Transvaginal Delivery of Drugs

• US 20110003000A1
• Filed: 07/06/2009
• Published: 01/06/2011
• Est. Priority Date: 07/06/2009
• Status: Abandoned Application

• Current Assignee: Femmepharma Holding Company Incorporated
• Original Assignee: Femmepharma Holding Company Incorporated
• Inventors: Ziemniak, John Andrew, Mays, Peter Kevin, DiPiano, Gerianne Tringali, Janicki, Thomas I.
• Application Number:
  US12/497,865
• Publication Number:
  US 20110003000A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 15/02 for disorders of the vagina

Abstract

Drug delivery compositions which are suitable for transvaginal administration for the treatment of diseases and disorders of the urogenital tract are described. The drug delivery compositions are administered directly to the vagina using a convenient transvaginal application that deposits a very small volume of drug at the desired site for delivery. This method of administration reduces the systemic levels of the drugs and decreases the side effects which are associated with systemic administration. In the preferred embodiment, the compositions are in the form of a gel. The formulation is administered in volumes of less than or equal to 1 milliliter. In the preferred embodiment, the composition contains an antimuscarinc drug, such as oxybutynin.

Claims

1. A transtransvaginal drug formulation comprising

a drug for relief of a disease or disorder of the uro-genital region of a female,

in a pharmaceutically acceptable carrier for administration to the vagina,

wherein the drug is in the formulation in an amount effective to provide relief from diseases or disorders of the urogenital system, and

wherein the formulation is in a volume of one milliliter or less.

2. The drug formulation of claim 1 wherein the drug is in the form of micro- or nano-particulates 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.

5. The drug formulation of claim 1 wherein the carrier is selected from the group consisting of a solution, dry powder, ointment, cream, foam, semi-solid suppository, ovual, or aerosol.

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

-adrenergic agonists and antimuscarinics.

7. The drug formulation of claim 1 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 8 wherein the drug is oxybutynin hydrochloride and the excipient is a gel.

10. The drug formulation of claim 9 wherein the formulation is in a volume of less than one milliliter and delivers between 4 and 12 mg per administration.

11. The drug formulation of claim 10 wherein the formulation is in a volume of 200 to 500 microliters.

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

administering to the vagina the drug formulation of any of claims 1-12.

14. The method of claim 13 administered to a patient in need of treatment for urinary incontinence.

15. The method of claim 13 wherein the drug is administered twice daily.

16. An applicator for transvaginal administration of a drug formulation, comprising the formulation of claim 1.

17. The application of claim 16 that is disposable and provided in a sterile package with instructions for use.

12. The drug formulation wherein the formulation provides controlled or sustained release of the drug.