A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/135 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01)
Patent
CA 2295790
This invention relates to a process for the production of an oral, controlled release preparation of tramadol or a physiologically compatible salt of tramadol having a storage stable active substance release profile by coating the active substance preparation with an aqueous ethylcellulose dispersion which contains at least one physiologically compatible, lipophilic diester of a C6-C40 aliphatic or aromatic dicarboxylic acid and a C1-C8 aliphatic alcohol as plasticiser, and, during coating, drying the coating at conventional temperatures, wherein a storage stable active substance release profile is obtained even without subsequent heat treatment, and, in order to increase the active substance release profile without impairing the storage stability thereof, optionally performing heat treatment at temperatures of >35°C until the desired, increased active substance release profile is achieved.
Bartholomaus Johannes Heinrich
Ziegler Iris
Fetherstonhaugh & Co.
Grunenthal Gmbh
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