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WO2001078691A1 - Bande therapeutique contenant, comme excipient, un compose organique en gel ou liquide - Google Patents

Bande therapeutique contenant, comme excipient, un compose organique en gel ou liquide Download PDF

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Publication number
WO2001078691A1
WO2001078691A1 PCT/US2000/012969 US0012969W WO0178691A1 WO 2001078691 A1 WO2001078691 A1 WO 2001078691A1 US 0012969 W US0012969 W US 0012969W WO 0178691 A1 WO0178691 A1 WO 0178691A1
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WO
WIPO (PCT)
Prior art keywords
fragrance
patch
therapeutic formulation
present
backing
Prior art date
Application number
PCT/US2000/012969
Other languages
English (en)
Inventor
David J. W. Goon
David Rolf
Original Assignee
Lectec Corporation
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 Lectec Corporation filed Critical Lectec Corporation
Priority to AU2000250055A priority Critical patent/AU2000250055A1/en
Publication of WO2001078691A1 publication Critical patent/WO2001078691A1/fr

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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

Definitions

  • U.S. Patent No. 4,675,009; U.S. Patent No. 5,536,263; and U.S. Patent No. 5,741,510 each describe a drug dispensing device for the delivery of medication to the skin. While the patches disclosed are generally effective in the delivery of a medicament (e.g., topical antitussive) to the skin, there exists a need for additional non-occlusive (i.e., breathable or vapor permeable), protective, adhesive patches that adhere to FDA regulations.
  • a medicament e.g., topical antitussive
  • non-occlusive i.e., breathable or vapor permeable
  • FDA regulations e.g., Federal Register, Vol. 48, No. 27, ⁇ 341 regulate what components (i.e., "active mgredients", in a specified amount, may be described as a cough reliever (i.e., topical antitussive).
  • active mgredients i.e., topical antitussive
  • FDA regulations e.g., Federal Register, Vol. 48, No. 27, ⁇ 341 regulate what components (i.e., "active mgredients"
  • active mgredients i.e., topical antitussive
  • FDA regulations e.g., Federal Register, Vol. 48, No. 27, ⁇ 341 regulate what components (i.e., "active mgredients"
  • topical antitussive i.e., topical antitussive
  • topical cough formulations include one or more components (e.g., camphor and menthol) that are recognized by the FDA as topical antitussives.
  • these formulations which are advertised as decongestants, include turpentine, which is flammable (i.e., the presence of turpentine in the formulation results in a premix mixture that has a flash point below 140 °F). As such, these cough formulations, upon being discarded, can be considered hazardous waste.
  • TheraPatch ® Vapor includes camphor, , menthol, adhesives, aloe vera, eucalyptus oil, glycerin, karaya, water and turpentine spirits.
  • the oil premix for TheraPatch® Vapor has a flash point of 114°F, and when this liquid is discarded, it is considered hazardous waste.
  • the flash point of the TheraPatch® Vapor patch was determined to be 140°C. This temperature is just above the cut off for liquids (i.e., the 140°C). However, there is no hazardous waste definition for solids based on the flash point of the solid.
  • the TheraPatch® Vapor upon being discarded, can be considered as non hazardous waste.
  • the transdermal patch. includes turpentine, which is not preferable for many children.
  • a vapor permeable (i.e., breathable), protective, adhesive patch that can be topically applied, that can relieve coughing, and that is free of components (e.g., turpentine) that contain an unpleasant odor.
  • an adhesive patch that can at least partially mask the unpleasant odor of antitussive medicinals such as camphor, menthol, eucalyptus oil, turpentine oil, thymol, or a combination thereof.
  • the needs also include the solubility and stability of the medicament (e.g., topical antitussive) during the manufacturing, packaging, shipping, and storage of the patch, and the need to maintain the pressure sensitive adhesive properties of the therapeutic formulation.
  • FDA regulations e.g., Federal Register, Vol. 48, No. 27, ⁇ 341
  • formulations including a topical antitussive include a topical antitussive.
  • the present invention provides for a vapor permeable adhesive patch.
  • the patch includes a porous backing having a front side and a back side.
  • the patch also includes a therapeutic formulation located on the front side of the backing.
  • the backing includes a flexible sheet of water insoluble porous material.
  • the therapeutic formulation includes a combination of a medicament, useful for relieving coughing; a liquid or gel-like, cosmetically acceptable organic compound to act as a carrier for the medicament and at least partially masks the odor of the medicament; and a pressure sensitive adhesive.
  • the liquid or gel-like, cosmetically acceptable organic compound is a fragrance.
  • the patch can be used to alleviate and/or relieve coughing in a mammal (e.g., human).
  • Figure 1 illustrates the front side of an adhesive patch.
  • Figure 2 illustrates the back side of an adhesive patch.
  • Figure 3 illustrates the front side of an adhesive patch with a backing liner attached to the patch.
  • Figure 4 illustrates the back side of an adhesive patch with a backing liner attached to the patch.
  • Figure 5 illustrates the back side of an adhesive patch with a backing liner attached to the patch, wherein the patch is partially detached from the backing liner.
  • Figure 6 illustrates the back side of an adhesive patch with a backing liner attached to the patch, wherein the patch is partially detached from the backing liner.
  • Figure 7 illustrates a top view of a specific patch of the present invention.
  • Figure 8 illustrates a side view of a specific patch of the present invention.
  • Figure 9 illustrates a specific patch of the present invention in use on the chest.
  • Figure 10 illustrates a specific patch of the present invention in use between the upper lip and the nose.
  • Figure 11 illustrates a specific patch of the present invention in use on the throat.
