Calcium Carbonate Granulation

• US 20070178154A1
• Filed: 02/15/2007
• Published: 08/02/2007
• Est. Priority Date: 07/31/2003
• Status: Active Grant

• Current Assignee: IVD LLC
• Original Assignee: Delavau LLC (Lesaffre & Co. SA)
• Inventors: Levin, Raya, Lang, Kevin, Murphy, Gregory, Dibble, James
• Granted Patent: US 7,695,528 B2
• Time in Patent Office: Days
• US Class Current: 424/464
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A61K 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/1664 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/1617
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/2059 Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
• CPC Class Codes: A61K 9/2068 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/2013
• CPC Class Codes: A61K 9/2095 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 mechanical aspects A61J3/00
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 19/10 for osteoporosis
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/14 for calcium homeostasis vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: C01F 11/18 Carbonates
• CPC Class Codes: Y10T 428/2982 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. The disclosed granulations are useful in pharmaceutical and nutraceutical tableting and provide smaller tablet sizes upon compression than previously available.

Claims

1. A process for preparing a calcium carbonate granulation comprising the steps of:

(a) mixing, in a mixer capable of creating high shear, a composition comprising;

(i) calcium carbonate powder having a median particle diameter between about 0.1 to about 20 μ

m;

(ii) water; and

(iii) one or more excipients selected from the group consisting of diluents, binders, glidants, lubricants, disintegrants, colors, flavors, sweeteners, solubility retarding agents, and combinations thereof; and

(b) drying the composition to a water content of less than about 1% by weight in a drier selected from the group consisting of a tray dryer, a vertical fluidized bed oven, a horizontal fluidized bed oven, a spray dryer, and an impingement oven;

to provide a calcium carbonate granulation.

2. The process of claim 1 wherein said calcium carbonate powder has a median particle diameter between about 1 to about 15 μ

m.

3. The process of claim 2 wherein said calcium carbonate powder has a median particle diameter between about 3 to about 4 μ

m.

4. The process of claim 2 wherein said calcium carbonate powder has a median particle diameter of about 6 μ

m.

5. The process of claim 2 wherein said calcium carbonate powder has a median particle diameter between about 10 to about 12 μ

m.

6. The process of claim 5 wherein said calcium carbonate powder has a median particle diameter of about 12 μ

m.

7. The process of claim 6 wherein said calcium carbonate powder has a particle size distribution wherein at least about 50% of the bulk volume of the powder has a particle size between 4 and 20 microns and at least about 30% of the bulk volume of the powder has a particle size between about 8 and 16 microns.

8. The process of claim 6 wherein said calcium carbonate powder has a particle size distribution broader than a distribution wherein at least about 50% of the bulk volume of the powder has a particle size between 4 and 20 microns and at least about 30% of the bulk volume of the powder has a particle size between about 8 and 16 microns.

9. The process of claim 2 wherein said calcium carbonate powder has a median particle size of about 15 μ

m.

10. The process of claim 1, wherein said drier is a tray dryer.

11. The process of claim 1, wherein said drier is a vertical fluidized bed oven.

12. The process of claim 1, wherein said drier is a horizontal fluidized bed oven.

13. The process of claim 1, wherein said drier is a spray dryer.

14. The process of claim 1, wherein said drier is an impingement oven.

15. The process of claim 1, wherein said mixer capable of creating high shear is a high shear mixer.

16. The process of claim 1, wherein said composition comprises between about 5 to about 20% by weight water based on the weight of said calcium carbonate powder.

17. The process of claim 1, wherein the tap density of said calcium carbonate granulation is between about 0.9 and about 2.0 g/cm³.

18. The process of claim 1, wherein the tap density of said calcium carbonate granulation is between about 1.1 and about 2.0 g/cm³.

19. The process of claim 1, wherein the tap density of said calcium carbonate granulation is between about 1.3 and about 2.0 g/cm³.

20. The process of claim 1, wherein said composition includes a binder.

21. The process of claim 20, wherein said binder includes maltodextrin.

22. The process of claim 21, wherein said maltodextrin comprises from about 2 to about 10% by weight of said calcium carbonate granulation.

23. The process of claim 1, wherein said composition includes oil.

24. The process of claim 23, wherein said oil comprises from about 0.1 to about 1% by weight of said calcium carbonate granulation.

25. The process of claim 1, wherein said composition includes gum acacia.