초록 ▼

Vaginal or rectal applicators for the delivery of a small volume of pharmaceutical preparation, i.e. less than 1 mL are disclosed herein. The delivery of a small volume of a pharmaceutical preparation allows for the transvaginal delivery of the preparation to the region of the upper vaginal vault or

Vaginal or rectal applicators for the delivery of a small volume of pharmaceutical preparation, i.e. less than 1 mL are disclosed herein. The delivery of a small volume of a pharmaceutical preparation allows for the transvaginal delivery of the preparation to the region of the upper vaginal vault or rectum for the treatment of diseases and disorders of the female urogenital system, cervix, uterus, ovaries, fallopian tubes and peritoneal cavity and the lower abdomen. The vaginal or rectal applicators contain four main parts, an applicator barrel, a plunger, a plunger tip, and an applicator cap. The applicator functions similar to a syringe. The applicator is filled with a pharmaceutical preparation with the plunger in the back position. The cap is attached to seal the pharmaceutical preparation in the applicator. To use the applicator, the cap is removed, the applicator is positioned, and the plunger is depressed.

대표청구항 ▼

We claim: 1. A vaginal applicator for transvaginal drug delivery comprising (a) an applicator barrel, wherein the applicator barrel has a size and shape suitable for insertion into the vagina, preventing penetration of the vaginal wall or cervix, and delivering a pharmaceutical composition to the u

We claim: 1. A vaginal applicator for transvaginal drug delivery comprising (a) an applicator barrel, wherein the applicator barrel has a size and shape suitable for insertion into the vagina, preventing penetration of the vaginal wall or cervix, and delivering a pharmaceutical composition to the upper vaginal vault, wherein the applicator barrel comprises a medication chamber at the proximal end of the applicator, wherein the medication chamber has a smaller diameter than the inner diameter of the applicator barrel and defines a cavity within the applicator barrel having a volume of 1 mL or less, wherein there is a space between the applicator barrel and the medication chamber, wherein the medication chamber is designed to contain 1 mL or less of the pharmaceutical composition in a form selected from the group consisting of powder, gel, cream, and lotion, wherein the proximal end of the applicator contains an opening suitable for filling the medication chamber with the pharmaceutical composition and dispensing the pharmaceutical composition from the medication chamber, wherein the medication chamber comprises a dispensing end that cannot extend past the proximal end of the applicator barrel, and wherein the applicator barrel comprises a barrier proximal to the opening; (b) a plunger, wherein the plunger is insertable in telescoping relation to the applicator barrel until the plunger reaches the barrier wherein the proximal end of the plunger comprises a plunger tip; (c) a flange at the distal end of the applicator; and (d) an applicator cap, wherein the applicator cap is removable from the proximal end of the applicator barrel. 2. The vaginal or rectal applicator of claim 1, wherein the applicator cap has a diameter that is effective at preventing insertion of the vaginal applicator into a vagina when the applicator cap is attached to the applicator barrel. 3. The vaginal or rectal applicator of claim 1, wherein the applicator cap forms an air-tight seal with the applicator barrel. 4. The vaginal or rectal applicator of claim 1, wherein the plunger tip forms an air-tight seal with the applicator barrel. 5. The applicator of claim 1, wherein the applicator has a rounded tip at the proximal end of the applicator. 6. A method of transvaginal drug delivery comprising (1) breech filling a vaginal applicator with 1 mL or less of a pharmaceutical formulation, wherein the vaginal applicator comprises (a) an applicator barrel, wherein the applicator barrel has a size and shape suitable for insertion into the vagina, preventing penetration of the vaginal wall or cervix and delivering the pharmaceutical formulation to the upper vaginal vault, wherein the applicator barrel comprises a medication chamber at the proximal end of the applicator, wherein the medication chamber has a smaller diameter than the inner diameter of the applicator barrel and defines a cavity having a volume of 1 mL or less, wherein there is a space between the applicator barrel and the medication chamber, wherein the medication chamber comprises a dispensing end that cannot extend past the proximal end of the applicator barrel, and wherein the applicator barrel comprises a barrier proximal to the opening; (b) a plunger, wherein the plunger is insertable in telescoping relation to the applicator barrel until the plunger reaches the barrier, wherein the proximal end of the plunger comprises a plunger tip; and (c) a flange at the distal end of the applicator; (2) inserting the applicator barrel into a patient's vagina, wherein the pharmaceutical formulation is in a form selected from the group consisting of a powder, gel, cream, and lotion, and (3) depressing the plunger until it reaches the barrier to administer all of the pharmaceutical formulation to the patient's upper vaginal vault. 7. The method of claim 6, wherein the pharmaceutical formulation is in an amount effective to treat disorders and diseases of the female urogenital system, cervix, uterus, ovaries, fallopian tubes, and peritoneal cavity. 8. The method of claim 6, further comprising, after step (1) and prior to step (2), placing an applicator cap on the proximal end of the applicator barrel and then removing the applicator cap from the proximal end of the applicator barrel. 9. The method of claim 6, wherein the applicator has a rounded tip at the proximal end of the applicator.