  • Figure 12 illustrates a specific patch of the present invention in use on the chin. Detailed Description of the Invention
  • the vapor permeable adhesive patch of the present invention contains a known, effective and stable amount of topical antitussive.
  • the vapor permeable adhesive patch does not include turpentine, or any other component that has an unpleasant odor.
  • the vapor permeable adhesive patch therefore, is safe, effective, and convenient for alleviating and/or relieving coughing.
  • the present invention provides a vapor permeable, adhesive patch that contains a medicament.
  • the medicament is present in the therapeutic formulation, which is present on and in at least a portion of the front side of the backing.
  • the medicament is useful for relieving coughing.
  • an adhesive patch can be manufactured wherein the adhesive patch maintains the desired pressure sensitive adhesive properties, retains the stability and solubility of the medicament in the therapeutic formulation, and is free of turpentine; wherein a liquid or gel, cosmetically acceptable organic compound is used as a carrier for the medicament and other ingredients of the therapeutic formulation.
  • the liquid or gel compound is a fragrance acceptable for cosmetic use and preferably acceptable for incidental ingestion or absorption into the human body.
  • the liquid or gel cosmetically acceptable organic compound will preferably have low to moderate volatility as measured by its ability to generate odor.
  • the volatility will not be so high as to significantly decrease the concentration of the liquid organic compound over the life of the patch.
  • the volatility will, however, be high enough such that when desirable, the odor or scent can be detected by the patient.
  • the therapeutic formulation 5 of the adhesive patch 1 will emit an odor or scent that is detected by the patient for a period of at least about 10 hours, at least about 8 hours, or at least about 6 hours.
  • the liquid gel cosmetically acceptable organic compound is an ester, terpene, alcohol, ketone, aldehyde, fatty acid, partially or fully esterified fatty acid wherein the structures are cyclic, alicyclic or aromatic, as well as organic compounds having combinations of these functional groups.
  • the liquid or gel, cosmetically acceptable organic compound will be termed a liquid or gel compound.
  • a vapor permeable, adhesive patch 1 of the present invention is provided.
  • the patch 1 includes a backing 2 and a therapeutic formulation 5.
  • the backing 2 is defined by a front side 3 (the side exposed to the skin during use) and a back side 4 (the side exposed to the environment during use).
  • the backing 2 includes a flexible porous sheet of water insoluble material that provides support for the patch 1.
  • the backing 2 should be nonirritating to human skin.
  • the backing 2 can be porous since porosity provides openings for receiving the therapeutic formulation 5 and it helps to assure that the patch 1 is vapor permeable.
  • the backing 2 can optionally be woven or non woven. Suitable backings 2 and methods for manufacturing the suitable backings are disclosed in U.S. Patent No. 4,675,009; U.S. Patent No. 5,536,263; U.S. Patent No. 4,696,854; U.S. Patent No. 5,741,510, and references cited therein.
  • the backing 2 can be manufactured from any suitable material, provided the suitable material can form a flexible, bendable, pliable, and/or stretchable sheet of water insoluble porous material.
  • the backing 2 includes a front side 3 and a back side 4.
  • the patch 1 includes a therapeutic formulation 5 located on and in the front side 3 of the backing 2, wherein the therapeutic formulation 5 includes a combination of a medicament 15 useful for relieving coughing; a pressure sensitive adhesive and a liquid or gel compound that dissolves the medicament 15.
  • the liquid or gel compound at least partially masks the unpleasant odor of the medicament 15 if such odor is present.
  • the therapeutic formulation is located on at least a portion of the front side 3 of the backing 2.
  • the patch 1, upon contact with skin will allow the skin to breathe. More preferably, the patch 1, upon prolonged contact with skin, will hold in place the therapeutic formulation 5 and allow the skin to breathe over prolonged periods of time, such as up to about 10 days, up to about 1 day, or up to about 8 hours.
  • the backing 2 is a porous, self-supporting sheet of water insoluble, polymeric or natural material that provides strength and integrity for the therapeutic formulation 5.
  • the backing 2 can be water insoluble polymeric fibers, open cell foam backing (e.g., polyurethane, polyvinyl chloride, or polyethylene), a porous film or any other kind of matrix with spaces within the matrix.
  • the backing 2 can be polyester, polyurethane, polyolefm, polyamide fibers, natural fibers, cotton fibers, polycellulose fibers, or any mixture thereof.
  • a specific backing 2 is a lightweight, porous, pliable strip composed of a nonwoven fabric of polymeric or natural fibers such as polyester, cotton or cellulose fibers bonded together with a sizing resin. Additional stable, water insoluble flexible sheet materials are disclosed in U.S. Patent No. 4,675,009; U.S. Patent No. 5,536,263; U.S. Patent No. 4,696,854; U.S. Patent No. 5,741,510, and references cited therein, and are suitable as backings according to the present invention. The infusion of the therapeutic formulation 5 into the backing 2 is accomplished with the use of a continuous process mixer, as disclosed in U.S. Patent No. 5,536,263, and references cited therein.
  • the patch 1 is preferably reversibly attached to a backing liner 10.
  • the backing liner 10 helps to maintain the adhesiveness of the patch 1 prior to use, such as during manufacturing, packaging, shipping, and/or storage. Any suitable backing liner can be employed for use in the present invention.
  • Suitable backing liners 10 are readily known to those of skill in the art. See, U.S. Patent No. 4,675,009; U.S. Patent No. 5,536,263; U.S. Patent No. 4,696,854; U.S. Patent No. 5,741,510, and references cited therein for further descriptions of backing liners useful in the present invention.
