US5567441A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Diltiazem controlled release formulation
Assignee: Andrx Pharmaceuticals LLC
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Filing: 1995-03-24
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Granted: 1996-10-22
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Expires: 2015-03-24
Abstract
Abstract A once-a-day controlled release diltiazem formulation is described which includes: (a) from 20 to 50% by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder; and a second layer which comprises a membrane comprising a pH dependent polymeric material; and (b) from 50% to 80% by weight of delayed pulse polymeric membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder and a second layer which comprises a polymeric membrane which will substantially maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and (c) a unit dose containment system.
Inventors
- 👤 Chih-Ming Chen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 16:17
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/50; A61K9/5084; A61K31/00; A61K31/33; A61K31/395; A61K31/55; A61K31/554; A61K9/5073; A61K9/5078
Claims Analysis
Total Claims: 7
Claim 1
Independent Claim
154 words
A once-a-day controlled release diltiazem formulation which comprises: (a) from 20 to 50% by weight of enteric polymer membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymer binder; and a second layer which comprises a membrane comprising polymer enteric coating material selected from the group consisting off shellac, methacrylic acid copolymers and cellulose acetate phthalate; and (b) from 50% to 80% by weight of delayed pulse polymer membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymer binder and a second layer which comprises a polymer membrane which will maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and (c) a unit dose containment system.
Claim 2
Dependent Claim
154 words
A once-a-day controlled release diltiazem formulation which comprises: (a) from 20 to 50% by weight of enteric polymer membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymer binder; and a second layer which comprises a membrane comprising polymer enteric coating material selected from the group consisting off shellac, methacrylic acid copolymers and cellulose acetate phthalate; and (b) from 50% to 80% by weight of delayed pulse polymer membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymer binder and a second layer which comprises a polymer membrane which will maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and (c) a unit dose containment system.
Claim 3
Dependent Claim
30 words
A once-a-day controlled release diltiazem formulation as defined in claim 1 wherein the enteric coating polymer material and the second layer on the delayed pulse pellets both contain a plasticizer.
Claim 4
Dependent Claim
25 words
A once-a-day controlled release diltiazem formulation as defined in claim 1 wherein the membrane on the enteric coating polymer material is a methacrylic acid copolymer.
Claim 5
Dependent Claim
32 words
A once-a-day controlled release diltiazem formulation as defined in claim 1 wherein the second layer on the delayed pulse polymer membrane coated pellets is a copolymer of acrylic and methacrylic acid esters.
Claim 6
Dependent Claim
148 words
A once-a-day controlled release diltiazem formulation which comprises: (a) from 20 to 50% by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem, a polymer binder and polysorbate 80; and a second layer which comprises a membrane comprising polymer enteric coating material which comprises polymethacrylic acid and ethylacrylate; and (b) from 50% to 80% by weight of delayed pulse polymer membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymer binder and a second layer which comprises a polymer membrane which will maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and (c) a unit dose containment system.
Claim 7
Dependent Claim
148 words
A once-a-day controlled release diltiazem formulation which comprises: (a) from 20 to 50% by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem, a polymer binder and polysorbate 80; and a second layer which comprises a membrane comprising polymer enteric coating material which comprises polymethacrylic acid and ethylacrylate; and (b) from 50% to 80% by weight of delayed pulse polymer membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymer binder and a second layer which comprises a polymer membrane which will maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and (c) a unit dose containment system.
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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) | 1999-10-22 | 2000-04-22 | 2000-10-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-10-22 | 2004-04-22 | 2004-10-22 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-10-22 | 2008-04-22 | 2008-10-22 | $7700.00 | Window Closed / Lapsed |