Oral administration of calcitonin

Abstract

Disclosed is a particular method of orally administering pharmaceutical compositions comprising calcitonin in combination with oral delivery agents, prior to the consumption of food in humans, and a method of treatment of disorders responsive to the action of calcitonin employing such method of administration; also oral calcitonin pharmaceutical compositions with particular ratios of the amount of oral delivery agent to the amount of calcitonin.

1 . A method of administration which comprises administering orally to a human host prior to the consumption of food a pharmaceutical composition comprising calcitonin in combination with one or more oral delivery agents.  
     
     
         2 . A method according to  claim 1 , wherein oral administration is in the range of about 5 to 30 minutes prior to a meal.  
     
     
         3 . A method according to claims  1 , wherein said pharmaceutical composition comprises: 
 a) an oral delivery agent being the disodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid, N-(10-[2-hydroxybenzoyl]aminodecanoic acid or N-(8-[2-hydroxybenzoyl]amino)caprylic acid, or a hydrate or solvate of a said disodium salt; and    b) about 0.1-2.5 mg of calcitonin; in which the ratio of the amount of the oral delivery agent, expressed as the corresponding amount of free acid, to the amount of calcitonin is in the range of about 10 to about 250:1 by weight.    
     
     
         4 . (canceled)  
     
     
         5 . (canceled)  
     
     
         6 . (canceled)  
     
     
         7 . An oral pharmaceutical composition comprising: 
 a) an oral delivery agent being the disodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid, N-(10-[2-hydroxybenzoyl]aminodecanoic acid or N-(8-[2-hydroxybenzoyl]amino)caprylic acid, or a hydrate or solvate of a said disodium salt; and    b) about 0.1-2.5 mg of calcitonin; in which the ratio of the amount of the oral delivery agent, expressed as the corresponding amount of free acid, to the amount of calcitonin is in the range of about 10 to about 250:1 by weight.    
     
     
         8 . An oral solid pharmaceutical composition according to  claim 7 , comprising N-(5-chlorosalicyloyl)-8-aminocaprylic acid disodium salt or a hydrate thereof and about 0.1-2.5 mg of salmon calcitonin, in which the ratio, as defined in said claim, of the amount of the oral delivery agent to the amount of calcitonin is in the range of about 10 to about 200:1 by weight.  
     
     
         9 . An oral solid pharmaceutical composition according to  claim 7 , in which the ratio is about 25 to about 100:1 by weight.  
     
     
         10 . An oral solid pharmaceutical composition according to claims  7 , which also comprises either or both of crospovidone and povidone.  
     
     
         11 . (canceled)  
     
     
         12 . The kit according to  claim 13 , whereas in the calcitonin is salmon calcitonin and about 0.1-2.5 mg of salmon calcitonin; in which the ratio of the amount of the oral delivery agent, expressed as the corresponding amount of free acid, to the amount of salmon calcitonin is in the range of about 10 to about 250:1 by weight.  
     
     
         13 . A kit comprising at least one pharmaceutical composition comprising calcitonin and an oral delivery agent, wherein said oral delivery agent is selected from the group consisting of the disodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid, N-(10-[2-hydroxybenzoyl]aminodecanoic acid, N-(8-[2-hydroxybenzoyl]amino)caprylic acid, and hydrates or solvates of a said disodium salt, for administration to a human according to a method of oral administration which provides that said pharmaceutical composition may be taken prior to the consumption of food.