  • the backing liner 10 can include a perforation 12 that allows the tab section 11 of the backing liner 10 to be removed (see, Figs. 5-6). Removal of the tab section 11 of the backing liner 10 allows the patch 1 to be removed from the backing liner 10 with relative ease.
  • the therapeutic formulation 5 includes a combination of a pressure sensitive adhesive and a medicament 15 useful for relieving coughing, and a liquid or gel compound that dissolves the medicament 15.
  • the medicament can be a topical antitussive, as disclosed in Federal Register, Vol. 48, No. 27, ⁇ 341.3(c) and ⁇ 341.14(b), and references cited therein; or Handbook of Nonprescription Drugs, 10th Edition, 1993.
  • the topical antitussive can effectively suppress coughing as disclosed in Federal Register, Vol. 48, No. 27, ⁇ 341.74, and references cited therein.
  • Suitable topical antitussives include camphor, menthol, eucalyptus oil, turpentine oil, thymol, or a combination thereof.
  • Preferred topical antitussives include camphor, menthol, or a combination thereof.
  • the medicament 15 can be present in any appropriate and suitable amount.
  • the medicament 15 can be present in about 0.01 wt.% to about 99.9 wt.% of the therapeutic formulation 5. More preferably, the amount of medicament 15 present in the therapeutic formulation 5 can depend upon the specific compound or compounds employed as the medicament 15. For example, camphor can be present up to about 99.9 wt.% of the therapeutic formulation 5 and menthol can be present up to about 99.9 wt.% of the therapeutic formulation 5.
  • the amount of medicament 15 present in the therapeutic formulation 5 follows FDA regulations, Federal Register, Vol. 48, No. 27, ⁇ 341 or complies with Handbook of Nonprescription Drugs, 10th Edition, 1993, p. 108.
  • the amount of medicament 15 present in the therapeutic formulation 5 can comply with FDA regulations (e.g., Federal Register, Vol. 48, No. 27, ⁇ 341), it is appreciated that those of skill in the art understand that the amount of camphor and/or menthol present in the therapeutic formulation 5 can be higher than the amount permitted by the FDA for cough or colds. See, e.g., Handbook of Nonprescription Drugs, 10th Edition, 1993. This is so because there can be a loss of concentration for the camphor and/or menthol during the manufacturing, shipping or storage of the adhesive patch 1. As such, the FDA allows for slightly more or slightly less (e.g., ⁇ 10%) camphor and/or menthol to be present in the stability studies.
  • FDA regulations e.g., Federal Register, Vol. 48, No. 27, ⁇ 3411
  • the FDA allows for slightly more or slightly less (e.g., ⁇ 10%) camphor and/or menthol to be present in the stability studies.
  • camphor can be present up to about 13.0 wt.% of the therapeutic formulation 5 and menthol can be present up to about 6.0 wt.% of the therapeutic formulation 5.
  • camphor can be present up to about 5.9 wt.% of the therapeutic formulation 5 and menthol can be present up to about 3.2 wt.% of the therapeutic formulation 5.
  • camphor can be present in about 4.2 wt.% to about 5.9 wt.% of the therapeutic formulation 5 and menthol can be present in about 2.1 wt.% to about 3.2 wt.% of the therapeutic formulation 5.
  • the medicament 15 preferably can be located on and in any portion of the therapeutic formulation on the front side 3 of the backing 2. Preferably, the medicament 15 can be located on and in the entire portion of the therapeutic formulation.
  • the adhesive skin patch 1 When the adhesive skin patch 1 is placed upon the skin of a patient, the medicament 15 can be in continuous contact with the skin of the patient
  • a suitable liquid or gel compound can be employed as a carrier, thereby obviating the need to employ conventional carriers and/or solvents (e.g., turpentine) to act as a carrier for, and preferably dissolve, the medicament 15.
  • the suitable liquid or gel compound is a non-irritant.
  • non-irritant refers to an agent, e.g., organic compound, that does not produce an appreciable or significant amount of inflammation or irritation when applied topically to the skin in the specified amount.
  • the liquid or gel compound can be employed as a co-carrier, and the amount of solvent, such as a premix solvent, is lowered.
  • a premix solvent such as propylene glycol
  • the use of lower amounts of premix solvent, such as propylene glycol allows the adhesive patch 1 to be more effectively coated during the manufacturing process.
  • the use of less premix solvent such as propylene glycol results in less bleed-through or leak-through of the therapeutic formulation 5 onto the back side of backing 2 in manufacturing of the adhesive patch 1.
  • the suitable liquid or gel compound can act as a carrier for, and preferably can dissolve, the medicament 15.
  • the liquid or gel compound at least partially mask the odor of the medicament 15, if such an odor is present.
  • the liquid or gel compound can be a fragrance.
  • the fragrance can be a floral scent, a food scent, a fruit scent, a plant leaf scent, or any combination thereof.
  • the liquid or gel compound can maintain the stability of the medicament 15 during the manufacturing, shipping, and storage of the medicament 15.
  • any suitable liquid or gel compound can be employed, provided that it effectively carries, and preferably dissolves the medicament 15 and the liquid or gel compound at least partially masks the odor of the medicament 15.
  • the therapeutic formulation remains stable over a prolonged period of time.
  • the therapeutic formulation 5 retains its adhesive properties over a prolonged period of time.
  • the odor is pleasant.
  • the liquid or gel compound can be an organic compound or the liquid or gel compound can be an inorganic compound.
  • the liquid or gel compound is an organic compound.
  • the liquid or gel organic liquid preferably is pharmaceutically acceptable for topical use.
