US5324280A
Expired / Lapsed
US
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Osmotic dosage system for delivering a formulation comprising liquid carrier and drug
Assignee: Alza Corp
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Filing: 1990-04-02
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Granted: 1994-06-28
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Expires: 2010-04-02
Abstract
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.
Inventors
- 👤 Patrick S. L. Wong
- 👤 Felix Theeuwes
- 👤 Brian L. Barclay
- 👤 Michael H. Dealey
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 16:12
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0002; A61K9/0004
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
97 words
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.
Claim 2
Dependent Claim
97 words
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.
Claim 3
Dependent Claim
30 words
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.
Claim 4
Dependent Claim
25 words
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.
Claim 5
Dependent Claim
21 words
The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the beneficial agent is diltiazem.
Claim 6
Dependent Claim
25 words
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.
Claim 7
Dependent Claim
48 words
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.
Claim 8
Dependent Claim
18 words
The osmotic system for delivering the beneficial agent according to claim 1, wherein the beneficial agent is steroid.
Claim 9
Dependent Claim
20 words
The osmotic system for delivering a beneficial agent formulation according to claim 1, wherein the beneficial agent is a polypeptide.
Claim 10
Dependent Claim
23 words
The osmotic system for the delivery of the beneficial agent formulation according to claim 1, wherein the lumen comprises a pharmaceutically acceptable carrier.
Claim 11
Dependent Claim
106 words
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.
Claim 12
Dependent Claim
106 words
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.
Claim 13
Dependent Claim
34 words
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.
Claim 14
Dependent Claim
36 words
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.
Claim 15
Dependent Claim
37 words
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.
Claim 16
Dependent Claim
26 words
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.
Claim 17
Dependent Claim
42 words
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.
Claim 18
Dependent Claim
129 words
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.
Claim 19
Dependent Claim
129 words
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.
Claim 20
Dependent Claim
32 words
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.
Claim 21
Dependent Claim
71 words
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.
Claim 22
Dependent Claim
65 words
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.
Claim 23
Dependent Claim
39 words
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.
Claim 24
Dependent Claim
103 words
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.
Claim 25
Dependent Claim
103 words
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.
Claim 26
Dependent Claim
32 words
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.
Claim 27
Dependent Claim
35 words
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.
Claim 28
Dependent Claim
23 words
The osmotic system for delivering at a controlled rate a beneficial agent formulation according to claim 21, wherein the lumen contains an antioxidant.
Claim 29
Dependent Claim
35 words
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.
Claim 30
Dependent Claim
48 words
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.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-06-27 | 1997-12-27 | 1998-06-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-06-27 | 2001-12-27 | 2002-06-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-06-27 | 2005-12-27 | 2006-06-28 | $7700.00 | Window Closed / Lapsed |