# US 10,369,340 B2 · Device and method for sustained release of low water solubility therapeutic agent in solubilizer

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- Number: US 10,369,340 B2
- Document ID: US10369340B2
- Status: Granted
- Kind: B2
- Application number: 14/908,157
- Filed: 2014-08-11
- Published: 2016-06-23
- Granted: 2019-08-06
- Earliest claimed: 2013-08-12
- Assignees: Nanomedical Systems, Inc.
- Applicants: Nanomedical Systems, Inc.
- Inventors: Michael Crowley; Randy Goodall; Lee Hudson
- Web page: https://patentgrep.com/patent/US10369340B2

## CPC

- 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)}
- 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 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K 31/569: substituted in position 17 alpha, e.g. ethisterone
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61M 2205/04: implanted
- 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)}
- 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)

## Abstract

Devices and methods for administering a therapeutic agent, including an implantable delivery device. Exemplary embodiments include a reservoir in fluid communication with a channeled member, and a compound including the therapeutic agent and a solubilizer disposed within the reservoir.

## Claims

### Claim 1

A device for administering a therapeutic agent, the device comprising:
an implantable device comprising a reservoir;
a channeled member in fluid communication with the reservoir; and
a compound comprising the therapeutic agent and a solubilizer disposed within the reservoir and in fluid communication with the channeled member, wherein:
the solubilizer comprises an oil;
the channeled member comprises a nanochannel; and
the nanochannel has a dimension in the range of 150-250 nm.

### Claim 2 (depends on 1)

The device of claim 1 wherein the compound comprises a testosterone ether, ester, or salt.

### Claim 3 (depends on 1)

The device of claim 1 wherein the solubilizer further comprises at least one of: Gelucire 44/14, Gelucire 50/13, Peceol, Labrafil M2125 CS, Labrafil M1944 CS, Labrasol, Tween 80, Crodasol, Brij 30, Glycerox 767, NOVOL (Oleyl Alcohol), ETOCAS (PEG-35 Castor Oil), Arlosolve (Dimethyl lsosobride), PEG300, Maisine 35-1, Transcutol HP, Glycerin, Span 80, Span 85, Compritol 888, Propylene Glycol, Dibutyl Sebacate, Triacetin, Miglyol 810, Miglyol 812, Myvacet, Softigen 701, Softigen 767, Kolliphor HS15, Kolliphor RH40, Kolliphor ELP, Stearic Acid, Cetyl Palmitate, Lauroglycol 90, Lauroglycol FCC, Labrafac PG, Labrafac Lipophile WL 1349, Miranol, soybean oil, corn oil, olive oil, castor oil, sesame oil, light mineral oil, heavy mineral oil, coconut oil, canola oil, dimethyl sulfoxide (DMSO), N-Methylpyrrolidone (NMP), Benzyl Benzoate, Capryol PGMC, Glyceryl Monostearate, Vitamin E TPGS and Benzyl Alcohol.

### Claim 4 (depends on 1)

The device of claim 1 wherein the channeled member comprises microchannels.

### Claim 5 (depends on 1)

The device of claim 1 wherein the device comprises an injection port.

### Claim 6 (depends on 1)

The device of claim 1 wherein the device comprises a vent.

### Claim 7

A method of administering a therapeutic agent, the method comprising:
inserting a device into an area of a human and or animal anatomy, wherein the device comprises:
a reservoir;
a channeled member in fluid communication with the reservoir; and
a compound comprising the therapeutic agent and a solubilizer disposed within the reservoir and in fluid communication with the channeled member, wherein:
the solubilizer comprises an oil;
the channeled member comprises a nanochannel; and
the nanochannel has a dimension in the range of 150-250 nm; and
releasing at least a portion of the therapeutic agent and a portion of the solubilizer comprising the oil from the device into the area of the human or animal anatomy.

### Claim 8 (depends on 7)

The method of claim 7 wherein the device is configured to release the therapeutic agent at a substantially constant release rate for a dosage period of at least one month.

### Claim 9 (depends on 7)

The method of claim 7 wherein the device is configured to release the therapeutic agent at a substantially constant release rate for a dosage period of at least six months.

### Claim 10 (depends on 7)

The method of claim 7, wherein the device is configured to release the therapeutic agent at a substantially constant release rate for a dosage period of at least one year.

### Claim 11 (depends on 7)

The method of claim 7 wherein the compound comprises a testosterone ether, ester, or salt.

### Claim 12 (depends on 7)

The method of claim 7 wherein the solubilizer further comprises at least one of: Gelucire 44/14, Gelucire 50/13, Peceol, Labrafil M2125 CS, Labrafil M1944 CS, Labrasol, Tween 80, Crodasol, Brij 30, Glycerox 767, NOVOL (Oleyl Alcohol), ETOCAS (PEG-35 Castor Oil), Arlosolve (Dimethyl Isosobride), PEG300, Maisine 35-1, Transcutol HP, Glycerin, Span 80, Span 85, Compritol 888, Propylene Glycol, Dibutyl Sebacate, Triacetin, Miglyol 810, Miglyol 812, Myvacet, Softigen 701, Softigen 767, Kolliphor HS15, Kolliphor RH40, Kolliphor ELP, Stearic Acid, Cetyl Palmitate, Lauroglycol 90, Lauroglycol FCC, Labrafac PG, Labrafac Lipophile WL 1349, Miranol, soybean oil, corn oil, olive oil, castor oil, sesame oil, light mineral oil, heavy mineral oil, coconut oil, canola oil, dimethyl sulfoxide (DMSO), N-Methylpyrrolidone (NMP), Benzyl Benzoate, Capryol PGMC, Glyceryl Monostearate, Vitamin E TPGS and Benzyl Alcohol.