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.

1 - 72 . (canceled) 
     
     
         73 . A method of assembling a gastroretentive dosage form (GRDF), comprising:
 coupling a polymeric component to a hinge assembly by welding;   wherein the polymeric component comprises a polymer and a plasticizer; and   wherein the polymeric component is manufactured by extruding the polymer and plasticizer by hot-melt-extrusion by injecting at least a portion of the hot-melt under pressure and heat through a mold to form an extruded strand having a predefined two dimensional shape and wherein the extruded strand is cooled and cut to a predefined size having a predefined three dimensional shape and is suitable for forming the polymeric component.   
     
     
         74 . The method of  claim 73 , wherein the plasticizer is selected from the group consisting of dibutyl sebacate, triethyl citrate, polyethylene glycol, polyethylene glycol monomethyl ether, acetyl tributyl citrate, triacetine, glycerin, sorbitol, sorbitan solutions, castor oil, diacetylated monoglycerides, triethyl citrate, tributyl citrate and combinations thereof. 
     
     
         75 . The method of  claim 73 , wherein the ratio of polymer to plasticizer is between 3:1 and 12:1. 
     
     
         76 . The method of  claim 73 , further comprising collapsing the GRDF and inserting into a capsule. 
     
     
         77 . The method of  claim 76 , wherein assembly of the GRDF is by a robotic automated machine. 
     
     
         78 . The method of  claim 76 , wherein encapsulation of the GRDF is by a robotic automated machine. 
     
     
         79 . The method of  claim 76 , wherein both assembly of the GRDF and encapsulation of the GRDF are by robotic automated machines. 
     
     
         80 . The method of  claim 73 , wherein the polymeric component further comprises an active pharmaceutical ingredient (API) or diagnostic. 
     
     
         81 . The method of  claim 73 , wherein the hinge assembly is manufactured by molding. 
     
     
         82 . A gastroretentive dosage form assembled by the method of  claim 73 . 
     
     
         83 . A composition for delivering a gastroretentive dosage form (GRDF) to a patient in need comprising:
 a hot-melt extruded polymeric component welded to a hinge assembly, wherein the polymeric component comprises an active pharmaceutical ingredient, a polymer and a plasticizer;   a capsule surrounding the hot-melt extruded polymeric component and hinge assembly, wherein the capsule is dimensioned to permit swallowing by the patient in need;   wherein prior to being welded to the hinge assembly, at least a portion of the hot-melt is extruded under pressure and heat through a mold to form an extruded strand having a predefined shape and wherein the extruded strand is cooled and cut to a predefined size having a predefined three dimensional shape.   
     
     
         84 . The dosage form of  claim 83 , wherein the plasticizer is selected from the group consisting of dibutyl sebacate, triethyl citrate, polyethylene glycol, polyethylene glycol monomethyl ether, acetyl tributyl citrate, triacetine, glycerin, sorbitol, sorbitan solutions, castor oil, diacetylated monoglycerides, triethyl citrate, tributyl citrate and combinations thereof. 
     
     
         85 . The dosage form of  83 , wherein the ratio of polymer to plasticizer is between 3:1 and 12:1. 
     
     
         86 . The dosage form of  claim 83 , wherein the GRDF is configured to be folded and retained in a collapsed configuration during administration by the capsule and is configured to assume an expanded configuration for gastric retention upon dissolution of the removal of the capsule.