Extended release composition containing Tramadol
AssigneeGalephar Pharmaceutical Research, Inc.
InventorsArthur M. Deboeck, Francis Vanderbist, Antonio Sereno
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Abstract
The present invention relates to a once daily extended release pharmaceutical preparation of Tramadol or its acceptable pharmaceutical salts. The preparation provides, effective blood concentration for a period of about 24 hours with reduced peak concentrations. It is characterized that effective Tramadol levels appear within the first hours after administration, the time to maximal Tramadol content Tmax is at least 10 hours and the peak Tramadol concentration is less than three times the concentration obtained after 24 hours of said administration.
Claims22
Oral Tramadol pharmaceutical composition suitable for once daily administration comprising an effective amount of Tramadol or its pharmaceutically acceptable salts providing in vivo, a time of Tramadol peak plasma concentration (Tmax) greater than 10 hours and a peak Tramadol plasma concentrations (Cmax) which are less than three times the plasma concentration obtained 24 hours after administration (C24h) of a single dose of such composition.
Composition of claim 10 wherein said pharmaceutical composition comprises at least one individual unit from which about 80% of Tramadol is released within about 6 hours.
Composition of claim 10 wherein said pharmaceutical composition comprises at least one individual unit from which about 80% of Tramadol is released within 1 hour.
Composition of claim 13 wherein said pharmaceutical composition comprises layers containing Tramadol from which at least 80% of Tramadol is released within about 6 hours.
Composition of claim 13 wherein said pharmaceutical composition comprises layers containing Tramadol from which at least 80% of Tramadol is released within about 1 hour.
Composition of claim 16 wherein said rapid Tramadol plasma concentration rise occurs within about 0.5 to 3 hours after administration.
Composition of claim 16 wherein said rapid Tramadol plasma is less than the peak concentration (Cmax) measured between successive administration.
A composition of claim 22 useful for the post surgery pain control.
Dependencies are inferred from the claim text.