Sustained release formulations of sotalol

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 . A sustained release composition comprising: 
 an effective amount of sotalol, or a pharmaceutically acceptable salt thereof; and    a sustained release system, whereby the sustained release composition is effective to provide sustained release of sotalol for at least about 24 hours when exposed to an environmental fluid.    
   
   
       2 . The sustained release composition of  claim 1 , wherein the sustained release system is at least one of a topical, rectal, oral and parenteral system.  
   
   
       3 . The sustained release composition of  claim 1 , wherein the 24 hours is any other period that is a sustained period relative to conventional drug activity duration and/or half-life of sotalol.  
   
   
       4 . The sustained release composition of  claim 1 , wherein the sotalol, or a pharmaceutically acceptable salt of sotalol, comprises at least one of an analog of sotalol, a derivative of sotalol, a mixture of sotalol constituents, an isomer of sotalol or a racemic mixture of sotalol.  
   
   
       5 . A sustained release composition comprising: 
 an effective amount of sotalol, or a pharmaceutically acceptable salt thereof;    a sustained release excipient system of a heteropolysaccharide gum or a homopolysaccharide gum that is capable of cross-linking;    an inert pharmaceutical diluent; 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 sotalol for at least about 24 hours when exposed to the environmental fluid or the environment of use.    
   
   
       6 . The sustained release composition of  claim 5 , 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 sotalol.  
   
   
       7 . The sustained release composition of  claim 5 , wherein the sotalol, or a pharmaceutically acceptable salt of sotalol, comprises at least one of an analog of sotalol, a derivative of sotalol, a mixture of sotalol constituents, an isomer of sotalol or a racemic mixture of sotalol.  
   
   
       8 . The sustained release composition of  claim 5 , wherein the sustained release excipient system is at least one of a topical, rectal, oral and parenteral system.  
   
   
       9 . A method of preparing a sustained release composition comprising: 
 preparing a sustained release composition described in  claim 1;     combining the sustained release composition with a gum to provide a drug/gum ratio determined to provide a desired degree of sustained release; and    tableting the combined sustained release composition and the gum such that each tablet includes a dose of sotalol effective to provide a therapeutic effect for at least about 24 hours.    
   
   
       10 . A method of preparing a sustained release composition comprising: 
 preparing a sustained release system;    combining the sustained release system with sotalol, or a pharmaceutically acceptable salt thereof; and    quantifying the mixture into discrete unit forms such that each unit includes a dose of sotalol in an effective amount to provide a therapeutic effect for at least about 24 hours.    
   
   
       11 . A method of treating a patient in need of treatment for a cardiac disorder, the method comprising administering an effective amount of a sustained release composition of sotalol, or a pharmaceutically acceptable salt thereof, to the patient in need of treatment to provide sustained release of the sotalol for at least 24 hours to the patient.  
   
   
       12 . The method of  claim 11  further comprising: 
 preparing a sustained release system;    combining the sustained release system with sotalol, or a pharmaceutically acceptable salt thereof; and    tableting or producing units of the combined sustained release system and sotalol such that each tablet or unit includes a dose of sotalol sufficient to provide a therapeutic effect for at least bout 24 hours; and    administering the tablets or units at a suitable dosing interval to the patient in need of treatment.