Patent ID: 7763635

Claim:
A once-a-day dosage formulation of a pharmaceutical composition suitable for treating a bladder dysfunction comprising: (a) a first plurality of sugar spheres coated with a layer comprising hydroxypropylmethylcellulose (HPMC) and a pharmaceutically acceptable salt of trospium (Tr + ), said layer being coated in turn with a layer comprising a methacrylic acid copolymer, thereby providing a delayed release (DR) component; and (b) a second plurality of sugar spheres coated with a layer comprising hydroxypropylmethylcellulose (HPMC) and a pharmaceutically acceptable salt of trospium (Tr + ), said layer being coated in turn with a layer comprising ethyl cellulose, thereby providing an extended release (XR) component; wherein at least a portion of said formulation releases trospium in the lower gastrointestinal (GI) tract; wherein said formulation, when administered orally to a patient suffering from a bladder dysfunction provides average steady state blood levels of Tr + ranging between 500 pg/ml and 2400 pg/ml, and wherein the bladder dysfunction is selected from the group consisting of urinary frequency, urgency, nocturia, urge-incontinence associated with detrusor instability, urge syndrome and detrusor hyperreflexia.