Device and method for treating urinary incontinence in females

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert

Reexamination Certificate

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92, C514S534000

Reexamination Certificate

active

06436428

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a new and useful device and method that utilizes trifluoropropylmethyl/dimethyl siloxane elastomer to locally deliver oxybutynin in a controlled manner for treating urinary incontinence for up to twenty-eight contiguous days, or as needed.
BACKGROUND OF THE INVENTION
Urinary incontinence is a debilitating disorder which afflicts at least 15% of the elderly population, and is present in approximately 50% of institutionalized elderly persons. Indeed, many elderly people are institutionalized because of their urinary incontinence. The costs for caring for such patients is extremely high, particularly since they require constant monitoring and changing of their clothes and bedding.
The elderly, however, are not the only group of the population that suffers from urinary incontinence. This disorder is also prevalent in postmenopausal women. In particular, pelvic relaxation due to childbirth can cause uterine prolapse and cystocele, which allows descent of the normal urethrovesical angle and contributes to urinary incontinence. The ramifications of the natural aging process in women, such as decreased levels of estrogen, also may result in urinary incontinence.
The therapeutic effect of oxybutynin (4-diethylamino-2-butynylphenylcyclohexylglycolate), which is described in the 1992 Physician's Desk Reference, pages 1332-1333 (with reference to the drug “DITROPAN” manufactured by Marion Merrill Dow), is well documented [Yarker, Y. E., Goe, K. L. & Fitton, A., Oxybutynin: A Review of its Pharmacodynamic and Pharmacokinetic Properties, and its Therapeutic Use in Detrusor Stability. Drugs & Aging 6(3):243-265 (1995)]. In particular, oxybutynin has an anticholinergic and spasmolytic effect on the bladder that leads to relaxation of the detrusor muscle, fewer spontaneous contractions, a decrease in the frequency and urge to urinate, and increased bladder-filling capacity.
Traditionally, oxybutynin has been administered orally at relatively high doses (5 mg tablets taken two to four times a day). Oxybutynin has also been incorporated into tablets, capsules, granules and pills containing 1-5 mg, preferably 5 mg of oxybutynin chloride, and syrups containing 1-5 mg, preferably 5 mg of oxybutynin chloride per 5 ml, and transdermal compositions (creams or ointments) containing 1-10 weight percent (wt %) oxybutynin chloride. Such administration techniques inherently permit oxybutynin to circulate throughout the body. Unfortunately however, oxybutynin has deleterious side effects when administered systemically. More specifically, anticholinergic side effects such as dry mouth, dry eyes, blurred vision, constipation, and headaches have been observed when oxybutynin is orally delivered. Moreover, N-desethyloxybutynin, a metabolite of oxybutynin produced in the liver, has similar antimuscarinic activity, and hence can have much of the same effects as oxybutynin both on the bladder's detrusor muscle and in other organs [Yarker, et al; Westlin, L., Anticholinergic Effects of Two Metabolites of Oxybutynin, Research Report No. 840625F, data on file, Smith and Nephew Pharmaceuticals, Ltd., 1985; Hughes, K. M., Lang, J. C. T., Lazare, R., et al., Measurement of Oxybutynin and its N-desethyl metabolite in Plasma, and its Application to Pharmacokinetic Studies in Young, Elderly and Frail Volunteers. Xenobiotica 22(7):859-69 (1992); Waldeck, K., Larsson, B., Andersson, K. E., Comparison of Oxybutynin and its Active Metabolite, N-desethyloxybutynin, in the Human Detrusor and Parotid Gland. Jnl. Of Urology 157:1093-97 (1997)]. Oral administration in particular has been shown to result in peak blood concentrations of the metabolite that are 6-9 times higher than the concentration of oxybutynin itself. Furthermore, the area under the plasma time concentration curve (or AUC, which measures the gross amount of drug present over time) is also higher for the metabolite (10-12 times) than for oxybutynin.
In order to ameliorate the effects of oxybutynin in the body and to limit the production of metabolite, efforts have been made to administer oxybutynin intravesically. Such delivery has demonstrated that oxybutynin can be delivered directly to the bladder of a patient, limit the circulation of oxybutynin in the body, and the deleterious side effects. However, intravesical delivery possesses inherent limitations. Initially, intravesical administration occurs through a catheter 3-4 times a day, and therefore is a cumbersome modality suited only to relatively immobile patients. Another limitation is that such delivery is uncomfortable to the patient. A major limitation of intravesical administration is that this method is simply not suited to frequent, long term use for most incontinence suffers.
Accordingly, what is needed is a new and useful device which delivers oxybutynin locally, i.e., directly to the detrusor muscle, in a controlled manner, and does not rely solely upon the body's circulatory system for such delivery. As a result, systemic circulation of oxybutynin and its metabolite to other body sites can be limited.
What is also needed is a new and useful device which is capable of locally delivering and controllably releasing a therapeutically effective amount of oxybutynin to a patient's detrusor muscle for up to twenty-eight (28) contiguous days. The citation of any reference herein should not be construed as an admission that such reference is available as “Prior Art” to the instant application.
SUMMARY OF THE INVENTION
There is provided, in accordance with the present invention, a device and method for locally delivering and controllably releasing a therapeutically effective amount of oxybutynin to the detrusor muscle in order to treat urinary incontinence in a female.
Broadly, the present invention extends to a device for locally delivering and controllably releasing oxybutynin to the cervical region of a female to treat urinary incontinence, wherein the device comprises a ring having a surface, and a bore running from the surface into the ring, wherein the ring comprises trifluoropropylmethyl/dimethyl siloxane elastomer. The ring of a device of the invention has a sufficient size such that it can be inserted into the vaginal canal of the female. Furthermore, a device of the invention comprises a pharmaceutical composition located within the bore, wherein the pharmaceutical composition comprises oxybutynin and an excipient. A device of the present invention also comprises a cap on the bore at the surface of the ring, wherein the cap prevents the pharmaceutical composition from diffusing out of the bore at the surface of the ring. Upon insertion of the ring into the vaginal canal, oxybutynin is controllably released from the ring in a therapeutically effective amount to treat the urinary incontinence.
A ring of a device of the invention can further comprise a first portion comprising trifluoropropylmethyl/dimethyl siloxane elastomer having a bore therein, and a second portion comprising a material into which oxybutynin is insoluble, such as a barium sulfate composite. A ring of a device of the invention can also comprise a first portion comprising trifluoropropylmethyl/dimethyl siloxane elastomer having a bore running from the surface of the first portion into the first portion, a second portion comprising polydimethylsiloxane elastomer, or a barium sulfate composite, and at least two shields located between the first and second portions, wherein the at least two shields comprise a material into which oxybutynin is insoluble, e.g., a barium sulfate composite or polytetrafluorethylene (PTFE). The two shields intersect the first and second portions, and prevent contact between the first and second portions. In a particular embodiment, the one bore intersects the surface of the first portion twice, and is capped at both ends with caps described above. As a result, the trifluoropropylmethyl/dimethyl siloxane elastomer of the first portion controllably releases oxybutynin contained within the bore, and the barium sulfa

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