EP4217013A2 - Flüssigkeitsverbandsystem - Google Patents

Flüssigkeitsverbandsystem

Info

Publication number
EP4217013A2
EP4217013A2 EP21814855.9A EP21814855A EP4217013A2 EP 4217013 A2 EP4217013 A2 EP 4217013A2 EP 21814855 A EP21814855 A EP 21814855A EP 4217013 A2 EP4217013 A2 EP 4217013A2
Authority
EP
European Patent Office
Prior art keywords
liquid bandage
composition
active component
pharmaceutical active
bandage composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21814855.9A
Other languages
English (en)
French (fr)
Inventor
Spiros Fotinos
Panaitescu LIGIA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lavipharm SA
Original Assignee
Lavipharm SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lavipharm SA filed Critical Lavipharm SA
Publication of EP4217013A2 publication Critical patent/EP4217013A2/de
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0023Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0052Mixtures of macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • A61L26/0066Medicaments; Biocides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • A61L26/0076Sprayable compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/204Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents

Definitions

  • the present invention relates in general to a fast drying solution or suspension leading to a film and in particular to a liquid bandage which can be used to protect and treat wounds.
  • U.S. Patent No. 10,350,433 describes a layer structure for epidermal radionuclide therapy including a proximal adherent layer for applying the layer structure on a patient's skin surface to be treated, an adherent layer consisting of a skin cream and/or skin gel being excluded; a flexible, transparent carrier layer that from a patient's view is located in a distal direction on top of the adherent layer; and at least one radionuclide-containing emission layer located on the carrier.
  • the adherent layer is formed on the skin surface prior to assembling the layer structure.
  • the adherent layer is formed on the skin surface prior to assembling the layer.
  • the adherent layer being formed from a structure of a synthetic film sprayable onto the skin, in particular a liquid bandage on the basis of polyurethanes, polyacrylates, especially poly(butyl methacrylate, methyl methacrylate); or 2- octyl cyanoacrylate.
  • the present invention relates to a fast drying solution of a film forming composition for protection of wounds and prevention of contamination of the wounds.
  • the fast drying film can be a liquid bandage which can be applied directly to the wound for covering the wound after the film dries.
  • Example of wounds include paper cuts, cuticle cuts, minor wounds, scratches and abrasions.
  • the liquid bandage can be formed of a liquid bandage composition including one or more film forming materials.
  • the film forming materials can be selected to have a short drying time to allow expeditious application of the liquid bandage.
  • the liquid bandage composition is a fast drying solution including one or more solvents and one or more film forming material.
  • the liquid bandage can include one or more additives.
  • the additive is a wound healing agent and/or an exudate absorber.
  • the additives can also include antimicrobials, antiseptics, pain reducers, transepidermal water loss (TEWL) prevention materials and ion exchanging ingredients.
  • a liquid bandage composition comprising a film forming material and a therapeutically-effective amount of at least one wound healing agent in which the liquid bandage when applied to a wound improves healing, beyond benefits provided without use of the liquid bandage.
  • the liquid bandage composition can be applied to the skin for example with a brush or airless system.
  • the liquid bandage composition can be applied as a spray.
  • the liquid bandage composition can be applied to a minor wound with a brush.
  • the liquid bandage composition can be applied as a spray onto a scratch or abrasion.
  • the liquid bandage composition dries to form a liquid bandage.
  • the liquid bandage can provide mechanical protection of the wound and isolation from external factors.
  • the external factors can include dangerous factors such as for example debris contaminants and irritants.
  • the applied liquid bandage can support the healing of the wounds in a shorter time with an acceptable quality of healing.
  • the liquid bandage composition can be formed of a material to provide wound oxygenation.
  • the liquid bandage composition can be formed of a material to provide water proofing.
  • the liquid bandage can have a long lasting wearing time. For example, the liquid bandage can maintain adherence to skin up to one week or more.
  • the present invention is also directed to methods to prepare a liquid bandage and methods to administer the liquid bandage to a human subject.
  • a liquid bandage can comprise a liquid bandage composition.
  • the liquid bandage composition can comprise one or more film forming materials.
  • the liquid bandage composition can be formed of a fast drying solution including one or more solvents and one or more film forming materials.
  • Suitable solvents for use in forming the liquid bandage composition include alcohol, ketones, ethers and ethyl acetate.
  • Suitable film forming materials include plasticizers and polymers to form quick setting films.
