Rapid-deposition thin-film forming compositions as effective wound care treatment
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Publication Number
US-11471481-B2
Publication Date
2022-10-18
Expiration Date
Abstract
The present invention provides thin-film forming compositions comprising an antiseptic (e.g., povidone iodine, chlorhexidine, or octenidine), a non-aqueous solvent, and a film-forming material dissolved in the non-aqueous solvent, wherein the composition yields a continuous and flexible protective film upon substantial removal of the solvent. The compositions are useful for the treatment and prevention of infections in wounds, ulcers (e.g., decubitus ulcers and stasis ulcers), cuts, or burns, or against infections from bacterial, mycobacterial, viral, fungal, or amoeba causes, as well as for prevention of such infections in appropriate clinical settings (e.g., as liquid bandages or dressings). Additionally, the compositions of this invention are also useful for the treatment of infections and as a disinfectant skin preparation for pre- and/or post-surgical operations.
Core Innovation
The invention relates to rapid-deposition non-aqueous thin-film wound care treatment compositions that include an antiseptic, a non-aqueous solvent system, and a dissolved film-forming polymer. The formulation yields a continuous, flexible protective film upon substantial removal of the non-aqueous solvent by evaporation, and the composition is free of polyvinyl alcohol while still forming the protective film.
The antiseptic is povidone iodine (PVP-I), and the film-forming material is polyvinylbutyral (PVB). The non-aqueous solvent system and the film-forming material are selected such that the composition forms a continuous flexible waterproof film after solvent evaporation.
The disclosure also describes maintained antiseptic activity with reduced toxicity/irritation, including extended or slow release of the antiseptic. It further reports iodine availability and stability under heat and light storage, film formation on skin, sustained-release behavior through diffusion and iodine release profiles, and in vivo efficacy comparisons and in vitro cytotoxicity and antimicrobial performance relative to established surface time-kill reduction targets.
Claims Coverage
The independent claim defines a single inventive composition concept with explicit formulation constraints and exclusions, and the inventive concept includes three core inventive features.
Non-aqueous thin-film forming composition with antiseptic and solvent
A non-aqueous thin-film forming composition comprising an antiseptic, a non-aqueous solvent, and a film-forming material dissolved in the non-aqueous solvent, wherein the composition is free of polyvinyl alcohol and yields a continuous and flexible protective film upon substantial removal of the solvent.
Povidone iodine antiseptic
The antiseptic is povidone iodine (PVP-I).
Polyvinylbutyral film-forming material
The film-forming material is polyvinylbutyral (PVB).
The claims cover a non-aqueous thin-film wound care composition in which povidone iodine (PVP-I) is combined with polyvinylbutyral (PVB) dissolved in a non-aqueous solvent to produce a continuous, flexible protective film after substantial solvent removal, while the composition is explicitly free of polyvinyl alcohol.
Stated Advantages
Film formation yields a continuous and flexible protective film after substantial removal of the solvent.
The film-forming approach reduces toxicity/irritation while maintaining antiseptic activity.
The composition provides extended or slow release of antiseptic (iodine release profile).
Antimicrobial performance meets or exceeds ASTM E1153 surface time kill reduction targets in the described testing context.
Cytotoxicity/cell viability results pass the described in vitro passing criteria relative to the stated assays and criteria.
Documented Applications
Wound care treatment using rapid-deposition non-aqueous thin-film forming compositions on skin, including formation of a protective film and sustained release of iodine/antiseptic.
In vivo efficacy testing in ICR mice, including comparisons versus commercial products and controls for wound-care related antimicrobial efficacy.
In vitro antimicrobial and cytotoxicity testing using described cell viability and surface time-kill evaluation frameworks.
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