# US 8,784,902 B2 · Calcium carbonate granulation

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- Number: US 8,784,902 B2
- Document ID: US8784902B2
- Status: Granted
- Kind: B2
- Application number: 13/451,548
- Filed: 2012-04-20
- Published: 2012-08-23
- Granted: 2014-07-22
- Earliest claimed: 2003-07-31
- Assignees: Delavau LLC
- Applicants: Kevin W. Lang; James W. Dibble; Raya Levin; Gregory B. Murphy
- Inventors: Kevin W. Lang; James W. Dibble; Raya Levin; Gregory B. Murphy
- Web page: https://patentgrep.com/patent/US8784902B2

## CPC

- A61K 9/2095: {Tabletting processes}
- A23L 33/16: Inorganic salts, minerals or trace elements
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/1664: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/1617)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- A61K 9/2068: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/2013)}
- A61K 33/10: Carbonates; Bicarbonates
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 3/14: for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04)
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 19/10: for osteoporosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C01F 11/18: Carbonates
- Y10T 428/2982: Particulate matter [e.g., sphere, flake, etc.]
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C01F: COMPOUNDS OF THE METALS BERYLLIUM, MAGNESIUM, ALUMINIUM, CALCIUM, STRONTIUM, BARIUM, RADIUM, THORIUM, OR OF THE RARE-EARTH METALS (metal hydrides {monoborane, diborane or addition complexes thereof} C01B6/00; salts of oxyacids of halogens C01B11/00; peroxides, salts of peroxyacids C01B15/00; sulfides or polysulfides of magnesium, calcium, strontium, or barium C01B17/42; thiosulfates, dithionites, polythionates C01B17/64; compounds containing selenium or tellurium C01B19/00; binary compounds of nitrogen with metals C01B21/06; azides C01B21/08; {compounds other than ammonia or cyanogen containing nitrogen and non-metals and optionally metals C01B21/082; amides or imides of silicon C01B21/087}; metal {imides or} amides C01B21/092, {C01B21/0923}; nitrites C01B21/50; {compounds of noble gases C01B23/0005}; phosphides C01B25/08; salts of oxyacids of phosphorus C01B25/16; carbides C01B32/90; compounds containing silicon C01B33/00; compounds containing boron C01B35/00; compounds having molecular sieve properties but not having base-exchange properties C01B37/00; compounds having molecular sieve and base-exchange properties, e.g. crystalline zeolites, C01B39/00; cyanides C01C3/08; salts of cyanic acid C01C3/14; salts of cyanamide C01C3/16; thiocyanates C01C3/20; {double sulfates of magnesium with sodium or potassium C01D5/12; with other alkali metals C01D15/00, C01D17/00})
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

A calcium carbonate granulation for pharmaceutical or nutraceutical tabletting comprising USP or food grade calcium carbonate powder having a median particle diameter from about 0.1 μm to about 20 μm; maltodextrin having a dextrose equivalent of 9 to 12; and a disintegrant, said granulation being highly compactable and free flowing, having sufficient cohesive properties for compression into tablets, and having a tap density between about 0.9 and about 2.0 g/cm3.

### Claim 2 (depends on 1)

A calcium carbonate granulation according to claim 1, wherein the granulation has a tap density between about 1.0 and about 2.0 g/cm3.

### Claim 3 (depends on 2)

A calcium carbonate granulation according to claim 2, wherein the granulation has a tap density between about 1.1 and about 2.0 g/cm3.

### Claim 4 (depends on 3)

A calcium carbonate granulation according to claim 3, wherein the granulation has a tap density between about 1.25 and about 2.0 g/cm3.

### Claim 5 (depends on 1)

A calcium carbonate granulation according to claim 1 prepared by a wet granulation process wherein said calcium carbonate powder, maltodextrin and disintegrant are mixed with water under shear.

### Claim 6 (depends on 5)

A calcium carbonate granulation according to claim 5, wherein said mixing under shear is carried out with an impeller blade operating at from about 200 to about 300 rpm.

### Claim 7 (depends on 1)

A calcium carbonate granulation according to claim 1, wherein said granulation has a water content of less than about 1% by weight.

### Claim 8 (depends on 1)

A calcium carbonate granulation according to claim 1, wherein said granulation is prepared by a process comprising drying said granulation in a fluidized bed.

### Claim 9 (depends on 1)

A calcium carbonate granulation according to claim 1, wherein said maltodextrin comprises between about 2% and about 10% by weight of said granulation.

### Claim 10 (depends on 1)

A tablet comprising the calcium carbonate granulation of claim 1.

### Claim 11 (depends on 5)

A tablet comprising the calcium carbonate granulation of claim 5.

### Claim 12 (depends on 8)

A tablet comprising the calcium carbonate granulation of claim 8.

### Claim 13 (depends on 9)

A tablet comprising the calcium carbonate granulation of claim 9.

### Claim 14

A calcium carbonate granulation for pharmaceutical or nutraceutical tabletting comprising: USP or food grade calcium carbonate powder having a median particle diameter from about 0.1 μm to about 20 μm; and maltodextrin having a dextrose equivalent (DE) of 9 to 12; said granulation being highly compactable and free flowing, having sufficient cohesive properties for compression into tablets, and having a tap density between about 0.9 and about 2.0 g/cm3.

### Claim 15 (depends on 14)

A calcium carbonate granulation according to claim 14, wherein the granulation has a tap density between about 1.0 and about 2.0 g/cm3.

### Claim 16 (depends on 14)

A tablet comprising the calcium carbonate granulation of claim 14.