Expandable gastroretentive dosage form

Abstract

An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

What is claimed: 
     
         1 . A gastroretentive dosage form (GRDF) for retention in a stomach, comprising:
 a hinge assembly;   two parts connected together by the hinge assembly; and   a composition comprising an active pharmaceutical ingredient (API) or diagnostic,   wherein the hinge assembly and the two parts are configured to transform between
 a collapsed configuration for ingestion, 
 an expanded configuration for retention within the stomach, and 
 a third configuration wherein at least one of the two parts disengages from the hinge assembly, 
   wherein said disengagement is due to at least partial erosion of the composition, and   wherein the disengaged parts are sized for exiting the stomach through the pyloric valve.   
     
     
         2 . The GRDF of  claim 1 , wherein the two parts are two arms. 
     
     
         3 . The GRDF of  claim 1 , wherein the two parts are pivotably connected to each other by the hinge assembly. 
     
     
         4 . The GRDF of  claim 1 , wherein the two parts comprise a pH dependent polymer that erodes in a basic environment. 
     
     
         5 . The GRDF of  claim 1 , wherein the two parts are erodible at a pH of 5 to 7.5. 
     
     
         6 . The GRDF of  claim 1 , wherein the at least one of the two parts comprises a cellulose ester and a plasticizer. 
     
     
         7 . The GRDF of  claim 6 , wherein the cellulose ester is cellulose acetate, cellulose triacetate, hydroxypropylmethylcellulose acetate succinate, cellulose proprionate, cellulose acetate proprionate, cellulose acetate butyrate, or a combination thereof. 
     
     
         8 . The GRDF of  claim 6 , wherein the plasticizer is dibutyl sebacate, triethyl citrate, polyethylene glycol, polyethylene glycol monomethyl ether, acetyl tri butyl citrate, triacetin, or a combination thereof. 
     
     
         9 . The GRDF of  claim 1 , comprising a volume for engaging the composition ranging from about 100 mm3 to about 2000 mm3. 
     
     
         10 . The GRDF of  claim 1 , wherein the partial erosion of the composition occurs after a predetermined time period of at least four hours has elapsed, preferably the predetermined time period is at least 12 hours. 
     
     
         11 . The GRDF of  claim 1 , wherein the disengagement is due to erosion of greater than 50% of the API or the diagnostic from the GRDF. 
     
     
         12 . The GRDF of  claim 1 , wherein the API or the diagnostic erodes at a controlled rate over more than 6 hours. 
     
     
         13 . The GRDF of  claim 1 , wherein the GRDF is maintained in the collapsed configuration by a retention mechanism that dissolves when introduced to a fluid environment and wherein said GRDF transitions to the expanded configuration upon at least partial dissolution of said retention mechanism in less than 5 minutes. 
     
     
         14 . The GRDF of  claim 1 , wherein the composition further comprises an excipient, and wherein a ratio of the weight of the excipient to the weight of the API or the diagnostic is from about 0.8 to about 0.05. 
     
     
         15 . The GRDF of  claim 1 , further comprising a second API or a second diagnostic. 
     
     
         16 . The GRDF of  claim 1 , wherein the parts are produced by injection molding or 3D printing. 
     
     
         17 . The GRDF of  claim 1 , wherein the composition is retained in the stomach for a time period of more than 6 hours. 
     
     
         18 . The GRDF of  claim 1 , wherein a size, shape, or durability of each of the two parts is substantially maintained prior to their disengagement. 
     
     
         19 . The GRDF of  claim 1 , further comprising a biasing element configured to transition the GRDF from the collapsed configuration to the expanded configuration. 
     
     
         20 . The GRDF of  claim 1 , having a mechanical durability to remain intact under a repeated force of at least about 400 grF, for a time period of at least 1 hour.