Dissolvable device for contraception or delivery of medication

• US 5,393,528 A
• Filed: 06/01/1993
• Issued: 02/28/1995
• Est. Priority Date: 05/07/1992
• Status: Expired due to Term

• Current Assignee: Robert J. Staab
• Original Assignee: Robert J. Staab
• Inventors: Staab, Robert J.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/068,778
• Time in Patent Office: 637 Days
• Field of Search: 424/400, 424/405, 424/407, 424/409, 424/430, 424/431, 424/432, 424/433, 424/436, 424/443, 424/444, 424/445, 424/486, 424/488, 424/DIG. 14, 514/772.3, 514/777, 514/781, 514/784, 514/785, 514/841, 514/843, 514/953, 514/967, 604/904, 604/358, 604/378
• US Class Current: 424/436
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 13/26 Means for inserting tampons , i.e. applicators
• CPC Class Codes: A61F 2013/00093 tubular
• CPC Class Codes: A61F 2013/00157 for burns or skin transplants A61F2013/00187 takes precedence; not adhering to the wound A61F2013/00217
• CPC Class Codes: A61F 2013/00642 soluble, e.g. in water
• 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 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/62 Compostable, hydrosoluble or hydrodegradable materials
• CPC Class Codes: A61L 2300/408 Virucides, spermicides
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: Y10S 424/14 Topical contraceptives and spermacides
• CPC Class Codes: Y10S 604/904 Tampons

Abstract

A dissolvable element containing an agent material is used for local administration of the agent material in an internal body area. The dissolvable element is made of dissolvable polymer material and/or complex carbohydrate material which are food grade materials and have selected dissolving properties, such that it remains in substantially solid form before use, and dissolves due to human body temperatures and moisture during use to release the agent material in a desired timed release and dosage. As a contraceptive, the dissolvable element is preferably a film made of polyvinyl alcohol, polyethylene oxide, hydroxypropyl methyl cellulose and/or carboxymethyl cellulose. The dissolvable element may be formed as a laminate of different film layers for compound release properties, or it may be ground into particles and incorporated in a tampon or suppository. The dissolvable element may be foamed as a means for increasing its dissolution rate. The agent material can be a spermicide, such as Nonoxynol-9, and/or a drug or medication. The device of the invention can also be applied topically as for example in the treatment of wounds, burns and ulcers, as well as to treat, irritations, Herpes, and ulcerations and blisters of the oral cavity. It is also possible to prepare dressings in which the dissolvable element of the invention comprises the bottom most layer. This permits painless application of medication to wounds.

Claims

1. A device for delivery of an agent material into a body cavity characterized by improved heat and humidity stability of up to 140°

F. and 97% respectively, comprising at least one dissolvable film formed from a member selected from the group consisting of polyvinyl alcohol, polyethylene oxide, hydroxy propyl methyl cellulose and mixtures thereof, at least one of said films having distributed throughout an inert gas, said agent material being incorporated in said dissolvable film, said device dissolving at the temperature of said body cavity in the presence of the moisture naturally present in said body cavity to release said agent material.

2. A device according to claim 1 wherein said film is formed of polyvinyl alcohol

3. A device according to claim 1 wherein said film is formed of hydroxy propyl methyl cellulose.

4. A device according to claim 1 wherein said film is formed of polyethylene oxide

5. A device according to claim 1 wherein said film is formed of a mixture of at least two of said group members

6. A device according to claim 1 wherein said film is formed of a mixture of different grades of one of said group members

7. A device according to claim 1 wherein said film has incorporated therein a plasticizer.

8. A device according to claim 1 wherein said agent material is a spermicide and said device is adapted for use as a contraceptive.

9. A device according to claim 1 wherein said agent material is a medication and said device is adapted for use for the delivery of said medication.

10. A device according to claim 1 wherein said film is a laminate formed of at least two film layers, each of said layers comprising a group member characterized by different dissolution properties.

11. A device according to claim 1 wherein said film is a laminate formed of at least two film layers, each of said layers comprising the same group member, but each characterized by a different temperature dissolution property.

12. A device according to claim 1, wherein said device has a tubular shape.

13. A device according to claim 1 wherein said device is a tubular shaped application for delivering a tampon or sponge.

14. A device according to claim 1, wherein said device is in the form of a fine powder filled into an insertable device or suppository.

15. A device according to claim 1, adapted for local administration of said agent material in an internal body area.

16. A device according to claim 15, wherein said internal body area is the vagina, rectum, mouth, nose, ear or eye.

17. A device according to claim 15, wherein the internal body area is the vaginal vault and the element is of sufficient thickness so that it functions as a physical barrier.

18. A device according to claim 1 wherein the dissolution rate of said film is adjusted by varying the amount of inert gas introduced into said film.

19. A device according to claim 18 wherein the amount of inert gas introduced is adjusted so that dissolution commences within five seconds of the contact of said device with the moisture present in said body cavity.

24. A device according to claim 1 wherein said agent material is a member selected from the group consisting of anti-infectives, anti-inflammatories, estrogenic steroids, progestational agents, prostaglandens, coronary vasodilators, antitussives, antihistamines, anesthetics, and decongestants.

20. A contraceptive device adapted for insertion into the vagina for local administration of spermicide and/or medication characterized by improved heat and humidity stability of up to 140°

F. and 97% respectively, comprising at least one dissolvable film formed from a member selected from the group consisting of polyvinyl alcohol, polyethylene oxide carboxy methyl cellulose and mixtures thereof, at least one of said films having distributed throughout an inert gas, said spermicide and/or medication being incorporated in said dissolvable film, said device dissolving at the temperature of the vagina in the presence of the moisture naturally present in the vagina.

21. A contraceptive device according to claim 20 wherein said film has a shape and area corresponding to that of a conventional diaphragm.

22. A contraceptive device according to claim 20 wherein said film is formed as a barrier contraceptive and includes a dissolvable flexible rim.

23. A contraceptive device according to claim 20 wherein said spermicide is Nonoxynol-9.