Shape changing drug delivery devices and methods

Patent metadata

Field	Value
Publication number	US-2022339108-A1
Application number	US-202217859820-A
Country	US
Kind code	A1
Filing date	Jul 7, 2022
Priority date	Nov 25, 2015
Publication date	Oct 27, 2022
Grant date	—

Abstract

Drug delivery using bio-affecting drugs, particularly with shape changing drug delivery devices. Embodiments are included for depots for delivery of a therapeutic agent that change from an elongated state ex vivo to a coil in vivo where the agent is released.

First claim

1 . A method of ocular delivery of a therapeutic agent to a patient comprising introducing a device for drug delivery to an ocular placement site, wherein the device comprises a therapeutic agent disposed in a solid vehicle that comprises a first xerogel and a second xerogel, wherein the first xerogel is a rod and the second xerogel is a layer on the first xerogel, wherein the first xerogel and the second xerogel differentially swell and/or elongate to change the rod into a curve shape in response to a physiological fluid of the tissue, wherein the solid vehicle provides a controlled release of the therapeutic agent.

2 . The method of claim 1 wherein the ocular placement site comprises in an eye, into a conjunctiva, on a cornea, on a sclera, inside a sclera, on an interior wall of an eye, intraocular, intravitreal, on a retina, near a retina but not touching a retina, suprachoroidal, in the choroid, in a potential space, in a lumen created to receive the vehicle, in a chamber of an eye, in the posterior chamber, in contact with vitreous humor, in the hyaline canal, in a vitreous humor, in an aqueous humor, or at a tissue.

3 . The method of claim 1 wherein the rod comprises a fiber, a ribbon, a cylindrical rod, or a braided strand.

4 . The method of claim 1 wherein the solid vehicle has an aspect ratio of at least 1:10.

5 . The method of claim 1 wherein the curve shape comprises a coil, a spiral, or a helix.

6 . The method of claim 5 with the solid vehicle forming the coil within 30 seconds of introducing.

7 . The method of claim 1 wherein the first xerogel has a first coefficient of elongation and/or a first coefficient of swelling in aqueous solution and the second xerogel has a second coefficient of elongation and/or a second coefficient of swelling in aqueous solution, with the first and the second coefficients being different.

8 . The method of claim 1 wherein the first xerogel has a first coefficient of elongation in aqueous solution and the second xerogel has a second coefficient of elongation in aqueous solution, wherein the first coefficient of elongation is less than 1 and the second coefficient of elongation is at least 1.

9 . The method of claim 7 wherein the first coefficient of elongation is from 0.1 to 0.5 and the second coefficient of elongation is from 1 to 10.

10 . The method of claim 7 wherein the first coefficient of swelling is from 1.0 to 2.0 and the second coefficient of swelling is from 2.0 to 10.

11 . The method of claim 1 wherein the vehicle is biodegradable.

12 . The method of claim 1 wherein the first xerogel and the second xerogel at the ocular placement site degrade at a rate independently selected from 2 days to 5 years.

13 . The method of claim 1 wherein the first xerogel comprises at least a first crosslinked polymer and the second xerogel comprises at least a second crosslinked polymer.

14 . The method of claim 1 wherein the first xerogel and the second xerogel are independently selected from the group consisting of natural, synthetic, and biosynthetic polymers.

15 . The method of claim 1 wherein the xerogel and the second xerogel are joined by covalent bonds.

16 . The method of claim 1 wherein introducing comprises deploying the vehicle from an applicator.

17 . The method of claim 1 wherein the therapeutic agent has a solubility in aqueous solution of no more than 10 micrograms per milliliter, is a protein with MW greater than 1000 Da, or is encapsulated in a microparticle.

18 . The method of claim 1 wherein the therapeutic agent comprises an anti-angiogenic agent, a tyrosine kinase inhibitor, an anti-VEGF agent, an anti-PDGF agent, an anti-Ang2 agent, a steroid, an NSAID, an anti-cancer drug, an antibody, an antibody fragment, a steroid, a corticosteroid, a PDGF inhibitor, a visualization agent, or combinations thereof.

19 . The method of claim 1 wherein the therapeutic agent comprises one or more of trimacinalone, trimacinalone acetonide, dexamethasone, dexamethasone acetate, fluocinolone, fluocinolone acetate, loteprednol etabonate, or analogues thereof.

20 . The method of claim 1 wherein the therapeutic agent is for treatment of an eye disease or an eye condition.

Assignees

• Incept Llc

Inventors

• Jarrett Peter
• Mcgrath Michael J
• Jarrett Timothy S
• El-Hayek Rami
• Vanslette Andrew C
• Rosales Courtney A
• Blizzard Charles D
• Sawhney Amarpreet S

Classifications

• A61K9/0051 Primary

  Ocular inserts or implants · CPC title

• A61K31/4439

  containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) · CPC title

• A61K9/2031

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers · CPC title

• A61K47/10 Primary

  Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers · CPC title

• A61P27/02

  Ophthalmic agents · CPC title