Dissolvable device for contraception or delivery of medication

• US 5,529,782 A
• Filed: 11/03/1994
• Issued: 06/25/1996
• Est. Priority Date: 05/07/1992
• Status: Expired due to Term

• Current Assignee: Robert Staab
• Original Assignee: Robert Staab
• Inventors: Staab, Robert
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/333,717
• Time in Patent Office: 600 Days
• Field of Search: 424/409, 424/430, 424/431, 424/432, 424/433, 424/436, 424/445, 424/DIG. 14, 514/772.3, 514/777, 514/781, 514/784, 514/785, 514/841, 514/843, 514/953, 514/967, 604/358, 604/378, 604/904
• 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 method for the delivery of an agent material into a body cavity, using a device characterized by improved heat and humidity stability of up to 140 degrees F. and up to 97% respectively, said device comprising at least one dissolvable film formed from a member selected from the group consisting of polyvinyl alcohol, polyethylene oxide, hydroxypropylmethyl 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, said method comprising introducing said device into said bodily cavity, whereby on dissolution of said film said agent material is delivered into said bodily cavity.

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

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

4. A method according to claim 1 wherein said agent material is a spermicide, said device is adapted for use as a contraceptive and said method comprises inserting and positioning said device in the vagina.

5. A method according to claim 1 wherein said agent material is a medication, said device is adapted for use for the delivery of said medication and said method comprises positioning said device in the body cavity where the medication is to be delivered.

6. A method according to claim 1 wherein in said device, 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.

7. A method 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.

8. A method according to claim 1, wherein said body cavity is the vagina, rectum, mouth, nose, ear or eye.

9. A method according to claim 8, wherein said body cavity is the vaginal vault and the device is of sufficient thickness so that it functions as a physical barrier.

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

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

12. A method according to claim 8 wherein said body cavity is the mouth.

13. A method for topical delivery of an agent material to an external body area, using a device characterized by improved heat and humidity stability of up to 140 degrees F. and up to 97% respectively, said device 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 at the temperature of said body cavity in the presence of the moisture naturally present in said body cavity to release said agent material, said method comprising applying said device onto an external body area, whereby on dissolution of said film said agent material is delivered topically to said external body area.