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(12) Patent Application Publication (10) Pub. No.: US 2004/0037881 A1 Guittard Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2004/0037881 A1 Guittard Et Al US 2004OO37881A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0037881 A1 Guittard et al. (43) Pub. Date: Feb. 26, 2004 (54) METHOD FOR THE MANAGEMENT OF Continuation-in-part of application No. 08/806,773, INCONTINENCE filed on Feb. 26, 1997, now Pat. No. 5,912,268, which is a continuation-in-part of application No. 08/706, (76) Inventors: George V. Guittard, Cupertino, CA 576, filed on Sep. 5, 1996, now Pat. No. 5,840,754, (US); Francisco Ja, San Jose, CA (US); which is a continuation-in-part of application No. Susan M. Marks, San Jose, CA (US); 08/445,849, filed on May 22, 1995, now Pat. No. David J. Kidney, Palo Alto, CA (US); 5,674,895. Fernando E. Gumucio, San Jose, CA (US) Publication Classification Correspondence Address: (51) Int. Cl.' .................. A61K 31/7024; A61K 31/205; PHILIP S. JOHNSON A61K 9/22 JOHNSON & JOHNSON (52) U.S. Cl. ............................. 424/468; 514/23: 514/554 ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 (US) (57) ABSTRACT Appl. No.: 10/645,467 (21) A composition and a dosage form are disclosed comprising (22) Filed: Aug. 20, 2003 Oxybutynin alone/or accompanied by another drug indicated for therapy. A method is disclosed for administering oxy Related U.S. Application Data butynin alone/or accompanied by a different drug or for administering oxybutynin and a different drug according to (63) Continuation of application No. 09/785,805, filed on a therapeutic program for the management of incontinence Feb. 16, 2001. alone, and for other therapy. US 2004/0037881 A1 Feb. 26, 2004 METHOD FOR THE MANAGEMENT OF 0005 The present management of incontinence consists INCONTINENCE in administering a Smooth muscle relaxant, Such as Oxybu tynin, which acts directly on the Smooth muscle at the Site CROSS-REFERENCE TO RELATED distal to the cholinergic receptor. The prior art administered APPLICATION Oxybutynin alone for this Stated therapeutic purpose. The prior art usual dose for the pharmacologic management of 0001. This application is a continuation-in-part of U.S. incontinence is repeated, nonsustained and noncontrolled patent application Ser. No. 08/806,773 filed Feb. 26, 1997, doses from two-to-four times a day for oxybutynin. The which application is a continuation-in-part of U.S. patent prior art administered separately the Steriods, estrogen and/ application Ser. No. 08/706,576 filed Sep. 5, 1996, now U.S. or progesterone hormone replacement therapy however, this Pat. No. 5,840,754 issued Nov. 24, 1998, which is a con Steroid therapy is insufficient for the management of incon tinuation-in-part of U.S. patent application Ser. No. 08/445, tinence. 849 filed May 22, 1995, now U.S. Pat. No. 5,674,895 issued Oct. 7, 1997, benefit is claimed of these applications, that are 0006. In light of the above presentation it will be appre assigned to the ALZA Corporation of Palo Alto, Calif. ciated by those versed in the medical and pharmaceutical dispensing arts to which this invention pertains that a FIELD OF THE INVENTION pressing need exists for a therapeutic method that can deliver the therapeutic drug oxybutynin in a controlled, 0002 This invention pertains to the management of Sustained-extended dose to a patient in clinical need of incontinence. More Specifically the invention relates to the incontinence management. The pressing need exists for an management of incontinence by administering to a patient oral method of therapy that can deliver oxybutynin alone at having the Symptoms of incontinence a therapeutically a Substantially Sustained release constant dose per unit time effective dose of oxybutynin alone, in combination with for its therapeutic effect. The need exists additionally for a another drug, proceeded by the administration of another method for delivering a dose of oxybutynin once-a-day, drug, or followed by the administration of another drug. when indicated, for its intended therapy while avoiding an Overdose and for lessening the Side effects that can accom BACKGROUND OF THE INVENTION pany the drug. The pressing need exists further for a method 0003. Many people are affected by urinary incontinence. that can administer Oxybutynin in combination with another Incontinence is particularly common in the elderly, urinary and different drug, or in different therapeutic programs for incontinence is present in approximately fifty percent of the management of incontinence and for the management of nursing home patients, and urinary incontinence is a well health and disease. known urologic problem in women. It will affect nearly all 0007. It will be appreciated by those skilled in the medi Women in Some form during their lifetime, and it is of cal and pharmaceutical arts