Method of reducing somnolence in patients treated with tizanidine

Abstract

An article and method for reducing somnolence in a patient receiving tizanidine therapy. Tizanidine may be administered in the form of an immediate release multiparticulate composition at or around the time food is consumed. The composition may be packaged in a container for distribution.

1 - 35 . (canceled) 
     
     
         36 . An immediate release multiparticulate tizanidine oral dosage formulation, said formulation comprising:
 a plurality of particles comprising from 2 mg to 12 mg of tizanidine, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient,   wherein said particles comprise immediate release beads comprising tizanidine layered over non-pareil seeds.   
     
     
         37 . The formulation according to  claim 36 , wherein said formulation has less somnolence associated with its use if taken with food than an immediate release tablet formulation of a same dosage strength taken with food. 
     
     
         38 . The formulation according to  claim 36 , wherein said formulation comprises from 4 mg to 8 mg of tizanidine. 
     
     
         39 . The formulation according to  claim 36 , wherein said formulation comprises from 2 mg to 6 mg of tizanidine. 
     
     
         40 . The formulation according to  claim 36 , wherein following administration in a fed state, said formulation produces a peak plasma tizanidine concentration earlier than about 4 hours from administration. 
     
     
         41 . The formulation according to  claim 40 , wherein administration occurs between 30 minutes prior to and 2 hours after consuming food. 
     
     
         42 . The formulation according to  claim 41 , wherein the administration to the patient is substantially at the same time as the consumption of the food. 
     
     
         43 . The formulation according to  claim 41 , wherein the administration to the patient is immediately after the consumption of food up to 1 hour after said consumption. 
     
     
         44 . The formulation according to  claim 36 , wherein administration of said formulation with food produces a peak plasma tizanidine concentration of from 4.32 to 4.82 ng/mL. 
     
     
         45 . The formulation according to  claim 36 , wherein said formulation has a potency of between 5 and 100 mg tizanidine per gram of multiparticulates. 
     
     
         46 . The formulation according to  claim 36 , wherein said formulation has a potency of between 10 and 40 mg tizanidine per gram of multiparticulates. 
     
     
         47 . The formulation according to  claim 36 , wherein said formulation has a potency of between 20 and 30 mg tizanidine per gram of multiparticulates. 
     
     
         48 . The formulation according to  claim 36 , wherein said formulation is in a capsule. 
     
     
         49 . The formulation according to  claim 36 , wherein all of the tizanidine is released from the dosage formulation in less than 60 minutes. 
     
     
         50 . The formulation according to  claim 36 , wherein at least 75% of the tizanidine is released from the dosage formulation in less than 60 minutes. 
     
     
         51 . The formulation according to  claim 50 , wherein at least 75% of the tizanidine is released from the dosage formulation in 30 minutes. 
     
     
         52 . The formulation according to  claim 36 , wherein the pharmaceutically acceptable excipient is chosen from inorganic carriers and organic carriers. 
     
     
         53 . The formulation according to  claim 52 , wherein the pharmaceutically acceptable excipient comprises at least one excipient chosen from sugar spheres, diluents, hydrophilic polymers, lubricants, plasticizers, binders, disintegrants, surfactants, and pH-modifiers. 
     
     
         54 . The formulation according to  claim 53 , wherein the pharmaceutically acceptable excipient comprises at least one lubricant and at least one binder.