Dosage system and method of using same

• US 4,717,566 A
• Filed: 06/23/1986
• Issued: 01/05/1988
• 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): Griffin, Ronald W.
• Application Number:
  US06/877,586
• Time in Patent Office: 561 Days
• Field of Search: 424/15, 424/438, 424/473, 424/DIG. 10, 604/890, 604/892, 514/53
• 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: Y10S 424/10 Insect repellent

Abstract

A dosage form is disclosed for delivering a beneficial agent. The dosage form comprises a wall that surrounds and defines an internal space, a composition comprising a beneficial agent, means in the space for aiding in delivering the compositions from the dosage form and, at least one passageway in the wall for delivering the composition from the dosage form.

Claims

1. A method for producing an antiparasitic effect in an animal suffering therewith, which method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose acetate butyrate and cellulose acetate, which wall defines an internal space;

(2) a composition comprising a dosage unit amount of avermectin and at least one wax for forming a dispensable formulation in the space;

(3) a composition comprising sodium carboxymethylcellulose and sodium chloride in the space;

(4) a density member in the space, which density member maintains the dosage form in the animal environment over a prolonged period of time; and

,

(5) at least one exit means in the dosage form for delivering the avermectin; and

,

(b) administering the avermectin by composition (3) expanding in the space and exerting pressure against (2), whereby the avermectin is delivered through (5) to the animal for producing the antiparasitic effect.

2. The method for producing the antiparasitic effect according to claim 1, wherein the method treats endoparasites.

3. The method for producing the antiparasitic effect according to claim 1, wherein the method treats ectoparasites.

4. The method for producing the antiparasitic effect according to claim 1, wherein the wall comprises tributyl citrate.

5. The method for producing the antiparasitic effect according to claim 1, wherein the wall comprises triethyl citrate.

6. The method for producing the antiparasitic effect according to claim 1, wherein the wall comprises tributyl citrate and triethyl citrate.

7. The method for producing the antiparasitic effect according to claim 1, wherein the composition comprising avermectin comprises two food grade waxes.

8. The method for producing the antiparasitic effect according to claim 1, wherein the avermectin produces an antiparasitic effect for managing ticks.

9. The method for producing the antiparasitic effect according to claim 1, wherein the avermectin is an ivermectin.

10. A method for producing an antiparasitic effect in an animal suffering therewith, which method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose acetate butyrate and cellulose acetate, which wall defines an internal space;

(2) a composition comprising a dosage unit amount of avermectin and at least one pharmaceutically acceptable wax for forming a dispensable formulation in the space;

(3) a composition comprising a carboxyvinyl polymer and an osmotic agent in the space;

(4) a density member in the space, which density member maintains the dosage form in the animal environment over a prolonged period of time; and

,

(5) at least one exit means in the dosage form for delivering the avermectin; and

,

(b) administering the avermectin by composition (3) expanding in the space and exerting pressure against (2), whereby the avermectin is delivered through (5) to the animal for producing the antiparasitic effect.

11. The method for producing an antiparasitic effect in an animal according to claim 10, wherein the carboxyvinyl polymer is sodium carboxyvinyl polymer and the osmotic agent is sodium chloride.

12. A method for producing an antiparasitic effect in an animal suffering therewith, which method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose acetate butyrate and cellulose acetate, which wall defines an internal space;

(2) an antiparasitic formulation in the space comprising a beneficial amount of avermectin;

(3) an expandable composition in the space comprising sodium polyacrlic acid and sodium chloride;

(4) a density member in the space, which density member maintains the dosage form in the animal over a prolonged period of time; and

,

(5) at least one exit means in the dosage form for releasing the avermectin; and

,

(b) administering the avermectin by the expandable composition expanding and urging the antiparasitic formulation through the exit means for producing the antiparasitic effect.

13. The method for producing the antiparasitic effect according to claim 12, wherein the method treats endoparasites.

14. The method for producing the antiparasitic effect according to claim 12, wherein the method treats ectoparasites.

15. The method for producing the antiparasitic effect according to claim 12, wherein the wall comprises tributyl citrate.

16. The method for producing the antiparasitic effect according to claim 12, wherein the wall comprises triethyl citrate.

17. The method for producing the antiparasitic effect according to claim 12, wherein the wall comprises tributyl citrate and triethyl citrate.

18. The method for producing the antiparasitic effect according to claim 12, wherein the composition comprising avermectin comprises two pharmaceutically acceptable food grade waxes.

19. The method for producing the antiparasitic effect according to claim 12, wherein the avermectin produces an antiparasitic effect for managing ticks.

