Dosage forms and related therapies

Abstract

This invention is directed in part to novel doses, dosage formulations, and routes of administration of such doses and dose formulations, said dose and dose formulations containing one or more copper chelators, for example, one or more trientine active agents, including trientine analogues, trientine salts, trientine prodrugs, and trientine derivatives, useful in the treatment of diseases, disorders and conditions, including in indications where copper may play a role.

1 - 128 . (canceled)  
     
     
         129 . A composition comprising a pharmaceutically acceptable carrier and an effective amount of a pharmaceutically acceptable acid addition salt of triethylenetetramine and succinic acid.  
     
     
         130 . The composition of  claim 129  comprising from 50 mg to 500 mg of a pharmaceutically acceptable acid addition salt of triethylenetetramine and succinic acid.  
     
     
         131 . The composition of  claim 129  comprising from 50 mg to 450 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         132 . The composition of  claim 129  comprising from 50-100 mg to about 400 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         133 . The composition of  claim 129  comprising from 50-100 mg to about 300 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         134 . The composition of  claim 129  comprising from 110 to 290 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         135 . The composition of  claim 129  comprising from 120 to 280 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         136 . The composition of  claim 129  comprising from 130 to 270 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         137 . The composition of  claim 129  comprising from 140 to 260 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         138 . The composition of  claim 129  comprising from 150 to 250 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         139 . The composition of  claim 129  comprising from 160 to 240 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         140 . The composition of  claim 129  comprising from 170 to 230 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         141 . The composition of  claim 129  comprising from 180 to 220 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         142 . The composition of  claim 129  comprising from 190 to 210 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         143 . The composition of  claim 129  comprising from 50 mg to 100 mg of an acid addition salt of triethylenetetramine and succinic acid.  
     
     
         144 . The composition of  claim 129  wherein the amount of the acid addition salt of triethylenetetramine and succinic acid is selected from the group consisting of 50 mg, 110 mg, 120 mg, about 130 mg, 140 mg, and 150 mg.  
     
     
         145 . A composition comprising a pharmaceutically acceptable carrier and a pharmaceutically acceptable acid addition salt of triethylenetetramine and succinic acid in an amount selected from the group consisting of 1.2 mg, 10 mg, 12 mg, 20 mg, 30 mg, and 40 mg.  
     
     
         146 . The composition of any of claims  129 - 144  or  145 , wherein said acid addition salt of triethylenetetramine and succinic acid is purified.  
     
     
         147 . The composition of  claim 146 , wherein said composition is in a form suitable for oral administration.  
     
     
         148 . The composition of  claim 147 , wherein said form suitable for oral administration is a capsule.  
     
     
         149 . The composition of  claim 147 , wherein said form suitable for oral administration is a tablet.  
     
     
         150 . The composition of  claim 149 , wherein said tablet is an enteric-coated tablet.  
     
     
         151 . The composition of  claim 149 , wherein said tablet is a layered tablet.  
     
     
         152 . The composition of  claim 147 , wherein said form suitable for oral administration is a sustained release preparation.  
     
     
         153 . The composition of  claim 152 , wherein said sustained release preparation is a delayed release preparation.  
     
     
         154 . The composition of  claim 152 , wherein said sustained release preparation is a slow release preparation.  
     
     
         155 . The composition of  claim 152 , wherein said sustained release preparation is a controlled release preparation.  
     
     
         156 . The composition of  claim 152 , wherein said sustained release preparation is an extended release preparation.  
     
     
         157 . The composition of  claim 146 , wherein said composition is in a form suitable for transdermal administration.  
     
     
         158 . The composition of  claim 146 , wherein said composition is in a form suitable for transmucosal administration.  
     
     
         159 . The composition of  claim 146 , wherein said composition is in a form suitable for administration as a suppository.  
     
     
         160 . The composition of  claim 146 , further comprising at least one delivery agent to enhance entry of the addition salt of triethylenetetramine and succinic acid to the systemic circulation.  
     
     
         161 . A dosage unit of  claim 160  wherein the delivery agent is selected from the group consisting of a vasodilator and a reverse active transport agent.  
     
     
         162 . A method of treating a subject for diabetes, comprising administering to said subject a composition according to  claim 146 .  
     
     
         163 . The method according to  claim 162 , wherein said subject has type 1 diabetes.  
     
     
         164 . The method according to  claim 162 , wherein said subject has type 2 diabetes.  
     
     
         165 . A method of treating a subject for cardiomyopathy, comprising administering to said subject a composition according to  claim 146 .  
     
     
         166 . The method according to  claim 165 , wherein said cardiomyopathy is selected from the group consisting of hypertensive cardiomyopathy, diabetic hypertensive cardiomyopathy, hypertensive cardiomyopathy associated with impaired glucose intolerance, hypertensive cardiomyopathy associated with impaired fasting glucose, ischemic cardiomyopathy associated with impaired glucose tolerance, ischemic cardiomyopathy associated with impaired fasting glucose, hypertensive cardiomyopathy not associated with any abnormality of glucose metabolism, ischemic cardiomyopathy not associated with any abnormality of glucose metabolism, ischemic cardiomyopathy, ischemic cardiomyopathy associated with coronary heart disease, idiopathic cardiomyopathy, metabolic cardiomyopathy, alcoholic cardiomyopathy, drug-induced cardiomyopathy, and hypertensive cardiomyopathy.  
     
     
         167 . A method of treating a subject further acute coronary syndrome, comprising administering to said subject a composition according to  claim 146 .  
     
     
         168 . The method according to  claim 167 , wherein said acute coronary syndrome is diabetic acute coronary syndrome, acute coronary syndrome associated with impaired glucose tolerance, acute coronary syndrome associated with impaired fasting glucose, acute coronary syndrome not associated with any abnormality of glucose metabolism.  
     
     
         169 . A method of treating a subject for myocardial infarction, comprising administering to said subject a composition according to  claim 146 .  
     
     
         170 . A method of treating a subject for myocarditis, comprising administering to said subject a composition according to  claim 146 .  
     
     
         171 . A method of treatment for the prevention or amelioration of tissue damage in a subject who does not have Wilson's disease, which comprises administering to said subject a a composition according to  claim 146.