CA2534056A1 - Calcium carbonate granulation - Google Patents

Calcium carbonate granulation Download PDF

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Publication number
CA2534056A1
CA2534056A1 CA002534056A CA2534056A CA2534056A1 CA 2534056 A1 CA2534056 A1 CA 2534056A1 CA 002534056 A CA002534056 A CA 002534056A CA 2534056 A CA2534056 A CA 2534056A CA 2534056 A1 CA2534056 A1 CA 2534056A1
Authority
CA
Canada
Prior art keywords
composition
powdered
particle diameter
granulated
median particle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002534056A
Other languages
French (fr)
Other versions
CA2534056C (en
Inventor
Kevin W. Lang
James W. Dibble
Raya Levin
Gregory B. Murphy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ivd LLC
Original Assignee
Delavau L.L.C.
Kevin W. Lang
James W. Dibble
Raya Levin
Gregory B. Murphy
Ivd, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34104222&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2534056(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Delavau L.L.C., Kevin W. Lang, James W. Dibble, Raya Levin, Gregory B. Murphy, Ivd, Llc filed Critical Delavau L.L.C.
Priority to CA2716449A priority Critical patent/CA2716449C/en
Publication of CA2534056A1 publication Critical patent/CA2534056A1/en
Application granted granted Critical
Publication of CA2534056C publication Critical patent/CA2534056C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10—Carbonates; Bicarbonates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01F—COMPOUNDS OF THE METALS BERYLLIUM, MAGNESIUM, ALUMINIUM, CALCIUM, STRONTIUM, BARIUM, RADIUM, THORIUM, OR OF THE RARE-EARTH METALS
    • C01F11/00—Compounds of calcium, strontium, or barium
    • C01F11/18—Carbonates
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

Abstract

Highly compactable granulations and methods for preparing highly compactable granulations are disclosed. More particularly, highly compactable calcium carbonate granulations are disclosed. The granulations comprise powdered materials such as calcium carbonate that have small median particle sizes. T he disclosed granulations are useful in pharmaceutical and nutraceutical tableting and provide smaller tablet size upon compression than previously available.

Claims (26)

