Delivery system comprising two sections for delivering somatotropin

• US 5,037,420 A
• Filed: 04/20/1990
• Issued: 08/06/1991
• 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): Rosenbaum, C. Fred
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/513,328
• Time in Patent Office: 473 Days
• Field of Search: 604/890.1-892.1, 604/27, 604/48, 604/49, 424/422, 424/438
• 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 method for delivering a somatotropin agent to an animal, wherein the method comprises:

(a) admitting into the animal a dispenser comprising;

(1) a wall that surrounds an internal lumen, said wall comprising a first section that substantially limits the passage of fluid through the wall and a second section that permits the passge of fluid through the wall and comprises a pair of ends with one end inside the other end and held together by a manufacture selected from the group consisting of bonding, welding and friction as a means for replacing one of the sections during use of the dispenser;

(2) a somatotropin composition comprising 5 nanograms to 20 grams in the lumen wherein the first section of the wall limits the passage of fluid for substantially protecting the somatotropin from the fluid present in the animal;

(3) an osmopolymer composition comprising an expandable hydrogel in the lumen initially present in the second section of the wall that permits the passage of fluid;

(4) at least one exit passageway in the wall for delivering the somatotropin from the dispenser; and

,

(b) delivering to somatotropin to the animal by the osmopolymer hydrogel imbibing fluid and thereby occupying space in the lumen, for pushing the somatotropin through the passageway to the animal.

2. The method for delivering the somatotropin to the animal according to claim 1, wherein the animal is a pig.

3. The method for delivering the somatotropin to the animal according to claim 1, wherein the somatotropin is porcine somatotropin.

4. The method for delivering the somatotropin to the animal according to claim 1, wherein a partition is between the somatotropin and the osmagent.

5. A dispenser for delivering a beneficial agent to an animal, the dispenser comprising:

a wall surrounding an internal lumen, said wall comprising a first section that substantially limits the passage of fluid through the wall and a second section that permits the passage of fluid through the wall;

said wall comprising a pair of ends with one end placed inside the other end, and held together by a manufacture selected from the group consisting of bonding, welding and friction as a means for releasably replacing one of the sections during use of the dispenser;

a beneficial agent formulation in the lumen comprising a pharmaceutically acceptable carrier and from 5 nanograms to 20 grams of a beneficial agent in the first section for substantially protecting the beneficial agent from an exterior fluid present in the animal;

an osmotic composition comprising 100% in the lumen in the second section, the osmotic composition comprising an osmopolymer for imbibing fluid for increasing its polymeric volume for displacing the beneficial agent formulation from the first section; and

at least one exit passageway in the dispenser for delivering the beneficial agent to the animal.