# US 12,109,301 B2 · Formulations, methods, and systems for treating genitourinary conditions

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- Number: US 12,109,301 B2
- Document ID: US12109301B2
- Status: Granted
- Kind: B2
- Application number: 18/055,595
- Filed: 2022-11-15
- Published: 2023-03-16
- Granted: 2024-10-08
- Earliest claimed: 2017-04-14
- Assignees: Massachusetts Institute of Technology; The General Hospital Corporation
- Applicants: Massachusetts Institute of Technology; The General Hospital Corporation
- Inventors: Xiang Li; Michael J. Cima; Brian H. Eisner
- Web page: https://patentgrep.com/patent/US12109301B2

## CPC

- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/0002: {Galenical forms characterised by the drug release technique; Application systems commanded by energy}
- A61K 31/415: 1,2-Diazoles
- A61K 31/4409: only substituted in position 4, e.g. isoniazid, iproniazid
- A61K 31/4422: 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
- A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine
- A61P 13/00: Drugs for disorders of the urinary system
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Provided are formulations and methods for treating one or more genitourinary conditions. The formulations may include a therapeutic agent that includes a calcium channel blocker, a rho kinase inhibitor, or a combination thereof. The methods may include locally administering a therapeutic agent into a ureter. Systems for delivering a therapeutic agent also are provided.

## Claims

### Claim 1

A formulation for local administration to a ureter of a patient, the formulation comprising:
a therapeutic agent selected from a calcium channel blocker, a rho kinase inhibitor, or a combination thereof; and
one or more pharmaceutically acceptable excipients,
wherein the formulation is suitable for local administration into the ureter, the formulation is configured to delay passage of the formulation from the ureter, and the formulation is in the form of a liquid solution or a viscous vehicle.

### Claim 2 (depends on 1)

The formulation of claim 1, wherein the therapeutic agent comprises the calcium channel blocker and the rho kinase inhibitor.

### Claim 3 (depends on 1)

The formulation of claim 1, wherein the calcium channel blocker is nifedipine.

### Claim 4 (depends on 1)

The formulation of claim 1, wherein the rho kinase inhibitor is Y-27632.

### Claim 5 (depends on 1)

The formulation of claim 1, wherein the one or more pharmaceutically acceptable excipients comprises a matrix material configured to control the rate of release of the therapeutic agent.

### Claim 6 (depends on 5)

The formulation of claim 5, wherein the matrix material is a resorbable or non-resorbable polymer.

### Claim 7 (depends on 5)

The formulation of claim 5, wherein the matrix material comprises a hydrogel.

### Claim 8

A drug delivery system comprising:
a delivery device, comprising at least a part thereof which is configured for insertion into a ureter of a patient; and
a formulation comprising a therapeutic agent selected from a calcium channel blocker, a rho kinase inhibitor, or a combination thereof, and wherein the formulation is in the form of a liquid solution or a viscous vehicle,
wherein the delivery device is configured to deliver the therapeutic agent to the ureter in an amount effective to relax human ureteral smooth muscle in vivo.

### Claim 9 (depends on 8)

The drug delivery system of claim 8, wherein the formulation is configured to delay passage of the formulation from the ureter.

### Claim 10 (depends on 8)

The drug delivery system of claim 8, wherein the device provides prolonged exposure of the therapeutic agent to the ureter.

### Claim 11 (depends on 8)

The drug delivery system of claim 8, wherein the delivery device comprises a cystoscope, a catheter, or a drug eluting stent.

### Claim 12 (depends on 8)

The drug delivery system of claim 8, wherein the delivery device comprises a transurethral catheter having a distal end portion configured for insertion into a ureter.

### Claim 13 (depends on 8)

The drug delivery system of claim 8, wherein the therapeutic agent comprises the calcium channel blocker and the rho kinase inhibitor.

### Claim 14 (depends on 8)

The drug delivery system of claim 8, wherein the calcium channel blocker is nifedipine.

### Claim 15 (depends on 12)

The drug delivery system of claim 12, wherein the rho kinase inhibitor is Y-27632.