Methods of treatment using sustained release sotalol formulations

Abstract

Sustained release compositions of sotalol, or a pharmaceutically acceptable salt thereof, are provided. In certain examples, sotalol, or a pharmaceutically acceptable salt thereof, may be administered in an effective amount to provide a therapeutic effect to a patient, such as, for example, a patient suffering from a cardiac disorder. In some examples, sotalol combined with a sustained release system may be administered to provide a sustained release of sotalol for a desired period, e.g., at least about 24 hours.

1 .- 12 . (canceled) 
     
     
         13 . A sustained release composition comprising:
 an effective amount of a racemic mixture of D-sotalol and L-sotalol, or a pharmaceutically acceptable salt thereof; and   a sustained release system, whereby the sustained release system is effective to provide sustained release of the racemic mixture of D-sotalol and L-sotalol or the pharmaceutically acceptable salt thereof for at least about 24 hours when exposed to an environmental fluid.   
     
     
         14 . The sustained release composition of  claim 13 , wherein the sustained release system is at least one of a topical, rectal, oral and parental system. 
     
     
         15 . The sustained release composition of  claim 13 , wherein the 24 hours is any other period that is a sustained period relative to conventional drug activity duration and/or half-life of the racemic mixture of D-sotalol and L-sotalol. 
     
     
         16 . The sustained release composition of  claim 13 , wherein the racemic mixture of D-sotalol and L-sotalol or a pharmaceutical acceptable salt thereof comprises at least one of an analog of sotalol, a derivative of sotalol, a mixture of sotalol constituents. 
     
     
         17 . A sustained release composition comprising:
 an effective amount of a racemic mixture of D-sotalol and L-sotalol, or a pharmaceutically acceptable salt thereof;   a sustained release excipient system comprising at least one of a heteropolysaccharide gum and a homopolysaccharide gum that is capable of cross-linking; and   a pharmaceutically acceptable cationic cross-linking agent capable of cross-linking with the gums and increasing the gel-strength of the gums when exposed to an environmental fluid or environment of use,   whereby the sustained release composition is effective to provide sustained release of the racemic mixture of D-sotalol and L-sotalol or the pharmaceutically acceptable salt thereof for at least about 24 hours when exposed to the environmental fluid or the environment of use.   
     
     
         18 . The sustained release composition of  claim 17 , wherein the 24 hours is any other period that is still a sustained period of time relative to conventional drug activity duration and/or half-life of the racemic mixture of D-sotalol and L-sotalol. 
     
     
         19 . The sustained release composition of  claim 17 , wherein the sustained release excipient system is at least one of a topical, rectal, oral and parenteral system. 
     
     
         20 . The sustained release composition of  claim 17 , wherein the racemic mixture of D-sotalol and L-sotalol or a pharmaceutical acceptable salt thereof comprises at least one of an analog of sotalol, a derivative of sotalol, a mixture of sotalol constituents. 
     
     
         21 . The sustained release composition of  claim 17 , further comprising an inert pharmaceutical diluent. 
     
     
         22 . The sustained release composition of  claim 21 , wherein the inert pharmaceutical diluent comprise one or more selected from the group consisting of lactose, dextrose, sucrose or mixtures thereof. 
     
     
         23 . The sustained release composition of  claim 13 , wherein the sustained release excipient system comprises a heteropolysaccharide gum and a homopolysaccharide gum and the ratio of heteropolysaccharide to homopolysaccharide is from 3:1 to about 1:3. 
     
     
         24 . The sustained release composition of  claim 13 , wherein the heteropolysaccharide gum is xanthan gum. 
     
     
         25 . The sustained release composition of  claim 13 , wherein the homopolysaccharide gum is locust bean gum. 
     
     
         26 . A sustained release composition comprising:
 an effective amount of a racemic mixture of D-sotalol and L-sotalol, or a pharmaceutically acceptable salt thereof; and   a sustained release system, whereby the sustained release system is effective to provide sustained release of the racemic mixture of D-sotalol and L-sotalol or the pharmaceutically acceptable salt thereof,   wherein the sustained release system is at least one of a topical, rectal, oral and parental system.