  • it is preferred that the liquid or gel organic liquid have a low to moderate volatility, so that its evaporation from the patch 1 is rendered minimal to moderate. The volatility will, however, be high enough such that when desirable, the odor or scent can be detected by the patient.
  • the therapeutic formulation 5 of the adhesive patch 1 will emit an odor or scent that is detected by the patient for a period of at least about 10 hours, at least about 8 hours, or at least about 6 hours.
  • the liquid or gel compound can be a low odor liquid or gel compound, a high odor liquid or gel compound, or a mixture thereof.
  • a high odor liquid or gel compound such as a fragrance
  • These cough formulations can include a liquid or gel compound that possesses a lower odor than the medicament 15. In such situations, the odor of the medicament 15 will be more noticeable or detectable than the odor of the liquid or gel compound because the liquid or gel compound will only partially mask the odor of the medicament 15.
  • suitable low odor liquid or gel compounds would be known to those skilled in the art. It is also appreciated that those skilled in the art understand that suitable low odor liquid or gel compounds are commercially available from, for example, Alpine Aromatics (Piscataway, N ), Andrea Aromatics (Princeton, N ), Arylessence, Inc. (Marietta, GA), Belmay Co., Inc. (Yonkers, NY), Crami Flavor & Fragrance Co., Inc. (City of Commerce, CA), Creative Fragrances Mfgr. Inc. (Dallas, TX), Drom International Co. (Tawaco, NJ), Fleurchem, Inc. (Middletown, NY), Great Lakes Chem. Corp. (Lafayette, IN), Kraus & Co., Inc. (Battle Creek, MI), The
  • the low odor liquid or gel compound can be any suitable low odor liquid or gel compound or compounds commercially available from, for example, the above vendors, or any combination thereof.
  • suitable low odor liquid or gel compounds are disclosed herein.
  • suitable exemplary low odor liquid or gel compounds include grape fragrance, musk fragrance, light vanilla fragrance, Jergens lotion fragrance, Vaseline Intensive Care fragrance, Nivea Lotion fragrance, Ivory Soap fragrance, or any combination thereof.
  • a low odor liquid or gel compound that can partially mask the odor of the medicament 15 is grape fragrance, methyl anthranilate.
  • the low odor liquid or gel compounds can be unidentifiable.
  • the therapeutic formulation can contain the liquid or gel compound that is of minimal odor.
  • An unidentifiable liquid or gel compound has odor that cannot be readily identified by the average consumer.
  • An unidentifiable liquid or gel compound does have an odor, but the odor cannot be readily identified by the average consumer.
  • a minimally odorous liquid or gel compound is one without any distinct odor. It is not odor-free but the odor is not recognizable and exceedingly faint.
  • cough formulations wherein the odor of the medicament 15 is not detectable to any appreciable degree.
  • These cough formulations can include a liquid or gel compound that possesses a higher odor than the medicament 15. In this situation, the odor of the medicament 15 will be less noticeable or detectable than the odor of the liquid or gel compound, such that the liquid or gel compound effectively masks the odor of the medicament 15.
  • suitable high odor liquid or gel compounds would be known to those skilled in the art. It is also appreciated that those skilled in the art understand that suitable high odor liquid or gel compounds are commercially available from, for example, Alpine Aromatics (Piscataway, NJ), Andrea Aromatics (Princeton, NJ), Arylessence, Inc.
  • the high odor liquid or gel compound can be any suitable high odor liquid or gel compound or compounds commercially available from, for example, the above vendors, or any combination thereof. As the number of suitable high odor liquid or gel compounds is too voluminous and expansive to exhaustively list herein, suitable exemplary high odor liquid or gel compounds are disclosed herein.
  • Suitable exemplary high odor liquid or gel compounds include amaretto, blueberry, coffee, egg nog, peanut butter, rum cake, honey almond, ginger bread house, coffee cake & spice, raspberry rose, sassafras, strawberry, grapefruit pink, home sweet, jeweled citrus, lemon, mango, mulberry, orange flower, passion fruit, pikaki, freesia, china rain, coconut, apple, baked bread, cornucopia, lemon chiffon, peppermint twist, white cake, cherry pie, sugar plum, plum, romantic, sea fresh, tea, green floral, honeydew, kiwi, lilac, may bouquet, neutralizer, patchouli, peach, pine apple blossom, chocolate mint, frankincense, balced apple pie, cappuccino, cran-apple, maple syrup, popcorn (buttered), sugar cookie, cotton candy, cranberry cobbler, plumeria, rum, spring fever, watermelon, guava, honeysuckle, hyacinth
  • the high odor liquid or gel compound that can effectively mask the odor of the medicament 15 can be bubble gum, candy cane, tutti frutti, rose, green apple, cinnamon, cherry, orange sherbet, or any combination thereof. More preferably, the high odor fragrance that can effectively mask the odor of the medicament 15 can be cherry fragrance.
  • the fragrance can be produced from a single liquid or gel compound or from a mixture of two or more liquid or gel compounds.
  • suitable liquid or gel compounds can include (a) at least one low odor liquid or gel compound, (b) at least one high odor liquid or gel compound, (c) a combination of at least one low odor liquid or gel compound and at least one high odor liquid or gel compound, (d) preferably eucalyptus oil, and one or more of a low odor or high odor liquid or gel compound or a combination thereof. Any suitable combination of low odor liquid or gel compound, high odor liquid or gel compound, and eucalyptus oil can be employed.
  • a suitable liquid or gel compound combination includes grape fragrance present up to about 5.0 wt.% of the therapeutic formulation 5 and eucalyptus oil present up to about 4.0 wt.% of the therapeutic formulation 5.
