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Publication Number
US-10758639-B2
Publication Date
2020-09-01
Expiration Date
Abstract
The present invention relates to pharmaceutical compositions and methods for the treatment of peri-implant diseases, in particular peri-implant disease characterized by the destruction of the crest of the alveolar bone supporting the implant. Specifically, the method comprising the step of applying to a peri-implant bone displaying crestal resorption a 5 pharmaceutical composition comprising biocompatible bone augmentation material coated with a matrix composition which provides local controlled and prolonged release of at least one pharmaceutically active agent at the bone loss site.
Core Innovation
The disclosed invention provides methods for treating peri-implantitis by surgically exposing a dental implant at a peri-implant bone loss site, debriding and decontaminating the exposed dental implant, and applying once a dose of a pharmaceutical composition to the peri-implant bone loss site. The pharmaceutical composition comprises a biocompatible bone augmentation material coated with a matrix composition, and in one instance coated and non-coated bone augmentation material.
The matrix composition includes a biocompatible polymer, a first lipid comprising at least one sterol, and a second lipid comprising at least one phospholipid with fatty acid moieties of at least 14 carbons. The matrix further includes at least one pharmaceutically active agent comprising doxycycline or doxycycline hyclate, and is characterized as providing local sustained release of the pharmaceutically active agent at the peri-implant bone loss site.
The disclosure also includes methods for treating an oral biofilm at a peri-implant site by surgically exposing the dental implant at the peri-implant site, debriding and decontaminating the exposed dental implant, and applying once to a peri-implant bone site a dose of the same type of pharmaceutical composition. The methods aim to reduce peri-implantitis defects and to treat or inhibit oral biofilm, including peri-implantitis associated with crestal peri-implant bone loss.
Claims Coverage
The provided set contains three independent claims. The common inventive features are a once-applied pharmaceutical composition based on coated bone augmentation material, a matrix composition with polymer, sterol-containing lipid, phospholipid with at least 14-carbon fatty acid moieties, and doxycycline or doxycycline hyclate, plus local sustained release; one claim also recites coated and non-coated bone augmentation material and specific compositional percentages.
Once treatment of peri-implantitis with coated matrix doxycycline composition
A method for treating a patient suffering from peri-implantitis by surgically exposing the dental implant in a peri-implant bone loss site, debriding and decontaminating the exposed dental implant, and applying once to the peri-implant bone loss site a dose of a pharmaceutical composition comprising a biocompatible bone augmentation material coated with a matrix composition. The matrix composition comprises a biocompatible polymer, a first lipid comprising at least one sterol, a second lipid comprising at least one phospholipid having fatty acid moieties of at least 14 carbons, and at least one pharmaceutically active agent comprising doxycycline or doxycycline hyclate, wherein the matrix composition provides local sustained release of the pharmaceutically active agent at the pen-implant bone loss site to reduce peri-implantitis defects.
Once treatment of oral biofilm at a peri-implant site using matrix doxycycline composition
A method for treating an oral biofilm at a peri-implant site of a patient by surgically exposing the dental implant at the peri-implant site, debriding and decontaminating the exposed dental implant, and applying once to a peri-implant bone site a dose of a pharmaceutical composition comprising a biocompatible bone augmentation material coated with a matrix composition. The matrix composition comprises a biocompatible polymer, a first lipid comprising at least one sterol, a second lipid comprising at least one phospholipid having fatty acid moieties of at least 14 carbons, and at least one pharmaceutically active agent comprising doxycycline or doxycycline hyclate, wherein the matrix composition provides local sustained release of the pharmaceutically active agent at the peri-implant site.
Crestal peri-implant bone loss peri-implantitis treatment with specific coated/non-coated and lipid/polymer percentages
A method for treating a patient suffering from peri-implantitis associated with crestal peri-implant bone loss by surgically exposing the dental implant in the peri-implant bone loss site, debriding and decontaminating the exposed dental implant, and applying to a peri-implant bone loss site a pharmaceutical composition comprising coated and non-coated bone augmentation material at a ratio of between about 1:3-10:1. The coated bone augmentation material comprises between about 80-90% (w/w) of bone augmentation material coated with between about 10-20% (w/w) of a matrix composition comprising 15-25% (w/w) PLGA, 5-15% (w/w) cholesterol, 50-70% (w/w) of a mixture of DPPC and DSPC with a DPPC:DSPC ratio between 5:1 and 2:1, and 7-12% (w/w) of doxycycline or doxycycline hyclate.
Across the independent claims, the core inventive approach is a once application of a pharmaceutically active composition based on coated bone augmentation material, with a matrix formed from a biocompatible polymer plus sterol-containing lipid plus phospholipid with at least 14-carbon fatty acid moieties, and doxycycline or doxycycline hyclate, providing local sustained release to reduce peri-implantitis defects and to treat oral biofilm. One claim additionally constrains coated and non-coated ratios and specifies PLGA, cholesterol, DPPC/DSPC lipid mixture, and doxycycline or doxycycline hyclate weight percentages.
Stated Advantages
Local sustained release of the pharmaceutically active agent at the peri-implant bone loss site.
Reducing peri-implantitis defects in the peri-implant bone loss site.
Treating an oral biofilm at a peri-implant site.
Documented Applications
Peri-implantitis treatment in a patient suffering from peri-implantitis, including peri-implant bone loss sites.
Treatment of oral biofilm at a peri-implant site in a patient.
Treatment of peri-implantitis associated with crestal peri-implant bone loss.
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