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NZ740931B2 - Extended use zirconium silicate compositions and methods of use thereof - Google Patents
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NZ740931B2 - Extended use zirconium silicate compositions and methods of use thereof - Google Patents

Extended use zirconium silicate compositions and methods of use thereof Download PDF

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Publication number
NZ740931B2
NZ740931B2 NZ740931A NZ74093116A NZ740931B2 NZ 740931 B2 NZ740931 B2 NZ 740931B2 NZ 740931 A NZ740931 A NZ 740931A NZ 74093116 A NZ74093116 A NZ 74093116A NZ 740931 B2 NZ740931 B2 NZ 740931B2
Authority
NZ
New Zealand
Prior art keywords
composition
less
ion
value
zirconium silicate
Prior art date
Application number
NZ740931A
Other versions
NZ740931A (en
Inventor
Alvaro F Guillem
Donald Jeffrey Keyser
Original Assignee
Zs Pharma Inc
Filing date
Publication date
Priority claimed from US14/883,428 external-priority patent/US9592253B1/en
Application filed by Zs Pharma Inc filed Critical Zs Pharma Inc
Publication of NZ740931A publication Critical patent/NZ740931A/en
Publication of NZ740931B2 publication Critical patent/NZ740931B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J39/00Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/02Processes using inorganic exchangers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J39/00Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/08Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
    • B01J39/14Base exchange silicates, e.g. zeolites
    • CCHEMISTRY; METALLURGY
    • C01INORGANIC CHEMISTRY
    • C01BNON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B39/00Compounds having molecular sieve and base-exchange properties, e.g. crystalline zeolites; Their preparation; After-treatment, e.g. ion-exchange or dealumination
    • C01B39/02Crystalline aluminosilicate zeolites; Isomorphous compounds thereof; Direct preparation thereof; Preparation thereof starting from a reaction mixture containing a crystalline zeolite of another type, or from preformed reactants; After-treatment thereof
    • CCHEMISTRY; METALLURGY
    • C01INORGANIC CHEMISTRY
    • C01BNON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B39/00Compounds having molecular sieve and base-exchange properties, e.g. crystalline zeolites; Their preparation; After-treatment, e.g. ion-exchange or dealumination
    • C01B39/02Crystalline aluminosilicate zeolites; Isomorphous compounds thereof; Direct preparation thereof; Preparation thereof starting from a reaction mixture containing a crystalline zeolite of another type, or from preformed reactants; After-treatment thereof
    • C01B39/06Preparation of isomorphous zeolites characterised by measures to replace the aluminium or silicon atoms in the lattice framework by atoms of other elements, i.e. by direct or secondary synthesis
    • C01B39/08Preparation of isomorphous zeolites characterised by measures to replace the aluminium or silicon atoms in the lattice framework by atoms of other elements, i.e. by direct or secondary synthesis the aluminium atoms being wholly replaced
    • C01B39/085Group IVB- metallosilicates
    • CCHEMISTRY; METALLURGY
    • C01INORGANIC CHEMISTRY
    • C01PINDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS
    • C01P2002/00Crystal-structural characteristics
    • C01P2002/70Crystal-structural characteristics defined by measured X-ray, neutron or electron diffraction data
    • C01P2002/72Crystal-structural characteristics defined by measured X-ray, neutron or electron diffraction data by d-values or two theta-values, e.g. as X-ray diagram
    • CCHEMISTRY; METALLURGY
    • C01INORGANIC CHEMISTRY
    • C01PINDEXING SCHEME RELATING TO STRUCTURAL AND PHYSICAL ASPECTS OF SOLID INORGANIC COMPOUNDS
    • C01P2004/00Particle morphology
    • C01P2004/60Particles characterised by their size
    • C01P2004/61Micrometer sized, i.e. from 1-100 micrometer
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07FACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F7/00Compounds containing elements of Groups 4 or 14 of the Periodic Table
    • C07F7/02Silicon compounds

Abstract

The present invention relates to zirconium silicate compositions having a lead content that is below 0.6 ppm and methods of manufacturing zirconium silicate at reactor volumes exceeding 200-L with a lead content below 1.1 ppm. The lead content of the zirconium silicate of this invention are within the levels that are considered acceptable for extended use given the dose requirements for zirconium silicate.

Claims (12)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. A cation exchange composition comprising a zirconium silicate of formula (I): A M Zr Si Ge O (I) p x 1-x n y m where A is a potassium ion, sodium ion, rubidium ion, cesium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof, M is at least one framework metal, wherein the framework metal is hafnium (4+), tin (4+), niobium (5+), titanium (4+), cerium (4+), germanium (4+), praseodymium (4+), terbium (4+) or mixtures thereof, "p" has a value from about 1 to 20, "x" has a value from 0 to less than 1, "n" has a value wherein 0 < n = 12, "y" has a value from 0 to 12, "m" has a value from 3 to 36 and 1 = n + y = 12, wherein the zirconium silicate is predominately ZS-9 and exhibits a lead content below 0.6 ppm, and has a potassium loading capacity between 2.7 and 3.7 mEq/g.
2. The composition of claim 1, wherein the lead content ranges from 0.1 to 0.5 ppm.
3. The composition of claim 1, wherein the lead content ranges from 0.3 to 0.5 ppm.
4. The composition of claim 1, wherein the lead content ranges from 0.3 to 0.45
5. The composition of claim 1, wherein less than 7 volume% of the particles in the composition have a diameter less than 3 microns.
6. The composition of claim 1, wherein less than 0.5 volume% of the particles in the composition have a diameter less than 1 microns.
7. The composition of claim 1, wherein less than 7 volume% of the particles in the composition have a diameter less than 3 microns, and the sodium content is below 12 wt%.
8. The composition of claim 1, wherein less than 7 volume% of the particles in the composition have a diameter less than 3 microns, and the sodium content is 9 wt% or less.
9. The composition of claim 1, wherein the composition exhibits an XRD diffractogram generated using a copper K-alpha radiation source having the two highest peaks occur at approximately 15.5 and 28.9 2-theta, with the highest peak occurring at 28.9 2-theta.
10. The composition of claim 1, wherein the pH ranges from 7 to 9.
11. The composition of claim 1, wherein the potassium loading capacity is approximately 3.5 mEq/g.
12. Use of a composition according to any one of claims 1 to 11 in the preparation of a medicament for the treatment of hyperkalemia.
NZ740931A 2016-10-10 Extended use zirconium silicate compositions and methods of use thereof NZ740931B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/883,428 US9592253B1 (en) 2015-10-14 2015-10-14 Extended use zirconium silicate compositions and methods of use thereof
PCT/US2016/056286 WO2017066128A1 (en) 2015-10-14 2016-10-10 Extended use zirconium silicate compositions and methods of use thereof

Publications (2)

Publication Number Publication Date
NZ740931A NZ740931A (en) 2024-12-20
NZ740931B2 true NZ740931B2 (en) 2025-03-21

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