Method for the Management of Incontinence

Abstract

A composition and a dosage form are disclosed comprising oxybutynin alone/or accompanied by another drug indicated for therapy. A method is disclosed for administering oxybutynin alone/or accompanied by a different drug or for administering oxybutynin and a different drug according to a therapeutic program for the management of incontinence alone, and for other therapy.

1 - 31 . (canceled)  
   
   
       32 . A method for treating involuntary incontinence in a patient, wherein the method comprises admitting orally into the patient a sustained release once-a-day dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, that is administered in a sustained rate to provide in the plasma of the patient an oxybutynin/desethyl metabolite ratio of between about 0.18 and about 0.41 for treating involuntary incontinence in the patient  
   
   
       33 . A method according  claim 32 , wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropylbutylcellulose, and hydroxypropyl pentylcellulose.  
   
   
       34 . A method according  claim 32 , wherein said dosage form is a tablet.  
   
   
       35 . A method according  claim 32 , wherein said salt is oxybutynin hydrochloride.  
   
   
       36 . A method according  claim 32 , wherein the incidence of side effects associated with oxybutynin treatment is reduced.  
   
   
       37 . A once-a-day dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, wherein said dosage form provides a sustained rate in the plasma of a patient an oxybutynin/desethyl metabolite ratio of between about 0.18 and about 0.41 for treating involuntary incontinence in the patient.  
   
   
       38 . A dosage form according  claim 37 , wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropyl butylcellulose, and hydroxypropyl pentylcellulose.  
   
   
       39 . A dosage form according  claim 37 , wherein said dosage form is a tablet.  
   
   
       40 . A dosage form according  claim 37 , wherein said salt is oxybutynin hydrochloride.  
   
   
       41 . A dosage form according  claim 37 , wherein the incidence of side effects associated with oxybutynin treatment is reduced.  
   
   
       42 . A method for the management of incontinence in a patient comprising administration to a subject of a once-a-day dosage form comprising 5 mg to 250 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, wherein said dosage form provides a maximum plasma oxybutynin concentration of about 0.28 ng/ml to about 0.45 ng/ml per mg of said member in said dosage form.  
   
   
       43 . The method according to  claim 42 , wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropyl butylcellulose, and hydroxypropylpentylcellulose.  
   
   
       44 . The method according to  claim 42 , wherein said salt is oxybutynin hydrochloride.  
   
   
       45 . The method according to  claim 44 , wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropyl butylcellulose, and hydroxypropyl pentylcellulose.  
   
   
       46 . The method according to  claim 42 , wherein said dosage form is a tablet.  
   
   
       47 . The method according to  claim 42 , wherein the incidence of side effects associated with oxybutynin treatment is reduced.  
   
   
       48 . A once-a-day dosage form comprising 5 mg to 250 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, wherein said dosage form provides a maximum plasma oxybutynin concentration of about 0.28 ng/ml to about 0.45 ng/ml per mg of said member in said dosage form for treating incontinence in a patient.  
   
   
       49 . The dosage form according to  claim 48 , wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropyl butylcellulose, and hydroxypropyl pentylcellulose.  
   
   
       50 . The dosage form according to  claim 48 , wherein said salt is oxybutynin hydrochloride.  
   
   
       51 . The dosage form according to  claim 50 , wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropyl butylcellulose, and hydroxypropylpentylcellulose.  
   
   
       52 . The dosage form according to  claim 48 , wherein said dosage form is a tablet.