1. A granulated composition comprising calcium carbonate, said granulated composition having an average density between about 0.9 and about 2,0 g/cm3.
2. The granulated composition of claim 1 wherein the average density of said composition is between about 1.1 and about 2.0 g/cm3.
3. The granulated composition of claim 1 wherein the average density of said composition is between about 1.3 and about 2.0 g/cm3.
4. A granulated composition comprising:
i. a first powdered composition comprising a median particle diameter from about to about 25 µm; and ii. a second. powdered composition comprising a median particle diameter from about 0.1 to about 10 µm.
5. The granulated composition of claim 4 wherein at least one of said first and second powdered compositions comprise calcium carbonate.
6. The granulated composition of claim 4 wherein said first and second powdered compositions each comprise calcium carbonate.
7. The granulated composition of any of claims 4-6 wherein said first powdered composition comprises from about 50 to about 100 weight % of the granulated composition and said second powdered composition comprises from about 0 to about 50 weight %
of the granulated composition.
8. The granulated composition of any of claims 4-6 wherein said first powdered composition has a median particle diameter from about 12 to about 17 µm and said second powdered composition has a median particle diameter from about 1 to about 5 µm.
9. The granulated composition of any of claims 4-6 wherein said, first powdered composition has a median particle diameter of about 15 µm and said second powdered composition has a median particle diameter of about 4 µm.
10. A granulated composition comprising:
i. a first powdered composition having a median particle diameter.from about 10 to about 25 µm;
ii. a second powdered composition having a median particle diameter from about to about 10 µm; and iii. a third powdered composition having a median particle diameter from about 0.1 to about 1 µm.
11. The granulated composition of claim 10 wherein at least one of said first, second, and third powdered compositions comprises calcium carbonate.
12. The granulated composition of claim 10 wherein each of said first; seconds and third powdered compositions comprises calcium carbonate.
13. The granulated composition of any of claims 10-12 wherein said first powdered composition comprises from about 50 to about 100 weight % of the granulated composition, said second powdered composition comprises from about 10 to about 50 weight % of the granulated composition, and said third powdered composition comprises from about 0 to about 20 weight %
of the granulated composition.
14. The granulated composition of any of claims 10-12 wherein said first powdered composition has a median particle diameter from about 12 to about 17 µm;
said second powdered composition has a median particle diameter from about 1 to about 5 µm; and said third powdered composition has a median particle diameter from about 0.5 to about 1 µm.
15. The granulated composition of any of claims 10-12 wherein said first powdered composition has a median particle diameter of about 15 µm; said second powdered composition has a median particle diameter of about 10 µm; and said third, powdered composition has a median particle diameter of about 0.7 µm.
16. A granulated composition comprising calcium carbonate, said calcium carbonate having a median particle diameter between about 0.1 and about 20 µm.
17. The granulated composition of claim 16 wherein said calcium carbonate has a median particle diameter of about 1 µm or smaller.
18. The granulated composition of claim 16 wherein said calcium carbonate has a median particle diameter of about 3 to about 4 µm.
19. The granulated composition of claim 16 wherein said calcium carbonate has a median particle diameter of about 6 µm.
20. The granulated composition of claim 16 wherein said calcium carbonate has a median.
particle diameter of about 10 to about 12 µm.
21. The granulated composition of claim 16 wherein said calcium carbonate has a median particle diameter of about 15 µm.
22. A tablet comprising the granulated composition of any of claims 1, 4, 10 and 16.
23. A granulation process comprising the steps of: (1) mixing a composition in a high shear mixer; and (2) drying the composition in a flat bed oven.
24. The process according to claim 23 wherein said composition comprises calcium carbonate.
25. The process according to claim 23 wherein said flat bed oven is a horizontal fluidized bed oven.
26. A granulation process comprising the steps of: (1) mixing powdered calcium carbonate, maltodextrin and optionally additional excipients in a mixer capable of creating high shear; (2) adding water to the composition and mixing therewith; (3) adding oil to the composition and mixing therewith; and (4) drying the resulting composition in a convection drying oven.
CA2534056A 2003-07-31 2004-07-14 Calcium carbonate granulation Active CA2534056C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2716449A CA2716449C (en) 2003-07-31 2004-07-14 Calcium carbonate granulation

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/631,923 2003-07-31
US10/631,923 US7198653B2 (en) 2003-07-31 2003-07-31 Calcium carbonate granulation
PCT/US2004/022500 WO2005011570A2 (en) 2003-07-31 2004-07-14 Calcium carbonate granulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2716449A Division CA2716449C (en) 2003-07-31 2004-07-14 Calcium carbonate granulation

Publications (2)

Publication Number Publication Date
CA2534056A1 true CA2534056A1 (en) 2005-02-10
CA2534056C CA2534056C (en) 2012-06-26

Family

ID=34104222

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2534056A Active CA2534056C (en) 2003-07-31 2004-07-14 Calcium carbonate granulation
CA2716449A Active CA2716449C (en) 2003-07-31 2004-07-14 Calcium carbonate granulation
CA2769570A Abandoned CA2769570A1 (en) 2003-07-31 2004-07-14 Calcium carbonate granulation

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA2716449A Active CA2716449C (en) 2003-07-31 2004-07-14 Calcium carbonate granulation
CA2769570A Abandoned CA2769570A1 (en) 2003-07-31 2004-07-14 Calcium carbonate granulation

Country Status (9)

Country Link
US (28) US7198653B2 (en)
EP (2) EP2417977A1 (en)
JP (5) JP4742037B2 (en)
CN (2) CN100543427C (en)
AU (2) AU2004260652C1 (en)
CA (3) CA2534056C (en)
IL (2) IL173443A (en)
MX (1) MXPA06001260A (en)
WO (1) WO2005011570A2 (en)

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