Dispenser with internal arrangement of lamina means for dispensing beneficial agent

• US 4,772,474 A
• Filed: 08/11/1986
• Issued: 09/20/1988
• Est. Priority Date: 08/09/1985
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Landrau, Felix A., Eckenhoff, James B., Cortese, Richard
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US06/895,613
• Time in Patent Office: 771 Days
• Field of Search: 604/890-895, 604/8-10, 514/962, 424/14-16, 424/19-21, 424/420, 424/438, 424/422, 424/465, 424/476
• US Class Current: 424/465
• 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 dispensing system is disclosed comprising a wall surrounding a lumen. The lumen comprises (1) a thermo responsive composition comprising a beneficial agent, (2) means for occupying space in the lumen for pushing the thermo responsive composition from the dispensing system, and (3) means for enhancing the amount of the beneficial agent dispensed from the system positioned between the thermo responsive composition and the means for occupying space.

Claims

1. A delivery system for delivering a beneficial agent formulation to an environment of use, the delivery system comprising:

(a) a wall that surrounds and defines an internal lumen, the wall comprising a semipermeable composition that is permeable to the passage of fluid and substantially impermeable to the passage of a beneficial agent;

(b) a hydrogel composition in the lumen which expands and occupies an increased volume of the lumen upon imbibing fluid;

(c) a heat sensitive beneficial agent formulation in the lumen that forms a dispensable formulation at a temperature of at least 25°

C.;

(d) lamina means in the lumen for lessening the incidence of mixing of the heat-sensitive beneficial agent formulation with the hydrogel composition, said lamina means being positioned between the heat-sensitive beneficial agent formulation and the hydrogel composition; and

(e) means in the delivery system for communicating with the lumen for delivering the beneficial agent formulation to the environement of use over time.

2. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the means in the delivery system for delivering the beneficial agent comprises at least one passageway.

3. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall that surrounds and defines the internal lumen comprises in at least a part a microporous member.

4. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, where the wall means that surrounds and defines the compartment comprises in at least a part an impermeable member.

5. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall that surrounds and defines the internal lumen comprises a microporous member laminated in part by a semipermeable member.

6. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the hydrogel composition contains an osmagnet.

7. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall comprises a member selected from the group consisting of a cellulose ester, cellulose diester, cellulose triester, cellulose ether, cellulose ester-ether, cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose acetate butyrate, cellulose propionate morpholinobutrate, and cellulose acetate phthalate.

8. The delivery system for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the delivery system further comprises means in the lumen for maintaining the delivery system in the environment of use over time, said means having a density of at least 1.2.

9. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, wherein the beneficical agent formulation comprises avermectin.

10. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, wherein the beneficial agent formulation comprises ivermectin.

11. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, wherein the heat-sensitive beneficial agent formulation comprises a block copolymer comprising 1,2-butylene oxide and ethylene oxide and ivermectin.

12. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, wherein the heat sensitive beneficial agent formulation comprises a food grade wax and ivermectin.

13. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, wherein the wall comprises cellulose acetate butyrate and polyethylene glycol.

14. The delivery system for delivering a beneficial agent formulaion to the environment of use according to claim 8, wherein the means for maintaining the delivery system in the environment of use comprises a member selected from the group consisting of iron, steel, iron magnesium alloy, and a mixture of cobalt and iron.

15. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, further comprising a body member located between the wall and at least the heat sensitive beneficial agent formulation.

16. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 15, wherein the body member comprises gelatin.

17. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 1, wherein the lamina means comprises a single lamina.

18. The delivery system for delivering a beneficial agent formulation to the environment of use according to claim 8, wherein the lamina means comprises a plurality of laminae.