IP Library Granted Patent US 9,907,816
Granted Patent B2
US 9,907,816 · App. 14/603,084 · Granted Mar 6, 2018

Water-insoluble, iron-containing mixed metal, granular material

Inventors: Ruth Diane Pennell (Wirral, GB); Maurice Sydney Newton (Sandbacj, GB); James David Morrison (Norwich, GB); Alexis John Toft (Warrington, GB); Nigel Peter Rhodes (Warrington, GB)
Assignee: OPKO IRELAND GLOBAL HOLDINGS, LTD.
A61K33/06A61K9/16A61K9/1611A61K9/1635A61K9/1652A61K9/2077A61K9/2846A61K9/2866A61K33/24A61K33/26
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Quick Facts
Patent No.
US 9,907,816
App. No.
14/603,084
Granted
Mar 6, 2018
Kind
B2
Abstract

There is provided a granular material comprising (i) at least 50% by weight based on the weight of the granular material of solid water-insoluble mixed metal compound capable of binding phosphate of formula (I): M II 1-x .M III x (OH) 2 A n− y .zH 2 O (I) where M II is at least one of magnesium, calcium, lanthanum and cerium; M II is at least iron(III); A n is at least one n-valent anion; x=Σny, 0<x≦0.67, 0<y≦1, and 0≦z<10; (ii) from 3 to 12% by weight based on the weight of the granular material of non-chemically bound water, and (iii) no greater than 47% by weight based on the weight of the granular material of excipient.

Claims (33)

1. A dried granular material comprising granules, each granule comprising a mixture of

(i) at least 50% by weight based on the weight of the granule of solid water-insoluble inorganic mixed metal compound capable of binding phosphate and which contains iron (III) and at least one of magnesium, calcium, lanthanum or cerium, wherein the mixed metal compound is not hydrothermally treated,

(ii) an excipient, present in an amount no greater than 47% by weight based on the weight of the granule,

wherein at least 50% by weight of the granules of the granular material have a diameter of from 106 micrometers to 1180 micrometers.

2. The dried granular material of claim 1 wherein the mixed metal compound comprises a layered double hydroxide.

3. The dried granular material of claim 1 , wherein the mixed metal compound is of formula (I):

M II 1-x M III x (OH) 2 A n− y .z H 2 O  (I)

where M II is at least one of magnesium, calcium, lanthanum and cerium;

M III is at least iron(III);

M III is at least one n-valent anion; x=Σny; 0<x≦0.67, 0<y≦1, and 0≦z≦10.

4. The dried granular material of claim 1 wherein the mixed metal compound contains at least one of hydroxyl and carbonate ions and contains as the metals iron (III) and magnesium.

5. The dried granular material of claim 1 , wherein the excipient comprises a cross-linked disintegrant.

6. The dried granular material of claim 1 , wherein the granular material comprises from 5 to 20% by weight of pregelatinised starch as excipient based on the weight of the granule.

7. The dried granular material of claim 1 , comprising from 1 to 15% by weight of cross linked polyvinyl pyrrolidone as excipient based on the weight of the granule.

8. The dried granular material of claim 1 wherein the excipient comprises at least pregelatinised starch and crospovidone.

9. The dried granular material of claim 1 wherein at least 95% by weight of the granules of the granular material have a diameter less than 1180 micrometers.

10. A unit dose, comprising:

(i) at least 50% by weight based on the weight of the granule of solid water-insoluble inorganic mixed metal compound capable of binding phosphate and which contains iron (III) and at least one of magnesium, calcium, lanthanum or cerium,

(ii) an excipient, present in an amount no greater than 47% by weight based on the weight of the granule, wherein the mixed metal compound is not hydrothermally treated,

wherein the mixed metal compound has a weight mean particle diameter (d50) in a range of 1 to 20 micrometers.