  • the suitable liquid or gel compound includes grape essence present in about 0.5 wt.% to about 4.0 wt.% of the therapeutic formulation 5 and eucalyptus oil present in about 0.5 wt.% to about 3.0 wt.% of the therapeutic formulation 5.
  • the liquid or gel compound includes grape essence present in about 0.75 wt.% to about 1.25 wt.% of the therapeutic formulation 5 and eucalyptus oil present in about 0.9 wt.% to about -1.5 wt.%) of the therapeutic formulation 5.
  • any suitable pressure sensitive adhesive can be employed, provided the pressure sensitive adhesive maintains its adhesive properties and maintains the appropriate stability of the medicament 15. Preferably, this maintenance and stability is over a prolonged period of time, e.g., at least about 2 years, at least about 1 year, or at least about 6 months, typically experienced in the manufacturing, shipping, and storage of the patch 1.
  • the pressure sensitive adhesive is optionally a gel.
  • the pressure sensitive adhesive preferably includes an acrylic ester copolymer, a polymer, and a humectant.
  • the amount of acrylic ester copolymer employed can depend upon the specific adhesive or adhesives employed.
  • the pressure sensitive adhesive can include an acrylic ester copolymer in about 0.1 wt.% to about 50 wt.% of the therapeutic formulation 5.
  • the pressure sensitive adhesive can include an acrylic ester copolymer in about 1.0 wt.% to about 25.0 wt.% of the therapeutic formulation 5. More preferably, the pressure sensitive adhesive can include an acrylic ester copolymer in about 3.0 wt.% to about 10.0 wt.%) of the therapeutic formulation 5. Any suitable polymer can be employed, provided the polymer maintains the adhesive properties of the pressure sensitive adhesive and maintains the appropriate stability of the medicament 15.
  • Suitable polymers include starch, starch derivatives, polyvinyl pyrrolidone, polyethylene oxide, polyacrylate quats, polymaleic acid, polymaleic anhydride, polyurethanes, polyureas, karaya, gum acacia, locust bean gum, xanthan gum, guar gum, modified guar gum, maltodextrin, carboxymethyl cellulose, carboxypropyl cellulose, polyacrylamide, polyvinyl alcohol, poly AMPS, and polyacrylates.
  • Other suitable polymers are disclosed, e.g., in U.S. Patent No. 4,675,009; U.S. Patent No. 5,536,263; U.S. Patent No. 4,696,854; U.S. Patent No. 5,741,510, and references cited therein.
  • the polymer is karaya.
  • karaya can be employed as the polymer in about 10 wt% to about 50 wt.% of the therapeutic formulation 5, in about 20 wt% to about 40 wt.% of the therapeutic formulation 5, in about 15 wt% to about 30 wt.% of the therapeutic formulation 5, or in about 20 wt% to about 40 wt.% of the therapeutic formulation 5.
  • karaya can be employed as the polymer in about 30 wt% to about 35 wt.% of the therapeutic formulation 5.
  • any suitable humectant can be employed, provided the humectant maintains the adhesive properties of the pressure sensitive adhesive and maintains the appropriate stability of the medicament 15.
  • the humectant provides a moistening effect to the pressure sensitive adhesive.
  • the humectant can hydrate the polymer.
  • Any suitable humectant can be employed, provided it hydrates the polymer.
  • One suitable humectant is glycerin.
  • Other suitable humectants include polyhydric alcohols such as ethylene glycol, propylene glycol, triethylene glycol, tetraethylene glycol, and sorbitol.
  • any suitable humectant can be employed, provided the amount of humectant maintains the adhesive properties of the pressure sensitive adhesive and maintains the appropriate stability of the medicament 15.
  • the suitable humectant in part can relate to the specific polymer or polymers employed.
  • glycerin can be employed as the humectant in about 20 wt% to about 70 wt.% of the therapeutic formulation 5, preferably about 30 wt% to about 60 wt.% of the therapeutic formulation 5, or more preferably in about 40 wt% to about 50 wt.%o of the therapeutic formulation 5.
  • the pressure sensitive adhesive can include a hot melt pressure sensitive adhesive or solvent based pressure sensitive adhesive (e.g., polyacrylate, polyisobutylene, and polybutene), rubber, silicone based pressure sensitive adhesives (e.g., polydimethylsiloxane and resin mixtures), polystyrene-polybutadiene-polystyrene, polystyrene-polyisoprene-polystyrene, polystyrene-poly(ethylene-butylene)-polystyrene block polymers, or any combination thereof.
  • a hot melt pressure sensitive adhesive or solvent based pressure sensitive adhesive e.g., polyacrylate, polyisobutylene, and polybutene
  • rubber silicone based pressure sensitive adhesives (e.g., polydimethylsiloxane and resin mixtures)
  • silicone based pressure sensitive adhesives e.g., polydimethylsiloxane and resin mixtures
  • the pressure sensitive adhesive can include a resin emulsion adhesive, wherein the resin emulsion adhesive can include vinyl acetate resin, acrylic ester copolymer, vinyl actetate/diocyl maleate copolymer, acrylic copolymer, or any combination thereof.
  • the pressure sensitive adhesive can be located on or in any portion of the therapeutic formulation. Preferably, the pressure sensitive adhesive is located on the entire skin contact side of the therapeutic formulation. When the adhesive skin patch 1 is placed upon the skin surface of a patient, the pressure sensitive adhesive in this configuration is in continuous contact with the skin surface of the patient.
  • the therapeutic formulation 5 can optionally include a premix solvent.
  • the premix solvent assists the combination of liquid or gel compound and the medicament 15.
