Claims for Patent: 10,925,897

Summary for Patent: 10,925,897

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:	16/906,648
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 starch comprises native starch and pregelatinized starch, wherein the iron oxy-hydroxide is stabilized by at least saccharose, native starch, and/or pregelatinized starch, wherein the composition is in a form of a chewable tablet, wherein the iron oxy-hydroxide comprises beta iron oxy-hydroxide, 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 composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 3. The pharmaceutical composition according to claim 1 further comprising at least one additional component chosen from flavouring agents, glidants, and superdisintegrants, wherein the flavouring agents, if present, is/are present in an amount of 0.1 to 1% (w/w) expressed in relation to the total weight of the composition, wherein the glidants, if present, is/are chosen from magnesium stearate, colloidal silica, pyrogenic silica, hydrated sodium silicoaluminate, colloidal silicon dioxide, and talcum, wherein the glidants, if present, is/are present in an amount of 0.1 to 5% (w/w) expressed in relation to the total weight of the composition, wherein the superdisintegrants, if present, is/are chosen from cross-linked polyvinylpyrrolidones, modified starches, and modified cellulose, and wherein the superdisintegrants, if present, is/are present in an amount of 0.5 to 8% (w/w) expressed in relation to the total weight of the composition. 4. 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. 5. The pharmaceutical composition according to claim 4, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 accordingto European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 6. 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. 7. The pharmaceutical composition according to claim 6, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 8. 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. 9. The pharmaceutical composition according to claim 8, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 10. 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. 11. The pharmaceutical composition according to claim 10, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 12. 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. 13. The pharmaceutical composition according to claim 1, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 10:1 to 0.5:1. 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 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 15. The pharmaceutical composition according to claim 13, 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. 16. The pharmaceutical composition according to claim 15, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 17. The pharmaceutical composition according to claim 13, 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. 18. The pharmaceutical composition according to claim 17, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 19. The pharmaceutical composition according to claim 13, 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. 20. The pharmaceutical composition according to claim 19, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 21. The pharmaceutical composition according to claim 13, 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. 22. The pharmaceutical composition according to claim 21, wherein the composition has an iron release rate of below 2.5% w/w as measured in water at a pH of 3 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 23. The pharmaceutical composition according to claim 13, 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. 24. The pharmaceutical composition according to claim 1, wherein native starch and pregelatinized starch are present in a ratio (native:pregelatinized) in the range of 2:1 to 1:1. 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 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 26. The pharmaceutical composition according to claim 24, 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. 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 according to European Pharmacopoeia Chapter 2.9.3, wherein samples were taken after 2 hours and iron content analyzed by titration. 28. The pharmaceutical composition according to claim 24, 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. 29. The pharmaceutical composition according to claim 24, 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. 30. The pharmaceutical composition according to claim 24, 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.