Opko Ireland Global Holdings, Limited

Cytochroma Development Inc.

Nigel Peter Rhodes

Maurice Sydney Newton

James David Morrison

Alexis John Toft

Richard Jonathan Applewhite

Ruth Diane Pennel

Christopher John Rickard

Ruth Diane Pennell

There is provided use of a mixed metal compound in the manufacture of medicament for neutralizing or buffering stomach acid, wherein the mixed metal compound contains at least one trivalent metal selected from iron (III) and aluminum and at least one divalent metal selected from of magnesium, iron, zinc, calcium, lanthanum and cerium, wherein (A) the mixed metal compound is of formula (I): MMOA.zHO (I) where Mis the at least one bivalent metal; Mis the at least one trivalent metal; Aat least one n-valent anion; 2+a=2b+&#x3a3;cn and &#x3a3;cn&#x3c;0.9a, and z is 2 or less, and/or (B) the mixed metal compound is provided in the form of a granular material comprising (i) at least 50% by weight, based on the weight of the granular material, of the mixed metal compound (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.

Mixed metal compounds used as antacids

The present invention relates to mixed metal compounds having pharmaceutical activity, especially as phosphate binders. It also extends to methods of manufacture of those compounds, as well as to pharmaceutical compositions containing such compounds. It further relates to their pharmaceutical use. In particular, the present invention relates to use of compounds of Formula (I): MMwherein M&#x2033; is at least one bivalent metal (i.e. with two positive charges); M1 is at least one trivalent metal (i.e. with three positive charges); and 1&#x3e;a&#x3e;0.4.

Mixed metal compounds for treatment of hyperphosphataemia

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.M(OH)A.zHO (I) where Mis at least one of magnesium, calcium, lanthanum and cerium; Mis at least iron(III); Ais at least one n-valent anion; x=&#x3a3;ny, 0&#x3c;x&#x2266;0.67, 0&#x3c;y&#x2266;1, and 0&#x2266;z&#x3c;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.

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

There is provided a method of producing a mixed metal compound comprising at least Mgand at least Fehaving an aluminium content of less than 10000 ppm, having an average crystal size of less than 20 nm (200 A) comprising the steps of: (a) combining a Mgsalt and a Fesalt with NaCOand NaOH to produce a slurry, wherein the pH of the slurry is maintained at from 9 5 to 1 1, and wherein the NaCOis provided at an excess of 0 to 4.0 moles than is required to complete the reaction (b) subjecting the slurry to mixing under conditions providing a power per unit volume of 0 03 to 1.6 kW/m(c) separating the mixed metal compound from the slurry, to obtain a crude product having a dry solid content of at least 10 wt % (d) drying the crude product either by (i) heating the crude product to a temperature of no greater than 150&#xb0; C. and sufficient to provide a water evaporation rate of 0.05 to 1 5 kg water per hour per kg of dry product, or (H) exposing the crude product to rapid drying at a water evaporation rate of 500 to 50000 kg water per hour per kg of dry product.

Method

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): MM(OH)A.ZHO (I) where Mis at least one of magnesium, calcium, lanthanum and cerium; Mis at least iron(III); Ais at least one n-valent anion; x=&#x3a3;ny; 0&#x3c;x&#x2266;0.67, 0&#x3c;y&#x2266;1, and 0&#x2266;z&#x3c;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.

There is provided a method of producing a mixed metal compound comprising at least Mgand at least Fehaving an aluminum content of less than 10000 ppm, having an average crystal size of less than 20 nm (200 A) comprising the steps of: (a) combining a Mgsalt and a Fesalt with NaCOand NaOH to produce a slurry, wherein the pH of the slurry is maintained at from 9 5 to 1 1, and wherein the NaCOis provided at an excess of 0 to 4.0 moles than is required to complete the reaction (b) subjecting the slurry to mixing under conditions providing a power per unit volume of 0 03 to 1.6 kW/m(c) separating the mixed metal compound from the slurry, to obtain a crude product having a dry solid content of at least 10 wt % (d) drying the crude product either by (i) heating the crude product to a temperature of no greater than 150&#xb0; C. and sufficient to provide a water evaporation rate of 0.05 to 1 5 kg water per hour per kg of dry product, or (H) exposing the crude product to rapid drying at a water evaporation rate of 500 to 50000 kg water per hour per kg of dry product.

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Warrington, United Kingdom

Nigel Peter Rhodes