Osmotic dosage system for delivering a formulation comprising liquid carrier and drug

• US 5,324,280 A
• Filed: 04/02/1990
• Issued: 06/28/1994
• Est. Priority Date: 04/02/1990
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix, Wong, Patrick S. L., Barclay, Brian L., Dealey, Michael H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US07/502,705
• Time in Patent Office: 1,548 Days
• Field of Search: 604/892.1, 424/453, 424/462, 424/463, 424/468, 424/471, 424/472, 424/474, 424/482
• 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 system is disclosed for delivering a beneficial agent formulation to an environment of use. The osmotic system comprises (a) an outside semipermeable wall, (b) a middle osmotically active layer, (c) a capsule comprising a beneficial agent, and (d) a passageway for dispensing the beneficial agent from the osmotic system.

Claims

1. An osmotic system for delivering at a controlled rate a beneficial agent formulation to a fluid environment of use, wherein the osmotic system comprises:

(a) a gelatin capsule comprising a body and a cap joined to provide an internal lumen;

(b) a dosage amount of a beneficial agent liquid formulation in the lumen;

(c) an osmagent composition on the outside wall of the capsule;

(d) a semipermeable composition surrounding the osmagent composition; and

(e) at least one orifice that communicates with the exterior and the lumen for delivering the beneficial agent liquid formulation from the osmotic system.

2. The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the orifice is formed when the osmotic system is in the environment of use.

3. The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the beneficial agent is a calcium channel blocking drug.

4. The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the beneficial agent is diltiazem.

5. The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the beneficial agent is an angiotensin converting enzyme inhibitor.

6. The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the beneficial agent is a member selected from the group consisting of lisinopril, captopril, ramipril, fosinopril, benazepril, libenzapril, cilazapril, cilazaprilat, perindopril, zofenopril, enalapril, imidapril, spirapril, rentiapril, delapril, alindapril, indolapril, imidapril, and quinapril.

7. The osmotic system for delivering the beneficial agent according to claim 1, wherein the beneficial agent is steroid.

8. The osmotic system for delivering a beneficial agent formulation according to claim 1, wherein the beneficial agent is a polypeptide.

9. The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the lumen comprises a pharmaceutically acceptable carrier.

10. An osmotic system for delivering at a controlled rate a beneficial agent formulation to a fluid environment of use, the osmotic system comprising:

(a) a wall in at least a part comprising a semipermeable composition, which wall surrounds;

(b) a layer comprising an osmopolymer composition, which layer surrounds;

(c) a gelatin capsule comprising a body and a matching cap telescopically joined to provide a lumen;

(d) a dosage amount of a therapeutically active drug liquid formulation in the lumen; and

,

(e) at least one orifice communicating with the lumen and the exterior of the osmotic system for delivering the therapeutically active drug from the osmotic system.

11. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 10, wherein the orifice is formed in the osmotic system when it is in the environment of use.

12. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 10, wherein the beneficial agent is a member selected from the group consisting of lisinopril, ramipril, enalapril, captopril, and enalaprilat.

13. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 10, wherein the beneficial agent is a member selected from the group consisting of famotidine, cimetidine, ranitidine, nizatidine, sucralfate and etintidine.

14. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 10, wherein a pharmaceutically acceptable carrier is in the lumen.

15. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 10, wherein the beneficial agent is a member selected from the group consisting of nimodipine, nitredipine, nisoldipine, nicardipine, felodipine, lidoflazine, tiapamil, gallopamil, amlodipine, diltiazem, and mioflazine.

16. An osmotic system for delivering at a controlled rate a beneficial agent formulation to a fluid environment of use, the osmotic system comprising:

(a) a wall in at least a part comprising 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, which wall surrounds;

(b) a layer comprising an osmotically effective solute, the layer surrounding;

(c) a one piece gelatin capsule comprising a lumen;

(d) a beneficial agent liquid formulation in the lumen; and

,

(e) at least one orifice that communicates with the lumen and the exterior of the osmotic system for delivering the beneficial agent formulation from the osmotic system.

17. The osmotic system for delivering at a controlled rate the beneficial agent formulation according to claim 16, wherein the orifice is formed when the osmotic system is in the environment of use.

18. The osmotic system for delivering at a controlled rate the beneficial agent formulation according to claim 16, wherein the lumen contains a member selected from the group consisting of a monoglyceride, propylene glycol monoester, succinylated monoglyceride, acetylated monoglyceride, glyceryl monostearate, monoglyceride water-in-oil emulsion, hydrogenated palm oil, hydrogenated palm oil stearine, hydrogenated soybean oil, hydrogenated vegetable oil, hydrogenated cotton seed oil, partially hydrogenated oils and blends of hydrogenated and partially hydrogenated oils.

19. The osmotic system for delivering at a controlled rate the beneficial agent formulation according to claim 16, wherein the lumen contains a member selected from the group consisting of vegetable oil, animal oil, marine oil, corn oil, almond oil, babassu oil, eucalyptus oil, cotton seed oil, palm oil, peanut oil, whale oil, herring oil, sunflower seed oil, rape seed oil, mint oil and mineral oil.

20. The osmotic system for delivering at a controlled rate the beneficial agent formulation according to claim 16, wherein the lumen contains a member selected from the group consisting of an emulsion, sol, colloid, suspension, solution, liquid and immiscible liquid.

21. An osmotic system for delivering at a controlled rate a beneficial agent formulation to a fluid environment of use, wherein the osmotic system comprises:

(a) a wall comprising a composition that is permeable to the passage of fluid and impermeable to the passage of agent, which wall surrounds;

(b) a layer comprising an osmopolymer, which layer surrounds;

(c) a one piece gelatin capsule comprising a lumen;

(d) a beneficial agent liquid formulation in the lumen; and

,

(e) at least one orifice that communicates with the lumen and the exterior of the osmotic system for delivering the beneficial agent formulation from the osmotic system.

22. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 21, wherein the orifice is formed when the osmotic systems is in the environment of use.

23. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 21, wherein the lumen contains a surfactant selected from the group consisting of a nonionic, cationic and anionic surfactant.

24. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 21, wherein the lumen contains an antioxidant.

25. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 21, wherein the beneficial agent is a drug and the lumen contains 0.05 ng to 5 g of drug.

26. The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 21, wherein the beneficial agent is a drug and the drug is mixed with a pharmaceutically acceptable carrier comprising a fluid selected from the group consisting of an organic and inorganic fluid.