Vaginal contraceptive system made from block copolymer

• US 4,215,691 A
• Filed: 10/11/1978
• Issued: 08/05/1980
• Est. Priority Date: 10/11/1978
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Rosenbaum, C. F.
• Application Number:
  US05/950,454
• Time in Patent Office: 664 Days
• Field of Search: 128/213, 128/223, 128/251, 128/260, 128/261, 128/268, 128/270-271, 424/19, 424/31
• US Class Current: 424/432
• 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

Abstract

An intravaginal contraceptive system for the pre-programmed, unattended delivery of an antifertility steroid is disclosed. The system comprises (a) an antifertility steroid, (b) a delivery module comprising a reservoir for storing the steroid in an amount for execution of the program, a rate controller which maintains the rate of steroid delivered in a contraceptive effective amount throughout the life of the system, an energy source for transferring steroid from the reservoir to the vagina, and a portal for releasing the steroid from the module to the vagina, (c) a platform which integrates the module into a unit sized, shaped and adapted for insertion and retention in a vagina, and (d) a contraceptive program which provides for the controlled release of steroid to produce an antifertility effect over a prolonged period of time.

Claims

1. An improved vaginal contraceptive system for delivering an antifertility steroid, comprising:

(a) a body sized, shaped and adapted for easy insertion and comfortable retention in the vagina, said body comprising;

(b) a shaped wall surrounding and forming a reservoir;

(c) an antifertility steroid selected from the group consisting of progestational and estrogenic steroids in the reservoir;

(d) a liquid carrier permeable to the passage of steroid and containing an amount of steroid for prolonged release in the reservoir;

(e) the improvement comprising forming the wall of non-toxic, vaginally acceptable release rate controlling thermoplastic styrene butadiene block copolymer permeable to the passage of steroid; and

,

(f) wherein the system when in operation and placed in the vagina releases at a controlled rate a contraceptively effective amount of steroid over a prolonged period of time to produce the desired antifertility effect.

2. The improved vaginal system for delivering steroid according to claim 1, wherein the block copolymer has the following formula:

##STR2## wherein x is 5×

10¹ to 10×

10⁴ and y is 1×

10³ to 2×

10⁴.

3. The improved vaginal system for delivering steroid according to claim 1, wherein the carrier is a member selected from the group consisting of alkylene glycols, dialkylene glycols, poly(alkylene glycols), and aqueous media mixed with poly(alkylene glycols).

4. The improved vaginal system for delivering steroid according to claim 1, wherein the progestional steroid is a member selected from the group consisting of progesterone, 17α

-hydroxyprogesterone, norethindrone, norethisterone acetate, norgestrel, norethynodrel, and methoxyprogesterone.

5. The improved vaginal system for delivering a steroid according to claim 1, wherein the estrogenic steroid is a member selected from the group consisting of estradiol, estrone, ethynyl estradiol, estriol, 17-ethynyl estradiol-3-methyl ether, and α

-estradiol 3-benzoate.

6. The improved vaginal system for delivering a steroid according to claim 1, wherein the system is ring-shaped.

7. The improved vaginal system for delivering a steroid according to claim 1, wherein the system is toroidal-shaped, the steroid is selected from the group consisting of progesterone and norethindrone, and the carrier is polyethylene glycol having a molecular weight of 400 to 6000.