# US 11,896,742 B2 · Compositions and devices incorporating water-insoluble therapeutic agents and methods of the use thereof

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- Number: US 11,896,742 B2
- Document ID: US11896742B2
- Status: Granted
- Kind: B2
- Application number: 17/360,329
- Filed: 2021-06-28
- Published: 2021-12-16
- Granted: 2024-02-13
- Earliest claimed: 2014-08-07
- Assignees: Cook Medical Technologies LLC
- Applicants: Cook Medical Technologies LLC
- Inventors: John Jackson; Lindsay Stuart Machan; Kevin Letchford
- Web page: https://patentgrep.com/patent/US11896742B2

## CPC

- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61L 27/34: Macromolecular materials
- A61L 27/44: having a macromolecular matrix
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 29/08: Materials for coatings
- A61L 29/085: {Macromolecular materials}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/08: Materials for coatings
- A61L 31/10: Macromolecular materials
- A61M 25/09: Guide wires
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61P 11/06: Antiasthmatics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 35/00: Antineoplastic agents
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/426: Immunomodulating agents, i.e. cytokines, interleukins, interferons
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2300/606: Coatings
- A61L 2300/61: containing two or more active agents in different layers
- A61L 2420/06: Coatings containing a mixture of two or more compounds
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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

## Abstract

Various aspects of the present invention provide compositions and implantable devices including a water-insoluble therapeutic agent solubilized in a matrix of a gallate-containing compound. Other aspects provide methods of manufacturing and using such compositions and devices.

## Claims

### Claim 1

A composition comprising:
a therapeutic preparation comprising a gallate containing compound and a water-insoluble therapeutic agent at least partly dissolved in a solid phase of the gallate containing compound, where the gallate containing compound is present in an amount by weight equal to or greater than the amount by weight of the water-insoluble therapeutic agent.

### Claim 2 (depends on 1)

The composition of claim 1, where the gallate containing compound is selected from a group consisting of epi gallo catechin gallate, tannic acid, and epi catechin gallate.

### Claim 3 (depends on 1)

The composition of claim 1, where the gallate containing compound is epi gallo catechin gallate.

### Claim 4 (depends on 1)

The composition of claim 1, where the gallate containing compound and the water-insoluble therapeutic agent are contained within a matrix of a polymeric microparticle.

### Claim 5 (depends on 4)

The composition of claim 4, where the polymeric matrix comprises a biodegradable polymer.

### Claim 6 (depends on 4)

The composition of claim 4, where the polymeric matrix comprises a non-biodegradable polymer.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the water-insoluble therapeutic agent is selected from the group consisting of antiproliferative agents immunosuppressive agents, restenosis-inhibiting agents, anti-cancer agents, analgesics/antipyretics, anesthetics, antiasthmatics, antibiotics, antidepressants, antidiabetics, antifungal agents, antihypertensive agents, anti-inflammatories, antineoplastics, antianxiety agents, sedatives/hypnotics, antianginal agents, nitrates, antipsychotic agents, antimanic agents, antiarrhythmics, antiarthritic agents, antigout agents, thrombolytic agents, hemorheologic agents, anticonvulsants, antihistamines, agents useful for calcium regulation, antibacterial agents, antiviral agents, antimicrobials, anti-infectives, bronchodilators, steroids and hormones.

### Claim 8 (depends on 1)

The composition of claim 1, where the water-insoluble therapeutic agent is paclitaxel.

### Claim 9 (depends on 1)

The composition of claim 1, where the water-insoluble therapeutic agent is docetaxel.

### Claim 10 (depends on 1)

The composition of claim 1, where the water-insoluble therapeutic agent is sirolimus.

### Claim 11 (depends on 1)

The composition of claim 1, where the water-insoluble therapeutic agent is amphotericin.

### Claim 12 (depends on 1)

The composition of claim 1, where the preparation is encapsulated in a polymer.

### Claim 13

A composition comprising:
a therapeutic preparation comprising a gallate containing compound and a water-insoluble therapeutic agent, where the water-insoluble therapeutic agent is at least partly dissolved in a solid phase of the gallate containing compound.

### Claim 14 (depends on 13)

The composition of claim 13, where the gallate containing compound is selected from a group consisting of epi gallo catechin gallate, tannic acid, and epi catechin gallate.

### Claim 15 (depends on 13)

The composition of claim 13, where the gallate containing compound is epi gallo catechin gallate.

### Claim 16 (depends on 13)

The composition of claim 13, where the water-insoluble therapeutic agent is solubilized within a matrix of the gallate containing compound.

### Claim 17 (depends on 13)

The composition of claim 13, where the therapeutic preparation comprises a solid or semi solid matrix of the gallate containing compound and the water-insoluble therapeutic agent.

### Claim 18 (depends on 13)

The composition of claim 13, where the therapeutic preparation is encapsulated in a polymer.

### Claim 19 (depends on 13)

The composition of claim 13, wherein the water-insoluble therapeutic agent is selected from the group consisting of antiproliferative agents immunosuppressive agents, restenosis-inhibiting agents, anti-cancer agents, analgesics/antipyretics, anesthetics, antiasthmatics, antibiotics, antidepressants, antidiabetics, antifungal agents, antihypertensive agents, anti-inflammatories, antineoplastics, antianxiety agents, sedatives/hypnotics, antianginal agents, nitrates, antipsychotic agents, antimanic agents, antiarrhythmics, antiarthritic agents, antigout agents, thrombolytic agents, hemorheologic agents, anticonvulsants, antihistamines, agents useful for calcium regulation, antibacterial agents, antiviral agents, antimicrobials, anti-infectives, bronchodilators, steroids and hormones.

### Claim 20

A composition comprising:
a therapeutic preparation comprising a gallate containing compound and a water-insoluble therapeutic agent, where the water-insoluble therapeutic agent is solubilized within a matrix of the gallate containing compound to form a solid solution.