EP1940367A2 - Pansement antiviral pour application aux lèvres - Google Patents

Pansement antiviral pour application aux lèvres

Info

Publication number
EP1940367A2
EP1940367A2 EP06805386A EP06805386A EP1940367A2 EP 1940367 A2 EP1940367 A2 EP 1940367A2 EP 06805386 A EP06805386 A EP 06805386A EP 06805386 A EP06805386 A EP 06805386A EP 1940367 A2 EP1940367 A2 EP 1940367A2
Authority
EP
European Patent Office
Prior art keywords
patch according
matrix
patch
plaster
topical
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.)
Ceased
Application number
EP06805386A
Other languages
German (de)
English (en)
Inventor
Stephan Maier
Ulrike Vollmer
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.)
Tesa Labtec GmbH
Original Assignee
Labtec Gesellschaft fuer Technologische Forschung und Entwicklung mbH
Labtec GmbH
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 Labtec Gesellschaft fuer Technologische Forschung und Entwicklung mbH, Labtec GmbH filed Critical Labtec Gesellschaft fuer Technologische Forschung und Entwicklung mbH
Publication of EP1940367A2 publication Critical patent/EP1940367A2/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

Definitions

  • the invention relates to a self-adhesive drug-containing topical application system for use as a lip patch in acute infections with herpes simplex viruses, preferably in labial or perioral infections with herpesviruses type I.
  • the first infection with type I herpesviruses is usually already in childhood, usually asymptomatic. By droplet or smear infection on injured skin or mucous membrane of the virus is transmitted.
  • the virus migrates into the epithelial cells along sensory nerves to the nerves. knots (ganglia). There, the viruses rest until certain factors such as stress, UV light, fever or disgust start the replication mechanism of the virus. New viruses are formed and migrate along the nerve tracts into the skin cells. This is where the typical symptoms occur: tingling, itching and a feeling of tightness are followed, after one to two days, by the appearance of blisters in groups on reddened ground. These dry in the following days to crusts and heal slowly. The affected area is usually less than 100 mm 2 , with 3 to 5 vesicles.
  • the blossoming of the herpes disease often restricts the affected people in their quality of life.
  • the frequency of these outbreaks is extremely variable, ranging from rare episodes every 5 to 10 years to monthly or even more frequent outbreaks.
  • the medicinal therapy of lip herpes is either topically by ointments and creams or perorally by tablets and capsules.
  • topical therapy among others, the following active ingredients are used: docosanol, tromcardine HCl, zinc sulfate, combinations of zinc sulfate and heparin-Na, silica, lemon balm extract, acyclovir, penciclovir.
  • peniclovir-containing Topika you will find for example the following dosage recommendation: for cold sores they should be applied every 2 hours (at least 6 to 8 times a day, on the second day of treatment as possible 10 to 12 times). This high frequency of application poses a major challenge to the patient's compliance.
  • Compliance with this recommendation is a major limitation of the patient's compliance normal daily routine.
  • the nocturnal therapy is a problem because here a two-hour application interval can not be met without significant restrictions on the quality of life.
  • ointments or creams applied at night are often quickly wiped off at nightwear or bedding. These dose-free intervals may contribute to a significant lengthening of the episode.
  • Peroral therapy is used for example: acyclovir, valaciclovir, pamciclovir, foscarnet.
  • acyclovir for the oral treatment of an acute outbreak, for example, the following dosage recommendation for acyclovir: 5 times daily 200-400 mg for 5 days.
  • a high frequency of use is required, which has a strong influence on the daily planning of the patient. Not only does the patient need to think about regular intake, he must also have his medicine and a drink to drink at all times.
  • Such a hydrocolloid includes, for example, polysaccharides and proteins which, as colloids, can dissolve in water and have high gelation ability. Such hydrocolloids are therefore unsuitable for use in the field of lip plasters, since the hydrocolloids just have no water-repellent properties. Also, when using hydrocolloids, no contour stability is ensured. This deficiency leads to impairments of cosmetic and physical coverage. A swollen hydrocolloid also provides an optimal breeding ground for microorganisms, so that there is a risk of inflammation within the scope.
  • an oral cavity matrix patch is provided which is applied to the oral cavity and releases the active ingredient in the oral cavity.
  • the oral cavity matrix patch described has an adhesive layer for adhering the patch to the oral mucosa and an active substance layer. Both layers are at least partially water-soluble.
  • WO 00/04884 describes a pharmaceutical preparation for the topical treatment of mucocutaneous herpes infections as well as the keratitis Herpetica of the eye.
  • a mucoadhesive therapeutic system in which a back layer of a water-soluble polymer is used.
  • WO 95/00184 describes a flexible and at the same time solid foam.
  • the foam provides a porous system which serves to receive a liquid medium and thereby form a hydrogel.
  • the object of the present invention is now to provide a self-adhesive topical patch for use in herpes labialis, wherein the disadvantages of previously used oral and topical administration forms should be avoided.
  • the patch must have sufficient adhesive power to ensure good adhesion even in the event of permanent mechanical stress (speaking) or contact with hot / cold liquids, fats, etc. (food) guarantee.
