US5364620A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Controlled absorption diltiazem formulation for once daily administration
Assignee: Perrigo Pharma International DAC
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Filing: 1992-07-28
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Granted: 1994-11-15
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Expires: 2012-07-28
Abstract
Abstract A diltiazem pellet formulation for oral administration comprises a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, and a multi-layer membrane surrounding the core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer. The number of layers in the membrane and the ratio of the water soluble to water insoluble polymer being effective to permit release of the diltiazem from the pellet at a rate allowing controlled absorption thereof over a twenty four hour period following oral administration.
Inventors
- 👤 Edward J. Geoghegan
- 👤 Seamus Mulligan
- 👤 Donald E. Panoz
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 16:35
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/55; A61K31/554; A61K9/00; A61K9/48; A61K9/50; A61K9/5073; A61K9/5078; A61K9/5084
Claims Analysis
Total Claims: 8
Claim 1
Independent Claim
141 words
A method of treating or controlling blood pressure in a subject suffering from mild to moderate hypertension, comprising administering to said subject on a once per day basis a dose effective to lower the blood pressure of said subject throughout said twenty four hour period, of a diltiazem-containing controlled absorption formulation to provide peak blood pressure lowering levels in the blood 6 to 18 hours following administration, said formulation comprising pellets having a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, the diltiazem component and the organic acid being present in a ratio of from about 20:1 to about 1:1, and a multi-layer membrane surrounding said core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer.
Claim 2
Independent Claim
141 words
A method of treating or controlling blood pressure in a subject suffering from mild to moderate hypertension, comprising administering to said subject on a once per day basis a dose effective to lower the blood pressure of said subject throughout said twenty four hour period, of a diltiazem-containing controlled absorption formulation to provide peak blood pressure lowering levels in the blood 6 to 18 hours following administration, said formulation comprising pellets having a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, the diltiazem component and the organic acid being present in a ratio of from about 20:1 to about 1:1, and a multi-layer membrane surrounding said core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer.
Claim 3
Dependent Claim
36 words
The method of claim 1 wherein said formulation further comprises a sufficient quantity of a rapid release form of diltiazem formulated to provide am effective blood pressure lowering amount of diltiazem within one hour following administration.
Claim 4
Dependent Claim
23 words
The method of claim 2 wherein said formulation contains up to about 25 % by weight of said rapid release form of diltiazem.
Claim 5
Independent Claim
154 words
A method of controlling or preventing angina attacks or reducing the incidence of angina attacks in a subject suffering from angina pectoris, comprising administering to said subject on a once per day basis a dose effective to improve the blood supply and hence increase the oxygen supply in the myocardium of said subject throughout said twenty four hour period of a diltiazem-containing controlled absorption formulation to provide peak myocardium oxygenating levels in the blood 6 to 18 hours following administration, said formulation comprising pellets having a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, the diltiazem component and the organic acid being present in a ratio of from about 20:1 to about 1:1, and a multi-layer membrane surrounding said core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic. polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer.
Claim 6
Independent Claim
154 words
A method of controlling or preventing angina attacks or reducing the incidence of angina attacks in a subject suffering from angina pectoris, comprising administering to said subject on a once per day basis a dose effective to improve the blood supply and hence increase the oxygen supply in the myocardium of said subject throughout said twenty four hour period of a diltiazem-containing controlled absorption formulation to provide peak myocardium oxygenating levels in the blood 6 to 18 hours following administration, said formulation comprising pellets having a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, the diltiazem component and the organic acid being present in a ratio of from about 20:1 to about 1:1, and a multi-layer membrane surrounding said core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic. polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer.
Claim 7
Independent Claim
34 words
The method of claims 4 wherein said formulation further comprises a sufficient quantity of a rapid release form of diltiazem effective to increase the oxygen supply to the myocardium within one hour following administration.
Claim 8
Dependent Claim
22 words
The method of claim 5 wherein said formulation contains up to about 25% by weight of said rapid release form of diltiazem.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1997-11-14 | 1998-05-16 | 1998-11-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-11-14 | 2002-05-16 | 2002-11-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-11-14 | 2006-05-16 | 2006-11-15 | $7700.00 | Window Closed / Lapsed |