Method for the management of hyperplasia

• US 4,961,931 A
• Filed: 09/09/1988
• Issued: 10/09/1990
• Est. Priority Date: 07/29/1982
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.-L.
• Primary Examiner(s): RYAN, PATRICK J
• Application Number:
  US07/242,249
• Time in Patent Office: 760 Days
• Field of Search: 424/430-433, 604/54-56, 604/893, 604/285, 604/288
• US Class Current: 424/430
• 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

The invention is for a vaginal dispenser comprising a wall surrounding an internal lumen and having a pair of ends with one end placed inside the other end to form a closed dispenser. A vaginally administrable beneficial agent is housed in the lumen for release by the dispenser over time.

Claims

1. A method for administering an estrogenic composition for estrogen replacement in a woman exhibiting a decrease in estrogen secretion, and for administering a progestational composition for the management of endometrial hyperplasia in said woman, which method comprises:

(a) placing in the vagina of said woman a vaginal dispenser adapted and shaped for easy placement and comfortable retention in the vagina, the dispenser comprising;

(1) a multiplicity of tubes with each tube comprising a wall that surrounds an internal space, said wall comprising a member selected from the group consisting of olefin, vinyl, condensation, addition and rubber diffusion and microporous polymers;

(2) a composition in the internal space, said composition comprising about 2 mcg to 7.5 g of an estrogenic steroid, pharmaceutically acceptable mass transfer carrier for said steroids;

(b) administering the estrogenic steroid through the wall from the dispenser into the vagina in a therapeutically effective amount for replacing the estrogen in said woman; and

,

(c) administering the progestational steroid through the wall in a therapeutically effective amount from the dispenser for substantially lessening endometrial hyperplasia in said woman.

2. A method of estrogen replacement for a woman in need of estrogen replacement, and for progestin management of endometrium hyperplasia responsive to a progestin in said woman, which method comprises:

(a) placing in the vagina of said woman a dispenser comprising;

(2) at least one tube comprising a wall composition that surrounds an internal lumen, said wall composition vinyl, condensation, and addition polymer that releases a steroid by passage through micropores in the wall, which micropores are formed by leaching a pore former from the wall, said dispenser adapted and shaped for easy placement and comfortable retention in the vagina;

(2) a pharmaeutically acceptable carrier in the lumen, said carrier comprising a member selected from the group consisting of solid, liquid and semi-liquid carriers and comprising up to 7.5 g of dissolved and undissolved estrogen and progestin steroids;

(b) administering the estrogen steroid from the dispenser through micropores in the wall into the vagina in a therapeutically effective amount for at least five days for replacing estrogen in said woman; and

,

(c) administering the progestin steroid from the dispenser through micropores in the wall into the vagina in endometrium hyperplasia in said woman.