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Semi-enteric drug delivery systems and methods for preparing same

Assignee: Warner Lambert Co LLC
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Filing: 1992-02-14
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Granted: 1992-12-01
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Expires: 2012-02-14
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Abstract

Abstract The present invention pertains to semi-enteric drug delivery systems which comprise (a) an inert core, (b) a first coating layer over the core comprising a medicament, and (c) a second coating layer over the first coating layer comprising a mixture of methacrylic acid copolymer, type C, and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively.

Inventors

  • 👤 Nouman Muhammad
  • 👤 Michael Harris
  • 👤 Jay Weiss
  • 👤 Russell U. Nesbitt

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-30 19:00
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/50; A61K9/5073; A61K9/5078

Claims Analysis

Total Claims: 24
Claim 1
Independent Claim 67 words
A semi-enteric drug delivery system which comprises: (a) an pharmacologically inert core; (b) a first coating layer over the core comprising a medicament; and (c) a second coating layer over the first coating layer comprising a mixture of an aqueous dispersion of an anionic copolymer based on methacrylic acid and ethylacrylate and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively.
Claim 2
Dependent Claim 67 words
A semi-enteric drug delivery system which comprises: (a) an pharmacologically inert core; (b) a first coating layer over the core comprising a medicament; and (c) a second coating layer over the first coating layer comprising a mixture of an aqueous dispersion of an anionic copolymer based on methacrylic acid and ethylacrylate and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively.
Claim 3
Dependent Claim 31 words
The drug delivery system according to claim 1, wherein the pharmacologically inert core is present in the drug delivery system in an amount from about 20% to about 50%, by weight.
Claim 4
Dependent Claim 40 words
The drug delivery system according to claim 1, wherein the medicament in the first coating layer is a water-soluble medicament selected from the group consisting of doxycycline hyclate, minocycline hydrochloride, oxytetracycline hydrochloride, chlortetracycline hydrochloride, and demeclocycline hydrochloride, and mixtures thereof.
Claim 5
Dependent Claim 31 words
The drug delivery system according to claim 1, wherein the first coating layer is present in the drug delivery system in an amount from about 37% to about 75%, by weight.
Claim 6
Dependent Claim 37 words
The drug delivery system according to claim 1, wherein the mixture of methacrylic acid copolymer, and povidone in the second coating layer is present in a ratio by weight of from about 4:1I to about 8:1, respectively.
Claim 7
Dependent Claim 31 words
The drug delivery system according to claim 1, wherein the second coating layer is present in the drug delivery system in an amount from about 5% to about 30%, by weight.
Claim 8
Dependent Claim 33 words
The drug delivery system according to claim 1, wherein the first coating layer further comprises a gliding agent present in the drug delivery system in an amount up to about 1%, by weight.
Claim 9
Dependent Claim 35 words
The drug delivery system according to claim 1, wherein the first coating layer further comprises a binding agent present in the drug delivery system in an amount from about 1% to about 4%, by weight.
Claim 10
Dependent Claim 33 words
The drug delivery system according to claim 1, wherein the second coating layer further comprises a plasticizing agent present in the drug delivery system in an amount up to about 3%, by weight.
Claim 11
Dependent Claim 33 words
The drug delivery system according to claim 1, wherein the second coating layer further comprises an anti-adhering agent present in the drug delivery system in an amount up to about 2%, by weight.
Claim 12
Independent Claim 112 words
A method for preparing a semi-enteric drug delivery system which comprises the steps of: (A) providing the following ingredients: (a) a pharmacologically inert core; (b) first coating layer over the core comprising a medicament; and (c) a second coating layer over the first coating layer comprising a mixture of an aqueous dispersion of an anionic copolymer based on methacrylic acid and ethylacrylate and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively; (B) powder layering the pharmacologically inert core with the first coating layer; and (C) spray coating the coated core of step (B) with the second coating layer to form the semi-enteric drug delivery system.
Claim 13
Independent Claim 112 words
A method for preparing a semi-enteric drug delivery system which comprises the steps of: (A) providing the following ingredients: (a) a pharmacologically inert core; (b) first coating layer over the core comprising a medicament; and (c) a second coating layer over the first coating layer comprising a mixture of an aqueous dispersion of an anionic copolymer based on methacrylic acid and ethylacrylate and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively; (B) powder layering the pharmacologically inert core with the first coating layer; and (C) spray coating the coated core of step (B) with the second coating layer to form the semi-enteric drug delivery system.
Claim 14
Dependent Claim 29 words
The method according to claim 11, wherein the pharmacologically inert core is present in the drug delivery system in an amount from about 20% to about 50%, by weight.
Claim 15
Dependent Claim 38 words
The method according to claim 11, wherein the medicament in the first coating layer is a water-soluble medicament selected from the group consisting of doxycycline hyclate, minocycline hydrochloride, oxytetracycline hydrochloride, chlortetracycline hydrochloride, and demeclocycline hydrochloride, and mixtures thereof.
Claim 16
Dependent Claim 29 words
The method according to claim 11, wherein the first coating layer is present in the drug delivery system in an amount from about 37% to about 75%, by weight.
Claim 17
Dependent Claim 35 words
The method according to claim 11, wherein the mixture of methacrylic acid copolymer, and povidone in the second coating layer is present in a ratio by weight of from about 4:1 to about 8:1, respectively.
Claim 18
Dependent Claim 29 words
The method according to claim 11, wherein the second coating layer is present in the drug delivery system in an amount from about 5% to about 30%, by weight.
Claim 19
Dependent Claim 31 words
The method according to claim 11, wherein the first coating layer further comprises a gliding agent present in the drug delivery system in an amount up to about 1%, by weight.
Claim 20
Dependent Claim 33 words
The method according to claim 11, wherein the first coating layer further comprises a binding agent present in the drug delivery system in an amount from about 1% to about 4%, by weight.
Claim 21
Dependent Claim 31 words
The method according to claim 11, wherein the second coating layer further comprises a plasticizing agent present in the drug delivery system in an amount up to about 3%, by weight.
Claim 22
Dependent Claim 31 words
The method according to claim 11, wherein the second coating layer further comprises an anti-adhering agent present in the drug delivery system in an amount up to about 2%, by weight.
Claim 23
Dependent Claim 86 words
A medicated composition which comprises a pharmaceutically acceptable carrier and a therapeutically effective amount of a semi-enteric drug delivery system, wherein the drug deliver system comprises: (a) a pharmacologically inert core; (b) a first coating layer over the core comprising a medicament; and (c) a second coating layer over the first coating layer comprising a mixture of an aqueous dispersion of an anionic copolymer based on methacrylic acid and ethylacrylate and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively.
Claim 24
Dependent Claim 86 words
A medicated composition which comprises a pharmaceutically acceptable carrier and a therapeutically effective amount of a semi-enteric drug delivery system, wherein the drug deliver system comprises: (a) a pharmacologically inert core; (b) a first coating layer over the core comprising a medicament; and (c) a second coating layer over the first coating layer comprising a mixture of an aqueous dispersion of an anionic copolymer based on methacrylic acid and ethylacrylate and povidone present in a ratio by weight of from about 2:1 to about 24:1, respectively.

References Cited (Backward Citations)

US4263273A Cited
US4644031A Cited
US4828840A Cited
US4800079A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1995-12-01 1996-06-01 1996-12-01 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-12-01 2000-06-01 2000-12-01 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-12-01 2004-06-01 2004-12-01 $7700.00 Window Closed / Lapsed

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