US5011692A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Sustained pulsewise release pharmaceutical preparation
Assignee: Sumitomo Pharma Co Ltd
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Filing: 1986-12-23
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Granted: 1991-04-30
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Expires: 2006-12-23
Abstract
Abstract The invention relates to sustained pulsewise release pharmaceutical preparation which comprices drug-containing polymeric material layers (layers A) and polymeric material layers containing the drug in question only in a slight amount or free of the drug (layers B) disposed alternatingly, with the whole surface extending in the direction perpendicular to the layer plane being coated with a polymeric material which is insoluble in water or scarcely soluble in water (polymeric material C). This pharmaceutical preparation of this invention is designed so that active ingredients which should desirably be released pulsewise can be released therefrom in a pulse-like and clinically significant manner and thereby the pharmacological effects of said active ingredients can be maintained for a prolonged period of time.
Inventors
- 👤 Keiji Fujioka
- 👤 Shigeji Sato
- 👤 Yoshihiro Takada
- 👤 Yoshio Sasaki
- 👤 Nobuhiko Tamura
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 02:34
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2072; A61K9/2086; A61K9/209
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
81 words
A sustained pulsewise-release pharmaceutical dosage form means for embedding beneath skin which embedded administration comprises (a) drug-containing polymeric material layers (layers A) and polymeric material layers free from the drug in question or containing only a slight and significantly smaller amount of the same (layers B) disposed alternatingly, and (b) a surface extending in a direction perpendicular to the layers and coated in its entirety with a polymeric material which is insoluble or scarcely soluble in water and in body fluids.
Claim 2
Dependent Claim
81 words
A sustained pulsewise-release pharmaceutical dosage form means for embedding beneath skin which embedded administration comprises (a) drug-containing polymeric material layers (layers A) and polymeric material layers free from the drug in question or containing only a slight and significantly smaller amount of the same (layers B) disposed alternatingly, and (b) a surface extending in a direction perpendicular to the layers and coated in its entirety with a polymeric material which is insoluble or scarcely soluble in water and in body fluids.
Claim 3
Dependent Claim
16 words
A pharmaceutical dosage form of claim 1, wherein the layers B contain no drug at all.
Claim 4
Dependent Claim
23 words
A pharmaceutical dosage form of claim 1, wherein layers B contain a drug which is different from the drug contained in layers A.
Claim 5
Dependent Claim
48 words
A pharmaceutical dosage form of claim 1, wherein the whole surface extending in a direction perpendicular to the layers and one face extending in a direction parallel to the layers are coated with a polymeric material which is insoluble or scarcely soluble in water and in body fluids.
Claim 6
Dependent Claim
34 words
A pharmaceutical dosage form of claim 1, wherein at least layers A or layers B comprise at least one member selected from the group consisting of collagen, gelatin, polylactic acid, polyglycolic acid and poly(lactide-co-glycolide).
Claim 7
Dependent Claim
39 words
A pharmaceutical dosage form of claim 1, wherein the polymeric material which is insoluble or scarcely soluble in water and in body fluids is a silicone polymer and covers the surface extending in a direction perpendicular to the layers.
Claim 8
Dependent Claim
22 words
A pharmaceutical dosage form of claim 1, wherein the drug is disposed in polymeric material layers, in a form of enclosed particles.
Claim 9
Dependent Claim
15 words
A pharmaceutical dosage form of claim 7, wherein the particles are liposome, microcapsules or microspheres.
Claim 10
Dependent Claim
29 words
A pharmaceutical dosage form of claim 7, wherein the particles are of a size which is generally within a range of from about 17 nm to about 1000 μm.
Claim 11
Dependent Claim
20 words
A pharmaceutical dosage form of one of claims 1-8, wherein the drug is a drug which is advantageously administered pulsewise.
Claim 12
Dependent Claim
41 words
A sustained pulsewise-release pharmaceutical dosage form of claim 1 which is adapted for embedded use beneath the skin, wherein the drug is one which is administrable by embedding beneath the skin and wherein layers B are substantially free from the drug.
Claim 13
Dependent Claim
23 words
A pharmaceutical dosage form of claim 1 wherein the polymeric material of each layer A and that of each layer B is degradable.
