Granular material comprising water-insoluble inorganic phosphate binders

A phosphate, soluble technology, applied to the particles of mixed metal compounds, the field of manufacturing the particles

Active Publication Date: 2009-03-04
CYTOCHROMA DEV
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In part, these problems arise from the fact that consi

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  • Granular material comprising water-insoluble inorganic phosphate binders
  • Granular material comprising water-insoluble inorganic phosphate binders

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[0209] The phosphate binder used in the following examples was formed by reacting aqueous solutions of magnesium sulfate and iron sulfate in the presence of sodium hydroxide and sodium carbonate. The synthesis reaction is described by the following formula: 4MgSO 4 +Fe 2 (SO 4 ) 3 +12NaOH+Na 2 CO 3 →Mg 4 Fe 2 (OH) 12 · CO 3 ·nH 2 O+7Na 2 SO 4 . Precipitation was performed at ambient temperature (15 to 25° C.) at about pH 10.3. Filtration, washing, drying, grinding and sieving of the formed precipitate were carried out successively, through which all materials were smaller than 106 microns. The chemical formula of this phosphate binder is Mg 4 Fe 2 (OH) 12 · CO 3 ·nH 2 O, and has the following XRF composition: MgO = 29.0%, Fe 2 o 3 =28.7%, Mg:Fe molar ratio=2:1. The XRF values ​​take into account any water present in the phosphate binder. XRD showed that the phosphate binder was characterized by the presence of a poorly crystalline hydrotalcite type struct...

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Abstract

The present invention provides a grainy material which comprises the following components: (i) at least 50wt% of solid water-insoluble mixed metal compound when the weight of the grainy material is taken as a reference, the mixed metal compound can combine with microcosmic salt of the formula (I): M<II>1-xM<II>x(OH)2A<n->y*zH2O (I), in the formula M<II> is magnesium, calcium, lanthanum and cerium; M<III> is iron at least; A<n-> is at least one n-valence anion; x is the summation of ny; 0<x<=0.67, 0<y<=1, and 0<=z<=10; (ii) non chemically combining water between 3 to 12wt% of the weight of the grainy material is taken as a reference; and (iii) excipient no larger than 47wt% of the weight of the grainy material is taken as a reference.

Description

technical field [0001] The present invention relates to particles containing water-insoluble inorganic solids, in particular pharmaceutically active mixed metal compounds as phosphate binders. The invention also relates to a process for the manufacture of the granules and their use in unit doses for oral administration. Background technique [0002] Various diseases can lead to high phosphate concentrations in the blood of animals, especially warm-blooded animals such as humans. It can lead to many physiological problems, such as the deposition of calcium phosphate. [0003] In patients with renal failure who are being treated with conventional hemodialysis, plasma phosphate concentrations are markedly elevated, and this condition, known as hyperphosphatasemia, can lead to deposition of calcium phosphate in soft tissues. Plasma phosphate levels can be reduced by oral administration of inorganic and organic phosphate binders. [0004] Classes of inorganic solid phosphate b...

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K9/28A61K33/06A61K33/24A61K33/26A61K45/06A61P7/00C01G49/00C01F7/00
CPCA61K9/16A61K9/1611A61K9/1635A61K9/1652A61K9/2077A61K9/2846A61K9/2866A61K33/06A61K33/24A61K33/26
Inventor R·D·潘尼尔M·S·牛顿J·D·莫里森A·J·托弗特N·P·罗迪斯
Owner CYTOCHROMA DEV
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