Calcium carbonate granulation
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.
1. A method for preparing a high density, highly compactable granulation comprising the steps of:
(a) mixing a composition comprising a powdered calcium carbonate having a median particle diameter of about 0.1 to about 20 μm, and additionally a material selected from the group consisting of dicalcium phosphate, calcium sulfate, ferrous sulfate, iron compounds, lactose, cellulose, micro-crystalline cellulose, kaolin, mannitol, maltodextrin, sodium chloride, starch, sugar, talc, silica, and combinations thereof, with water in a high shear mixer; and
(b) drying the composition in a horizontal fluidized bed oven;
thereby providing a high density, highly compactable granulation having a tap density between about 0.9 and about 2.0 g/cm 3 and that is free-flowing and has sufficient cohesive properties for compression into pharmaceutical or nutraceutical tablets.
2. A method according to claim 1 , wherein the high shear mixer operates at impeller speeds of from about 200 rpm to about 300 rpm.
3. A method according to claim 1 , wherein said drying step comprises heating the composition to a temperature of between about 50° C. to about 150° C.
4. The method of claim 1 wherein said material comprises dicalcium phosphate.
5. The method of claim 1 wherein said material comprises calcium sulfate.
6. The method of claim 1 wherein said material comprises ferrous sulfate.
7. The method of claim 1 wherein said material comprises lactose.
8. The method of claim 1 wherein said material comprises cellulose.
9. The method of claim 1 wherein said material comprises micro-crystalline cellulose.
10. The method of claim 1 wherein said material comprises kaolin.
11. The method of claim 1 wherein said material comprises mannitol.
12. The method of claim 1 wherein said material comprises sodium chloride.
13. The method of claim 1 wherein said material comprises starch.
14. The method of claim 1 wherein said material comprises sugar.
15. The method of claim 1 wherein said material comprises talc.
16. The method of claim 1 wherein said material comprises silica.
17. A method according to claim 1 , wherein the water is added to the high shear mixer as steam.
18. A method according to claim 1 , wherein the water is added to the high shear mixer in an amount of between about 5% and about 20% by weight of calcium carbonate.
19. The method of claim 1 wherein said powdered calcium carbonate has a median particle diameter between about 1 and about 15 μm.
20. A method according to claim 1 , wherein the water is heated before being added to the high shear mixer.
21. The method of claim 1 wherein said powdered calcium carbonate has a median particle diameter between about 10 μm and about 12 μm.
22. A method according to claim 1 , wherein said calcium carbonate is from a limestone source.
23. A method according to claim 1 , wherein the composition further comprises magnesium stearate.
24. The method of claim 1 further comprising adding to the composition an oil selected from the group consisting of canola oil, mineral oil, coconut oil, cotton seed oil, rape seed oil, sunflower seed oil, palm oil, vegetable oil and soy oil.
25. A method according to claim 24 , wherein the oil is sprayed onto the composition in the high shear mixer using a spray nozzle.