  • the patch at the end of the application interval, it must be possible to remove the patch painlessly without damaging the infected skin area underneath. In addition, a foreign body sensation should be avoided as far as possible.
  • This object is achieved in that for use in herpes labiales at least one anti- containing virally active drug and that the matrix is disposed on a flexible carrier sheet which is both water-repellent and permeable to water vapor.
  • auxiliaries and types of polymers are of particular importance, as the following example of a wearing test on 5 subjects shows.
  • Table 1 Influence of the topcoat on wearing time and foreign body sensation, tested on 5 test persons
  • a self-adhesive topical patch By using a self-adhesive topical patch, a high concentration of active ingredient can be achieved locally in the long term. For example, it is known for acyclovir that rapid and adequate delivery of the active ingredient is crucial for therapeutic success. In addition, it is easier and more convenient for the patient, instead of having to use an ointment or cream 6-12 times a day, or to swallow one tablet 5 times a day, thinking of the application only once or once every 24 hours.
  • the application time of the self-adhesive patch averaging 8 hours significantly increases patient compliance and thus contributes significantly to the success of the therapy.
  • the thin, flexible plaster may contain one or more color pigments, creating a Covering the most unsightly lesions is achieved.
  • the plaster is ideal for make-up.
  • Another decisive advantage of covering the infected skin area with the plaster is the avoidance of spreading / transmission of the virus infection by droplet or smear infection. Tingling, itching and tightness often cause patients to touch their infected skin with their fingers, delaying the infection. The plaster prevents direct contact with the infection. In addition, this facilitates the healing of the wounds after the bubble phase.
  • Possible active ingredients are, for example, docosanol, tromcardine HCl, zinc sulfate, heparin-Na, silica, lemon balm extract, acyclovir, penciclovir, alone or in combination.
  • other substances from other indications such as healing substances such as dexpanthenol may be included.
  • the self-adhesive topical plaster according to the invention is a single-layer or multi-layer matrix system which either consists only of at least two-layered matrix or, in addition to a single-layer or multi-layer matrix, can have a moisture-resistant and impermeable cover layer and a peelable protective layer.
  • the impermeable cover layer are polyester, polypropylene, polyurethane, ethylene vinyl acetate or polyethylene in question.
  • Suitable for the peelable protective layer are polyester, polypropylene, polysiloxane, polyacrylate, ethylene-vinyl acetate, polyurethane, polyisobutene or paper with silicone and / or polyethylene coating.
  • a particular embodiment of the invention is a two-layer matrix system which contains neither a cover layer nor a protective layer.
  • This two-layer system can consist of a water-insoluble polymer layer, in which various excipients are incorporated, as well as of a non-self-adhesive, moisture-activated and water-soluble second polymer layer which contains one or more active ingredients and other auxiliaries.
  • the medically customary matrix formers such as polyacrylate, silicone, polyisobutylene, rubber, rubber-like synthetic homo-, co- or block polymers, butyl rubber, styrene / isoprene copolymer, polyurethanes, copolymers of ethylene, polysiloxanes, or styrene / Butadiene copolymer can be used individually and / or in combination.
  • the silicone-based matrix formers may be silicone adhesives based on two major components: a polymer or adhesive, especially polysiloxane, and a tack-enhancing resin.
  • the polysiloxane adhesive is usually prepared with a crosslinking agent for the adhesive, typically with a high molecular weight polydiorganosiloxane, and with the resin to give a three-dimensional silicate structure via an appropriate organic solvent. Blending the resin into polymer is the most important factor in changing the physical properties of the polysiloxane adhesives; see. For example, Sobieski, et al., "Silicone Pressure Sensitive Adhesives", Handbook of Pressure Sensitive Adhesive Technology, 2nd Ed. 508-517 (D. Satas, ed.), Van Nostrand Reinhold, New Sive Tech. nology, 2nd ed., pp. 508-517 (D. Satas, ed.), Van No- strand Reinhold, New York (1989).
  • silicone-based pressure-sensitive adhesive is trimethylated silica which has been treated with trimethylsiloxy-terminated polydimethylsiloxane.
  • silicone elastomers have proven to be particularly suitable.
  • These cross-linked elastomers often referred to as "soft-skin adhesives", are addition products of vinyl-terminated polydimethylsiloxane and hydrogen-functional siloxanes. These adhesives show the special property that they can be easily and painlessly removed from the skin and / or lip.
  • the high degree of flexibility, the good permeability to moisture and the reduced adhesion to non-intact skin prove to be very advantageous for the solution of the underlying task of the invention.
  • the acrylate-based matrix formers may be any homopolymer, copolymer or terpolymer consisting of various acrylic acid derivatives.
  • the acrylate polymers may be polymers of one or more monomers of acrylic acids and other copolymerizable monomers.
  • the acrylate polymers may comprise copolymers of alkyl acrylates and / or methacrylates and / or copolymerizable secondary monomers or monomers having functional groups. If one modifies the amount of each species added as a monomer, the cohesive eigen- Shafts of the resulting acrylate polymers are changed.
  • the acrylate polymer consists of at least 50% by weight of an acrylate, methacrylate, alkyl acrylate or alkyl methacrylate monomer, 0 to 20% of a functional monomer copolymerizable with acrylate, and 0 to 40% of another monomer ,
