Residence structures and related methods

Patent metadata

Field	Value
Publication number	US-10610482-B2
Application number	US-201816177704-A
Country	US
Kind code	B2
Filing date	Nov 1, 2018
Priority date	Jun 11, 2014
Publication date	Apr 7, 2020
Grant date	Apr 7, 2020

Abstract

Certain embodiments comprise administering 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. 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, and, optionally, a linker. In some such embodiments, the linker may be configured to degrade.

First claim

What is claimed is:

1. A gastric residence structure comprising at least one active substance, the gastric residence structure comprising:
one or more arms comprising a loadable polymeric component, wherein the loadable polymeric component comprises an active substance, and at least one active substance comprises an antiretroviral agent;
an elastic polymeric component; and
a separate linker component, said linker connecting the one or more arms with the elastic polymeric component;
wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape; and
wherein the linker degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity and passage out of a gastric cavity.

2. A gastric residence structure comprising one or more active substances, the gastric residence structure comprising:
a plurality of loadable polymeric components, each loadable polymeric component comprising the one or more active substances, wherein at least one active substance comprises an antiretroviral agent; and
a central elastic polymeric component;
wherein the plurality of loadable polymeric components are each connected to the central elastic polymeric component via a separate linker component;
wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the central elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape; and
wherein said linker degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity and passage out of a gastric cavity.

3. A method of making a gastric residence structure comprising an active substance comprising:
forming a plurality of arms, wherein at least one arm comprises a loadable polymeric component, wherein the loadable polymeric component comprises one or more polymeric materials and at least one active substance, and wherein at least one active substance of at least one arm comprises an antiretroviral agent; and
connecting at least one of the plurality of arms to an elastic polymeric component using a separate linker component;
wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape; and
wherein the linker degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity and passage out of a gastric cavity.

4. A method of making an orally administrable gastric residence system comprising an active substance comprising:
forming a plurality of arms, wherein at least one arm comprises a loadable polymeric component, wherein the loadable polymeric component comprises one or more polymeric materials and at least one active substance, and wherein at least one active substance of at least one arm comprises an antiretroviral agent; and
connecting at least one of the plurality of arms to an elastic polymeric component using a separate linker component to form a gastric residence structure, said linker connecting the loadable polymeric component with the elastic polymeric component,
wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape,
wherein the linker degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity and passage out of a gastric cavity; and
inserting the gastric residence system in the folded shape into a capsule to form an administrable gastric residence system.

5. A method of making a gastric residence structure comprising an active substance comprising:
forming a plurality of arms, wherein at least one arm comprises a loadable polymeric component, wherein each polymeric component is formed from one or more polymeric materials and at least one active substance, and forming the loadable polymeric component comprises powder mixing, solvent loading, melt loading, or physical blending the one or more polymeric materials with the at least one active substance, and wherein at least one active substance of at least one arm comprises an antiretroviral agent; and
connecting at least one of the plurality of arms to an elastic polymeric component using a separate linker component;
wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape; and
wherein the linker degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention shape integrity and passage out of a gastric cavity.

6. A method of making a gastric residence structure comprising an active substance comprising:
forming a plurality of loadable polymeric components, each loadable polymeric component being formed from one or more polymeric materials and at least one active substance, wherein at least one active substance of at least one loadable polymeric component comprises an antiretroviral agent, and wherein at least one of the plurality of loadable polymeric components comprises at least 10 wt % active substance of the total weight of the at least one loadable polymeric component; and
connecting each of the plurality of loadable polymeric components to a central elastic polymeric component using a separate linker component;
wherein the gastric residence structure is configured to be folded and physically constrained during administration and is configured to assume an open retention shape upon removal of a constraint, wherein change between the folded shape and the open retention shape is mediated by the central elastic polymeric component that undergoes elastic deformation when the residence structure is in the folded shape and recoils when the gastric residence structure assumes the open retention shape; and
wherein the linker component degrades, dissolves, disassociates, or mechanically weakens in a gastric environment which results in loss of retention

Assignees

• Massachusetts Inst Technology
• Brigham & Womens Hospital Inc
• Tokitae Llc

Inventors

• Bellinger Andrew
• Zhang Shiyi
• Traverso Carlo Giovanni
• Langer Robert S
• Mo Stacy
• Grant Tyler
• Jafari Mousa
• Glettig Dean Liang
• Diciccio Angela
• Wood Jr Lowell L
• Eckhoff Philip A

Classifications

• C08L33/02

  Homopolymers or copolymers of acids; Metal or ammonium salts thereof · CPC title

• A61K47/6901

  Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title

• C08L33/08

  Homopolymers or copolymers of acrylic acid esters · CPC title

• A61K31/65

  Tetracyclines · CPC title