20. The method for producing the antiparasitic effect according to claim 12, wherein the avermectin is an ivermectin.

21. A method for administering selenium to an animal, which method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose acetate butyrate and cellulose acetate, which wall defines an internal space;

(2) a composition comprising a beneficial amount of selenium and at least one wax carrier in the space;

(3) a composition comprising sodium carboxymethylcellulose and sodium chloride in the space;

(4) a density member in the space, which density member maintains the dosage form in the animal over a prolonged period of time; and

,

(5) at least one dosage means in the dosage form for delivering the selenium; and

,

(b) administering the selenium to the animal by composition (3) expanding and exerting pressure against composition (2), whereby selenium is delivered through (5) to the animal over a prolonged period of time.

22. The method for administering selenium to the animal according to claim 21, wherein the wall comprises tributyl citrate.

23. The method for administering selenium to the animal according to claim 21, wherein the wall comprises triethyl citrate.

24. The method for administering selenium to the animal according to claim 21, wherein the selenium is sodium selenite.

25. The method for administering selenium to the animal according to claim 21, wherein the composition comprising slenium comprises two different waxes.

26. A method for administering selenium to an animal, which selenium method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose acetate butyrate and cellulose acetate, which wall defines an internal space;

(2) a composition comprising a beneficial amount of selenium and at least one nontoxic wax carrier in the space;

(3) an expandable composition in the space comprising sodium polyacrylic acid and sodium chloride;

(4) a density member in the space, which density member maintains the dosage form in the animal over a prolonged period of time; and

,

(5) at least one exit means in the dosage form for releasing the selenium; and

,

(b) administering the selenium by the expandable composition expanding and urging the selenium through the exit means for administering it to the animal.

27. A method for establishing a blood level of avermectin in an animal in need of avermectin for the management of an infestation, which method comprises:

introducing into the rumen of the animal a dosage form, which dosage form comprises a wall that surrounds and defines an internal lumen;

a dosage amount of avermectin in the lumin;

a pharmaceutically acceptable lipophilic carrier for avermectin in the lumin; and

means for delivering said avermectin from the dosage form to the rumen of the animal at a controlled rate over a prolonged period of time for establishing the blood level of avermectin in said animal.

28. A method for the controlled release of trace elements in the digestive tract of an animal in need of a trace element, which method comprises;

introducing into the digestive tract of the animal a dosage form, which dosage form comprise a wall that surrounds and defines a lumen;

a dosage amount of a trace element in the lumen;

a pharmaceutically acceptable lipophilic carrier for trace elements in the lumen; and

means in the dosage form for delivering said trace element into the digestive tract at a controlled rate over a prolonged period of time.

29. A method for producing a blood level of invermectin in a ruminant in need of invermectin for the management of an infestation, which method comprises:

admitting into the ruminant a delivery device comprising a wall that surrounds and forms an internal compartment;

a dosage amount of invermectin of the compartment;

a pharmaceutically acceptable lipophilic carrier for invermectin in the compartment;

means in the delivery device for delivering the ivermectin from the delivery device; and

which delivery device administers the ivermectin to the ruminant at a controlled rate over a prolonged period of time for producing the blood level of ivermectin in the ruminant.

30. A method for producing a growth promotion effect in a warm-blooded animal by treating endo and ectoparasites in an animal afflicted with same, which method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose formulation, which wall defines an internal space;

(2) a beneficial formulation in the space comprising an effective amount of avermectin;

(3) an expandable composition in the space comprising a polyacrylic acid;

(4) a density member in the space, which density member maintains the dosage form in the animal over a prolonged period of time; and

,

(5) at least one exit means in the dosage form for releasing the avermectin; and

,

(b) administering the avermectin by the expandable composition expanding and urging the beneficial formulation through the exit means for treating the endo and ectoparasites thereby producing a growth promotion effect.

31. A method for producing a growth promotion effect in a warm-blooded animal by treating endo and ectoparasites in an animal suffering with same, which method comprises:

(a) admitting into the animal a dosage form comprising;

(1) a wall comprising cellulose formulation, which wall defines an internal space;

(2) a composition comprising a dosage unit amount of avermectin in at least one pharmaceutically acceptable carrier for forming a dispensable formulation in the space;

(3) a composition comprising carboxymethylcellulose in the space;

(4) a density member in the space, which density member maintains the dosage form in the animal environment over a prolonged period of time; and

,

(5) at least one exit means in the dosage form for delivering the avermectin; and

,

(b) administering the avermectin by the composition comprising carboxymethylcellulose expanding and urging the avermectin through the exit means for treating the endo and ectoparasites thereby producing a growth promotion effect.