  • acrylate monomers which can be used with acrylic acid, methacrylic acid, butyl acrylate, butyl methacrylate, hexyl acrylate, hexyl methacrylate, isooctyl acrylate, isooctyl methacrylate, 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, decyl acrylate, decyl methacrylate, dodecyl acrylate, dodecyl methacrylate, tridecyl acrylate and tridecyl methacrylate ,
  • acrylates, methacrylates, alkyl acrylates or methacrylates can be used, for example acrylic acid, methacrylic acid, maleic acid, maleic anhydride, hydroxyethyl acrylate, hydroxypropyl acrylate, acrylamide, dimethylacrylamide, acrylonitrile, dimethylaminoethyl acrylate, dimethylaminoethyl methacrylate , tert. Butylaminoethyl acrylate, tert. - Butylaminoethylmethacrylat, methoxyethyl acrylate and methoxyethyl methacrylate.
  • Permeationsf ⁇ rderer can be mono- and / or polyhydric aliphatic, cycloaliphatic and / or aromatic aliphatic alcohols having in each case up to eight C atoms, for example ethanol, 1,2-propanediol, dexpanthenol and / or polyethylene glycol; Alcohol / water mixtures, - saturated and / or unsaturated fatty alcohols with 8-18 C atoms each; Terpenes, eg cineole, carveol, menthone, terpineol, verbenone, menthol, limonene, thymol, cymene, terpinene-4-ol, neomenthol, geraniol, fenchone; Mixtures of terpenes and ethanol and / or propylene glycol; tea tree oil; saturated and / or unsaturated cyclic ketones, - alkyl methyl sulfoxides, - saturated and
  • Example 1 Two-layer matrix plaster, without cover and protective layer, adhesive side moisture-activated
  • ethanol 96% 6 g Carbopol 971 are homogenized.
  • the homogeneous mass is spread on a non-siliconized PET film (e.g., 100 ⁇ m) and dried.
  • Example 3 Single-layer matrix plaster with cover and protective layer
  • Each 4.8 g of the two components of a silicone elastomer (zB7-9800 Soft Skin Part A and Part B, Dow Corning Corp.) are mixed. To the mixture are added 0.29 g of Aerosil and 4.8 g of an amine-compatible silicone adhesive (eg BlOPSA 7-4302, Dow Corning Corp.) and 2.4 g of acyclovir and color pigments added.
  • the homogeneous coating solution is spread on a polyurethane film (eg 50 ⁇ m) or on a polyethylene film and dried.
  • the peelable protective layer eg, a fluoropolymer-coated polyester film
  • Plasters with an area of 1 cm 2 are punched out.
  • the essential properties of the lip patch according to the invention are summarized below again.
  • the lip patch has a water-repellent back layer so it can be worn on the lip for several hours.
  • the lip patch retains its thin and flexible properties as well as its contour stability.
  • the contour stability ensures that during the entire period of application, a cosmetic and physical coverage of the herpes Lasion can be done.
  • the flexible thin carrier film used for the lip patch has water-repellent, semi-occlusive and soft properties.
  • films of polyurethane are suitable.
  • a carrier film made of polyurethane is semi-permeable and reliably protects against microorganisms and moisture. Due to the semipermeable properties, however, a gas exchange is possible, so that in particular excess water vapor can escape. The herpes lesion can thus heal quickly and gently in a moist but not wet environment.
  • the constructive realization of the lip patch ensures that it delivers the active ingredient locally to the lip or the surrounding skin areas when used on the lip or on the lip surrounding Hautreallen.
  • the lip patch according to the invention makes it possible, in particular, to achieve an active ingredient concentration of more than 40% by weight.
  • it is thought to form the lip patch at least two layers, wherein at least one of the layers is realized as a polymer film.
  • the polymer film provides an adhesive layer that can be made thin and bubble-free. This assists in good adhesion of the system to the site of application.
  • a particular full-surface adhesion of the patch on the intended skin area supports the desired drug diffusion into the site of action.
  • the already mentioned active ingredient loading of at least 40 percent by weight allows a high concentration of active ingredient at the site of action over the entire period of wear and thus for a period of at least eight hours. Despite this high loading with active ingredient, the self-adhesive matrix an extremely good adhesion.
  • Fig. 1 is a topical patch with topcoat and protective layer
  • Fig. 2 shows a topical patch with a two-layer matrix without protective layer and topcoat.
  • FIG. 1 shows the already described embodiment of a topical patch having an at least single-layered matrix (1) which is provided in the area of one of its surfaces with the cover layer (2) and in the region of an opposite surface with the protective layer (3).
  • the usually self-adhesive matrix (1) can be glued to the application site.
  • the cover layer (2) allows overpainting of the glued topical patch.
  • FIG. 2 shows the embodiment of the two-layer matrix (1) without cover layer (2) and protective layer (3), wherein one matrix layer is water-insoluble and the other matrix layer is water-soluble and moisture-activatable.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne un patch pour les lèvres autocollant topique qui présente au moins une matrice monocouche et qui contient au moins un médicament à action antivirale conçu pour être utilisé en cas d'herpès labial. La matrice est placée sur un film de support souple qui est à la fois hydrofuge et perméable à la vapeur d'eau.
EP06805386A 2005-10-20 2006-10-09 Pansement antiviral pour application aux lèvres Ceased EP1940367A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005050654A DE102005050654A1 (de) 2005-10-20 2005-10-20 Lippenpflaster
PCT/DE2006/001768 WO2007045212A2 (fr) 2005-10-20 2006-10-09 Patch pour les levres antiviral

