Articles and methods for administration of therapeutic agents

Abstract

Articles and methods for delivering a therapeutic agent to a subject are described. These articles and methods may be useful, in some cases, for the delivery of therapeutic agents to the colon of a subject. In some embodiments, an article is configured to release a secretion inducing agent e.g., to stimulate the release of intestinal fluids. The article, in some embodiments, comprises a therapeutic agent such that the stimulated release of intestinal fluid increases the amount of therapeutic agent available for absorption by the colon. For example, in some embodiments, the articles and methods described herein advantageously promote increased absorption of therapeutic agents in subjects as compared to traditionally administered therapeutic agents without additional components such as a secretion inducing agent. In some embodiments, articles and methods described herein may increase the motility of the colon of a subject. The increase in contractions and movement of fluidic in the colon caused by increase motility may advantageously facilitate the dissolution or absorption of the therapeutic agent.

1 . An article configured for release of a therapeutic agent in a colon of a subject, comprising:
 a first portion comprising a secretion inducing agent;   a second portion adjacent the first portion, the second portion comprising a therapeutic agent; and   a degradable coating associated with the article.   
     
     
         2 . An article configured for release of a therapeutic agent in a portion of an intestine of a subject, comprising:
 a first component configured to increase the amount of intestinal fluid present in the intestine of the subject; and   a second component associated with the first component configured to release a therapeutic agent in the intestine of the subject.   
     
     
         3 . An article of  claim 2 , wherein the portion of the intestine is the colon of the subject. 
     
     
         4 . An article of  claim 1 , wherein the secretion inducing agent is configured to increase the water content in the colon of the subject. 
     
     
         5 . (canceled) 
     
     
         6 . An article of  claim 1 , wherein the secretion inducing agent is a bile acid or a salt thereof. 
     
     
         7 . An article of  claim 1 , wherein the secretion inducing agent is chenodeoxycholic acid or a salt thereof. 
     
     
         8 . An article of  claim 1 , wherein the degradable coating comprises Eudragit S100, Phloral, HPMC or duocaot. 
     
     
         9 . An article of  claim 1 , wherein a local concentration of the secretion inducing agent is at least 3 mM. 
     
     
         10 . (canceled) 
     
     
         11 . An article as in  claim 1 , wherein the article further comprises hydroxypropylmethyl cellulose. 
     
     
         12 . An article as in  claim 1 , wherein the article further comprises magnesium stearate. 
     
     
         13 . (canceled) 
     
     
         14 . A method for administering a therapeutic agent, comprising:
 administering, to a subject, an article, the article comprising a first portion comprising a secretion inducing agent, a second portion adjacent the first portion, the second portion comprising the therapeutic agent, and a degradable coating associated with the article,   wherein the secretion inducing agent is configured to increase an amount of intestinal fluid present in an intestine of the subject; and   releasing the therapeutic agent from article to the intestine of the subject.   
     
     
         15 . A method as in  claim 14 , wherein secretion inducing agent is a bile acid or a salt thereof. 
     
     
         16 . A method as in  claim 14 , wherein the secretion inducing agent is chendeoxycholic acid or a salt thereof. 
     
     
         17 . A method as in  claim 14 , wherein the secretion inducing agent is configured to fully dissolve within one-fifth of the distance between the ileocecal valve and the hepatic flexure. 
     
     
         18 . A method as in  claim 14 , wherein a local concentration of the secretion inducing agent is at least 3 mM. 
     
     
         19 . (canceled) 
     
     
         20 . A method as in  claim 14 , wherein the secretion inducing agent and the therapeutic agent are introduced orally via a tablet, a pill, or a capsule comprising the secretion inducing agent and the therapeutic agent. 
     
     
         21 . A method as in  claim 14 , wherein the secretion inducing agent does not induce abdominal pain in the subject. 
     
     
         22 . An article as in  claim 14 , wherein the secretion inducing agent is configured to increase the motility of the gastrointestinal tract of the subject. 
     
     
         23 . An article as in  claim 1 , wherein the secretion inducing agent is a bile acid or a salt thereof, and the therapeutic agent is a bile acid or a salt thereof. 
     
     
         24 . An article as in  claim 1 , wherein the section inducing agent is chenodeoxycholic acid or a salt thereof, and the therapeutic agent is a bile acid or salts thereof. 
     
     
         25 . An article as in  claim 1 , wherein the amount of the secretion-inducing agent is greater than or equal to 5 mg and less than or equal to 5 g. 
     
     
         26 . An article as in  claim 14 , wherein the amount of the therapeutic agent present in the article is greater than or equal to 10 mg and less than or equal to 10 g. 
     
     
         27 . An article as in  claim 1 , wherein the wt % of the secretion-inducing agent relative to the total weight of the article is greater than or equal to 10 wt % and less than or equal to 95 wt %. 
     
     
         28 . An article as in  claim 1 , wherein a wt % of the therapeutic agent relative to the total weight of the article is greater than or equal to 10 wt % and less than or equal to 95 wt %. 
     
     
         29 . An article as in  claim 1 , wherein a ratio of the first portion and the second portion is greater than or equal to 1:1 and less than or equal to 1:99. 
     
     
         30 . (canceled) 
     
     
         31 . An article as in  claim 1 , wherein a mass ratio of the secretion-inducing agent to the therapeutic agent is greater than or equal to 10:90 and less than or equal to 90:10.