Modified release dosage forms of skeletal muscle relaxants

Abstract

A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once—daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

What is claimed is: 
     
         1 - 22 . canceled 
     
     
         23 . A dosage form comprising a plurality of active-containing particles comprising 15 or 30 mg of cyclobenzaprine hydrochloride and a dissolution rate controlling polymer granulated together,
 wherein the dissolution rate controlling polymer is selected from the group consisting of ethers of cellulose and esters of cellulose;   wherein the dosage form provides a therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions.   
     
     
         24 . The dosage form of  claim 23 , wherein the particles are selected from the group consisting of pellets, beads, granules, and mini-tablets. 
     
     
         25 . The dosage form of  claim 23 , wherein the particles are pellets. 
     
     
         26 . The dosage form of  claim 23 , wherein the particles are beads. 
     
     
         27 . The dosage form of  claim 23 , wherein the particles are granules. 
     
     
         28 . The dosage form of  claim 23 , wherein the particles are mini-tablets. 
     
     
         29 . The dosage form of  claim 23 , wherein the pharmaceutical dosage form provides an AUC 0-168  within the range of about 80% to 125% of about 740 ng·hr/mL following oral administration of a single 30 mg cyclobenzaprine hydrochloride dose. 
     
     
         30 . The dosage form of  claim 23 , wherein said pharmaceutical dosage form provides a T max  within the range of 80% to 125% of about 7 hours following oral administration of a single 30 mg cyclobenzaprine hydrochloride dose. 
     
     
         31 . The dosage form of  claim 28 , wherein the pharmaceutical dosage form provides a maximum blood plasma concentration (C max ) within the range of about 80% to 125% of about 20 ng/mL of cyclobenzaprine HCl, an AUC 0-168  within the range of about 80% to 125% of about 740 ng·hr/mL, and a T max  within the range of 80% to 125% of about 7 hours following oral administration of a single 30 mg cyclobenzaprine hydrochloride dose. 
     
     
         32 . The dosage form of  claim 23 , wherein the pharmaceutical dosage form provides an AUC 0-168  within the range of about 80% to 125% of about 320 ng·hr/mL following oral administration of a single 15 mg cyclobenzaprine hydrochloride dose. 
     
     
         33 . The dosage form of  claim 23 , wherein said pharmaceutical dosage form provides a maximum blood plasma concentration (C max ) within the range of 80% to 125% of about 8 ng/mL of cyclobenzaprine hydrochloride following oral administration of a single 15 mg cyclobenzaprine hydrochloride dose. 
     
     
         34 . The dosage form of  claim 28 , wherein the pharmaceutical dosage form provides a maximum blood plasma concentration (C max ) within the range of about 80% to 125% of about 8 ng/mL of cyclobenzaprine HCl and an AUC 0-168  within the range of about 80% to 125% of about 320 ng·hr/mL following oral administration of a single 15 mg cyclobenzaprine hydrochloride dose. 
     
     
         35 . A capsule filled with the dosage form of  claim 23 . 
     
     
         36 . A capsule filled with the dosage form of  claim 28 . 
     
     
         37 . A method of relieving muscle spasms in a patient in need thereof, comprising administering the dosage form of  claim 23  to the patient. 
     
     
         38 . A method of relieving muscle spasms in a patient in need thereof, comprising administering the dosage form of  claim 28  to the patient. 
     
     
         39 . A method of relieving muscle spasms in a patient in need thereof, comprising administering the dosage form of  claim 35  to said patient.