  • the premix solvent can be any of the polyhydric alcohols disclosed herein above for the humectant. Suitable premix solvents include propylene glycol, ethylene glycol, triethylene glycol, tetraethylene glycol, and sorbitol.
  • premix solvent can be present up to about 20 wt.% of the therapeutic formulation 5.
  • the premix solvent can be present up to about 10.0 wt.% of the therapeutic formulation 5. More preferably, propylene glycol can be present up to about 6.0 wt.% of the therapeutic formulation 5.
  • the therapeutic formulation 5 can optionally include a topical moisturizer (i.e., skin conditioner). Any suitable topical moisturizer can be employed. Suitable topical moisturizers include calamine, aloe, Vitamin E (i.e., tocopheryl), Vitamin E acetate (i.e., tocopheryl acetate), Vitamin C (i.e., L-(+)- ascorbic acid), and lanolin.
  • a topical moisturizer i.e., skin conditioner.
  • Suitable topical moisturizers include calamine, aloe, Vitamin E (i.e., tocopheryl), Vitamin E acetate (i.e., tocopheryl acetate), Vitamin C (i.e., L-(+)- ascorbic acid), and lanolin.
  • calamine is a pink powder of zinc oxide and a skin protectant containing about 98% zinc oxide and about 0.5% ferric oxide
  • aloe is the dried latex of leaves of Curaco Aloe (Aloe barbadenis Miller, Aloe vera Linne) or Cape Aloe (Aloeferox Miller and hybrids), of the family Liliacaea
  • Vitamin E is 3,4-dihydro-2,5,7,8-tetramefhyl-2-(4,8,12- trimethyltridecyl)-2H-l-benzopyran-6-ol
  • Vitamin E acetate is 3,4-dihydro- 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-l-benzopyran-6-ol acetate
  • lanolin is the fat-like secretion of the sebaceous glands of sheep (i.e., complex mixture of
  • the topical moisturizer can be aloe.
  • Aloe is commercially available as Aloe Vera Gel from Terry Laboratories (Melbourne, FL).
  • Aloe Vera Gel is commercially available as Aloe Vera Gel 40X (20.0 wt.% solution in water), Aloe Vera Gel IX (0.5 wt.% solution in water), Aloe Vera Gel 10X (5.0 wt.% solution in water), or solid Aloe Vera.
  • the solid Aloe Vera can be dissolved in a carrier, such as water, to the desired concentration.
  • the commercially available forms of Aloe Vera are optionally available as decolorized Aloe Vera.
  • any suitable amount of topical moisturizer can be employed, provided the amount of topical moisturizer maintains the adhesive properties of the pressure sensitive adhesive and maintains the appropriate stability of the medicament 15.
  • the suitable amount of topical moisturizer will depend in part upon the specific moisturizer or moisturizers present in the therapeutic formulation 5.
  • Aloe Vera Gel, IX can be present up to about 40.0 wt.% of the therapeutic formulation 5.
  • Aloe Vera Gel, IX can be present up to about 5.0 wt.% of the therapeutic formulation 5. More preferably, Aloe Vera Gel, IX can be present up to about 1.0 wt.% of the therapeutic formulation 5.
  • the therapeutic formulation 5 can optionally include deionized water (DI). Any suitable amount of deionized water can be employed, provided the amount of deionized water maintains the adhesive properties of the pressure sensitive adhesive and maintains the appropriate stability of the medicament 15.
  • deionized water can be present up to about 90 wt.% of the therapeutic formulation 5 or up to about 40.0 wt.% of the therapeutic formulation 5.
  • deionized water can be present up to about 10.0 wt.% of the therapeutic formulation 5. More preferably, deionized water can be present up to about 6.0 wt.% of the therapeutic formulation 5.
  • the therapeutic formulation 5 preferably can remain stable over prolonged period of time, such as from more than about a month to more than about two years.
  • the packaging, shipping, and storage of the adhesive skin patch 1 may have an effect upon the duration.
  • the stability of the medicament 15 is due in part to the therapeutic formulation 5 including the medicament 15 in an adhesive formulation.
  • the adhesive formulation is a hydrogel that holds the medicament 15 in an available form while maintaining the necessary stability, pressure sensitive adhesion and effectiveness over prolonged periods of time.
  • the therapeutic formulation 5 can be positioned on any portion of the front side 3 of the backing 2. Preferably, the therapeutic formulation 5 is positioned on the entire front side 3 of the backing 2. In this latter configuration, the therapeutic formulation 5 will be in continuous contact with the entire front side 3. When the adhesive skin patch 1 is placed upon the skin surface of a patient, the therapeutic formulation 5 will be in continuous contact with the skin surface of the patient.
  • a portion of the front side of the backing can contain the therapeutic formulation 5 and other portions of the front side of the backing can contain any combination of the pressure sensitive adhesive, medicament 15, and liquid or gel compound.
  • a central circular portion of the front side of the backing can contain the therapeutic formulation 5 while the remaining ring portion of the front side contains only the pressure sensitive adhesive.
  • the adhesive skin patch 1 can be applied to the vicinity of a patient. The vicinity of the patient includes the patient and everything within about five feet from the patient.
  • the vicinity of the patient will typically include the patient (e.g., patient's skin surface, patient's, hair, and patient's clothing), items usually found on or near a bed (e.g., a bed sheet, blanket, pillow, pillow case) and components of the bed (e.g., head-board, mattress, bed frame and bed post).
  • the patient e.g., patient's skin surface, patient's, hair, and patient's clothing
  • items usually found on or near a bed e.g., a bed sheet, blanket, pillow, pillow case
  • components of the bed e.g., head-board, mattress, bed frame and bed post.
