Pharmaceutical composition for topical wound treatment
Inventors
RAMOS VERNIERI, Alberto • DE LOS ANGELES LAZARTE, Maria • CHAVEZ JARA, Romina Mabel • CERUSICO, Nicolas Abel
Assignees
Consejo Nacional de Investigaciones Cientificas y Tecnicas CONICET • Untech Inc • Ardac Inc
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Publication Number
US-12280051-B2
Publication Date
2025-04-22
Expiration Date
Abstract
A pharmaceutical composition for topical wound treatment comprising one or more nitrogenous heterocyclic compound of 5 or 6 atoms with imide group; one or more deoxyribonuclease enzyme with activity pH between 4.5 and 6.5; and one or more carboxylic acid; kits and process to obtain this pharmaceutical composition and uses for wounds treatment.
Core Innovation
The invention provides a topical wound-treatment pharmaceutical formulation kit and a device for administering the kit. The kit includes at least two specified components in defined concentration ranges: recombinant human Dornase-alpha, ethosuximide, and an aqueous component with a pH between 4.5 and 6.8.
The device includes multiple containers, including a first container with a first composition that is solid and comprises a gelling agent powder, a second container with a second composition that is solid and comprises recombinant human Dornase-alpha, and a third container with a third composition having a pH between 4.5 and 6.8. The third composition is an aqueous liquid comprising either ethosuximide or citric acid.
The container arrangement supports isolating the compositions prior to administration. In the described device configuration, the first container and the second container are separated by a first collapsible membrane, and the second container and the third container are separated by a second collapsible membrane. The pharmaceutical composition is described as designed for chronic wound healing and biofilm control, including inhibition and disruption of biofilms and related effects associated with MMP inhibition and collagen/α-SMA and VEGF/angiogenesis effects.
Claims Coverage
The document includes one independent claim. It specifies a device that administers a pharmaceutical formulation kit with defined component concentration ranges and a pH-defined aqueous liquid component, using multiple containers separated by collapsible membranes for isolation.
Device for administering a pharmaceutical formulation kit with specified components
A device for administering a pharmaceutical formulation kit comprising at least two of recombinant human Dornase-alpha, ethosuximide, and citric acid, with the kit further characterized by a pH-defined aqueous liquid component having a pH between 4.5 and 6.8.
First and second containers with solid gelling agent and solid recombinant human Dornase-alpha
The device comprises a first container containing a solid first composition comprising a gelling agent powder, and a second container containing a solid second composition comprising recombinant human Dornase-alpha.
Third container providing an aqueous liquid at pH 4.5-6.8 with either ethosuximide or citric acid
The device comprises a third container having a pH between 4.5 and 6.8, where the third composition is an aqueous liquid comprising either ethosuximide or citric acid.
Collapsible membrane isolation between container pairs
The device comprises at least one of a first collapsible membrane separating the first and second containers to keep the first and second compositions isolated, and a second collapsible membrane separating the second and third containers to keep the second and third compositions isolated.
Overall, the claim coverage centers on a multi-container administration device for a kit built from specified quantities of recombinant human Dornase-alpha and ethosuximide and/or citric acid, with a pH-defined aqueous liquid component and collapsible membranes that isolate adjacent containers containing solid compositions from each other and from the aqueous liquid.
Stated Advantages
Functional synergies producing broad-spectrum bacteriostatic/bactericidal activity.
Inhibition and disruption of biofilms, including Pseudomonas aeruginosa and Staphylococcus aureus.
MMP-related inhibition via acidification/chelation.
Increased collagen/α-SMA formation.
VEGF/angiogenesis induction.
Extended stability of enzymatic activity versus LAPS (Lactobacillus plantarum supernatant).
Documented Applications
Topical wound treatment and chronic wound healing, including biofilm control.
Biofilm inhibition and disruption assays for organisms including Pseudomonas aeruginosa and Staphylococcus aureus.
Assessment of enzyme activity conservation over time.
Assessment of antioxidant activity (DPPH activity) and chelation (Ca/Zn/Mg) in described assays.
Angiogenesis-related assessment using CAM assay (chorioallantoic membrane) and VEGF gene expression changes.
In vivo rat excisional wound model with histopathology results.
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