Delayed release carnitine

Abstract

A sustained release, orally administered pharmaceutical composition comprising carnitine and an acceptable pharmaceutical excipient is described for the treatment of carnitine deficiency and other carnitine responsive conditions. The sustained release formulation avoids the characteristic problems of gastrointestinal invitation, dumping in the urine and bacterial degradation attendant previously known oral formulations of carnitine.

1 . A sustained release oral medicament for administration to a human being, said human being having gastrointestinal fluid, said medicament comprising: 
 (a) a unitary dosage amount of carnitine;    (b) a means for slowly releasing said carnitine from said medicament upon exposure of said medicament to gastrointestinal fluid;    (c) an acceptable pharmaceutical excipient.    
     
     
         2 . A sustained release oral medicament as claimed in  claim 1 , wherein said carnitine is slowly released over a period of time greater than two hours upon exposure to gastrointestinal fluid.  
     
     
         3 . A sustained release oral medicament as claimed in  claim 1 , wherein said carnitine is L-carnitine.  
     
     
         4 . A sustained release oral medicament as claimed in  claim 1 , wherein said carnitine is gamma-butyrobetaine.  
     
     
         5 . A sustained release oral medicament as claimed in  claim 1 , wherein said means for slowly releasing said carnitine comprises a slowly water permeable polimerisation product which coats said carnitine.  
     
     
         6 . A sustained release oral medicament for administration to a human being, said human being having gastrointestinal fluid, said medicament comprising: 
 (a) a unitary dosage amount of carnitine;    (b) a slowly water permeable polimerisation product coating said carnitine;    (c) an acceptable pharmaceutical excipient.    
     
     
         7 . A sustained release oral medicament as claimed in  claim 6 , wherein said carnitine is released over a period of time greater than two hours upon exposure to gastrointestinal fluid.  
     
     
         8 . A sustained release oral medicament as claimed in  claim 6 , wherein said carnitine is L-carnitine.  
     
     
         9 . A sustained release oral medicament as claimed in  claim 6 , wherein said carnitine is gamma-butyrobetaine.  
     
     
         10 . A sustained release oral medicament as claimed in  claim 6 , wherein said means for slowly releasing said carnitine comprises a slowly water permeable polimerisation product which coats said carnitine.  
     
     
         11 . A sustained release oral medicament as claimed in  claim 6 , further comprising a unitary dosage amount of DHEA.  
     
     
         12 . A method of preventing gastrointestinal irritation associated with oral administration of carnitine, comprising the steps of: 
 (a) granulating said carnitine;    (b) coating said granulated carnitine with a slowly water permeable polimerisation product so as to form coated carnitine;    (c) incorporating a unit dosage amount of said coated carnitine and an acceptable pharmaceutical excipient into an oral medicament;    (d) orally administering said medicament.    
     
     
         13 . A method for treating and preventing osteoporosis, comprising the step of: orally administering daily in a sustained release formulation an effective amount of L-carnitine and DHEAS along with an acceptable pharmaceutical excipient.  
     
     
         14 . A method for treating and preventing osteoporosis as claimed in  claim 13 , wherein said sustained release formulation