Vaginal delivery of drugs

• US 8,226,972 B2
• Filed: 12/19/2002
• Issued: 07/24/2012
• Est. Priority Date: 12/20/2001
• Status: Active Grant

• Current Assignee: FemmePharma Global Healthcare, Inc. (Apollo Global Management, Inc.)
• Original Assignee: Femmepharma Holding Company Incorporated
• Inventors: DiPiano, Gerianne Tringali, Ziemniak, John A., Janicki, Thomas
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US10/324,624
• Publication Number:
  US 20030143278A1
• Time in Patent Office: 3,505 Days
• Field of Search: 424/430, 424/431, 424/432, 424/433, 424/434
• US Class Current: 424/430
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives

Abstract

Drug delivery compositions which are suitable for vaginal administration for the treatment of diseases and disorders in the urogenital tract are described. The compositions may be in the form of a tablet, liquid suspension or dispersion, dried powder, topical ointment, cream, foam, suppository, or aerosol.

The drug delivery compositions are administered directly to the vagina and do not require the use of a solid device. This method of administration reduces the systematic levels of the drugs.

Claims

1. A method for treating urinary incontinence comprising

administering into the vagina a dosage of a drug formulation wherein the active agent consists of between about 1 mg and about 20 of

a drug selected from the group consisting of tolterodine tartrate, propantheline, and oxybutynin hydrochloride, in a pharmaceutically acceptable carrier suitable for delivery through the vagina selected from the group consisting of topical ointment, cream, foam, gel, dry powder and aerosol, and providing immediate release of an effective amount of the drug to provide regionally effective drug levels which are less than the systemically effective levels of the drug, wherein the level is effective to increase bladder compliance, increase functional capacity and decrease the intravesical pressure at which a micturition reflex is generated.

2. The method of claim 1 wherein the carrier is selected from the group consisting of a gel.

3. The method of claim 1 wherein the drug is oxybutynin hydrochloride.

4. The method of claim 3 in a dosage effective to treat urinary incontinence in the absence of an effect on the vascular response.

5. The method of claim 1 wherein the drug is administered once or twice daily.

6. The method of claim 5 wherein the drug is oxybutynin hydrochloride in a gel for administration to the vagina.

7. The method of claim 3 wherein the oxybutynin hydrochloride is in an amount effective to inhibit acetycholine stimulated bladder contractions.