Osmotic delivery system having space efficient piston

• US 6,997,922 B2
• Filed: 10/05/2004
• Issued: 02/14/2006
• Est. Priority Date: 12/31/1998
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/959,489
• Publication Number:
  US 20050085797A1
• Time in Patent Office: 497 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604130-133, 604/141, 604/143, 604/151, 604/218, 424/422, 424/451, 424/452, 424/464, 424/465
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic delivery system having a space-efficient piston is provided. The enclosure has an interior holding the piston, a beneficial agent, and an osmopolymer including a tablet. The piston is movable with respect to an interior surface of the capsule, and defines a movable seal with the interior surface of the capsule. The movable seal separates the osmopolymer from the beneficial agent. The piston has a recess that receives at least a portion of the osmopolymer. The osmopolymer imbibes liquid from a surrounding environment through a semipermeable body to cause the piston to move and, in turn, cause delivery of the beneficial agent from the capsule.

Claims

1. An osmotic delivery system comprising:

an enclosure having an interior for holding a beneficial agent, said interior having an interior surface;

an osmopolymer located in said interior;

a semipermeable body in liquid communication with said enclosure for permitting liquid to permeate through said semipermeable body to said osmopolymer; and

a piston located within said interior of said enclosure, the piston being movable with respect to said interior of said enclosure and defining a movable seal with said interior of said enclosure that separates said osmopolymer from the beneficial agent, the piston having a recess that receives a sleeve having an interior that receives at least a portion of said osmopolymer, said osmopolymer located between said piston and said semipermeable body, said osmopolymer for imbibing liquid from a surrounding environment through said semipermeable body to cause said piston to move and in turn cause delivery of said beneficial agent from said enclosure.

2. The osmotic delivery system of claim 1, wherein the osmopolymer is a polyhydroxy-alkyl methacrylate with a molecular weight of from 30,000 to 5,000,000;

a polyvinylpyrrolidone with a molecular weight of from 10,000 to 360,000;

an anionic hydrogel;

a cationic hydrogel;

a polyelectrolyte complex;

polyvinyl alcohol having low acetate residual and having a degree of polymerization of from 200 to 30,000;

a mixture of methyl cellulose, cross-linked agar, and carboxymethylcellulose;

a mixture of hydroxypropyl methylcellulose and sodium carboxymethylcellulose;

a polymer of N-vinyllactams;

a polyoxyethylene-polyoxypropylene gel;

a polyoxybutylene-polyethylene block copolymer gel;

carob gum;

a polyacrylic gel;

a polyester gel;

a polyurea gel;

a polyether gel;

a polyamide gel;

a polypeptide gel;

a polyamino acid gel;

a polycellulosic gel;

a carbopol acidic carboxy polymer having a molecular weight of from 250,000 to 4,000,000;

a polyacrylamide;

a cross-linked indene-maleic anhydride polymer;

a polyacrylic acid having a molecular weight of from 80,000 to 200,000;

a Polyox Polyethylene oxide polymer having a molecular weight of from 100,000 to 5,000,000;

a starch graft copolymer;

or an acrylate polymer polysaccharide.

3. The osmotic delivery system according to claim 1, wherein the osmopolymer is in a form of a tablet, pellet, or powder at least partially within the recess.

4. The osmotic delivery system according to claim 1, wherein said semipermeable body is located at least partially within said interior of said enclosure.

5. The osmotic delivery system according to claim 1, wherein said enclosure includes an opening and said semipermeable body includes a semipermeable plug, said semipermeable plug located at least partially within said opening.

6. The osmotic delivery system according to claim 1, wherein said enclosure includes an opening and said semipermeable body includes a semipermeable membrane, said semipermeable membrane located at least partially within said opening.

7. The osmotic delivery system according to claim 1, wherein said enclosure is a capsule.

8. The osmotic delivery system according to claim 1, wherein said enclosure includes a cylindrical tube.

9. The osmotic delivery system according to claim 1, wherein said osmopolymer is located between said semipermeable body and said piston.

10. The osmotic delivery system according to claim 1, wherein a portion of said osmopolymer is located outside of the recess.

11. The osmotic delivery system according to claim 1, wherein the recess is a concave indentation, square cavity, conical pit, gouge, or depression.

12. The osmotic delivery system according to claim 1, wherein said piston includes at least one rib for effecting a movable seal with said enclosure.

13. The osmotic delivery system according to claim 1, wherein said sleeve is cup-shaped.

14. The osmotic delivery system according to claim 1, wherein said beneficial agent is located in said interior of said enclosure, said beneficial agent being delivered from said enclosure when said piston moves.

15. The osmotic delivery system according to claim 1, wherein said beneficial agent is located in said interior of said enclosure, said piston defining said movable seal that separates said osmopolymer from said beneficial agent.

16. The osmotic delivery system according to claim 1, further comprising:

an opening in the enclosure; and

a plug located in said opening, the plug having a delivery port for delivery of the beneficial agent from the interior of the capsule.

17. The delivery system according to claim 1, further comprising:

a delivery port in the enclosure for delivery of the beneficial agent from the interior of the enclosure.

