US4309406A
Expired / Lapsed
US
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Sustained release pharmaceutical compositions
Assignee: Wyeth LLC
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Filing: 1981-01-30
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Granted: 1982-01-05
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Expires: 2001-01-30
Abstract
Abstract Novel sustained release compositions comprising a core containing a drug, a seal coating surrounding the core and a sugar coating surround the seal coated core are disclosed.
Inventors
- 👤 Paul C. Guley
- 👤 Richard J. DeNeale
- 👤 George Milosovich
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 11:30
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2072; A61K9/2086; A61K9/209
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
171 words
A sustained release pharmaceutical composition comprising a compressed core containing a drug, a seal coating surrounding the core and a sugar coating surrounding the seal coated core wherein, (a) the core comprises a therapeutically effective amount of at least one drug in an amount of about 29% to about 64% by weight of the core, and the cellulose polymers hydroxypropyl methylcellulose and ethylcellulose in an amount of 30% to about 45% by weight of the core; and (b) the seal coating comprises a film coating material selected from the group consisting of enteric and nonenteric materials and mixtures thereof; and (c) the sugar coating comprises sugar and a loading dose of at least one drug contained in the core in which the ratio of said one drug in the sugar coating to said one drug in the core is from about 1:15 to about 1:3 and with the proviso that when the seal coating consists essentially of an enteric-coating material the drug is other than propranolol or its pharmaceutically acceptable salts.
Claim 2
Dependent Claim
171 words
A sustained release pharmaceutical composition comprising a compressed core containing a drug, a seal coating surrounding the core and a sugar coating surrounding the seal coated core wherein, (a) the core comprises a therapeutically effective amount of at least one drug in an amount of about 29% to about 64% by weight of the core, and the cellulose polymers hydroxypropyl methylcellulose and ethylcellulose in an amount of 30% to about 45% by weight of the core; and (b) the seal coating comprises a film coating material selected from the group consisting of enteric and nonenteric materials and mixtures thereof; and (c) the sugar coating comprises sugar and a loading dose of at least one drug contained in the core in which the ratio of said one drug in the sugar coating to said one drug in the core is from about 1:15 to about 1:3 and with the proviso that when the seal coating consists essentially of an enteric-coating material the drug is other than propranolol or its pharmaceutically acceptable salts.
Claim 3
Dependent Claim
14 words
The composition of claim 1 wherein the seal coating comprises an enteric coating material.
Claim 4
Dependent Claim
14 words
The composition of claim 1 wherein the seal coating comprises a nonenteric coating material.
Claim 5
Dependent Claim
48 words
The composition of claims, 1,2 or 3 in which the ratio of drug in the core to said cellulose polymers is in the range of about 0.8:1 to about 2.1:1 and the ratio of hydroxypropyl methylcellulose to ethylcellulose is in the range of about 10:1 to about 1.5:1.
Claim 6
Dependent Claim
33 words
The composition of claims 1, 2 or 3 wherein the ratio of said one drug in the sugar coating to said one drug in the core is from about 1:8 to about 1:6.
Claim 7
Dependent Claim
26 words
The composition of claim 5 in which the sugar coating further comprises at least one drug used in adjunct therapy with a drug in the core.
Claim 8
Dependent Claim
112 words
A sustained release pharmaceutical composition comprising a compressed core, a seal coating surrounding the core and a sugar coat surrounding the seal coated core wherein, (a) the core comprises propranolol or a pharmaceutically acceptable acid addition salt thereof in an amount of about 29% to about 64% by weight of the core, and the cellulose polymers hydroxypropyl methylcellulose and ethylcellulose in an amount of about 30% to about 45% by weight of the core; (b) the seal coating comprises a film coating material selected from the group consisting of nonenteric materials and mixtures of nonenteric materials with enteric materials. (c) the sugar coating comprises sugar and a loading dose of said propranolol.
Claim 9
Dependent Claim
112 words
A sustained release pharmaceutical composition comprising a compressed core, a seal coating surrounding the core and a sugar coat surrounding the seal coated core wherein, (a) the core comprises propranolol or a pharmaceutically acceptable acid addition salt thereof in an amount of about 29% to about 64% by weight of the core, and the cellulose polymers hydroxypropyl methylcellulose and ethylcellulose in an amount of about 30% to about 45% by weight of the core; (b) the seal coating comprises a film coating material selected from the group consisting of nonenteric materials and mixtures of nonenteric materials with enteric materials. (c) the sugar coating comprises sugar and a loading dose of said propranolol.
Claim 10
Dependent Claim
25 words
The composition of claim 7 wherein the sugar coating further comprises at least one drug used in adjunct therapy with a 62 -adrenergic blocking agent.
Claim 11
Dependent Claim
12 words
The composition of claim 7 wherein the sugar coating further comprises hydrochlorothiazide.
Claim 12
Dependent Claim
14 words
The composition of claim 7 wherein the sugar coating further comprises hydrochlorothiazide and triamterene.
Claim 13
Dependent Claim
72 words
The composition of claims, 7, 8, 9 or 10 in which the ratio of said propranolol in the sugar coating to said propranolol in the core is in the range of about 1:15 to about 1:3; the ratio of said propranolol in the core to said cellulose polymers is in the range of about 0.8:1 to about 2.:1:1; and the ratio of hydroxypropyl methylcellulose to ethylcellulose is about 10:1 to about 1.5:1.
Claim 14
Dependent Claim
67 words
The composition of claim 11 in which the ratio of said propranolol in the sugar coating to said propranolol in the core is in the range of about 1:6 to about 1:8; the ratio of said propranolol in the core to said cellulose polymers is in the range of about 1:1 to about 1:1.5 the ratio of hydroxypropyl methylcellulose to ethylcellulose is about 5:1 to about 1.5:1.
Claim 15
Dependent Claim
12 words
The composition of claim 11 comprising about 40-320 mg. of propranolol hydrochloride.
Claim 16
Dependent Claim
12 words
The composition of claim 11 comprising about 80-160 mg. of propranolol hydrochloride.
Claim 17
Dependent Claim
76 words
The composition of claim 11 comprising about 80-160 mg. of propranolol hydrochloride in which the ratio of said propranolol in the sugar coating to said propranolol in the core is about 1:7; the ratio of said propranolol to said cellulose polymers is about 1:1 to about 1.5:1; and the ratio of hydroxypropyl methylcellulose having a viscosity of 15,000 cps at 20° C. to ethylcellulose having a viscosity of 7 cps at 20° C. is about 4:1.
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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) | 1985-01-04 | 1985-07-06 | 1986-01-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1989-01-04 | 1989-07-06 | 1990-01-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1993-01-04 | 1993-07-06 | 1994-01-05 | $7700.00 | Window Closed / Lapsed |