Compositions and methods for the treatment and prophylaxis of surgical site infections
Inventors
Assignees
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Publication Number
US-11471414-B2
Publication Date
2022-10-18
Expiration Date
Abstract
The present invention provides methods for preventing, inhibiting or treating a surgical site infection associated with a surgical operation comprising the step of applying to the surgical site a biocompatible, biodegradable substrate being impregnated and/or having its surface coated fully or partially with a matrix composition which provides local controlled and prolonged release of at least one pharmaceutically active agent at the surgical site.
Core Innovation
The invention provides a method for treatment or prophylaxis of a soft-tissue incision site infection associated with a surgical operation. The method administers directly to the soft-tissue incision site a biodegradable mineral substrate shaped in the form of particles, the mineral substrate being impregnated or having its surface coated fully or partially with a matrix composition that governs local release at the incision site.
The matrix composition comprises a biodegradable polyester together with a first lipid component comprising at least one sterol. The at least one sterol is non-covalently associated with the biodegradable polyester, and a second lipid component comprises at least one phospholipid having fatty acid moieties of at least 12 carbons. The matrix is defined to support sustained release behavior for the pharmaceutically active agent delivered at the incision site.
An antibiotic agent is included in the matrix composition, selected from doxycycline and doxycycline hyclate. In the disclosed context, the formulation is intended for local treatment and prophylaxis of soft-tissue incision site infection, including involvement of biofilm formation.
Claims Coverage
Independent claim clm-00001 defines 5 inventive features centered on a particle-shaped biodegradable mineral substrate administered directly to a soft-tissue incision site infection associated with a surgical operation. The matrix includes a biodegradable polyester–lipid system with sterol, phospholipid, and an antibiotic agent selected from doxycycline or doxycycline hyclate. Dependent claims further refine sustained release behavior and constituent types and ranges.
Direct administration to soft-tissue incision site infection with particle-shaped mineral substrate
Administering directly to the soft-tissue incision site a biodegradable mineral substrate shaped in the form of particles for treatment or prophylaxis of a soft-tissue incision site infection associated with a surgical operation.
Biodegradable polyester–sterol non-covalent matrix on mineral particles
Providing a matrix composition on the mineral substrate, the matrix composition comprising a biodegradable polyester and a first lipid component comprising at least one sterol non-covalently associated with the biodegradable polyester.
Phospholipid second lipid component with fatty acid moieties of at least 12 carbons
Including in the matrix composition a second lipid component comprising at least one phospholipid having fatty acid moieties of at least 12 carbons.
Antibiotic agent doxycycline or doxycycline hyclate in the matrix
Including in the matrix composition an antibiotic agent selected from the group consisting of doxycycline and doxycycline hyclate.
Hospital-acquired resistant bacteria including MRSA
Limiting the method to hospital-acquired resistant bacteria comprising Methicillin-resistant S. aureus (MRSA).
Overall, the claim set centers on a particle-shaped biodegradable mineral substrate administered directly to the soft-tissue incision site, where a biodegradable polyester–lipid matrix delivers doxycycline or doxycycline hyclate. The inventive matrix structure is defined by non-covalent sterol association with the polyester and a phospholipid second component with fatty acid moieties of at least 12 carbons.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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