Claim 14
Dependent Claim
23 words
A pharmaceutical dosage form of claim 6 wherein the silicone polymer also covers a surface extending in a direction parallel to the layers.
Claim 15
Dependent Claim
92 words
A sustained pulsewise-release pharmaceutical tablet means for embedding beneath the skin and administration comprising a plurality of substantially planar parallel layers surrounded by a surface perpendicular to the layers; said layers being of at least two different types: a first type comprising drug-containing polymeric material and being disposed alternatingly with a second type containing polymeric material which is free from or substantially free from the drug in the first type; the surrounding perpendicular surface being coated with a polymeric material which is insoluble or substantially insoluble in water and in body fluids.
Claim 16
Dependent Claim
92 words
A sustained pulsewise-release pharmaceutical tablet means for embedding beneath the skin and administration comprising a plurality of substantially planar parallel layers surrounded by a surface perpendicular to the layers; said layers being of at least two different types: a first type comprising drug-containing polymeric material and being disposed alternatingly with a second type containing polymeric material which is free from or substantially free from the drug in the first type; the surrounding perpendicular surface being coated with a polymeric material which is insoluble or substantially insoluble in water and in body fluids.
Claim 17
Dependent Claim
89 words
A sustained pulsewise-release pharmaceutical dosage form which comprises (a) drug-containing polymeric material layers (layers A) and polymeric material layers free from or substantially free from the drug in question (layers B) disposed alternatingly, and (b) a surface extending in a direction perpendicular to the layers and coated in its entirety with a polymeric material which is insoluble or scarcely soluble in water and in body fluids; the pharmaceutical preparation being in a form suitable for and the drug being one which is administrable by being embedded beneath the skin.
Claim 18
Dependent Claim
89 words
A sustained pulsewise-release pharmaceutical dosage form which comprises (a) drug-containing polymeric material layers (layers A) and polymeric material layers free from or substantially free from the drug in question (layers B) disposed alternatingly, and (b) a surface extending in a direction perpendicular to the layers and coated in its entirety with a polymeric material which is insoluble or scarcely soluble in water and in body fluids; the pharmaceutical preparation being in a form suitable for and the drug being one which is administrable by being embedded beneath the skin.
Claim 19
Dependent Claim
34 words
A dosage form of claim 1, claim 14, or claim 15 in which the drug is a peptide protein type drug for embedded use and which is unstable to heat and to organic solvents.
Claim 20
Dependent Claim
13 words
A pharmaceutical dosage form of claim 1, wherein the drug is GRF (1-29).
Claim 21
Dependent Claim
15 words
A pharmaceutical dosage form of claim 1, wherein peptide protein type active substance is interferon.
Claim 22
Dependent Claim
22 words
An implantable pharmaceutical preparation of one of claims 1-8, wherein the layers A and layers B are layers formed by compression molding.
Claim 23
Independent Claim
104 words
A method of pulsewise administering a pharmaceutical which comprises embedding a dosage form beneath the skin of a host in need of such therapy, and wherein the dosage form is a sustained pulsewise-release pharmaceutical dosage form which comprises (a) drug-containing polymeric material layers (layers A) and polymeric material layers free from the drug in question or containing only a slight and significantly smaller amount of the same (layers B) disposed alternatingly, and (b) a surface extending in a direction perpendicular to the layers and coated in its entirety with a polymeric material which is insoluble or scarcely soluble in water and in body fluids.
Claim 24
Independent Claim
104 words
A method of pulsewise administering a pharmaceutical which comprises embedding a dosage form beneath the skin of a host in need of such therapy, and wherein the dosage form is a sustained pulsewise-release pharmaceutical dosage form which comprises (a) drug-containing polymeric material layers (layers A) and polymeric material layers free from the drug in question or containing only a slight and significantly smaller amount of the same (layers B) disposed alternatingly, and (b) a surface extending in a direction perpendicular to the layers and coated in its entirety with a polymeric material which is insoluble or scarcely soluble in water and in body fluids.
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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) | 1994-04-29 | 1994-10-29 | 1995-04-30 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-04-29 | 1998-10-29 | 1999-04-30 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-04-29 | 2002-10-29 | 2003-04-30 | $7700.00 | Window Closed / Lapsed |