11. The unit dose of claim 10 wherein the mixed metal compound comprises a layered double hydroxide.

12. The unit dose of claim 10 , wherein the mixed metal compound is of formula (I):

M II 1-x .M III x (OH) 2 A n− y .z H 2 O  (I)

where M II is at least one of magnesium, calcium, lanthanum and cerium;

M III is at least iron(III);

A n− is at least one n-valent anion; x=Σny; 0<x≦0.67, 0<y≦1, and 0≦z≦10.

13. The unit dose of claim 10 , wherein the mixed metal compound contains at least one of hydroxyl and carbonate ions and contains as the metals iron (III) and magnesium.

14. The unit dose of claim 10 , wherein the excipient comprises a cross-linked disintegrant.

15. The unit dose of claim 10 , wherein the granular material comprises from 5 to 20% by weight of pregelatinised starch as excipient based on the weight of the unit dose.

16. The unit dose of claim 10 , comprising from 1 to 15% by weight of cross linked polyvinyl pyrrolidone as excipient based on the weight of the unit dose.

17. The unit dose of claim 10 , wherein the excipient comprises at least pregelatinised starch and crospovidone.

18. The unit dose of claim 10 , further comprising from 3 to 10% by weight based on the weight of the unit dose of non-chemically bound water.

19. The unit dose of claim 10 , wherein the unit dose is capsule or a tablet.

Assignments (10)
CONFIRMATORY ASSIGNMENT Recorded May 6, 2021
From: OPKO IRELAND GLOBAL HOLDINGS, LTD.
To: EIRGEN PHARMA LTD.
Reel/Frame 056167/0196 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 29, 2015
From: PENNEL, RUTH DIANE; NEWTON, MAURICE SYDNEY; MORRISON, JAMES DAVID; RHODES, NIGEL PETER
To: INEOS HEALTHCARE LIMITED
Reel/Frame 036209/0596 →
CHANGE OF NAME Recorded Jul 29, 2015
From: JOSEPH CROSFIELD & SONS LIMITED
To: INEOS SILICAS LIMITED
Reel/Frame 036209/0772 →
NUNC PRO TUNC ASSIGNMENT Recorded Jul 29, 2015
From: INEOS SILICAS LIMITED
To: INEOS HEALTHCARE LIMITED
Reel/Frame 036209/0874 →
NUNC PRO TUNC ASSIGNMENT Recorded Jul 29, 2015
From: INEOS HEALTHCARE LIMITED
To: CYTOCHROMA DEVELOPMENT INC.
Reel/Frame 036209/0969 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 29, 2015
From: TOFT, ALEXIS JOHN
To: JOSEPH CROSFIELD & SONS LIMITED
Reel/Frame 036213/0949 →
CONFIRMATORY PATENT RIGHTS AGREEMENT Recorded Jul 29, 2015
From: CYTOCHROMA DEVELOPMENT INC.
To: CYTOCHROMA CAYMAN ISLANDS, LTD.
Reel/Frame 036214/0582 →
CONFIRMATORY PATENT RIGHTS AGREEMENT Recorded Jul 29, 2015
From: CYTOCHROMA CAYMAN ISLANDS, LTD.
To: OPKO IP HOLDINGS, INC.
Reel/Frame 036216/0056 →
CONFIRMATORY PATENT RIGHTS AGREEMENT Recorded Jul 29, 2015
From: OPKO IP HOLDINGS, INC.
To: OPKO HOLDINGS, INC.
Reel/Frame 036216/0224 →
CONFIRMATORY PATENT RIGHTS AGREEMENT Recorded Jul 29, 2015
From: OPKO HOLDINGS, INC.
To: OPKO IRELAND GLOBAL HOLDINGS, LTD.
Reel/Frame 036227/0134 →
Priority Claims (2)
GB 601899.8 · Jan 31, 2006 · national
GB 603984.6 · Feb 28, 2006 · national
Continuity (2)
Continuation 12162914
Related Publication 20150132407A1 · May 14, 2015