|Title:||Once daily dosage forms of trospium|
|Abstract:||A pharmaceutical composition of a pharmaceutically acceptable trospium salt, with upon administration to a human patient generates an average steady state blood levels of trospium with a minimum (C.sub.min) and maximum (C.sub.max) blood levels of about 0.5-2.5 ng/ml and about 2.0-6.0 ng/ml, respectively.|
|Inventor(s):||Kidane; Argaw (Montgomery Village, MD), Flanner; Henry H. (Montgomery Village, MD), Bhatt; Padmanabh (Rockville, MD), Raoufinia; Arash (McLean, VA)|
|Assignee:||Supermus Pharmaceuticals, Inc. (Rockville, MD)|
1. 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.sup.+), 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.sup.+), 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.sup.+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.
2. The formulation of claim 1 in which the pharmaceutically acceptable salt of trospium is selected from the group consisting of a fluoride, chloride, bromide and iodide salt of trospium.
3. The formulation of claim 1 in which the pharmaceutically acceptable salt of trospium is trospium chloride.
4. The formulation of claim 1 in which the DR component includes 30 mg of trospium chloride.
5. The formulation of claim 1 in which the XR component includes 30 mg of trospium chloride.
6. The formulation of claim 3 in which the DR component includes 30 mg of trospium chloride and the XR component includes 30 mg of trospium chloride.
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