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US4666702A Expired / Lapsed US ⏱️ 0.0 years remaining

Dosage units for controlled release of active material

Assignee: Thiemann Arzneimittel GmbH
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Filing: 1985-04-11
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Granted: 1987-05-19
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Expires: 2005-04-11
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Abstract

Abstract A drug delivery system in the form of dosage units for controlled release of active material comprising a core and a coating layer enclosing said core. The coating material contains a microporous synthetic thermoplastic polymer and is compressed into a suitable coating layer enclosing the core with the aid of relatively low compression forces.

Inventors

  • 👤 Hans E. Junginger

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 12:28
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/28; A61K9/2806; A61K9/2833; A61K9/284; A61K9/2004; A61K9/2022; A61K9/2027; A61K9/2072; A61K9/2086; A61K9/209; A61K9/2853

Claims Analysis

Total Claims: 21
Claim 1
Independent Claim 141 words
A substantially zero order delivery system in the form of dosage units comprising: (a) a core comprising at least one active material and (b) a relatively thin, 100 to 600 millimicron thick coating layer enclosing or covering said core comprising compression bonded particles having a particle size between about 25 and about 200 millimicrons of one or more synthetic thermopolastic polymers, at least 50% of which are microporous polymers in the form of particles having open cells therein having an average diameter of 0.1 to 100 millimicrons, with pores having an average diameter smaller than that of the cells, said microporous particles having a total void volume of from about 20% to about 95% by volume, said polymer particulates being formed into the coating layer by conventional compression pressure within the range of from 25 to about 750 Kg. Cm 2.
Claim 2
Dependent Claim 141 words
A substantially zero order delivery system in the form of dosage units comprising: (a) a core comprising at least one active material and (b) a relatively thin, 100 to 600 millimicron thick coating layer enclosing or covering said core comprising compression bonded particles having a particle size between about 25 and about 200 millimicrons of one or more synthetic thermopolastic polymers, at least 50% of which are microporous polymers in the form of particles having open cells therein having an average diameter of 0.1 to 100 millimicrons, with pores having an average diameter smaller than that of the cells, said microporous particles having a total void volume of from about 20% to about 95% by volume, said polymer particulates being formed into the coating layer by conventional compression pressure within the range of from 25 to about 750 Kg. Cm 2.
Claim 3
Dependent Claim 39 words
A delivery system according to claim 1 in which the said coating layer is comprised of at least 75% by weight of at least one microporous synthetic thermoplastic polymer and has a thickness varying between 100 and 600 μm.
Claim 4
Dependent Claim 26 words
A delivery system according to claim 1 characterized in that the coating layer is obtained by applying compressional forces not exceeding about 750 kg/cm 2 .
Claim 5
Dependent Claim 67 words
A delivery system according to claim 1, in which the said coating layer contains a wetting agent in a quantity sufficient to accelerate the release of active material but not in amounts great enough to cause the formation of additional pores in the coating layer through the dissolution of materials in said coating layer and in no case exceeding 10% by weight of the total coating material.
Claim 6
Dependent Claim 34 words
A delivery system according to claim 4, in which the wetting agent in the coating layer comprises the same active material, as present in the core, said active material being highly soluble in water.
Claim 7
Dependent Claim 34 words
A delivery system according to claim 1 characterized in that the synthetic thermoplastic microporous polymer is selected from polyethylene, polypropylene, polylactic acid, polyglycolic acid, copolymer from polylactic acid and polyglycolic acid, and mixtures thereof.
Claim 8
Dependent Claim 17 words
A delivery system according to claim 1, in which the active material is a biologically active substance.
Claim 9
Dependent Claim 14 words
A drug delivery system according to claim 7 in the form of a tablet.
Claim 10
Dependent Claim 19 words
A drug delivery system according to claim 7 in the form of multiple coated particles contained in a capsule.
Claim 11
Dependent Claim 24 words
The delivery system of claim 2, wherein the coating layer is obtained by applying a compressional force not exceeding about 750 kg/cm 2 .
Claim 12
Dependent Claim 18 words
The delivery system of claim 10, wherein said compressional force is between 100 and 500 kg/cm 2 .
Claim 13
Dependent Claim 64 words
The delivery system of claim 2, wherein said coating layer contains a wetting agent in a quantity sufficient to accelerate the release of active material but not in amounts great enough to cause the formation of additional pores in the coating layer through the dissolution of materials in said coating layer and in no case exceeding 10% by weight of the total coating material.
Claim 14
Dependent Claim 64 words
The delivery system of claim 3, wherein said coating layer contains a wetting agent in a quantity sufficient to accelerate the release of active material but not in amount great enough to cause the formation of additional pores in the coating layer through the dissolution of materials in said coating layer and in no case exceeding 10% by weight of the total coating material.
Claim 15
Dependent Claim 37 words
The delivery system of claim 2 wherein said synthetic thermoplastic microporous polymer is selected from the group consisting of polyethylene, polypropylene, polylactic acid, polyglycolic acid, a copolymer of polylactic acid and polygly colic acid, and mixtures thereof.
Claim 16
Dependent Claim 36 words
The delivery system of claim 3 wherein said synthetic thermoplastic microporous polymer is selected from the group consisting of polyethylene, polypropylene, polylactic acid, polyglycolic acid, a copolymer of polylactic acid and polyglycolic acid, and mixtures thereof.
Claim 17
Dependent Claim 36 words
The delivery system of claim 4 wherein said synthetic thermoplastic microporous polymer is selected from the group consisting of polyethylene, polypropylene, polylactic acid, polyglycolic acid, a copolymer of polylactic acid and polyglycolic acid, and mixtures thereof.
Claim 18
Dependent Claim 36 words
The delivery system of claim 5 wherein said synthetic thermoplastic microporous polymer is selected from the group consisting of polyethylene, polypropylene, polylactic acid, polyglycolic acid, a copolymer of polylactic acid and polyglycolic acid, and mixtures thereof.
Claim 19
Dependent Claim 53 words
The delivery system of claim 2, wherein said coating layer is comprised of 90-100% by weight of at least one microporous synthetic thermoplastic polymer and has a thickness varying between 250 and 500 μm, and wherein said coating layer is obtained by applying compressional forces of between 100 and 500 kg/cm 2 .
Claim 20
Dependent Claim 33 words
The delivery system of claim 1, characterized in that the synthetic thermoplastic polymer particulates comprise one or more homopolymers, compolymers or mixtures thereof selected from among condensation polymers, oxidation polymers and olefinic polymers.
Claim 21
Dependent Claim 41 words
The delivery system of claim 19, characterized in that the synthetic thermoplastic polymer particulates comprise one or more homopolymers, copolymers or mixtures thereof selected from among nylon, polylactic acid, polyglycolic acid, polyphenylene oxide, polyethylene, polypropylene, polyvinylchloride, polymethyl-acrylate, polymethylmethacrylate and ethylene-acrylic acid.

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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) 1990-05-18 1990-11-17 1991-05-19 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1994-05-18 1994-11-17 1995-05-19 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1998-05-18 1998-11-17 1999-05-19 $7700.00 Window Closed / Lapsed

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