Delivery system comprising means for governing fluid into the system and for restricting fluid into the system

• US 5,630,808 A
• Filed: 03/01/1994
• Issued: 05/20/1997
• Est. Priority Date: 12/13/1988
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Magruder, Judy A., Eckenhoff, James B., Wright, Jeremy C., Peery, John R., Cortese, Richard
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/203,967
• Time in Patent Office: 1,176 Days
• Field of Search: 424/422, 424/438, 424/473, 424/423, 604/27, 604/48, 604/49, 604/890.1-892.1
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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

A delivery system is disclosed for delivering a beneficial agent to an animal. The delivery system comprises a wall that surrounds a lumen, said wall comprising a composition that limits the passage of fluid into the system and a composition that permits the passage of fluid into the system. The lumen comprises a beneficial agent and an expandable member. The delivery system comprises an exit means for delivering the beneficial agent.

Claims

1. A dispenser for delivering a beneficial agent formulation to a fluid environment of an animal, and for protecting the beneficial agent from the fluid environment of the animal, the dispenser comprising:

(a) a wall that surrounds an internal lumen, which wall comprises;

(1) a first section that surrounds a first area of the lumen, comprising means impervious to the passage of fluid into the first section, a lead end and a receiving end;

(2) a second section that surrounds a second area of the lumen, comprising means pervious to the passage of fluid into the second section, is free of the means impervious to the passage of fluid, a receiving end which forms a tight fit with said receiving end in said first section and a closed rear end to form said wall which surrounds said internal lumen, said wall being continuous;

(b) 20 nanograms to 20 grams of a beneficial agent formulation in the first section for protecting the beneficial agent formulation from fluid;

(c) a solid composition comprising a member selected from the group consisting of an osmagent and an osmopolymer in the second section; and

(d) exit means in the wall that connects the exterior of the dispenser with the lead end of the first section for delivering the beneficial agent formulation from the dispenser to the animal over a prolonged period of time.

2. The dispenser for delivering the beneficial agent formulation according to claim 1, wherein the beneficial agent formulation comprises a member selected from the group consisting of somatotropin, somatotropin analogue, procine somatotropin, bovine somatotropin, and somatotropin derivatives for delivery to the animal over time.

3. A dispenser for delivering a beneficial agent to a fluid environment of an animal, the dispenser comprising:

(a) a single wall that surrounds a single lumen which wall comprises two different compositions with different properties of fluid impermeable and fluid permeable in separate sections thereof which sections form the single wall by friction, telescopic fit, fusion or adhesion;

(b) exit means in the wall connecting the exterior of the dispenser with the lumen of the dispenser;

(c) 20 nanograms to 20 grams of the beneficial agent in the lumen section impermeable to fluid and adjacent to the exit means in the wall; and

(d) a solid composition in the lumen distant from the exit means in the section permeable to fluid for occupying space in the lumen and for pushing the beneficial agent through the exit means from the dispenser.

4. A method for maximizing the delivery of a beneficial agent sensitive to an animal fluid environment of use, wherein the method comprises:

(a) admitting into the animal a dispenser comprising;

(1) wall that surrounds an internal lumen, which wall comprises two different wall forming compositions with different fluid fluxes to provide separate sections that limits the flux of fluid and permits the flux of fluid, which sections comprise ends that are formed by friction, fusion or adhesion to define a single continuous wall;

(2) a beneficial agent in the internal lumen in the section that limits the fluid flux into the lumen;

(3) a solid composition in the internal lumen comprising means for occupying space in the section that permits fluid flux into the lumen;

(4) a passageway in the dispenser in contact with the beneficial agent for delivering the beneficial agent from the dispenser;

(b) delivering the beneficial agent by fluid entering the dispenser into the section that permits the flux of fluid for contacting the composition comprising the means for occupying space causing it to increase in the lumen and urge the beneficial agent through the passageway from the dispenser; and

,

(c) maximizing the delivery of the beneficial agent by delivering the beneficial agent from the section that limits the fluid flux into the dispenser to the animal over time.

5. The method for maximizing the delivery of the beneficial agent according to claim 4, wherein the animal is a human.

6. The method for maximizing the delivery of the biological agent according to claim 4, wherein the fluid is a biological fluid.

7. The method for maximizing the delivery of the beneficial agent according to claim 4, wherein the beneficial agent comprises a member selected from the group consisting of a peptide, protein, anabolic hormone, growth promoting hormone, endocrine hormone, hormones produced by recombinant DNA, gonadotropic releasing hormones, follicle stimulating hormone, luteinizing hormone, growth hormone releasing factor, gonadotropin releasing factor and polypeptide.

8. The method for maximizing the delivery of the beneficial agent according to claim 4, wherein the dispenser is an implant.