# US 9,433,573 B2 · Microfabricated nanopore device for sustained release of therapeutic agent

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- Number: US 9,433,573 B2
- Document ID: US9433573B2
- Status: Granted
- Kind: B2
- Application number: 14/727,581
- Filed: 2015-06-01
- Published: 2015-09-17
- Granted: 2016-09-06
- Earliest claimed: 2001-09-14
- Assignees: Delpor, Inc.
- Applicants: Delpor, Inc.
- Inventors: Francis J. Martin; Anthony A. Boiarski
- Web page: https://patentgrep.com/patent/US9433573B2

## CPC

- A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas}
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61K 9/0097: {Medicinal compositions released by microdevices, e.g. microelectromechanical systems [MEMS], microdevices comprising chips or microdevices on silicon}
- A61K 9/1694: {resulting in granules or microspheres of the matrix type containing more than 5% of excipient}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 38/02: Peptides of undefined number of amino acids; Derivatives thereof
- A61K 38/19: Cytokines; Lymphokines; Interferons
- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- A61K 38/38: Albumins
- A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases
- A61M 5/14276: {specially adapted for implantation}
- A61M 5/16804: {Active flow controllers}
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61P 5/06: of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
- A61P 25/02: for peripheral neuropathies
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 35/00: Antineoplastic agents
- C12Y 302/01017: Lysozyme (3.2.1.17)
- A61M 2207/00: Methods of manufacture, assembly or production
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Y: ENZYMES

## Abstract

A drug delivery device that includes a capsule for implantation into the body; the capsule further includes a reservoir for containing a substance such as a therapeutic agent, at least one port for allowing the substance to diffuse from or otherwise exit the reservoir, and a nanopore membrane in communication with the capsule at or near the exit port for controlling the rate of diffusion of the substance from the exit port. The device also includes an optional screen for providing structural stability to the nanopore membrane and for keeping the pores of the nanopore membrane clear. One embodiment of the drug delivery device includes an osmotic engine internal to the device for creating fluid flow through the device.

## Claims

### Claim 1

A method for delivering a peptide or a protein, comprising
providing a device comprising a capsule for implantation into the body, said capsule comprising a first end, a second end and a fluid impermeable wall extending from the first end to the second end to define a reservoir; said capsule further comprising an exit port in communication with the reservoir and a nanopore membrane in communication with the exit port, wherein said device comprises a peptide or a protein in the reservoir, said peptide or protein having a Stoke's diameter, and wherein said nanopore membrane has pores between about 1-5 times the Stoke's diameter of the peptide or protein, and wherein an amount of the peptide or protein is contained in the reservoir for release at a rate that approaches zero-order release for a period of several weeks.

### Claim 2 (depends on 1)

The method of claim 1, wherein said nanopore membrane comprises an array of parallel, annular channels.

### Claim 3 (depends on 2)

The method of claim 2, wherein channels in the array of parallel, annular channels have a pore size of between 2-100 nm.

### Claim 4 (depends on 1)

The method of claim 1, wherein said nanopore membrane comprises an array of parallel, rectangular channels.

### Claim 5 (depends on 4)

The method of claim 4, wherein channels in the array of parallel, rectangular channels have a width of between 2-100 nm.

### Claim 6 (depends on 1)

The method of claim 1, wherein the peptide or protein is dispersed within said reservoir as an aqueous solution or aqueous suspension.

### Claim 7 (depends on 1)

The method of claim 1, wherein the peptide or protein is in dry form.

### Claim 8 (depends on 1)

The method of claim 1, wherein the peptide or protein is a hormone, a hormone agonist or a hormone antagonist.

### Claim 9 (depends on 1)

The method of claim 1, wherein the peptide or protein is a growth hormone or a cytokine.

### Claim 10 (depends on 1)

The method of claim 1, wherein the peptide or protein is an immune modulator.

### Claim 11 (depends on 1)

The method of claim 1, wherein the peptide or protein is an anti-infective or an anti-inflammatory.

### Claim 12 (depends on 1)

The method of claim 1, wherein the device comprises an internal volume of about 250 μL to about several mLs.

### Claim 13 (depends on 1)

The method of claim 1, wherein the device is about 45-100 mm in length.