Claims for Patent: 11,013,762

Summary for Patent: 11,013,762

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:	17/151,064
Patent Claims:	1. A pharmaceutical composition comprising iron oxy-hydroxide, saccharose, and starch, wherein the iron oxy-hydroxide is present in the amount of 10 to 80% (w/w) expressed in relation 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 suitable for oral administration, wherein the iron oxy-hydroxide is essentially non-bioabsorbable, and wherein the amount of iron oxy-hydroxide per dosage form is 300 mg to 2000 mg. 2. 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. 3. The pharmaceutical composition according to claim 1, wherein the starch comprises native starch and pregelatinized starch. 4. The pharmaceutical composition according to claim 3, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 5. The pharmaceutical composition according to claim 1, wherein the dosage form is capable of rapid disintegration in the oral cavity or in a small amount of liquid prior to ingestion. 6. The pharmaceutical composition according to claim 1, wherein the dosage form is chosen from chewable pills, granules, sachets containing granules, and stick packs containing granules. 7. The pharmaceutical composition according to claim 1, wherein the composition in the form of a tablet and wherein the amount of iron oxy-hydroxide per dosage form is about 400 mg. 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 7, wherein the starch comprises native starch and pregelatinized starch. 10. The pharmaceutical composition according to claim 6, wherein the amount of iron oxy-hydroxide per dosage form is 700 mg to 1700 mg. 11. The pharmaceutical composition according to claim 10, wherein the dosage form is chosen from sachets containing granules and stick packs containing granules. 12. The pharmaceutical composition according to claim 5, wherein the dosage form is chosen from dry powders and granules and wherein the amount of iron oxy-hydroxide per dosage form is about 400 mg. 13. The pharmaceutical composition according to claim 12, wherein the starch comprises native starch and pregelatinized starch. 14. The pharmaceutical composition according to claim 5, wherein the dosage form is chosen from chewable pills, granules, sachets containing granules, and stick packs containing granules. 15. The pharmaceutical composition according to claim 6, wherein the starch comprises native starch and pregelatinized starch. 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 50% (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 suitable for oral administration, wherein the iron oxy-hydroxide is essentially non-bioabsorbable, and wherein the amount of iron oxy-hydroxide per dosage form is 300 mg to 2000 mg. 17. 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. 18. The pharmaceutical composition according to claim 16, wherein the starch comprises native starch and pregelatinized starch. 19. The pharmaceutical composition according to claim 18, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 20. The pharmaceutical composition according to claim 16, wherein the dosage form is capable of rapid disintegration in the oral cavity or in a small amount of liquid prior to ingestion. 21. The pharmaceutical composition according to claim 16, wherein the dosage form is chosen from chewable pills, granules, sachets containing granules, and stick packs containing granules. 22. The pharmaceutical composition according to claim 16, wherein the composition in the form of a tablet and wherein the amount of iron oxy-hydroxide per dosage form is about 400 mg. 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 22, wherein the starch comprises native starch and pregelatinized starch. 25. The pharmaceutical composition according to claim 21, wherein the amount of iron oxy-hydroxide per dosage form is 700 mg to 1700 mg. 26. The pharmaceutical composition according to claim 25, wherein the dosage form is chosen from sachets containing granules and stick packs containing granules. 27. The pharmaceutical composition according to claim 20, wherein the dosage form is chosen from dry powders and granules and wherein the amount of iron oxy-hydroxide per dosage form is about 400 mg. 28. The pharmaceutical composition according to claim 20, wherein the dosage form is chosen from chewable pills, granules, sachets containing granules, and stick packs containing granules. 29. The pharmaceutical composition according to claim 28, wherein the starch comprises native starch and pregelatinized starch. 30. The pharmaceutical composition according to claim 21, wherein the starch comprises native starch and pregelatinized starch.