Ruminant dispensing device with thermo-activated memory

• US 4,704,118 A
• Filed: 08/16/1985
• Issued: 11/03/1987
• Est. Priority Date: 08/16/1985
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Eckenhoff, James B.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Smith, Jr., Jerome R.
• Application Number:
  US06/766,456
• Time in Patent Office: 809 Days
• Field of Search: 604/890-897
• 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: 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 device is disclosed for delivering a beneficial agent. The device comprises (1) a housing defining an internal space, (2) an expandable composition comprising a dense member in the space, (3) a composition comprising a beneficial agent and a non-toxic heat responsive carrier in the space, and (4) a passageway in the housing for delivering the beneficial agent from the dispensing device.

Claims

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

(a) wall means for surrounding and forming an internal space;

(b) means in the wall connecting the internal space with the exterior of the dispensing device for releasing beneficial agent from the device;

(c) carrier means in the internal space for containing a beneficial agent and for forming a dispensable beneficial agent formulation in the dispensing device when the dispensing device is in the environment of use;

(d) a beneficial agent present in the carrier means;

(e) expandable means in the internal space for moving from a rested position to an expanded position for occupying an increasing area of the internal space thereby urging the beneficial agent formulation through the means for releasing beneficial agent over time; and

,

(f) weight means contained in the expandable means, said weight means possessing a density of at least 1.0 for increasing the density of the dispensing device, thereby maintaining the dispensing device in the environment of use during its delivery period.

2. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the carrier means melts at a temperature of at least 24°

C.

3. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the carrier means forms a fluid dispensable beneficial agent formulation at a temperature of at least 24°

C.

4. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the carrier means forms a soft paste dispensable beneficial agent formulation at a temperature of at least 24°

C.

5. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the beneficial agent is a member selected from the group consisting of avermectin and ivermectin.

6. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the carrier means comprises a block copolymer of 1,2-butylene oxide and ethylene oxide.

7. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the expandable means comprises a salt of polyacrylic acid and an osmotically effective solute.

8. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the weight means contained in the expandable means is delivered through the passageway after the delivery period of the beneficial agent thereby reducing the density of the device to permit it to be passed by the ruminant.

9. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the weight means comprises a member selected from the group consisting of iron, steel, iron magnesium alloy and a mixture of cobalt and iron.

10. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the wall is formed of 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 butyrate, cellulose propionate morpholinobutyrate, and cellulose acetate phthalate.

11. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the wall means comprises an outer wall in laminar arrangement with an inner wall.

12. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the expandable means comprises an osmagent.

13. The dispensing device for delivering a beneficial agent formulation to an environment of use according to claim 1, wherein the expandable means comprises an osmopolymer.

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

22. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein the outer 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 morpholinobutyrate, and cellulose acetate phthalate.

23. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein the outer wall comprises a flux regulating agent selected from the group consisting of a polyhydric alcohol, polyalkylene glycol, polyalkylene diols, and a polyester of alkylene glycol.

24. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein the outer wall comprises a flux regulator selected from the group consisting of diethyl phthalate, dimethoxyethyl phthalate, dimethyl phthalate, triphenyl phthalate, citric acid ester, glycerol acetate esters, and butyl benzyl phthalate.

25. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein the first means comprises a member selected from the group consisting essentially of poly(ethylene oxide), poly(acrylamide), poly(hydroxyalkylacrylate), poly(acrylic acid), and poly(saccharide).

26. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein the first means comprises an osmotically effective solute.

27. The delivery system for de1ivering a beneficial agent formulation to an environment of use according to claim 14, wherein the heat sensitive formulation comprises a member selected from the group consisting of a block copolymer of 1,2-butylene oxide and ethylene oxide, propylene glycol monostearate, propylene glycol distearate, triglyceride of saturated vegetable fatty acid, polyethylene glycol monostearate and a mixture of cocoa butter and beeswax.

28. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein the heat sensitive beneficial agent formulation comprises a beneficial agent selected from the group consisting of mebendazole, levamisole, oxfendazole, praxiquantel, morantel, pirantel, avermectin, ivermectin, cephalosporin, sulfamethazine, sulfathiazole, dexamethazone and flumethazone.

29. The delivery system for delivering a beneficial agent formulation to an environment of use according to claim 14, wherein, after the delivery period of heat sensitive beneficial agent formulation, said first means comprising said second means is delivered through the passageway thereby allowing the delivery system to be passed by the ruminant.

15. (a) an inner body member having an internal lumen and provided with an opening for establishing communication with the lumen;

16. (b) an outer wall surrounding the inner body member, the outer wall comprising in at least a part of a semipermeable composition that is permeable to the passage of fluid;

17. (c) releasing means in the outer wall for communicating with the lumen and for releasing beneficial agent from the delivery system;

18. (d) a heat sensitive beneficial agent formulation in the lumen that forms a deliverable formulation at an environment of use temperature of at least 31°

C.;

19. (e) a beneficial agent present in the heat sensitive beneficial agent formulation;

20. (f) first means in the lumen for expanding and increasing in size, said first means adjacent to the heat sensitive formulation for pushing it through the passageway over time;

and,

21. (g) second means in the lumen for maintaining the delivery system in the environment of use over time, said second means having a density of at least 1.2 and dispersed throughout said first means.