Method of tizanidine therapy

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.

We claim:  
     
         1 . A method of reducing somnolence in a patient receiving tizanidine therapy comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food.  
     
     
         2 . The method of  claim 1  wherein the therapeutically effective amount is 0.5 mg to 12 mg.  
     
     
         3 . The method of  claim 1  wherein the therapeutically effective amount is 2 mg to 8 mg.  
     
     
         4 . The method of  claim 1  wherein the administration to the patient occurs between 30 minutes prior to 2 hours after consuming food.  
     
     
         5 . The method of  claim 1  wherein the administration to the patient is substantially at the same time as the consumption of the food.  
     
     
         6 . The method of  claim 1  wherein the administration to the patient is immediately after the consumption of food up to 1 hour after said consumption.  
     
     
         7 . The method of  claim 1  wherein the immediate release multiparticulate formulation comprises a multiparticulate form of tizanidine on beads.  
     
     
         8 . The method of  claim 7  wherein the immediate release multiparticulate formulation is in unit dosage form.  
     
     
         9 . The method of  claim 8  wherein the unit dosage form contains from 2 to 6 milligrams of tizanidine  
     
     
         10 . A method of reducing the peak plasma concentration from an oral dosage form of tizanidine in a patient in need of a therapeutic effect thereof comprising administering to the patient a therapeutically effective amount of tizanidine in an immediate release multiparticulate pharmaceutical composition with food.  
     
     
         11 . The method of  claim 10  wherein the therapeutically effective amount is about 0.5 mg to about 12 mg.  
     
     
         12 . The method of  claim 10  wherein the therapeutically effective amount is from about 2 mg to about 8 mg.  
     
     
         13 . The method of  claim 10  wherein the administration to the patient occurs between about 30 minutes prior to about 2 hours after consuming food.  
     
     
         14 . The method of  claim 10  wherein the administration to the patient is substantially at the same time as the consumption of the food.  
     
     
         15 . The method of  claim 10  wherein the administration to the patient is immediately after the consumption of food up to about one hour after said consumption.  
     
     
         16 . The method of  claim 10  wherein the immediate release multiparticulate formulation comprises a multiparticulate form of tizanidine on beads.  
     
     
         17 . The method of  claim 16  wherein the immediate release multiparticulate formulation is in unit dosage form.  
     
     
         18 . The method of  claim 17  wherein the unit dosage form contains from 2 to 6 milligrams of tizanidine  
     
     
         19 . An item of manufacture comprising a container containing an immediate release pharmaceutical composition of tizanidine or a pharmaceutically acceptable salt thereof, wherein the container is associated with printed labeling advising that an immediate release tablet composition has less somnolence associated with its use if taken on an empty stomach and an immediate release multiparticulate composition has less somnolence associated with its use if taken with food.  
     
     
         20 . The item of manufacture of  claim 19  wherein the pharmaceutical composition is a tablet unit dosage form containing tizanidine hydrochloride.  
     
     
         21 . The item of manufacture of  claim 19  wherein the pharmaceutical composition is an immediate release multiparticulate unit dosage form containing tizanidine hydrochloride.  
     
     
         22 . An item of manufacture comprising a container containing an immediate release pharmaceutical composition of tizanidine or a pharmaceutically acceptable salt thereof, wherein the container is associated with printed labeling advising that an immediate release tablet composition has less somnolence associated with its use if taken on an empty stomach.  
     
     
         23 . The item of manufacture of  claim 22  wherein the pharmaceutical composition is a tablet unit dosage form containing tizanidine hydrochloride.  
     
     
         24 . The item of manufacture of  claim 22  wherein the pharmaceutical composition is an immediate release multiparticulate unit dosage form containing tizanidine hydrochloride.  
     
     
         25 . An item of manufacture comprising a container containing an immediate release pharmaceutical composition of tizanidine or a pharmaceutically acceptable salt thereof, wherein the container is associated with printed labeling advising that an immediate release multiparticulate composition has less somnolence associated with its use if taken with food.  
     
     
         26 . The item of manufacture of  claim 25  wherein the immediate release pharmaceutical composition is a tablet unit dosage form containing tizanidine hydrochloride.  
     
     
         27 . The item of manufacture of  claim 25  wherein the immediate release pharmaceutical composition is an immediate release multiparticulate unit dosage form containing tizanidine hydrochloride.  
     
     
         28 . An immediate release multiparticulate pharmaceutical composition comprising a therapeutic amount of tizanidine in multiparticulate form, wherein the immediate release multiparticulate dosage form has less somnolence associated with its use if taken with food than an immediate release tablet formulation of same dosage strength taken with food.  
     
     
         29 . The immediate release multiparticulate pharmaceutical composition of  claim 28 , wherein the multiparticulate form of tizanidine is beads.  
     
     
         30 . The immediate release multiparticulate pharmaceutical composition of  claim 28 , wherein the potency of the multiparticulate form has a potency of between 5 and 100 mg tizanidine per gram of multiparticulates.  
     
     
         31 . The immediate release multiparticulate pharmaceutical composition of  claim 29 , wherein the potency of the multiparticulate form is between 10 and 40 mg tizanidine per gram of multiparticulates.  
     
     
         32 . The immediate release multiparticulate pharmaceutical composition of  claim 30 , wherein the potency of the multiparticulate form is between 20 and 30 mg tizanidine per gram of multiparticulates.  
     
     
         33 . The immediate release multiparticulate pharmaceutical composition of  claim 28 , wherein the therapeutically effective amount is 0.5 mg to 12 mg.  
     
     
         34 . The immediate release multiparticulate pharmaceutical composition of  claim 33 , wherein the therapeutically effective amount is 2 mg to 8 mg.  
     
     
         35 . The immediate release multiparticulate pharmaceutical composition of  claim 28 , wherein the therapeutic amount of tizanidine in multiparticulate form is present in a capsule.