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US 6,149,943 AGranted
Microcrystalline cellulose particles having active core
AssigneeMcNeil-PPC, Inc.
InventorsDaniel McTeigue, Indukumar G. Shah, Karen Swider, David W. Wynn
Life of this patent
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Abstract
The present invention provides a core of predominately microcrystalline cellulose, on which an active drug is layered onto the core via solution coating. The coated particles have a narrower particle size distribution than coated granules provided by other processes. An optional final coating of a pharmaceutically acceptable polymeric coating is provided to provide tastemaking or controlled release, and protection of the drug-layered particles.
Claims9
A particle comprising:
- a center core of greater than about 90 weight percent microcrystalline cellulose having an average particle size of about 160 to about 220 microns with a particle size standard deviation of from about 75 to about 200 microns;
- pharmaceutically active material coating the center core of microcrystalline cellulose and a tapped bulk density of from about 0.40 to about 0.45 grams per cubic centimeters;
- wherein the coated particle is from about 40 to about 75 weight percent microcrystalline cellulose;
- pharmaceutically active ingredient is from about 25 to about 60 weight percent;
- and a particle size of from about 200 to about 325 microns and a particle size standard deviation of from about 30 to about 175 microns.
2 more elements
A method for making a pharmaceutically active particle comprising:
- providing a center core of greater than about 90 weight percent microcrystalline cellulose having an average particle size of about 160 to about 220 microns with a particle size standard deviation of from about 75 to about 200 and a tapped bulk density of from about 0.40 to about 0.45 grams per cubic centimeters;
- coating said microcrystalline cellulose with a pharmaceutically active ingredient;
- wherein the coated particle is from about 40 to about 75 weight percent microcrystalline cellulose;
- the pharmaceutically active ingredient is from about 25 to about 60 weight percent;
- has a particle size of from about 200 to about 325 microns;
- a particle size standard deviation of from about 30 to about 175 microns;
- wherein the coating of the microcrystalline cellulose is performed in the absence of a granulation step.
4 more elements
Dependencies are inferred from the claim text.