  • the film forming material can also include pyroxyline. In one embodiment, the proxyline is about 10 to about 12% nitrated.
  • the film forming material can also include collodion, flexible collodion and the like.
  • Suitable materials include United States Pharmacopeia (USP) collodion and United States Pharmacopeia (USP) flexible collodion.
  • the film forming material can include cellulose and cellulose derivatives. Suitable materials include cellulose acetate phthalates with plasticizers and water insoluble cellulose derivatives. The film forming material can also include cyanoacrylate.
  • the liquid bandage can be formed of a material to provide wound oxygenation.
  • the liquid bandage can be formed of a material to provide water proofing.
  • the material can be a film forming material that could be breathable to the skin.
  • the liquid bandage composition can include a therapeutically-effective amount of at least one pharmaceutical component as an active component.
  • the pharmaceutical active component can include one or more wound healing ingredients.
  • An example wound healing ingredient is alginate.
  • the pharmaceutical active component can include one or more exudate absorbers. Suitable compounds or materials for exudate absorbers can include, without limitation, cellulosic derivatives, chitosan, styptics and astringents. Example astringents, without limitation, include glycolic extracts, alcoholic extracts, green tea extract, and Hamamelis extract.
  • the pharmaceutical active component can include one or more antibacterial or anti-microbial components. Preferably, the antimicrobial is soluble in the solvent used to form the liquid bandage composition.
  • Example antimicrobials which can be used in the liquid bandage compositions include, without limitation, octenidine, phenoxyethanol, iodine, tea tree oil, and mastic oil.
  • the antimicrobial can be (a cationic antimicrobial.
  • Example cationic antimicrobials include benzalkonium and benzalkonium chloride.
  • Suitable antimicrobials also include cinnamon zeylanicum oil, glycereth h-18 at 1-2% and ethylhexanol, honey comb extract and chios mastic oil or mastic extracts.
  • the pharmaceutical active component can also include hydroxy-acetophenone, laurus nobilis leaves extract, PCA ethyl cocoyl alginate, phytosphingosine, propolis cera, silver oxide, sodium chlorate, viola tricolor extract, zinc citrate, octenidine, benzalkonium chloride and phenoxyethanol.
  • the pharmaceutical active component can include antibiotics.
  • Suitable antibiotics include beta-lactam, macrolides, tetracycline, fluoroquinolones, and aminoglycoside.
  • the pharmaceutical active component can include an antifungal.
  • Example antifungal ingredients which can be used in the present invention include azoles, amphotericin B, nikkomycins, imidazoles, triazoles, allyl amines, fluconazole, itraconazole, imidazole and triazole derivatives.
  • the antifungal ingredient can include an allylamine such as for example naftifine and terbinafine.
  • the antifungal ingredient can include an ethinocandin such as for example caspofungin.
  • the antifungal ingredient can be used for treating candidiasis and tinea.
  • the pharmaceutical active component can include an antiviral for topical use.
  • the pharmaceutical active component can include an essential oil.
  • the liquid bandage composition can include a therapeutically-effective amount of one or more topical antimicrobials.
  • Suitable topical antimicrobials can be used to treat acne.
  • Example topical antimicrobials include erythromycin, clindamycin, benzoyl peroxide, sulfa cetamide, sulfur, salicylic acid and azelaic acid.
  • Topical antimicrobials can include Over the Counter medicines including for example, mupirocin 2%, neomycin, bacitracin and polymyxin B.
  • the liquid bandage can include a therapeutically-effective amount of one or more topical compositions for treating skin infections and fungal infections, such as, for example, griseofulvine.
  • the liquid bandage can include one or more topical compositions to treat nail fungus, such as for example a nail lacquer of ciclopirox.
  • the liquid bandage can include a therapeutically-effective amount of sulfonamides for topical use.
  • the liquid bandage can include one or more ingredients for treating bums. Suitable ingredients can include silver sulfadiazine or matenide.
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients for treating acne.
  • the liquid bandage can include sulfacetamide or metronidazole.
  • the liquid bandage can include ingredients for treating cutaneous infections.
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients of mupirocin 2%, polymixin, bacitracin and fucidine
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients for treating actinic keratoses, actinic cheilitis and superficial basal cell carcinomas.
  • the liquid bandage can include flurouracil (5-FU ) or masopocol.
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients for treating vitiligo.
  • the liquid bandage includes tacrolimus for topical use with an ultra violet filter.
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients for treating anti-black spots of the skin.
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients for treating psoriasis.
  • the ingredients can be provide via an aerosol.
