Patent ID: 8895066

Claim:
A bilayer composition for the delivery of tramadol and acetaminophen, the bilayer composition comprising: a. a first layer defining a rapid release portion of the composition and comprising a first amount of acetaminophen; and b. a second layer defining a sustained release portion of the composition comprising a second amount of acetaminophen, tramadol, and a controlled release excipient selected from the group consisting of cross-linked high amylose starch, and hydroxypropylmethylcellulose, and a mixture thereof, wherein, when tested in a U.S.P. Type III Apparatus at 20 dips per minute at 37° C. in 250 mL of a solution of potassium phosphate monobasic pH 6.8 for one hour, after which the solution is removed and replaced with a fresh 250 mL of potassium phosphate monobasic pH 6.8 for eleven hours, the acetaminophen and tramadol are released with the following kinetics Time Acetaminophen Tramadol (hours) % release (by weight) % release (by weight) 1 30-60 ≦35 4 60-90 45-65 8 80-90 ≦90 12 ≧90 ≧90, and wherein a single bolus administration of the bilayer composition to a subject achieves (i) an effective plasma concentration of acetaminophen within about half an hour after initial administration, and (ii) effective plasma concentrations of acetaminophen and tramadol over a twelve hour period following initial administration.