to which this invention pertains, Significant medical and Social concern to all humans who that if a novel and unique method of administration is made experience it. Urinary incontinence arises from the anatomy available that delivers oxybutynin alone, or in combination and from the physiology of the urinary tract, which is with another drug in a therapeutically effective dose over a composed of a bladder and a Sphincter. Anatomically, the Sustained time for the management of incontinence, while bladder consists of the bladder musculature, also known as lessening the incidence of over and under dose, Such a detrusor, and the trigone. The Sphincter includes the bladder method of therapy would represent an advancement and a neck and the proximal urethra. The detrusor muscle is valuable contribution for providing practical therapy. innervated by the pelvic nerve through the parasympathetic nervous System, and the bladder neck and proximal urethra SUMMARY OF THE INVENTION are innervated by the Sympathetic nervous System. 0008 According to the invention, it is an object of the 0004. The major functions of the bladder are the storage invention to provide a method for the management of and expulsion of urine. The bladder is responsible for urinary incontinence with oxybutynin and/or its pharmaceu accommodating increasing Volumes of urine at low pres tically acceptable Salt alone, or in combination with another Sures. Normally, the bladder remains closed during bladder drug, or preceeded by or followed by the administration of filling and continence is maintained as long as the bladder another drug, for the management of incontinence in human neck and urethral pressure exceeds intravesical pressure. male and female patients. The object of the invention further Voluntary voiding occurs when intravesical pressure comprises a method for administering oxybutynin alone, exceeds bladder neck and urethral pressure, and involuntary and/or in combination with or preceded by or followed by an Voiding also known as involuntary incontinence occurs estrogen and/or a progestin for treating urinary incontinence when the travesical pressure exceeds the bladder neck and in pregnant, non-pregnant, postpartum, menopause, post urethral pressure. Involuntary incontinence also known as menopausal, and during climaterix period of change occur urge incontinence and overactive bladder, occurs with a loSS ring in the transition to menopause in a patient in need of of a large Volume of urine accompanied by Symptoms of therapy. urgency, frequency and nocturia caused by an unstable bladder or detrusor instability. The patient may lose urine DETAILS OF THE INVENTION with a change in position or with auditory Stimulation. The loSS of Small Volumes of urine usually occurs because 0009. The scientific terms and scientific phrases used in bladder overdistension by a large amount of residual urine this Specification embrace the following definitions: Dosage referred to as overflow incontinence. Urinary incontinence is form denotes a drug delivery System for administering a also known as overactive bladder with Symptoms of urinary therapeutically effective dose of drug, for example oxybu frequency or urge incontinence. tynin to a patient in need of therapy. The dosage form may US 2004/0037881 A1 Feb. 26, 2004 be administered once-daily, that is, as a once-a-day dosage 0012 Representative of a drug that can be administered form for increasing patient compliance for treating overac with oxybutynin according to the method of the invention, tive bladder, or more frequently as indicated by a physician, or administered Separately in a separate administration in for example twice-daily or thrice-daily. Sustained release twenty-four hours include an estrogen Steroid possessing denotes the constant delivery of drug for up to twenty-hours. estrogenic activity Selected from the group consisting estra Controlled release denotes the delivery of the drug at a rate diol, estradiol Valerate, estradiol benzoate, estradiol cypi controlled by a dosage form by the method of the invention. onate, estradiol propionate, estradiol dipropionate, estradiol Zero-order release denotes the method of delivery of drug at acetate, ethinyl estradiol, 17O-ethinyl estradiol-esters, 17C.- a uniform rate to dampen the peaks and Valleys observed in ethinyl estradiol acetate, 17O-ethinyl estradiol benzoate, non-Zero order method of drug delivery. Therapeutically 17O-ethinyl estradiol ethers, estrone, estrone acetate, estrone effective amount denotes the dose of delivered drug suffi Sulfate, estriol, estriol Succinate, estriol triacetate, conju cient to provide a local or a Systemic effect in a patient. gated equine estrogens, and estradiol esters. The dose of Menopause denotes the period of natural cessation of men estrogen and its estrogen derivatives is
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