Acamprosate formulations, methods of using the same, and combinations comprising the same

Abstract

Embodiments disclosed herein generally relate to acamprosate formulations, methods of use of the formulations, to methods of using the formulations optionally in combination with at least one other medication, and to combination products and compositions comprising acamprosate and at least one other medication, such as neuroleptic (antipsychotic) and/or antidepressant drugs.

1 - 66 . (canceled) 
     
     
         67 . A tablet composition comprising:
 a polymer matrix comprised of at least one polymer, wherein the at least one polymer comprises a carbomer;   a dose of prazosin dispersed within the polymer matrix, the dose being within a range of about 1.0 mg to about 15 mg; and   a dose of acamprosate dispersed within the polymer matrix, wherein:
 the dose of acamprosate is within a range of about 400 mg to about 1500 mg; or 
 the acamprosate is present at a level that is about 20% to about 90% of the total weight of the composition; and 
   optionally at least one pharmaceutically acceptable excipient.   
     
     
         68 . The tablet composition of  claim 67 , wherein the carbomer comprises a carbomer selected from the group consisting of carbomer homopolymer type A and carbomer homopolymer type B. 
     
     
         69 . The tablet composition of  claim 67 , wherein the carbomer is present at a level that is from about 1% to about 25% of the total weight of the composition. 
     
     
         70 . The tablet composition of  claim 67 , wherein the tablet composition has a longest dimension within a range of 10-30 mm. 
     
     
         71 . The tablet composition of  claim 67 , wherein the longest dimension of the tablet composition does not change more than 20% when maintained for a period of at least 4-12 hours at a pH within a range of pH 1.0 to pH 4.5, inclusive. 
     
     
         72 . The tablet composition of  claim 67 , wherein the tablet composition substantially retains its shape and dimensions in a subject's GI tract after administration to the subject, whether in the fed state or in the fasted state. 
     
     
         73 . The tablet composition of  claim 67 , wherein the acamprosate is present in a pharmaceutically acceptable salt form. 
     
     
         74 . The tablet composition of  claim 67 , wherein the tablet composition is characterized in that, when the tablet composition is placed in either acetate solution (pH 4.5) or HCl solution (pH 1.0) in vitro, it releases acamprosate at a rate that is approximately linear with the square root of time and remains comparable. 
     
     
         75 . The tablet composition of  claim 67 , wherein the polymer matrix comprises 60 mg of carbomer homopolymer type B, and the dose of acamprosate is 800 mg. 
     
     
         76 . A method comprising a step of
 administering to a subject suffering from or susceptible to an anxiety disorder, PTSD, or panic disorder, a combination of prazosin therapy and acamprosate therapy.   
     
     
         77 . The method of  claim 76 , comprising administering the tablet composition of  claim 67 . 
     
     
         78 . The method of  claim 76 , wherein the subject is suffering from or susceptible to PTSD. 
     
     
         79 . The method of  claim 76 , wherein the combination is administered independent of the subject's fed vs fasted state. 
     
     
         80 . A tablet composition comprising:
 a dose of acamprosate, that is (i) less than 1 g; and (ii) distributed within a polymer matrix that comprises a carbomer homopolymer type A; and   optionally at least one pharmaceutically acceptable excipient.   
     
     
         81 . The tablet composition of  claim 80 , wherein the carbomer is present at a level that is from about 1% to about 25% of the total weight of the composition. 
     
     
         82 . The tablet composition of  claim 80 , wherein the tablet composition substantially retains its shape and dimensions in a subject's GI tract after administration to the subject, whether in the fed state or in the fasted state. 
     
     
         83 . The tablet composition of  claim 80 , wherein the acamprosate is present in a pharmaceutically acceptable salt form. 
     
     
         84 . The tablet composition of  claim 80 , wherein the tablet composition is characterized in that, when the tablet composition is placed in either acetate solution (pH 4.5) or HCl solution (pH 1.0) in vitro, it releases acamprosate at a rate that is approximately linear with the square root of time and remains comparable. 
     
     
         85 . The tablet composition of  claim 80 , wherein the polymer matrix comprises 60 mg of carbomer homopolymer type A, and the dose of acamprosate is 800 mg. 
     
     
         86 . The tablet composition of  claim 80 , wherein the polymer matrix comprises 80 mg of carbomer homopolymer type A, and the dose of acamprosate is 800 mg.