Dispenser comprising hydrophilic osmopolymer

• US 5,000,957 A
• Filed: 03/28/1989
• Issued: 03/19/1991
• Est. Priority Date: 03/19/1984
• 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): NOT, DEFINED
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/329,917
• Time in Patent Office: 721 Days
• Field of Search: 604/890.1, 424/438, 424/439, 424/469, 424/473
• US Class Current: 424/438
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0068 Rumen, e.g. rumen bolus
• 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 dispensing device for delivering a beneficial agent formulation to an environment of use, the dispensing device comprising:

(a) wall means that surrounds and defines an internal compartment, said wall means comprising at least in part a composition permeable to the passage of fluid present in the environment of use;

(b) thermoplastic means in the compartment for absorbing thermal energy from the environment of use for dispensing a beneficial agent;

(c) a beneficial agent present in the thermoplastic means for absorbing thermal energy for dispensing the beneficial agent;

(d) a hydrophilic osmopolymer in the compartment for expanding, occupying an increasing area of the compartment, and for pushing the thermoplastic means from the compartment;

(e) lamina means for enhancing the amount of beneficial agent delivered from the dispensing device in the compartment positioned between the thermoplastic means and the hydrophilic osmopolymer; and

(f) exit means in the wall for releasing the beneficial agent from the dispensing device to the environment of use over time.

2. The dispensing device for delivery the beneficial agent formulation to the environment of use according to claim 1, wherein the hydrophilic osmopolymer comprises an osmagent.

3. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall means comprises in at least a part a semipermeable composition.

4. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the exit means in the wall for delivering the beneficial agent comprises at least one passageway.

5. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the exit means in the wall for delivering the beneficial agent comprises at least one passageway formed in the environment of use.

6. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall means that surrounds and defines the compartment comprises in at least a part a microporous polymer member.

7. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall means that surrounds and defines the compartment comprises in at least a part an impermeable polymer member.

8. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the exit means in the wall for delivering the beneficial agent from the device comprises a passageway forming material that is removed therefrom by fluid present in the environment of use.

9. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall means comprises a microporus member laminated in part to a semipermeable member.

10. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the thermoplastic means form a dispensable composition at a temperature greater than 25°

C.

11. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall means 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, cellusose triacylate, cellulose acetate, cellulose acetate butyrate, cellulose propionate morphilinobutyrate, and cellulose aetate phthalate.

12. The dispensing device for delivering the beneficial agent formulation to the environment of use according to claim 1, wherein the wall means 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, cellusose triacylate, cellulose acetate, cellulose acetate butyrate, cellulose propionate morphilinobutyrate, and cellulose aetate phthalate, and a pore former.

13. A dispensing device for delivering a beneficial agent formulation to an environment of use, the dispensing system comprising:

(a) a hollow body member having an internal lumen;

(b) a thermoplastic heat-sensitive beneficial agent formulation in the lumen that forms a deliverable formulation at a temperature of at least 25°

C.;

(c) hydrogel means in the lumen for expanding from a first size to an increased size;

(f) laminar means in the lumen for lessening the mixing of the thermoplastic means with hydrogel means, said laminar means positioned between the thermoplastic means and the hydrogel means;

(e) a wall surrounding the hollow body, the wall comprising in at least a part a composition that is permeable to the passage of fluid; and

,

(f) at least one passageway means in the wall communicating with the lumen for delivering the formulation to the environment of use at a controlled rate over a prolonged period of

14. A dispensing device for delivering a beneficial agent formulation to an environment of use, the delivering system comprising:

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

(b) 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;

(c) hydrogel means in the lumen for expanding and occupying an increased volume of the lumen;

(d) a heat-sensitive means in the lumen that forms a dispensable carrier at a temperature greater than 25°

C.;

(e) a beneficial agent present in the heat-sensitive means;

(f) lamina means in the lumen between the hydrogel means and the heat-sensitive means, said lamina means positioned there between for lessening the migration of beneficial agent from the heat-sensitive means into the hydrogen means; and

,

(g) exit means in the wall for communicating with the lumen for delivering the beneficial agent to the environment of use over time.

15. The delivery system for delivering a beneficial agent formulation according to claim 14, wherein the beneficial agent formulation is avermectin.

16. The delivery system for delivering a beneficial agent formulation according to claim 14, wherein the beneficial agent formulation comprises ivermectin.

17. The delivery system for delivering a beneficial agent formulation according to claim 14, wherein the heat-sensitive beneficial agent formulation comprises a block copolymer comprising 1,2-butylene oxide and ethylene oxide and ivermectin.

18. The delivery system for delivering a beneficial agent formulation according to claim 14, wherein the heat-sensitive means comprises a food grade wax and ivermectin.

19. The delivery system for delivering a beneficial agent formulation according to claim 14, wherein the hydrogel means comprises a sodium salt of polyacrylic acid and sodium chloride.

20. The delivery system for delivering a beneficial agent formulation according to claim 14, wherein the wall comprises cellulose acetate butyrate and polyethylene glycol.

21. The delivery system for delivering a beneficial agent formulation according to claim 14, 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.