Residence structures and related methods

Abstract

Residence structures, systems, and related methods are generally provided. Certain embodiments comprise administering (e.g., orally) a residence structure to a subject (e.g., a patient) such that the residence structure is retained at a location internal to the subject for a particular amount of time (e.g., at least about 24 hours) before being released. The residence structure may be, in some cases, a gastric residence structure. In some embodiments, the structures and systems described herein comprise one or more materials configured for high levels of active substances (e.g., a therapeutic agent) loading, high active substance and/or structure stability in acidic environments, mechanical flexibility and strength in an internal orifice (e.g., gastric cavity), easy passage through the GI tract until delivery to at a desired internal orifice (e.g., gastric cavity), and/or rapid dissolution/degradation in a physiological environment (e.g., intestinal environment) and/or in response to a chemical stimulant (e.g., ingestion of a solution that induces rapid dissolution/degradation). In certain embodiments, the structure has a modular design, combining a material configured for controlled release of therapeutic, diagnostic, and/or enhancement agents with a structural material necessary for gastric residence but configured for controlled and/or tunable degradation/dissolution to determine the time at which retention shape integrity is lost and the structure passes out of the gastric cavity. For example, in certain embodiments, the residence structure comprises a first elastic component, a second component configured to release an active substance (e.g., a therapeutic agent), and, optionally, a linker. In some such embodiments, the linker may be configured to degrade such that the residence structure breaks apart and is released from the location internally of the subject after a predetermined amount of time.

1 - 79 . (canceled) 
     
     
         80 . A residence structure, comprising:
 a loadable polymeric component;   a second polymeric component; and   a linker comprising at least one polymer selected from the group consisting of polycaprolactone, poly(propylene fumarate), poly(glycerol sebacate), poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid), polybutyrate, polyhydroxyalkanoate, polyether, polyamide, polyvinyl alcohol, polyoxetane, polyacrylate, polymethacrylate, polyanhydride, polyurethane, an enteric polymer, and co-polymers thereof;   wherein a connection between the loadable polymeric component and the second polymeric component mechanically weakens or separates when the linker dissolves, degrades, mechanically weakens, or mechanically separates.   
     
     
         81 . The residence structure of  claim 80 , wherein the linker comprises an enteric polymer. 
     
     
         82 . The residence structure of  claim 80 , wherein the linker comprises a first polymer selected from the group consisting of polycaprolactone, poly(propylene fumarate), poly(glycerol sebacate), poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid), polybutyrate, polyhydroxyalkanoate, polyether, polyamide, polyvinyl alcohol, polyoxetane, polyacrylate, polymethacrylate, polyanhydride, polyurethane, an enteric polymer, and co-polymers thereof, and a second polymer different than the first polymer. 
     
     
         83 . The residence structure of  claim 82 , wherein the second polymer is selected from the group consisting of polycaprolactone, poly(propylene fumarate), poly(glycerol sebacate), poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid), polybutyrate, polyhydroxyalkanoate, polyether, polyamide, polyvinyl alcohol, polyoxetane, polyacrylate, polymethacrylate, polyanhydride, polyurethane, an enteric polymer, and co-polymers thereof 
     
     
         84 . The residence structure of  claim 80 , wherein the loadable polymeric component comprises polycaprolactone (PCL), poly(ethylene-co-vinyl acetate), or polyethylene glycol (PEG). 
     
     
         85 . The residence structure of  claim 80 , wherein the second polymeric component comprises an elastic polymeric component. 
     
     
         86 . The residence structure of  claim 82 , wherein the elastic polymeric component comprises a polymer selected from the group consisting of polyesters, polyethers, polysiloxanes, polyamides, polyacrylates, polymethacrylates, polyanhydrides, and polyurethanes. 
     
     
         87 . The residence structure of  claim 80 , wherein the loadable polymeric component is coupled with the second polymeric component via the linker. 
     
     
         88 . The residence structure of  claim 80 , wherein the linker comprises cellulose acetate phthalate (CAP), hydroxypropyl methyl cellulose, and/or poly(methacrylic acid-co-ethyl acrylate). 
     
     
         89 . The residence structure of  claim 80 , wherein the loadable polymeric component comprises an active substance. 
     
     
         90 . The residence structure of  claim 89 , wherein the active substance is an antipsychotic. 
     
     
         91 . The gastric residence structure of  claim 90 , wherein the antipsychotic comprises risperidone. 
     
     
         92 . The gastric residence structure of  claim 89 , wherein the active substance is a substance abuse treatment. 
     
     
         93 . The gastric residence structure of  claim 92 , wherein the substance abuse treatment is methadone. 
     
     
         94 . The gastric residence structure of  claim 89 , wherein the active substance is a statin. 
     
     
         95 . The gastric residence structure of  claim 89 , wherein the active substance is an analgesic. 
     
     
         96 . The gastric residence structure of  claim 89 , wherein the active substance is buprenorphine. 
     
     
         97 . A system for delivering a residence structure according to  claim 80  at a location internally of a subject, comprising:
 a containing structure; 
 a residence structure contained within the containing structure; 
 wherein the residence structure is constructed and arranged to have a first configuration after release from the containing structure; and 
 wherein the residence structure is constructed and arranged to have a second configuration when contained within the containing structure. 
 
     
     
         98 . The system of  claim 97 , wherein the first configuration is a multi-armed star shape. 
     
     
         99 . The system of  claim 97 , wherein the residence structure is configured to be folded and physically constrained in the second configuration during administration and is configured to assume the first configuration upon removal of a constraint, wherein change between the second configuration and the first configuration is mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the second configuration and recoils when the gastric residence structure assumes the first configuration. 
     
     
         100 . The system of  claim 97 , wherein the residence structure is a gastric residence structure. 
     
     
         101 . A method for delivering a residence structure, comprising administering to a subject the containing structure containing the residence structure as in  claim 80 . 
     
     
         102 . The method of  claim 101 , wherein the subject is a human.