  • the adhesive skin patch 1 can be applied to the skin surface of a patient.
  • the adhesive skin patch 1 can be applied to any suitable location on the patient.
  • the adhesive skin patch 1 can be applied to the chest of the patient (as shown in Fig. 9), to the throat of the patient (as shown in Fig. 11), between the upper lip and nose of the patient (as shown in Fig. 10), or to the chin of the patient (as shown in Fig. 12).
  • the adhesive skin patch 1 is positioned or located such that the medicament 15 can be effectively inhaled by the patient (see Figs. 9-12).
  • the adhesive skin patch 1 can have any suitable size and shape.
  • the adhesive skin patch 1 can be cut, as desired, to provide an adhesive skin patch 1 of a suitable size and shape.
  • the adhesive skin patch 1 can be cut with any suitable cutting device such as a scissors, scalpel, or knife.
  • the adhesive skin patch 1 may have a length of about
  • the adhesive skin patch 1 can have a width of about 3 inches to about 4 inches, of about 2.75 inches to about 3.75 inches, or about 1.75 inches to about 2.25 inches.
  • the adhesive skin patch 1 can have a width of about 0.1 inch to about 1.0 inch, of about 0.1 inch to about 0.5 inch, or about 0.1 inch to about 0.25 inch.
  • the adhesive skin patch 1 can have a thickness of about less than about 0.1 inch, less than about 0.01 inch, or less than about 0.001 inch.
  • the adhesive skin patch 1 can have a length of about 3.0 inches and a width of about 2.0 inches. See, Fig. 7. In another specific embodiment of the present invention, the adhesive skin patch 1 can have a length of about 3.0 inches and a width of about 0.25 inch. See, Fig. 8.
  • the vapor permeable adhesive skin patch 1 is individually wrapped. Some consumers have shown a preference for adhesive skin patches that are individually wrapped. The individually wrapped vapor permeable adhesive skin patch 1 offers to the consumer the ability and convenience of being able to carry a few (e.g., 1, 2, or 3) adhesive skin patches 1 without the extra packaging material.
  • Example 23 Therapeutic Formulation (in wt.%)
  • Example 24 Therapeutic Formulation (in wt.%)
  • Example 25 Therapeutic Formulation (in wt.%)
  • Example 26 Therapeutic Formulation (in wt.%)
  • Example 27 Therapeutic Formulation (in wt.%)
  • Example 28 Therapeutic Formulation (in wt.%)
  • Example 29 Therapeutic Formulation (in wt.%.)
  • Example 30 Therapeutic Formulation (in wt.%)
  • Example 1 Therapeutic Formulation (in wt.%)
  • Example 32 Therapeutic Formulation (in wt.%)
  • Example 33 Therapeutic Formulation (in wt.%)
  • Example 34 Therapeutic Formulation (in wt.%)
  • Example 35 Therapeutic Formulation (in wt.%)
  • Example 36 Therapeutic Formulation (in wt.%)
  • Example 37 Therapeutic Formulation (in wt.%)
  • Example 38 Therapeutic Formulation (in wt.%)
  • Example 39 Therapeutic Formulation (in wt.%)
  • Example 40 Therapeutic Formulation (in wt.%)
  • Example 41 Therapeutic Formulation (in wt.%)
  • Example 42 Therapeutic Formulation (in wt.%)
  • Example 44 Therapeutic Formulation (in wt.%)
  • Example 45 Therapeutic Formulation (in wt.%)
  • Example 46 Therapeutic Formulation (in wt.%.)
  • the vapor permeable adhesive patch of the present invention can be formulated or manufactured employing the above components.
  • the vapor permeable adhesive patch of the present invention can be formulated or manufactured using any suitable technique.
  • the vapor permeable adhesive patch can be formulated or manufactured as described in U.S. Patent No. 5,536,263 and U.S. Patent No. 5,741,510, and references cited therein; wherein the oil premix includes menthol, camphor, propylene glycol, and a fragrance; the glycerin premix includes glycerin and aloe vera gel; and the adhesive premix includes the adhesive and water.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une bande adhésive perméable à la vapeur, qui comporte un support poreux ayant un côté face et un côté dos, ainsi qu'une formulation thérapeutique placée sur le côté face du support. Ce dernier comprend une feuille souple en matière poreuse insoluble dans l'eau. La formulation thérapeutique renferme une combinaison d'un médicament pour calmer la toux, un composé organique liquide ou en gel, cosmétiquement acceptable, servant de support au médicament et masquant au moins partiellement l'odeur du médicament, et un adhésif auto-collant. Le composé organique liquide ou en gel, cosmétiquement acceptable, peut être un parfum.