18. An osmotic delivery system comprising:

a capsule having an interior for holding a beneficial agent, said capsule having an interior surface and a first opening;

an osmopolymer located in said interior;

a semipermeable body in liquid communication with said capsule for permitting liquid to permeate through said semipermeable body to said osmopolymer, said semipermeable body including a first plug located at least partially in said first opening in contact with the interior surface; and

a piston located within said interior of said capsule, the piston being movable with respect to said interior surface of said capsule and defining a movable seal with said interior surface of said capsule that separates said osmopolymer from the beneficial agent, the piston having a recess that receives a sleeve having an interior that receives at least a portion of said osmopolymer, said osmopolymer located between said piston and said semipermeable body, said osmopolymer for imbibing liquid from a surrounding environment through said semipermeable body to cause said piston to move and, in turn, cause delivery of the beneficial agent from said capsule.

19. The osmotic delivery system according to claim 18, further comprising:

a second opening in the capsule; and

a second plug located in said second opening, the second plug having a delivery port for delivery of the beneficial agent from the interior of the capsule.

20. The osmotic delivery system according to claim 18, wherein the first plug includes at least one rib, thread, ridge, or lip for forming a seal with the interior surface.

21. The osmotic delivery system according to claim 18, further comprising:

glue or adhesive for sealing the first plug against the interior surface.

22. The osmotic delivery system of claim 18, wherein the osmopolymer is a polyhydroxy-alkyl methacrylate with a molecular weight of from 30,000 to 5,000,000;

polyvinylpyrrolidone with a molecular weight of from 10,000 to 360,000;

an anionic hydrogel;

a cationic hydrogel;

a polyelectrolyte complex;

a polyvinyl alcohol having low acetate residual and having a degree of polymerization of from 200 to 30,000;

a mixture of methyl cellulose, cross-linked agar, and carboxymethylcellulose;

a mixture of hydroxypropyl methylcellulose and sodium carboxymethylcellulose;

a polymer of N-vinyllactams;

a polyoxyethylene-polyoxypropylene gel;

a polyoxybutylene-polyethylene block copolymer gel;

carob gum;

a polyacrylic gel;

a polyester gel;

a polyurea gel;

a polyether gel;

a polyamide gel;

a polypeptide gel;

a polyamino acid gel;

a polycellulosic gel;

a carbopol acidic carboxy polymer having a molecular weight of from 250,000 to 4,000,000;

a polyacrylamide;

a cross-linked indene-maleic anhydride polymer;

a polyacrylic acid having a molecular weight of from 80,000 to 200,000;

a Polyox Polyethylene oxide polymer having a molecular weight of from 100,000 to 5,000,000;

a starch graft copolymer;

or an acrylate polymer polysaccharide.

23. An osmotic delivery system comprising:

an enclosure having an interior for holding a beneficial agent, an osmotic agent located in said enclosure, and a semipermeable body in liquid communication with said enclosure for permitting liquid to permeate through said semipermeable body to said osmotic agent; and

a piston located within said enclosure, said piston defining a movable seal within said enclosure that separates said osmotic agent from said beneficial agent, said piston having a recess that receives a sleeve having an interior that receives at least a portion of said osmotic agent, said osmotic agent located between said piston and said semipermeable body, said osmotic agent for imbibing liquid from a surrounding environment through said semipermeable body to cause said piston to move and, in turn, cause delivery of the beneficial agent from said enclosure, wherein the osmotic agent consists of a semisolid or a solid.

24. The osmotic delivery system according to claim 23, wherein the osmotic agent is in a form of a tablet, pellet, or powder.

25. The osmotic delivery system according to claim 23, wherein said enclosure is a capsule.

26. The osmotic delivery system according to claim 23, wherein said enclosure comprises a cylindrical tube.

27. The osmotic delivery system according to claim 23, wherein the osmotic agent comprises an osmagent or an osmopolymer.

28. The osmotic delivery system according to claim 23, wherein the osmotic agent is magnesium sulfate, magnesium chloride, potassium sulfate, sodium chloride, sodium sulfate, lithium sulfate, sodium phosphate, potassium phosphate, d-mannitol, sorbitol, inositol, urea, magnesium succinate, tartaric acid, raffinose, sucrose, glucose, lactose, fructose, dextran, poly(hydroxy-alkyl methacrylate) with a molecular weight of from about 30,000 to about 5,000,000, poly(vinylpyrrolidone) with a molecular weight of from about 10,000 to about 360,000, an anionic hydrogel, a cationic hydrogel, a polyelectrolyte complex, poly(vinyl alcohol) having low acetate residual, optionally cross-linked with glyoxal, formaldehyde or glutaraldehyde and having a degree of polymerization of from about 200 to about 30,000, a mixture of methyl cellulose, cross-linked agar, and carboxymethylcellulose, a mixture of hydroxypropyl methylcellulose and sodium carboxymethylcellulose, a polymer of N-vinyllactams, polyoxyethylene-polyoxypropylene gel, a polyoxybutylene-polyethylene block copolymer gel, carob gum, polyacrylic gel, polyester gel, polyurea gel, polyether gel, polyamide gel, polypeptide gel, polyamino acid gel, polycellulosic gel, carbopol acidic carboxy polymer having a molecular weight of from about 250,000 to about 4,000,000, cyanamer polyacrylamide, cross-linked indene-maleic anhydride polymer, polyacrylic acid having a molecular weight of from about 80,000 to about 200,000, Polyox Polyethylene oxide polymer having a molecular weight of from about 100,000 to about 5,000,000, starch graft copolymer, or an acrylate polymer polysaccharide.