EP0388220A2
Expired / Lapsed
EP
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Compositions for the sustained release of chlorhexidine
Assignee: Yissum Research Development Co of Hebrew University of Jerusalem
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Filing: 1990-03-16
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Granted: —
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Expires: 2010-03-16
Abstract
Abstract Biodegradable sustained-release compositions capable of achieving the sustained release of chlorhexidine, comprise chlorhexidine digluconate, a protein such as gelatin (which may be cross-linked) and optionally a plasticiser such as glycerin. The compositions can be formed into implant devices which may be used to treat a wide variety of diseases and conditions. The implants are especially useful in treating disease such as periodontal disease which require prolonged drug release.
Inventors
- 👤 Michael Friedman
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-08 14:54
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0053; A61K9/0063; A61K31/00; A61K31/13; A61K31/155; A61K6/00; A61K6/50; A61P; A61P1/00; A61P1/02
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
43 words
A sustained-release composition for permitting the sustained release of chlorhexidine in a periodontal pocket which comprises an implant adapted for implantation in a periodontal pocket of a patient, the implant comprising an effective amount of chlorhexidine digluconate, and a water insoluble protein matrix.
Claim 2
Dependent Claim
43 words
A sustained-release composition for permitting the sustained release of chlorhexidine in a periodontal pocket which comprises an implant adapted for implantation in a periodontal pocket of a patient, the implant comprising an effective amount of chlorhexidine digluconate, and a water insoluble protein matrix.
Claim 3
Dependent Claim
16 words
A composition as claimed in claim 1, wherein the implant is essentially two dimensional or bullet-shaped.
Claim 4
Dependent Claim
51 words
A composition as claimed in claim 1 or 2, wherein the protein is cross-linked and/or wherein the composition contains a cross-linking agent, the cross-linking agent preferably comprising an aldehyde, an alcohol, divalent ions, trivalent ions, tetravalent ions, an acyl chloride, bis-diazobenzidine, phenol-2,4-disulfonyl chloride, 1,5-difluoro-2,4-dinitrobenzene, urea, 3,6-bis(mercurimethyl)-dioxane urea, dimethyl adipimidate, and N,N′-ethylene-bis(iodo-acetamide).
Claim 5
Dependent Claim
43 words
A composition as claimed in claim 3 wherein the protein is cross-linked and/or the cross-linking agent is present in an amount sufficient to render the protein insoluble but not in an amount which prevents the release of the active agent from the composition.
Claim 6
Dependent Claim
28 words
A composition as claimed in claim 3 or 4, wherein the cross-linking agent is present in said composition in an amount of from about 0.01% to about 26%.
Claim 7
Dependent Claim
19 words
A composition as claimed in claim 3, 4 or 5, wherein the cross-linking agent comprises formaldehyde or, preferably, glutaraldehyde.
Claim 8
Dependent Claim
23 words
A composition as claimed in any one of claims 1 to 6 wherein the cross-linked protein is cross-linked by heat, pressure and/or radiation.
Claim 9
Dependent Claim
55 words
A composition as claimed in any one of claims 1 to 7 wherein the protein is present at a concentration sufficient to provide the composition with structural stability, but not at so great a concentration as to render the composition (i) incapable of biodegradation, or (ii) incapable of permitting the release of said chlorhexidine digluconate.
Claim 10
Dependent Claim
29 words
A composition as claimed in any one of claims 1 to 8 wherein the protein comprises gelatin, collagen, albumin, an enzyme and/or fibrinogen, preferably gelatin which is optionally hydrolysed.
Claim 11
Dependent Claim
27 words
A composition as claimed in any one of claims 1 to 9, wherein the protein is present at a concentration of from about 14% to about 93%.
Claim 12
Dependent Claim
18 words
A composition as claimed in any one of claims 1 to 10, wherein the implant comprises a plasticiser.
Claim 13
Dependent Claim
34 words
A composition as claimed in claim 11, wherein the plasticiser is present in an amount sufficient to effect brittleness but not at so great a concentration as to prevent the release of the chlorhexidine.
Claim 14
Dependent Claim
43 words
A composition as claimed in claim 11 or 12, wherein the plasticiser comprises a phthalate ester, a phosphate ester, a glycol derivative, a hydrocarbon, an oil, and/or a fatty acid, wherein a glycol derivative is preferred and may be sorbitol or, preferably, glycerin.
Claim 15
Dependent Claim
25 words
A composition as claimed in claim 11, 12 or 13, wherein the plasticiser is present at a concentration of from about 0.01% to about 52%.
Claim 16
Dependent Claim
50 words
A composition as claimed in any one of claims 1 to 14, wherein the implant is in the form of a film, wherein the film is from about 3 to about 10mm in length, from about 1 to about 5mm in width and from about 0.01 to 0.5mm in depth.
Claim 17
Dependent Claim
55 words
A composition as claimed in any one of claims 1 to 17 wherein the chlorhexidine and the protein are present at a relative weight ratio which ranges from about 0.01:7 to about 3:1, and/or wherein the plasticiser and the protein are present at a relative weight ratio which ranges from about 0.01:7 to about 4:7.
Claim 18
Dependent Claim
26 words
A composition as claimed in any one of claims 1 to 18, wherein the composition has a flexibility which ranges from about 0.1kg/mm² to about 50kg/mm².
Claim 19
Dependent Claim
54 words
The use of chlorhexidine digluconate and protein in the preparation of an implant adapted for implantation in a periodontal pocket of a patient, the implant comprising an effective amount of chlorhexidine digluconate, a water insoluble protein matrix, which may be cross linked, and optionally a plasticiser, for treating a patient in need of chlorhexidine.
Claim 20
Dependent Claim
54 words
The use of chlorhexidine digluconate and protein in the preparation of an implant adapted for implantation in a periodontal pocket of a patient, the implant comprising an effective amount of chlorhexidine digluconate, a water insoluble protein matrix, which may be cross linked, and optionally a plasticiser, for treating a patient in need of chlorhexidine.
Claim 21
Dependent Claim
15 words
The use as claimed in claim 18, wherein the implant additionally contains a cross-linking agent.
Claim 22
Dependent Claim
18 words
The use as claimed in claim 18 or 19 wherein the patient suffers from the condition the pericoronitis.
Claim 23
Dependent Claim
33 words
The use as claimed in claim 18, 19 or 20, wherein the treatment is an adjunct to endodontic treatment, and/or an adjunct to a tooth implantation procedure, and/or an adjunct to an epiectomy.
Claim 24
Dependent Claim
42 words
A process for preparing a sustained release composition, wherein the composition is in the form of an implant adapted for implantation in a periodontal pocket of a patient, the process comprising incorporating chlorhexidine digluconate, and optionally a plasticiser, in a protein matrix.
Claim 25
Dependent Claim
42 words
A process for preparing a sustained release composition, wherein the composition is in the form of an implant adapted for implantation in a periodontal pocket of a patient, the process comprising incorporating chlorhexidine digluconate, and optionally a plasticiser, in a protein matrix.
References Cited (Backward Citations)
No citation records indexed.
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