# US 10,500,200 B2 · Drug delivery systems and methods for treatment of bladder dysfunction or disorder using trospium

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- Number: US 10,500,200 B2
- Document ID: US10500200B2
- Status: Granted
- Kind: B2
- Application number: 14/658,699
- Filed: 2015-03-16
- Published: 2015-07-02
- Granted: 2019-12-10
- Earliest claimed: 2012-09-18
- Assignees: TARIS Biomedical LLC
- Applicants: TARIS Biomedical LLC
- Inventors: Dennis Giesing
- Web page: https://patentgrep.com/patent/US10500200B2

## CPC

- A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- 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 13/00: Drugs for disorders of the urinary system
- A61P 13/10: of the bladder
- 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

Methods, devices, and medicaments that include trospium are provided for use in the treatment of bladder dysfunction by locally administering the trospium into the bladder to achieve a sustained concentration of trospium in urine in the bladder sufficient to produce a therapeutic concentration of trospium in bladder tissue. The drug may be delivered into the bladder from an intravesical drug delivery device inserted into the bladder, wherein the device continuously releases the drug into the urine in the bladder over an extended period of hours or days.

## Claims

### Claim 1

A method of administering trospium to a patient in need of treatment of overactive bladder, the method comprising:
locally administering trospium into the bladder of a patient to achieve a sustained concentration of trospium in urine in the bladder sufficient to produce a therapeutic concentration of trospium in bladder tissue over a treatment period from 1 week to 6 months,
wherein the locally administering into the patient's bladder is from an intravesical drug delivery device which continuously releases the trospium into the urine in the bladder at a mean average amount of from 0.15 mg/day to about 15 mg/day over the treatment period,
wherein the sustained concentration of trospium in urine in the bladder is from 0.05 μg/ml to 100 μg/ml continuously over the treatment period.

### Claim 2 (depends on 1)

The method of claim 1, wherein the trospium is released from the intravesical drug delivery device by diffusion to through a wall of the device, by diffusion to through one or more defined apertures in a wall of the device, by osmotic pressure through an aperture in the device, or a combination thereof.

### Claim 3 (depends on 1)

The method of claim 1, further comprising administering a second therapeutic agent to the patient.

### Claim 4 (depends on 3)

The method of claim 3, wherein the second therapeutic agent is administered intravesically.

### Claim 5 (depends on 1)

The method of claim 1, wherein the sustained concentration of trospium in urine in the bladder is from 0.1 μg/ml to 100 μg/ml continuously over the treatment period.

### Claim 6 (depends on 1)

The method of claim 1, wherein the sustained concentration of trospium in urine in the bladder is from 10 μg/ml to 100 μg/ml continuously over the treatment period.

### Claim 7 (depends on 1)

The method of claim 1, wherein the sustained concentration of trospium in urine in the bladder is from 1 μg/ml to 10 μg/ml continuously over the treatment period.