PCT/US2000/012969 2000-04-13 2000-05-12 Bande therapeutique contenant, comme excipient, un compose organique en gel ou liquide WO2001078691A1 (fr)

Priority Applications (1)

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AU2000250055A AU2000250055A1 (en) 2000-04-13 2000-05-12 Therapeutic patch containing a liquid or gel organic compound as a carrier

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54852600A 2000-04-13 2000-04-13
US09/548,526 2000-04-13

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003063817A1 (fr) * 2002-01-28 2003-08-07 Lectec Corporation Patch cosmetique
DE10220114A1 (de) * 2002-05-06 2003-11-20 Beiersdorf Ag Ätherische Öle enthaltendes Matrixpflaster auf Polyurethanbasis
WO2005025547A1 (fr) * 2003-09-11 2005-03-24 Lts Lohmann Therapie-Systeme Ag Cataplasme medical a teneur en huiles essentielles pour traiter des maladies dues a un refroidissement, et procede de preparation dudit cataplasme
WO2004110401A3 (fr) * 2003-06-10 2005-06-30 Lectec Corp Patch antiviral d'inhalation
WO2006081996A1 (fr) * 2005-02-07 2006-08-10 Lts Lohmann Therapie-Systeme Ag Systeme de gel hydrophile destine aux soins corporels a base de gomme de karaya
US20070218087A1 (en) * 2001-12-07 2007-09-20 Norbert Hoenzelaer Method of controlled release of vanillin for nasal and/or pulmonary uptake
US10842729B2 (en) 2017-09-13 2020-11-24 Living Proof, Inc. Color protectant compositions
US10987300B2 (en) 2017-09-13 2021-04-27 Living Proof, Inc. Long lasting cosmetic compositions
US11622929B2 (en) 2016-03-08 2023-04-11 Living Proof, Inc. Long lasting cosmetic compositions
US12029805B2 (en) 2017-11-20 2024-07-09 Living Proof, Inc. Properties for achieving long-lasting cosmetic performance
US12048760B2 (en) 2018-04-27 2024-07-30 Living Proof, Inc. Long lasting cosmetic compositions

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Publication number Priority date Publication date Assignee Title
WO1986002270A1 (fr) * 1984-10-12 1986-04-24 "Béke" Mgtsz Compositions calmantes de la toux
WO1993000115A1 (fr) * 1991-06-28 1993-01-07 Fischel Ghodsian Fariba Dispositif de diffusion controlee de medicaments vaporeux et d'agents de repulsion d'insectes
EP0674913A2 (fr) * 1994-03-30 1995-10-04 LecTec Corporation Corps adhésif non-occlusif pour l'administration d'un médicament à la peau
US5456745A (en) * 1988-08-13 1995-10-10 Lts Lohmann Therapie-Systeme Gmbh & Co. Kg Flexible, hydrophilic gel film, the process for its production and the use of it
EP0750905A2 (fr) * 1995-06-27 1997-01-02 Kao Corporation Pansement comprenant une feuille adhésive soluble dans l'eau
WO1997039741A1 (fr) * 1996-04-23 1997-10-30 Pharmacia & Upjohn Ab Administration transdermique d'acetylcysteine servant d'agent mucolytique
US6090403A (en) * 1998-08-17 2000-07-18 Lectec Corporation Inhalation therapy decongestant with foraminous carrier

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1986002270A1 (fr) * 1984-10-12 1986-04-24 "Béke" Mgtsz Compositions calmantes de la toux
US5456745A (en) * 1988-08-13 1995-10-10 Lts Lohmann Therapie-Systeme Gmbh & Co. Kg Flexible, hydrophilic gel film, the process for its production and the use of it
WO1993000115A1 (fr) * 1991-06-28 1993-01-07 Fischel Ghodsian Fariba Dispositif de diffusion controlee de medicaments vaporeux et d'agents de repulsion d'insectes
EP0674913A2 (fr) * 1994-03-30 1995-10-04 LecTec Corporation Corps adhésif non-occlusif pour l'administration d'un médicament à la peau
EP0750905A2 (fr) * 1995-06-27 1997-01-02 Kao Corporation Pansement comprenant une feuille adhésive soluble dans l'eau
WO1997039741A1 (fr) * 1996-04-23 1997-10-30 Pharmacia & Upjohn Ab Administration transdermique d'acetylcysteine servant d'agent mucolytique
US6090403A (en) * 1998-08-17 2000-07-18 Lectec Corporation Inhalation therapy decongestant with foraminous carrier

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070218087A1 (en) * 2001-12-07 2007-09-20 Norbert Hoenzelaer Method of controlled release of vanillin for nasal and/or pulmonary uptake
WO2003063817A1 (fr) * 2002-01-28 2003-08-07 Lectec Corporation Patch cosmetique
DE10220114A1 (de) * 2002-05-06 2003-11-20 Beiersdorf Ag Ätherische Öle enthaltendes Matrixpflaster auf Polyurethanbasis
WO2004110401A3 (fr) * 2003-06-10 2005-06-30 Lectec Corp Patch antiviral d'inhalation
DE10341933A1 (de) * 2003-09-11 2005-04-14 Lts Lohmann Therapie-Systeme Ag Medizinische Hautpflaster mit einem Gehalt an ätherischen Ölen zur Behandlung von Erkältungskrankheiten, sowie Verfahren für deren Herstellung
WO2005025547A1 (fr) * 2003-09-11 2005-03-24 Lts Lohmann Therapie-Systeme Ag Cataplasme medical a teneur en huiles essentielles pour traiter des maladies dues a un refroidissement, et procede de preparation dudit cataplasme
WO2006081996A1 (fr) * 2005-02-07 2006-08-10 Lts Lohmann Therapie-Systeme Ag Systeme de gel hydrophile destine aux soins corporels a base de gomme de karaya
US11622929B2 (en) 2016-03-08 2023-04-11 Living Proof, Inc. Long lasting cosmetic compositions
US10842729B2 (en) 2017-09-13 2020-11-24 Living Proof, Inc. Color protectant compositions
US10987300B2 (en) 2017-09-13 2021-04-27 Living Proof, Inc. Long lasting cosmetic compositions
US11707426B2 (en) 2017-09-13 2023-07-25 Living Proof, Inc. Color protectant compositions
US12029805B2 (en) 2017-11-20 2024-07-09 Living Proof, Inc. Properties for achieving long-lasting cosmetic performance
US12048760B2 (en) 2018-04-27 2024-07-30 Living Proof, Inc. Long lasting cosmetic compositions

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