  • the liquid bandage can include a therapeutically-effective amount of one or more ingredients for treating warts. Suitable ingredients include salicylic acid, urea and podophyllum resin. In some embodiments, the liquid bandage can include propylene glycol , N- methyl-2-pyrrolidone or butyl glycol
  • the pharmaceutical active component can include one or more pain reducer or local anesthetics.
  • Example local anesthetics which can be used in the liquid bandage composition, without limitation, include lidocaine, benzocaine, prilocaine and tetracaine.
  • the pharmaceutical active component according to the present invention can include pharmaceutically acceptable forms thereof, including isomers such as diastereomers and enantiomers, salts, solvates, and polymorphs, as well as racemic mixtures.
  • the liquid bandage composition can comprise one or more additives to provide desired properties of a liquid bandage.
  • the additives can include, without limitation, transepidermal water loss (TEWL) prevention materials and ion exchanging ingredients.
  • TEWL transepidermal water loss
  • the liquid bandage composition can comprise from about 0.1% to about 80% by weight or by volume of the film forming material, for example, 1.0- 80%, 5-75%, 10-60%, 20-40%, 25- 40%, or 30-40% by weight or by volume.
  • the liquid bandage composition can comprise from about 0.1% to about 80% by weight or by volume of the solvent, for example, 1.0- 80%, 5-75%, 10-60%, 20-40%, 25-40%, or 30- 40% by weight or by volume.
  • the liquid bandage composition can comprise from about 0.1% to about 45% by weight or by volume of the pharmaceutical or otherwise active agent, for example, 0.1-1.0%, 0.1-0.9%, 0.1-0.8%, 0.1-0.7%, 0.1-0.6%, 0.1-0.5%, 0.1-0.3%, 0.1-0.2%, l%-45%, 5%-40%, 10-35%, 10- 30%, 15-30.%, 20-30% or 25-30% by weight or by volume.
  • the pharmaceutical or otherwise active agent is a wound healing agent which is present in an amount of 1 to 40 %, 1 to 30%, 5-40%, 10-35%, 10-30%, 15-30.%, 20-30% or 25-30% by weight or by volume.
  • the composition can comprise from about 0.1% to about 10% by weight or by volume of the additive, for example, 0.1-1.0%, 0.1-0.9%, 0.1-0.8%, 0.1-0.7%, 0.1-0.6%, 0.1-0.5%, 0.1- 0.3%, 0.1-0.2%, 1-5%, 2-5%, 2-6%, 3-8%, 4.0-9%, 5-8%, 6-9 %,5-10%, 7-10%, or 9-10%, by weight or by volume.
  • the composition comprises a film forming material present in an amount of about 1% to about 50% weight percent of the composition, a solvent present in an amount of about 1% to about 30% weight percent of the composition and a wound healing agent present in an amount of about 1% to about 20% weight percent of the composition.
  • the liquid bandage composition can be formulated by mixing two or more of the ingredients at room temperature. In one embodiment, all ingredients of the liquid bandage composition can be mixed at room temperature. Alternatively, the ingredients during mixing could be heated up to 50°C. In one embodiment, the solids content of the liquid bandage is 97%.
  • the liquid bandage according to the present invention can be administered to or applied to a human or other animal subject.
  • the liquid bandage may be suitable for administration or application to skin of a human subject.
  • the liquid bandage is for protection of wounds and prevention of contamination of the wounds.
  • the liquid bandage composition can be applied directly to the wound for covering the wound.
  • the liquid bandage composition dries after application to the skin to form a film covering the wound.
  • the liquid bandage composition can be applied by brushing the liquid bandage composition over the wound.
  • the liquid bandage composition can be applied with an airless system, such as a for example a pump bottle.
  • the liquid bandage composition can be applied as a spray of the liquid bandage composition.
  • the present invention provides a method of wound care and improving healing of a wound in a subject comprising administering a therapeutically effective amount of a liquid bandage composition comprising a therapeutically-effective amount of at least one film forming material and at least one pharmaceutical therapeutic active component.
  • the present invention further provides a liquid bandage comprising a therapeutically- effective of at least one pharmaceutical active component, wherein the at least one pharmaceutical active component improves healing of a wound beyond benefits provided by not applying the liquid bandage to the wound.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)
EP21814855.9A 2020-09-23 2021-09-23 Flüssigkeitsverbandsystem Pending EP4217013A2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063082031P 2020-09-23 2020-09-23
PCT/IB2021/000655 WO2022064276A2 (en) 2020-09-23 2021-09-23 Liquid bandage system

Publications (1)

Publication Number Publication Date
EP4217013A2 true EP4217013A2 (de) 2023-08-02

Family

ID=78770816

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21814855.9A Pending EP4217013A2 (de) 2020-09-23 2021-09-23 Flüssigkeitsverbandsystem

Country Status (2)

Country Link
EP (1) EP4217013A2 (de)
WO (1) WO2022064276A2 (de)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011050848B4 (de) 2011-06-06 2015-10-01 ITM Isotopen Technologien München AG Schichtaufbau zur epidermalen Radionuklidtherapie
CN108135745B (zh) * 2016-06-29 2021-05-14 艾威药业(珠海)有限公司 用于伤口处理的有效新型快速沉积薄膜形成组合物

Also Published As

Publication number Publication date
WO2022064276A2 (en) 2022-03-31
WO2022064276A3 (en) 2022-06-09

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