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US 8,137,734 B2Granted
Preparation of controlled release skeletal muscle relaxant dosage forms
AssigneeAptalis Pharmatech, Inc.
InventorsGopi M. Venkatesh, James M. Clevenger, Timothy Grinstead
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Abstract
The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.
Claims28
A method of preparing a pharmaceutical composition comprising:
- a) coating inert particles with a drug layering composition comprising cyclobenzaprine or a pharmaceutically acceptable salt, solvate, and/or ester thereof, and a pharmaceutically acceptable solvent, thereby forming IR beads;
- b) coating the IR beads with an ER coating composition comprising a pharmaceutically acceptable water-insoluble polymer, under an atmosphere having a dew point ranging from about 5-20° C., thereby forming ER beads;
- and
- c. curing the ER beads at about 60° C. for about 4-12 hours under an atmosphere having a dew point ranging from about 5-20° C.
1 more element
Dependencies are inferred from the claim text.