thereof or a solvate thereof 0.3 to 2.4 mass %.
8. A pharmaceutical composition comprising a pemafibrate crystal having a moisture content of 0.3 to 2.4 mass %.
9. The pharmaceutical composition according to claim 8 , wherein the pemafibrate crystal has a peak at one or more diffraction angles (2θ) selected from the group consisting of around 7.3±0.2°, around 14.6±0.2°, around 15.3±0.2°, around 16.2±0.2°, around 18.2±0.2°, around 18.9±0.2°, around 20.6±0.2°, around 21.5±0.2°, around 22.5±0.2° and around 24.1±0.2° in a powder X-ray diffraction pattern obtained by irradiation with Cu-Kα radiation.
10. The pharmaceutical composition according to claim 9 , wherein the pemafibrate crystal has peaks at diffraction angles (2θ) of around 14.6±0.2°, around 15.3±0.2°, around 20.6±0.2° and around 22.5±0.2° in a powder X-ray diffraction pattern obtained by irradiation with Cu-Kα radiation.
11. The pharmaceutical composition according to claim 9 , wherein the pemafibrate crystal has peaks at diffraction angles (2θ) of around 7.3±0.2°, around 14.6±0.2°, around 15.3±0.2°, around 16.2±0.2°, around 18.2±0.2°, around 18.9±0.2°, around 20.6±0.2°, around 21.5±0.2°, around 22.5±0.2° and around 24.1±0.2° in a powder X-ray diffraction pattern obtained by irradiation with Cu-Kα radiation.
12. The pharmaceutical composition according to claim 8 , wherein the pemafibrate crystal is a crystal having a melting point of 95 to 101° C.
13. The pharmaceutical composition according to claim 8 , wherein the moisture content of the pharmaceutical composition is 0.5 to 2.1 mass %.
14. The pharmaceutical composition according to claim 8 , wherein the moisture content of the pharmaceutical composition is 0.8 to 1.9 mass %.
15. The pharmaceutical composition according to claim 8 , wherein the moisture content of the pharmaceutical composition is 1.0 to 1.7 mass %.
16. The pharmaceutical composition according to claim 8 , wherein the moisture content of the pharmaceutical composition is 1.2 to 1.5 mass %.
17. The pharmaceutical composition according to claim 8 , wherein the pharmaceutical composition is a solid preparation.
18. The pharmaceutical composition according to claim 17 , wherein the pharmaceutical composition is a tablet, a capsule, a granule, a powder or a pill.
19. The pharmaceutical composition according to claim 8 , wherein the pharmaceutical composition is an agent for prevention and/or treatment of a disease selected from dyslipidemia, NAFLD and primary biliary cirrhosis.
20. A pharmaceutical preparation obtained by storing the pharmaceutical composition according to claim 8 in a tight package.
21. The pharmaceutical preparation according to claim 20 , wherein the tight package is one or more selected from the group consisting of a bottle package, an SP package, a PTP package, a pillow package and a stick package.