Vaginal delivery of drugs

• US 20030143278A1
• Filed: 12/19/2002
• Published: 07/31/2003
• Est. Priority Date: 12/20/2001
• Status: Active Grant

• Current Assignee: FemmePharma Global Healthcare, Inc. (Apollo Global Management, Inc.)
• Original Assignee: FemmePharma, Inc.
• Inventors: Ziemniak, John A., Janicki, Thomas, DiPiano, Gerianne Tringali
• Granted Patent: US 8,226,972 B2
• Time in Patent Office: Days
• US Class Current: 424/489
• 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 transvaginal drug formulation comprising a drug in an amount effective to provide relief from diseases or disorders of the urogenital system in a pharmaceutically acceptable carrier for administration to the vagina.

2. The drug formulation of claim 1 wherein the drug is suspended in a pharmaceutically acceptable carrier.

3. The drug formulation of claim 1 wherein the drug is soluble in aqueous solutions.

4. The drug formulation of claim 1 wherein the drug is insoluble in aqueous solutions and is in the form of micro- or nano-particulates.

5. The drug formulation of claim 1 wherein the carrier is selected from the group consisting of a tablet, solution, dried powder, topical ointment, cream, foam, suppository, ovual, and an aerosol.

6. The drug formulation of claim 1 wherein the drug is selected from the group consisting of steroids, α

-adrenergic agonists, and antimuscarinics.

7. The drug formulation of claim 6 wherein the drug is a steroid selected from the group consisting of progestins, estrogens, antiestrogens, and antiprogestins.

8. The drug formulation of claim 6 wherein the drug is an antimuscarinic selected from the group consisting of tolterodine tartrate, propantheline, and oxybutynin hydrochloride.

9. The drug formulation of claim 1 in a dosage effective to treat urinary incontinence.

10. A method for treating a disease or disorder of the urogenital system comprising

administering to the vagina a drug formulation in an amount to effective to provide relief from diseases or disorders of the urogenital system.

11. The method of claim 11 wherein the drug is insoluble in aqueous solutions and is in the form of micro- or nano-particulates.

12. The method of claim 11 wherein the carrier is selected from the group consisting of a tablet, solution, dried powder, topical ointment, cream, foam, suppository, ovual, and an aerosol.

13. The method of claim 11 wherein the drug is selected from the group consisting of steroids, α

-adrenergic agonists, and antimuscarinics.

14. The method of claim 13 wherein the drug is a steroid selected from the group consisting of progestins, estrogens, antiestrogens and antiprogestins.

15. The method of claim 13 wherein the drug is an antimuscarinic selected from the group consisting of tolterodine tartrate, propantheline, and oxybutynin hydrochloride.

16. The method of claim 11 in a dosage effective to treat urinary incontinence.

17. The method of claim 11 wherein the drug is administered twice daily.

18. The method of claim 17 wherein the disorder is urinary incontinence and the drug is an antimuscarinic.