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Method for the treatment of periodontal disease by sustained delivery of a therapeutic agent to the periodontal pocket, composition of matter therefor and apparatus for the administration thereof

Assignee: Wyeth Holdings LLC
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Filing: 1989-11-27
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Granted: —
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Expires: 2009-11-27
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Abstract

Abstract Oral compositions for the local administration of a therapeutic agent to a periodontal pocket of a patient for alleviating dental disease comprise a plurality of dry, discrete microparticles each of which comprise an effective amount of at least one therapeutic agent dispersed in a matrix comprising a biocompatible and biodegradable polymer. Apparatus and methods are also provided for the dispensing of the dry microparticles to the periodontal pocket whereby they become tacky and adhere to the involved tissue so as to induce long term therapeutic benefits.

Inventors

  • 👤 Nancy Susan Brizzolara
  • 👤 Michael Gerard Lanzilotti
  • 👤 James Ronald Lawter

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-26 19:10
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/48; A61K9/50; A61C; A61C19/00; A61C19/06; A61C19/063; A61K9/0012; A61K9/0053; A61K9/0063; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1641; A61K9/1647; A61K9/5005; A61K9/5021; A61K9/5031

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 55 words
An oral composition for the local administration of a therapeutic agent to the periodontal pocket, said composition adapted to be administered as a plurality of dry, discrete microparticles, the composition comprising microparticles comprised of: (i) an effective amount of at least one therapeutic agent dispersed in (ii) a matrix comprising a biocompatible and biodegradable polymer.
Claim 2
Dependent Claim 55 words
An oral composition for the local administration of a therapeutic agent to the periodontal pocket, said composition adapted to be administered as a plurality of dry, discrete microparticles, the composition comprising microparticles comprised of: (i) an effective amount of at least one therapeutic agent dispersed in (ii) a matrix comprising a biocompatible and biodegradable polymer.
Claim 3
Dependent Claim 111 words
An oral composition as defined in Claim 1 wherein the said therapeutic agent comprises an agent having antibiotic activity and is selected from the group consisting of tetracycline or a pharmaceutically acceptable salt or hydrate thereof, doxycycline or a pharmaceutically acceptable salt or hydrate thereof, minocycline or a pharmaceutically acceptable salt or hydrate thereof, and mixtures of more than one of the foregoing, and the matrix comprises a polymer selected from the group consisting of polyglycolide, poly (l-lactide), poly (dl-lactide), poly (glycolide-co-­dl-lactide), poly (glycolide-l-lactide), poly (alphahydroxybutyric acid), poly (orthoesters), poly (p-dioxanone), block copolymers of polyglycolide, trimethylene carbonate and polyethylene oxide, and mixtures of more than one of any of the foregoing.
Claim 4
Dependent Claim 56 words
An oral composition as defined in Claim 1 wherein said polymer becomes tacky upon contact with water, and said microparticles comprise from about 20 to about 30 parts by weight of minocycline HCl or doxycycline hyclate and from about 70 to about 80 parts by weight of poly(glycolide-co-dl-lactide) per 100 parts by weight of said microparticles.
Claim 5
Dependent Claim 68 words
An oral composition as defined in Claim 1 wherein said microparticles are made by a phase separation process in which the residual hardening agent comprises less than about 3% by weight of said microparticles, said microparticles have a diameter of from about 0.1 to about 1000'microns, and said therapeutic agent comprises from about .00001 to about 50 parts by weight per 100 parts by weight of said microparticles.
Claim 6
Independent Claim 54 words
A method for alleviating dental diseases comprising administering between the gum and teeth of a patient in need of such treatment, an effective amount of a plurality of dry, discrete microparticles which comprise: (i) an effective amount of at least one therapeutic agent dispersed in (ii) a matrix comprising a biocompatible and biodegradable polymer.
Claim 7
Independent Claim 54 words
A method for alleviating dental diseases comprising administering between the gum and teeth of a patient in need of such treatment, an effective amount of a plurality of dry, discrete microparticles which comprise: (i) an effective amount of at least one therapeutic agent dispersed in (ii) a matrix comprising a biocompatible and biodegradable polymer.
Claim 8
Dependent Claim 109 words
A method as defined in Claim 5 wherein said therapeutic agent comprises an agent having antibiotic activity and is selected from the group consisting of tetracycline or a pharmaceutically acceptable salt or hydrate thereof, doxycycline or a pharmaceutically acceptable salt or hydrate thereof, minocycline or a pharmaceutically acceptable salt or hydrate thereof, and mixtures of more than one of the foregoing, and the matrix comprises a polymer selected from the group consisting of polyglycolide, poly (l-lactide), poly (dl-lactide), poly (glycolide-co-­dl-lactide), poly (glycolide-co-dl-l-lactide), poly (alphahyroxybutyric acid), poly (orthoesters), poly (p-dioxanone), block copolymers of polyglycolide, trimethylene carbonate and polyethylene oxide, and mixtures of more than one of any of the foregoing.
Claim 9
Dependent Claim 56 words
A method as defined in Claim 5 wherein said polymeric material becomes tacky upon contact with water, said microparticles have a diameter of from about 0.1 to about 1000 microns, and said microparticles are made by a phase separation process in which the residual hardening agent comprises less than about 3% by weight of said microparticles.
Claim 10
Dependent Claim 118 words
Apparatus for dispensing an oral composition for alleviating dental diseases by local administration of a therapeutic agent to the periodontal pocket of a patient in need of such treatment, said apparatus comprising: (1) a container ending in outlet means adapted to fit the periodontal pocket between the patient's gum and teeth; (2) means to translate an externally applied force onto said microparticles contained within the outlet means so as to dispense them through said outlet means tip into said periodontal pocket; and, in said outlet means, (3) a composition comprised of dry, therapeutic agent-containing microparticles which comprise: (i) an effective amount of at least one therapeutic agent dispersed in (ii) a matrix comprising a biocompatible and biodegradable polymer.
Claim 11
Dependent Claim 118 words
Apparatus for dispensing an oral composition for alleviating dental diseases by local administration of a therapeutic agent to the periodontal pocket of a patient in need of such treatment, said apparatus comprising: (1) a container ending in outlet means adapted to fit the periodontal pocket between the patient's gum and teeth; (2) means to translate an externally applied force onto said microparticles contained within the outlet means so as to dispense them through said outlet means tip into said periodontal pocket; and, in said outlet means, (3) a composition comprised of dry, therapeutic agent-containing microparticles which comprise: (i) an effective amount of at least one therapeutic agent dispersed in (ii) a matrix comprising a biocompatible and biodegradable polymer.
Claim 12
Dependent Claim 65 words
An apparatus as defined in Claim 8 wherein container (1) comprises a barrel ending in a hollow delivery tip; said means to translate force and dispense said microparticles (2) comprises a plunger rod; and which also includes (3) a disposable closure on the open end of said outlet means to maintain the integrity of the contents, wherein said apparatus is enclosed in a sterilized package.
Claim 13
Dependent Claim 26 words
An apparatus as defined in Claim 8, wherein the composition (3) is comprised of the oral composition of any of Claims 1, 2, 3 or 4.

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