US4758437A
Expired / Lapsed
US
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Composition for long acting nicardipine preparation and process of producing the composition
Assignee: Astellas Pharma Inc
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Filing: 1987-02-11
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Granted: 1988-07-19
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Expires: 2007-02-11
Abstract
Abstract A spherical pellet like composition of nicardipine composed of small granular nuclei such as sugar particles coated with amorphous nicardipine or a salt thereof, a pH-dependent additive and a surface active agent. The spherical pellet like composition of nicardipine may have a further coating of a medicament permeating material as an outermost coating. The spherical pellet like composition may be mixed with the spherical pellet like composition coated with the medicament permeating material.
Inventors
- 👤 Takashi Sonobe
- 👤 Hiroitsu Kawata
- 👤 Masayoshi Aruga
- 👤 Tadayoshi Ohmura
- 👤 Satoru Yoneya
- 👤 Chiharu Yamada
- 👤 Yukio Kubota
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 09:19
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/44; A61K9/00; A61K9/48; A61K9/50; A61K9/5073; A61K9/5078; A61K9/5084
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
147 words
A spherical pellet-like nicardipine long acting composition comprising a pharmaceutically inert core coated with the following components: (a) a pharmaceutically active amount of amorphous nicardipine or a hydrochloride salt thereof, (b) a pH-dependent additive selected from the group consisting of hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, poly(methacrylic acid, methylmethacrylate) and shellac, (c) a surface active agent selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene alkyl ether and polyoxyethylene hydrogenated castor oil, and further coated with (d) at least one medicament penetrating material selected from the group consisting of poly(ethylacrylate, methylmethacrylate, trimethylammonioethylmethacrylate chloride) and ethyl cellulose; wherein the ratio of components (a), (b) and (c) to said inert core is 1:01 to 1:10, and wherein said composition is comprised of from 99 to 85 parts of said inert core plus components (a), (b) and (c), and from 1 to 15 parts of component (d).
Claim 2
Dependent Claim
147 words
A spherical pellet-like nicardipine long acting composition comprising a pharmaceutically inert core coated with the following components: (a) a pharmaceutically active amount of amorphous nicardipine or a hydrochloride salt thereof, (b) a pH-dependent additive selected from the group consisting of hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, poly(methacrylic acid, methylmethacrylate) and shellac, (c) a surface active agent selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene alkyl ether and polyoxyethylene hydrogenated castor oil, and further coated with (d) at least one medicament penetrating material selected from the group consisting of poly(ethylacrylate, methylmethacrylate, trimethylammonioethylmethacrylate chloride) and ethyl cellulose; wherein the ratio of components (a), (b) and (c) to said inert core is 1:01 to 1:10, and wherein said composition is comprised of from 99 to 85 parts of said inert core plus components (a), (b) and (c), and from 1 to 15 parts of component (d).
Claim 3
Dependent Claim
15 words
The long acting composition of claim 1 wherein said core is coated with amorphous nicardipine.
Claim 4
Dependent Claim
16 words
The long acting composition of claim 1 wherein said core is coated with amorphous nicardipine hydrochloride.
Claim 5
Dependent Claim
15 words
The long acting composition of claim 1 wherein said pH-dependent additive is hydroxypropylmethyl cellulose phthalate.
Claim 6
Dependent Claim
15 words
The long acting composition of claim 1 wherein said pH-dependent additive is cellulose acetate phthalate.
Claim 7
Dependent Claim
15 words
The long acting composition of claim 1 wherein said pH-dependent additive is poly(methacrylic acid, methylmethacrylate).
Claim 8
Dependent Claim
13 words
The long acting composition of claim 1 wherein said pH-dependent additive is shellac.
Claim 9
Dependent Claim
18 words
The long acting composition of claim 1 wherein said surface active agent is polyoxyethylene sorbitan fatty acid ester.
Claim 10
Dependent Claim
16 words
The long acting composition of claim 1 wherein said surface active agent is polyoxyethylene alkyl ether.
Claim 11
Dependent Claim
17 words
The long acting composition of claim 1 wherein said surface active agent is polyoxyethylene hydrogenated castor oil.
Claim 12
Dependent Claim
17 words
The long acting composition of claim 1 wherein said medicament penetrating material is poly(ethylacrylate methylmethacrylate trimethylammonioethylmethacrylate chloride).
Claim 13
Dependent Claim
15 words
The long acting composition of claim 1 wherein said medicament penetrating material is ethyl cellulose.
Claim 14
Dependent Claim
111 words
A spherical pellet-like nicardipine long acting composition comprising a pharmaceutically inert core coated with the following components: (a) a pharmaceutically active amount of amorphous nicardipine hydrochloride, (b) a pH-dependent additive consisting of hydroxypropylmethyl cellulose phthalate, (c) a surface active agent consisting of polyoxyethylene sorbitan fatty acid ester, and further coated with (d) a medicament penetrating material consisting of poly(ethylacrylate, methylmethacrylate, and trimethylammonioethylmethacrylate chloride); wherein the ratio of components (a), (b) and (c) to said inert core is 1:01 to 1:10, and wherein said composition is comprised of from 99 to 85 parts of said inert core plus components (a), (b) and (c), and from 1 to 15 parts of component (d).
Claim 15
Dependent Claim
111 words
A spherical pellet-like nicardipine long acting composition comprising a pharmaceutically inert core coated with the following components: (a) a pharmaceutically active amount of amorphous nicardipine hydrochloride, (b) a pH-dependent additive consisting of hydroxypropylmethyl cellulose phthalate, (c) a surface active agent consisting of polyoxyethylene sorbitan fatty acid ester, and further coated with (d) a medicament penetrating material consisting of poly(ethylacrylate, methylmethacrylate, and trimethylammonioethylmethacrylate chloride); wherein the ratio of components (a), (b) and (c) to said inert core is 1:01 to 1:10, and wherein said composition is comprised of from 99 to 85 parts of said inert core plus components (a), (b) and (c), and from 1 to 15 parts of component (d).
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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) | 1991-07-19 | 1992-01-18 | 1992-07-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-07-19 | 1996-01-18 | 1996-07-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-07-19 | 2000-01-18 | 2000-07-19 | $7700.00 | Window Closed / Lapsed |