Claims for Patent: 11,013,761

Summary for Patent: 11,013,761

Title:	Pharmaceutical compositions
Abstract:	Pharmaceutical compositions for oral administration, in particular administration as an oral delivery system to be swallowed directly or capable of disintegration in the oral cavity, comprising iron oxy-hydroxide in high loading.
Inventor(s):	Weibel; Ludwig Daniel (Waldstatt, CH), Philipp; Erik (Arbon, CH)
Assignee:	VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD. (St. Gallen, CH)
Application Number:	17/150,529
Patent Claims:	1. A pharmaceutical composition comprising iron oxy-hydroxide, saccharose, and starch, wherein the total amount of iron oxy-hydroxide, saccharose, and starch is greater than 70% (w/w) expressed relative to the total weight of the composition, wherein the iron oxy-hydroxide is stabilized by at least saccharose and/or starch, wherein the composition is in a form of a chewable tablet, wherein the iron oxy-hydroxide is essentially non-bioabsorbable, and wherein the amount of iron oxy-hydroxide per tablet is 700 mg to 1700 mg. 2. The pharmaceutical composition according to claim 1, wherein the starch comprises native starch and pregelatinized starch. 3. The pharmaceutical composition according to claim 2, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 4. The pharmaceutical composition according to claim 1, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 5. The pharmaceutical composition according to claim 4, wherein the starch comprises native starch and pregelatinized starch. 6. The pharmaceutical composition according to claim 5, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 7. The pharmaceutical composition according to claim 1, wherein the iron oxy-hydroxide is present in an amount of about 30 to about 65% (w/w) expressed in relation to the total weight of the composition. 8. The pharmaceutical composition according to claim 7, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 9. The pharmaceutical composition according to claim 1, wherein the iron oxy-hydroxide is present in an amount of about 30 to about 35% (w/w) expressed in relation to the total weight of the composition. 10. The pharmaceutical composition according to claim 9, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 11. The pharmaceutical composition according to claim 1, wherein the iron oxy-hydroxide is present in an amount of about 27 to about 35% (w/w) expressed in relation to the total weight of the composition. 12. The pharmaceutical composition according to claim 11, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 13. The pharmaceutical composition according to claim 1, wherein the iron oxy-hydroxide is present in an amount of about 27 to about 32% (w/w) expressed in relation to the total weight of the composition. 14. The pharmaceutical composition according to claim 13, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 15. The pharmaceutical composition according to claim 1, wherein the iron oxy-hydroxide is present in an amount of about 29 to about 32% (w/w) expressed in relation to the total weight of the composition. 16. A pharmaceutical composition comprising iron oxy-hydroxide, saccharose, and starch, wherein the total amount of iron oxy-hydroxide, saccharose, and starch is greater than 70% (w/w) expressed relative to the total weight of the composition, wherein the iron oxy-hydroxide is stabilized by at least saccharose and/or starch, wherein the composition is in a form of a chewable tablet, wherein the iron oxy-hydroxide is essentially non-bioabsorbable, and wherein the amount of iron oxy-hydroxide per tablet is about 800 mg. 17. The pharmaceutical composition according to claim 16, wherein the starch comprises native starch and pregelatinized starch. 18. The pharmaceutical composition according to claim 17, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 19. The pharmaceutical composition according to claim 16, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 20. The pharmaceutical composition according to claim 19, wherein the starch comprises native starch and pregelatinized starch. 21. The pharmaceutical composition according to claim 20, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 22. The pharmaceutical composition according to claim 16, wherein the iron oxy-hydroxide is present in an amount of about 30 to about 65% (w/w) expressed in relation to the total weight of the composition. 23. The pharmaceutical composition according to claim 22, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 24. The pharmaceutical composition according to claim 16, wherein the iron oxy-hydroxide is present in an amount of about 30 to about 35% (w/w) expressed in relation to the total weight of the composition. 25. The pharmaceutical composition according to claim 24, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 26. The pharmaceutical composition according to claim 16, wherein the iron oxy-hydroxide is present in an amount of about 27 to about 35% (w/w) expressed in relation to the total weight of the composition. 27. The pharmaceutical composition according to claim 26, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 28. The pharmaceutical composition according to claim 16, wherein the iron oxy-hydroxide is present in an amount of about 27 to about 32% (w/w) expressed in relation to the total weight of the composition. 29. The pharmaceutical composition according to claim 28, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3, wherein samples were taken after 2 hours and iron content analyzed by titration. 30. The pharmaceutical composition according to claim 16, wherein the iron oxy-hydroxide is present in an amount of about 29 to about 32% (w/w) expressed in relation to the total weight of the composition.