Publications (1)

Publication Number Publication Date
EP1940367A2 true EP1940367A2 (fr) 2008-07-09

Family

ID=37882289

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06805386A Ceased EP1940367A2 (fr) 2005-10-20 2006-10-09 Pansement antiviral pour application aux lèvres

Country Status (4)

Country Link
US (1) US20090175928A1 (fr)
EP (1) EP1940367A2 (fr)
DE (2) DE102005050654A1 (fr)
WO (1) WO2007045212A2 (fr)

Families Citing this family (9)

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Publication number Priority date Publication date Assignee Title
IL192335A0 (en) * 2008-06-19 2011-08-01 Avivi Easy Life Ltd Antiviral compounds
EP2196197A1 (fr) * 2008-12-15 2010-06-16 Bouty S.P.A. Patch antiviral
WO2012048455A1 (fr) * 2010-10-12 2012-04-19 武汉大学 Timbre d'absorption transdermique de médicament antiviral et son procédé de préparation
US20120107768A1 (en) * 2010-10-29 2012-05-03 Diedwardo William A Dental protective device and method of use
US8936026B2 (en) 2011-02-08 2015-01-20 Orvance Technologies, Llc Orthodontic appliance shield
US11622929B2 (en) 2016-03-08 2023-04-11 Living Proof, Inc. Long lasting cosmetic compositions
WO2019055445A2 (fr) 2017-09-13 2019-03-21 Living Proof, Inc. Compositions de protection de couleur
CN111133023B (zh) 2017-09-13 2022-10-18 生活实验公司 持久化妆品组合物
CN115778926A (zh) * 2023-01-30 2023-03-14 南京天纵易康生物科技股份有限公司 一种含贻贝粘蛋白的可降解唇部护理贴剂及其制备方法

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WO2005051333A1 (fr) * 2003-11-28 2005-06-09 Coloplast A/S Bande adhesive

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JPH0645536B2 (ja) * 1989-01-31 1994-06-15 日東電工株式会社 口腔粘膜貼付剤および口腔粘膜貼付製剤
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WO2000041670A2 (fr) * 1999-01-11 2000-07-20 Ahmet Degirmenci Formulations pharmaceutiques et procedes associes permettant une continuite de penetration
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Also Published As

Publication number Publication date
WO2007045212A3 (fr) 2007-06-14
DE102005050654A1 (de) 2007-04-26
DE112006003470A5 (de) 2008-09-18
WO2007045212A2 (fr) 2007-04-26
US20090175928A1 (en) 2009-07-09

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