Osmotic capsule

• US 4,627,850 A
• Filed: 11/02/1983
• Issued: 12/09/1986
• Est. Priority Date: 11/02/1983
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Eckenhoff, James B., Theeuwes, Felix, Deters, Joseph C., Mullins, Kevin J.
• Primary Examiner(s): Schofer, Joseph L.
• Assistant Examiner(s): TESKIN, FRED M
• Application Number:
  US06/548,219
• Time in Patent Office: 1,133 Days
• Field of Search: 428/308.4, 428/318.6, 428/321.5, 428/478.4, 428/479.3, 210/500.2, 210/506, 604/892, 604/893, 604/896, 106/122, 106/196, 424/21, 424/19, 526/930
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: Y10S 526/93 Water swellable or hydrophilic
• CPC Class Codes: Y10T 428/249958 Void-containing component is synthetic resin or natural rubbers
• CPC Class Codes: Y10T 428/249988 Of about the same composition as, and adjacent to, the void-containing component
• CPC Class Codes: Y10T 428/31772 Next to cellulosic

Abstract

An osmotic capsule is disclosed for delivering a beneficial agent formulation to an environment of use. The osmotic capsule comprises an outer semipermeable wall surrounding and laminating an inner capsule wall formed of a different polymeric composition than the outer wall. The walls define an interior space containing the beneficial agent formulation. A passageway through the walls connects the exterior of the osmotic capsule with the interior of the osmotic capsule.

Claims

1. An osmotic capsule for the delivery at a controlled rate of a beneficial agent formulation to a fluid environment of use, the osmotic capsule comprising:

(a) a lamina comprising in at least a part of a semipermeable composition that substantially maintains its integrity in the environment of use, is permeable to the passage of fluid present in the environment of use, and substantially impermeable to the passage of a beneficial agent formulation, the lamina surrounding;

(b) a capsule comprising a hydrophilic body and a matching cap telescopically joined to define a lumen;

(c) a beneficial agent formulation in the lumen, said formulation a member selected from the group consisting of solid, powdered, pulverized, micronized and particle formulations that form, when the osmotic capsule is in operation in the environment of use in the presence of fluid that enters the osmotic capsule, a member selected from the group consisting of a solution and suspension; and

,

(d) at least one orifice through the lamina and the capsule communicating with the lumen and the exterior of the osmotic capsule for delivering the beneficial agent formulation from the osmotic capsule.

2. The osmotic capsule for the delivery at a controlled rate of the beneficial agent formulation according to claim 1, wherein the semipermeable composition is a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose ester, and cellulose acetate butyrate.

3. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 1, wherein a lamina comprising a microporous composition is in laminar arrangement with the lamina formed of the semipermeable material.

4. The osmotic capsule for the delivery at a controlled rate the beneficial agent according to claim 1, wherein the capsule comprises a member selected from the group consisting of poly(hydroxyalkyl methacrylate), gelatin, polyethylene oxide, polyvinyl pyrrolidone and polyvinyl alcohol.

5. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 1, wherein the capsule comprises a composition comprising a plasticizer and a hydrophilic polymer that expands and retains fluid imbibed into the osmotic capsule.

6. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 1, wherein the capsule comprises a composition that exhibits an osmotic pressure gradient across the semipermeable material against an external fluid and erodes in the presence of fluid imbibed into the lumen.

7. The osmotic capsule for delivering at a controlled rate the beneficial agent according to claim 1, wherein the agent is a drug and the lumen contains a nontoxic carrier.

8. An osmotic capsule for the delivery at a controlled rate of a beneficial agent formulation to a fluid environment of use, the osmotic capsule comprising:

(a) a lamina comprising in at least a part a semipermeable composition that substantially maintains its integrity in the environment of use, is permeable to the passage of fluid present in the environment of use and is substantially impermeable to the passage of beneficial agent formulation, the lamina surrounding;

(b) a one piece capsule comprising a hydrophilic lamina capsuling a lumen;

(c) a beneficial agent formulation in the lumen, said formulation a member selected from the group consisting of solid, powdered pulverized, micronized and particle formulations that form, when the osmotic capsule is in operation in the environment of use in the presence of fluid that enters the osmotic capsule, a member elected from the group consisting of a solution and suspension; and

,

(d) at least one orifice through the lamina and the capsule communicating with the lumen and the exterior of the osmotic capsule for delivering the beneficial agent formulation from the osmotic capsule.

9. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 8, wherein the semipermeable composition is a member selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, and cellulose triacetate, cellulose ester, and cellulose acetate butyrate.

10. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 8, wherein a lamina comprising a microporous composition is in laminar arrangement with the lamina formed of a semipermeable material.

11. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 8, wherein the lamina comprising the capsule is a hydrophilic material selected from the group consisting of poly(hydroxyalkyl methacrylate), gelatin, polyethylene oxide, polyvinyl pyrrolidone, and polyvinyl alcohol.

12. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 8, wherein the lamina comprising the capsule comprises a composition of a hydrophilic polymer and a plasticizer.

13. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 8, wherein the lamina comprising the capsule exhibits an osmotic pressure gradient across the semipermeable material against an external fluid and swells, then erodes in the presence of fluid imbibed into the osmotic capsule.

14. The osmotic capsule for the delivery at a controlled rate the beneficial agent formulation according to claim 8, wherein the agent is a drug, and the capsule contains a nontoxic carrier.

15. An osmotic capsule comprising a member selected from the group consisting of a single section and a two section capsule for the controlled delivery of a beneficial drug formulation to a biological environment of use, the osmotic capsule comprising:

(a) a shaped wall comprising an inner lamina comprising a composition permeable to the passage of fluid present in the environment of use, and an outer lamina comprising a composition permeable to the passage of fluid present in the environment of use and substantially impermeable to the passage of drug formulation, the wall capsuling;

(b) a compartment;

(c) a dosage unit amount of a drug formulation in the compartment, said formulation a member selected from the group consisting of solid, powdered, pulverized, micronized and particle formulations that form, when the osmotic capsule is in operation in the environment of use and in the presence of fluid that enters the osmotic capsule, a member selected from the group consisting of a solution and suspension; and

,

(d) at lease one orifice in the shaped wall communicating with the compartment and the exterior of the osmotic capsule for delivering the drug formulation to the environment of use over a prolonged period of time.

16. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the drug formulation exhibits an osmotic pressure gradient across the shaped wall against a fluid present in the environment of use.

17. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the drug formulation comprises an osmotically effective compound that exhibits an osmotic pressure gradient across the shaped wall against a fluid present in the environment of use.

18. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the compartment contains a pharmaceutically acceptable carrier.

19. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein a lamina comprising a microporous composition is in laminar arrangement with the outer lamina.

20. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the osmotic capsule is a hard osmotic capsule.

21. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the osmotic capsule is a soft osmotic capsule.

22. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the environment of use is the gastrointestinal tract.

23. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the environment of use is a human and the osmotic capsule is shaped and sized for oral admittance into the human.

24. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the inner lamina is soluble in aqueous and biological fluids.

25. The osmotic capsule for the controlled delivery of the beneficial drug formulation according to claim 15, wherein the inner lamina is cross-linked.

26. The osmotic capsule for the delivery at a controlled rate of the beneficial drug formulation according to claim 15, wherein the orifice is formed when the osmotic capsule is in the environment of use.