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 - 72 . (canceled) 
     
     
         73 . A gastroretentive dosage form (GRDF) for extended retention in a stomach, comprising:
 a hinge assembly;   a first polymeric component coupled to the hinge assembly via a first linker;   a second polymeric component coupled to the hinge assembly via a second linker;   wherein at least a polymeric component comprises an active pharmaceutical ingredient (API), a diagnostic, and/or an excipient;   wherein the GRDF is configured to be folded and retained by a retention mechanism in a collapsed configuration during administration to a subject, and is configured to assume an expanded configuration upon removal of the retention mechanism;   wherein at least one linker erodes in a gastric environment of the subject and results in a loss of mechanical integrity of the GRDF, and passage thereof from the stomach through the pyloric valve.   
     
     
         74 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the hinge assembly is elastically deformable. 
     
     
         75 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the hinge assembly is a living hinge. 
     
     
         76 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the hinge assembly comprises a polymeric material. 
     
     
         77 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the at least one linker erodes in a gastric environment in a time dependent manner. 
     
     
         78 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the hinge assembly is elastically deformed in the collapsed configuration. 
     
     
         79 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein a transition between the collapsed configuration and the expanded configuration is mediated by the hinge assembly that undergoes elastic deformation when the GRDF is in the collapsed configuration and opens when the GRDF moves into the expanded configuration. 
     
     
         80 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the GRDF is configured such that it is in the stomach of the subject for a time period of more than 24 hours. 
     
     
         81 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the first polymeric component and the second polymeric component comprise an active pharmaceutical ingredient. 
     
     
         82 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the first polymeric component and the second polymeric component comprise the same active pharmaceutical ingredient. 
     
     
         83 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the first polymeric component and the second polymeric component comprise different active pharmaceutical ingredients. 
     
     
         84 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the active pharmaceutical ingredient, diagnostic and/or excipient is a radiopaque material. 
     
     
         85 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the dosage form changes less than 10 wt % during the first 24 hours of exposure to gastric fluid. 
     
     
         86 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the hinge assembly is free of active pharmaceutical ingredients. 
     
     
         87 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the first polymeric component comprises at least 5 wt % active pharmaceutical ingredient of the total weight of the first polymeric component. 
     
     
         88 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the active pharmaceutical ingredient is contained within a polymer matrix of the first polymeric component. 
     
     
         89 . The gastroretentive dosage form (GRDF) of  claim 73 , wherein the first polymeric component comprises polyethylene glycol. 
     
     
         90 . A gastroretentive dosage form (GRDF) for extended retention in a stomach, comprising:
 a hinge assembly;   a first structure coupled to the hinge assembly via a first linker;   a second structure coupled to the hinge assembly via a second linker;   wherein at least a structure comprises an active pharmaceutical ingredient (API), a diagnostic, and/or an excipient;   wherein at least one linker erodes in a gastric environment which results in a loss of mechanical integrity and passage from a stomach through the pyloric valve;   wherein the GRDF is configured to be folded and retained in a collapsed configuration during administration by a retention mechanism and is configured to assume an expanded configuration for gastric retention upon removal of the retention mechanism;   wherein the expanded configuration for gastric retention is due to at least a structure having a length, a width, and/or a thickness; and   wherein the transition between the collapsed configuration and the expanded configuration is mediated by the hinge assembly that undergoes elastic deformation when the GRDF is in the collapsed configuration and opens when the GRDF moves into the expanded configuration.   
     
     
         91 . The gastroretentive dosage form (GRDF) of  claim 90 , wherein the hinge assembly is elastically deformed in the collapsed configuration. 
     
     
         92 . The gastroretentive dosage form (GRDF) of  claim 90 , wherein the GRDF is configured such that it is in the stomach of the subject for a time period of more than 24 hours.