Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
1999-03-29
2001-07-17
Williamson, Michael A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C424S464000, C424S468000, C424S474000, C424S475000, C424S479000, C424S480000, C424S484000, C424S486000, C424S488000
Reexamination Certificate
active
06262115
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to the management of incontinence. More specifically the invention relates to the management of incontinence by administering to a patient having the symptoms of incontinence a therapeutically effective dose of oxybutynin alone, in combination with another drug, proceeded by the administration of another drug, or followed by the administration of another drug.
BACKGROUND OF THE INVENTION
Many people are affected by urinary incontinence. Incontinence is particularly common in the elderly, urinary incontinence is present in approximately fifty percent of nursing home patients, and urinary incontinence is a well known urologic problem in women. It will affect nearly all women in some form during their lifetime, and it is of significant medical and social concern to all humans who experience it. Urinary incontinence arises from the anatomy and from the physiology of the urinary tract, which is composed of a bladder and a sphincter. Anatomically, the bladder consists of the bladder musculature, also known as detrusor, and the trigone. The sphincter includes the bladder neck and the proximal urethra. The detrusor muscle is innervated by the pelvic nerve through the parasympathetic nervous system, and the bladder neck and proximal urethra are innervated by the sympathetic nervous system.
The major functions of the bladder are the storage and expulsion of urine. The bladder is responsible for accommodating increasing volumes of urine at low pressures. Normally, the bladder remains closed during bladder filling and continence is maintained as long as the bladder neck and urethral pressure exceeds intravesical pressure. Voluntary voiding occurs when intravesical pressure exceeds bladder neck and urethral pressure, and involuntary voiding also known as involuntary incontinence occurs when the travesical pressure exceeds the bladder neck and urethral pressure. Involuntary incontinence also known as urge incontinence and overactive bladder, occurs with a loss of a large volume of urine accompanied by symptoms of urgency, frequency and nocturia caused by an unstable bladder or detrusor instability. The patient may lose urine with a change in position or with auditory stimulation. The loss of small volumes of urine usually occurs because bladder over distension by a large amount of residual urine referred to as overflow incontinence. Urinary incontinence is also known as overactive bladder with symptoms of urinary frequency or urge incontinence.
The present management of incontinence consists in administering a smooth muscle relaxant, such as oxybutynin, which acts directly on the smooth muscle at the site distal to the cholinergic receptor. The prior art administered oxybutynin alone for this stated therapeutic purpose. The prior art usual dose for the pharmacologic management of incontinence is repeated, nonsustained and noncontrolled doses from two-to-four times a day for oxybutynin. The prior art administered separately the steriods, estrogen and/or progesterone hormone replacement therapy however, this steroid therapy is insufficient for the management of incontinence.
In light of the above presentation it will be appreciated by those versed in the medical and pharmaceutical dispensing arts to which this invention pertains that a pressing need exists for a therapeutic method that can deliver the therapeutic drug oxybutynin in a controlled, sustained-extended dose to a patient in clinical need of incontinence management. The pressing need exists for an oral method of therapy that can deliver oxybutynin alone at a substantially sustained release constant dose per unit time for its therapeutic effect. The need exists additionally for a method for delivering a dose of oxybutynin once-a-day, when indicated, for its intended therapy while avoiding an overdose and for lessening the side effects that can accompany the drug. The pressing need exists further for a method that can administer oxybutynin in combination with another and different drug, or in different therapeutic programs for the management of incontinence and for the management of health and disease.
It will be appreciated by those skilled in the medical and pharmaceutical arts to which this invention pertains, that if a novel and unique method of administration is made available that delivers oxybutynin alone, or in combination with another drug in a therapeutically effective dose over a sustained time for the management of incontinence, while lessening the incidence of over and under dose, such a method of therapy would represent an advancement and a valuable contribution for providing practical therapy.
SUMMARY OF THE INVENTION
According to the invention, it is an object of the invention to provide a method for the management of urinary incontinence with oxybutynin and/or its pharmaceutically acceptable salt alone, or in combination with another drug, or preceeded by or followed by the administration of another drug, for the management of incontinence in human male and female patients. The object of the invention further comprises a method for administering oxybutynin alone, and/or in combination with or preceded by or followed by an estrogen and/or a progestin for treating urinary incontinence in pregnant, nonpregnant, postpartum, menopause, post menopausal, and during climaterix period of change occurring in the transition to menopause in a patient in need of therapy.
DETAILS OF THE INVENTION
The scientific terms and scientific phrases used in this specification embrace the following definitions: Dosage form denotes a drug delivery system for administering a therapeutically effective dose of drug, for example oxybutynin to a patient in need of therapy. The dosage form may be administered once-daily, that is, as a once-a-day dosage form for increasing patient compliance for treating overactive bladder, or more frequently as indicated by a physician, for example twice-daily or thrice-daily. Sustained release denotes the constant delivery of drug for up to twenty-hours. Controlled release denotes the delivery of the drug at a rate controlled by a dosage form by the method of the invention. Zero-order release denotes the method of delivery of drug at a uniform rate to dampen the peaks and valleys observed in non-zero order method of drug delivery. Therapeutically effective amount denotes the dose of delivered drug sufficient to provide a local or a systemic effect in a patient. Menopause denotes the period of natural cessation of menstruation in the female. Post menopausal denotes the time occurring after menopause. Pregnancy denotes the state of containing an unborn fetus within the female. Postpartum denotes the period following birth.
The present invention provides a therapeutic composition comprising 240 ng to 650 mg (nanogram to milligrams) of oxybutynin or an oxybutynin therapeutically acceptable salt. The pharmaceutically acceptable salt is selected from the group consisting of acetate, bitartrate, citrate, edetate, chloride, edisylate, estolate, esylate, fumarate, gluceptate, gluconate, glutamate, hydrobromide, hydrochloride, lactate, malate, maleate, mandelate, mesylate, methylnitrate, mucate, napsylate, nitrate, pamoate, pantothenate, phosphate, salicylate, stearate, succinate, sulfate, tannate, and tartrate. The drug oxybutynin can be present as the racemate, as the R-enantiomer or as the S-enantiomer. The oxybutynin and its pharmaceutically acceptable salt can be administered at a controlled mean release rate of 0.10 ng per hour to 25 mg per hour for the management of incontinence up to 24 hours. The dosage forms provided by the invention can administer oxybutynin in doses such as 5 mg, 10 mg, 15 mg, 20 mg etc. for the management of incontinence. The oxybutynin can be administered alone, or in therapeutic programs with another and different drug, from the same dosage form or from different dosage forms.
Representative of a drug, for example a steroid, that can be administered with prior to or followed by the administration of oxybutynin, according to the method of the inve
Guittard George V.
Gumucio Fernando E.
Jao Francisco
Kidney David J.
Marks Susan M.
ALZA Coporation
Dhuey John A.
Stone Steven F.
Williamson Michael A.
LandOfFree
Method for the management of incontinence does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for the management of incontinence, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for the management of incontinence will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2502218