Pharmaceutical composition, comprising phosphate binder particles
View Patent ↗The present invention relates to pharmaceutical composition, comprising certain phosphate binder particles having a certain particle size distribution, a process for the manufacture of the pharmaceutical composition and the use of sucroferric oxyhydroxide having a certain particle size distribution for the manufacture of a pharmaceutical composition.
1. A pharmaceutical composition for oral administration comprising:
sucroferric oxyhydroxide particles;
wherein at least 60% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm;
wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 40 μm to 80 μm;
wherein said pharmaceutical composition is in the form of a chewable tablet;
wherein the chewable tablet has a disintegration time of less than 30 minutes as measured according to the European Pharmacopoeia 04/2011:20901; and
wherein the weight of said chewable tablet is between 2000 mg and 3000 mg.
2. The pharmaceutical composition according to claim 1 , further comprising at least one pharmaceutically acceptable excipient, and wherein at least 60% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 5 μm to 160 μm.
3. The pharmaceutical composition according to claim 2 , wherein at least 80% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 5 μm to 160 μm.
4. The pharmaceutical composition according to claim 2 , wherein the hardness of the chewable tablet is between 80 to 200 N as measured according to the European Pharmacopoeia 01/2008:20908.
5. The pharmaceutical composition according to claim 2 , wherein the friability of the chewable tablet is between 0% to 7% as measured according to the European Pharmacopoeia 01/2010:20907.
6. The pharmaceutical composition according to claim 3 , wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 42 μm to 75 μm.
7. The pharmaceutical composition according to claim 4 , wherein the chewable tablet is formed by direct compression.
8. A pharmaceutical composition for oral administration comprising:
about 2500 mg of sucroferric oxyhydroxide particles;
wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 40 μm to 80 μm;
wherein said pharmaceutical composition is in the form of a chewable tablet; and
wherein the chewable tablet has a disintegration time of less than 30 minutes as measured according to the European Pharmacopoeia 04/2011:20901.
9. The pharmaceutical composition according to claim 8 , wherein the hardness of the chewable tablet is between 80 to 200 N as measured according to the European Pharmacopoeia 01/2008:20908.
10. The pharmaceutical composition according to claim 9 , wherein at least 60% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.
11. The pharmaceutical composition according to claim 9 , wherein at least 80% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.
12. The pharmaceutical composition according to claim 9 , wherein at least 90% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.
13. The pharmaceutical composition according claim 11 , wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 42 μm to 75 μm.
14. The pharmaceutical composition according to claim 11 , wherein said chewable tablet is a compressed tablet.
15. The pharmaceutical composition according to claim 13 , wherein said chewable tablet is formed by direct compression.
16. The pharmaceutical composition according to claim 11 , wherein the friability of the tablet is between 0% to 7% as measured according to the European Pharmacopoeia 01/2010:20907.
17. The pharmaceutical composition according to claim 11 , wherein the chewable tablet diameter is between 16 mm and 30 mm and the chewable tablet thickness is between 4.5 mm and 7.5 mm.
18. A pharmaceutical composition for oral administration comprising:
sucroferric oxyhydroxide particles;
wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 40 μm to 80 μm;
wherein said pharmaceutical composition is in the form of a chewable tablet;
wherein the weight of said chewable tablet is between 2000 mg and 3000 mg;
wherein the chewable tablet has a disintegration time of less than 30 minutes as measured according to the European Pharmacopoeia 04/2011:20901; and
wherein the sucroferric oxyhydroxide particles is more than 90% of the total weight of the chewable tablet (by weight on a dry weight basis).
19. The pharmaceutical composition according to claim 18 , wherein the hardness of the chewable tablet is between 80 to 200 N as measured according to the European Pharmacopoeia 01/2008:20908.
20. The pharmaceutical composition according to claim 19 , wherein at least 60% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.
21. The pharmaceutical composition according to claim 19 , wherein at least 80% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.
22. The pharmaceutical composition according to claim 21 , wherein at least 80% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 5 μm to 160 μm.
23. The pharmaceutical composition according claim 22 , wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 42 μm to 75 μm.
24. The pharmaceutical composition according to claim 23 , wherein said chewable tablet is a compressed tablet.
25. The pharmaceutical composition according to claim 23 , wherein said chewable tablet is formed by direct compression.
26. The pharmaceutical composition according to claim 23 , wherein the friability of the chewable tablet is between 0% to 7% as measured according to the European Pharmacopoeia 01/2010:20907.
27. The pharmaceutical composition according to claim 26 , wherein the chewable tablet diameter is between 16 mm and 30 mm and the chewable tablet thickness is between 4.5 mm and 7.5 mm.
28. The pharmaceutical composition according to claim 19 , wherein at least 90% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.
29. The pharmaceutical composition according to claim 27 , wherein at least 90% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm.