Vaginal cavity dispensing means and method

• US 3,995,634 A
• Filed: 12/02/1975
• Issued: 12/07/1976
• Est. Priority Date: 12/02/1975
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Drobish, James Lee
• Primary Examiner(s): Mancene, Louis G.
• Assistant Examiner(s): Cutting, Robert F.
• Application Number:
  US05/636,897
• Time in Patent Office: 371 Days
• Field of Search: 128/260, 128/130, 128/129
• US Class Current: 128/832
• CPC Class Codes: A61F 6/08 Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion
• 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: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Improved dispensing means for medicaments, especially contraceptives, which can be retained in the vagina during intercourse are provided.

Claims

1. An article for use within the vaginal cavity characterized by:

a plurality of containers, said containers releasably containing a biologically active agent, said containers protruding through a dimensionally stable, pliable retaining ring, said containers being held in place in said retaining ring by virtue of their bulbous shape.

2. An article according to claim 1 wherein said retaining ring is made from a pliable material which is a biologically inert member selected from the group consisting of hydrocarbon plastics, natural or synthetic rubbers and silicones.

3. An article according to claim 2 which is in a substantially circular configuration.

4. A controlled release article according to claim 3 especially adapted to maintaining a useful concentration of a biologically active surfactant compound in the vaginal cavity, wherein at least a portion of the walls of said containers comprise a microporous membrane, and wherein said containers are substantially filled with a biologically active agent consisting essentially of an aqueous solution of a micelle-forming surfactant compound, said solution having a concentration above the critical micelle concentration of the surfactant compound.

5. An article according to claim 4 wherein the containers comprise cellulose.

6. An article according to claim 5 wherein the surfactant compound is characterized by a critical micelle concentration of at most about 1×

10.sup.^-3 Molar.

7. An article according to claim 6 wherein the combination of surfactant and cellulose membrane exhibits a monomer transport curve having a ratio of slopes S₂ /S₁ in the range of 0 to about 0.1.

8. An article according to claim 7 wherein the surfactant has an R value greater than 1.

9. An article according to claim 8 wherein the surfactant is a biocidal or biostatic agent.

10. A contraceptive article according to claim 9 wherein the surfactant is a member selected from the group consisting of spermicidal surfactants.

11. A contraceptive article according to claim 10 wherein the surfactant is a nonionic surfactant selected from ethylene oxide condensates of aliphatic alcohols.

12. A contraceptive article according to claim 11 wherein the nonionic surfactant is C₁₀ EO₅.

13. A contraceptive article according to claim 11 wherein the nonionic surfactant is C₁₀ EO₆.

14. A contraceptive article according to claim 11 wherein the nonionic surfactant is selected from C₁₀ EO₅ or C₁₀ EO₆, or mixtures thereof, the containers comprise water-swollen microporous cellulose having a dry thickness of ca. 5-25μ

and a swollen thickness of ca. 10-50μ

, and the retaining ring is biologically inert silicone.

15. A means for assembling a vaginally-retainable article for delivering micelle-forming surfactants to the vaginal cavity, said article having a pre-selected configuration, comprising the steps of partially filling a cellulose container with a micelle-forming surfactant solution, sealing said container with a seal fin, passing said container through a hole in a dimensionally stable retaining ring having the desired configuration, said hole being sufficiently large to permit passage of said partially filled container therethrough but too small to allow passage of said seal fin, and, as the final step, swelling said container by means of osmotic forces to a bulbous shape which is larger than said hole and which cannot return therethrough.