US20080207771A1 - Topical Compositions - Google Patents

Topical Compositions Download PDF

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Publication number
US20080207771A1
US20080207771A1 US11/914,429 US91442906A US2008207771A1 US 20080207771 A1 US20080207771 A1 US 20080207771A1 US 91442906 A US91442906 A US 91442906A US 2008207771 A1 US2008207771 A1 US 2008207771A1
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US
United States
Prior art keywords
topical pharmaceutical
cosmetic composition
composition according
glycerol
water
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.)
Abandoned
Application number
US11/914,429
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English (en)
Inventor
Shabtay Dikstein
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.)
Resdevco Research and Development Co Ltd
Original Assignee
Resdevco Research and Development Co Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36952425&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20080207771(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Resdevco Research and Development Co Ltd filed Critical Resdevco Research and Development Co Ltd
Assigned to RESDEVCO RESEARCH AND DEVELOPMENT CO. LTD. reassignment RESDEVCO RESEARCH AND DEVELOPMENT CO. LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DIKSTEIN, SHABTAY
Publication of US20080207771A1 publication Critical patent/US20080207771A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/42—Amides
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/74—Biological properties of particular ingredients
    • A61K2800/75—Anti-irritant

Definitions

  • the present invention provides a new combination of topically active substances, for the prevention and alleviation of cell damage, caused by preservatives, detergents or drugs, used in topical pharmaceutical, cosmetic or veterinary compositions.
  • Topical products include such topically applied substances as cosmetics, over-the-counter and prescription topical drugs, and a variety of other products such as soaps and detergents.
  • Topical products occur in a variety of forms, including solids, liquids, suspensions, semisolids (such as creams, gels, pastes or “sticks”), powders or finely dispersed liquids such as sprays or mists.
  • topical products commonly classified as “cosmetics” include skin care products such as creams, lotions, moisturizers and “treatment cosmetics” such as exfoliants and/or skin cell renewal agents; fragrances such as perfumes and colognes, and deodorants; shaving-related products such as creams, “bracers” and aftershaves; depilatories and other hair removal products; skin cleansers, toners and astringents; pre-moistened wipes and washcloths; tanning lotions; bath products such as oils; eye care products such as eye lotions and makeup removers; foot care products such as powders and sprays; skin colorant and make-up products such as foundations, blushes, rouges, eye shadows and liners, lip colors and mascaras; lip bal
  • topical drugs examples include over-the-counter and/or prescription products such as antiperspirants, insect repellents, sunscreens and sunburn treatments, anti-acne agents, antibiotics, topical respiratory agents, ocular drugs such as eyedrops and saline solutions, therapeutic retinoids, anti-dandruff agents, external analgesics such as capsaicin products, topical contraceptives, topical drug delivery systems, gastrointestinal agents such as suppositories, enemas and hemorrhoid treatments, reproductive system agents such as vaginal treatments, oral treatments such as lozenges, and many other products with therapeutic or other effects.
  • topical products include hand, facial and body soaps and detergents and other forms of skin cleansers, as well as household detergents and many other household products such as solvents, propellants, polishes, lubricants, adhesives, waxes and others which are either applied topically or are topically exposed to the body during normal use.
  • topical products contain chemicals which may produce “irritation,” including various inflammation symptoms or signs, when applied to the skin or mucosa.
  • the present invention is directed to compositions for inhibiting the irritation associated with such topical products.
  • the occurrence, frequency and nature of topical-product-induced irritation often varies from user to user.
  • the severity of irritation to the susceptible user may range from subclinical to mild to severe.
  • Typical symptoms of “irritation” include itching (pruritus), stinging, burning, tingling, “tightness,” erythema (redness) or edema (swelling).
  • the irritation response may be due to the direct effect on the skin of certain topical product chemicals or to a response by the immune system directed toward the chemicals alone or in combination with skin components (e.g. antigens).
  • Topical product active ingredients including chemicals that may also be classified as drugs, produce irritation when applied to the skin. These include, but are not limited to, such ingredients as exfoliants and skin cell renewal agents, anti-acne drugs, antiperspirant compounds, antihistamines, anti-inflammatory agents, skin protective agents, insect repellent chemicals, sunscreens and many others. Where more than one chemical irritant is present, their irritating effects may be additive. Furthermore, chemical ingredients may react with one another, or in the environment of the skin, to form new chemicals which are irritating. The vehicles in which the active drug ingredients are formulated may also produce irritation in sensitive people.
  • the present invention relates to topical compositions for combating damaging effects of preservatives or other irritants, found, e.g. in multi-dose eye drops, to mucous cells, especially in the corneal cells and simultaneously beneficial to those tissues.
  • preservatives such as benzalkonium chloride, cetrimonium bromide, sodium ethylene diamine tetraacetate, etc. Not all the polyhydroxy compounds have such anti-irritant properties.
  • isotonic sodium chloride is toxic to the corneal cells, whereas isotonic glycerol is not toxic. (Follmann, P. et. al. Szemészet 141, 305-308, 2004.)
  • Increased viscosity is achieved by high molecular weight (equal to more than 0.5 million Dalton) polymers. Increased spread is achieved by surface active agents, however after chronic use the surface active agents usually have damaging effects. (See Animal Studies, a).
  • topical pharmaceutical or cosmetic compositions for the prevention and treatment of irritation of mucous cells, or skin cells, comprising a combination of:
  • the present invention provides topical pharmaceutical or cosmetic compositions for the prevention and treatment of irritation of mucous cells, comprising a combination of:
  • the present invention further provides topical pharmaceutical or cosmetic compositions, for the prevention and treatment of irritation of skin cells, comprising a combination of:
  • the present invention preferably provides a non-irritant topical cosmetic or pharmaceutical composition for mucous cells or for the skin, as defined above, for the prevention of cell damage caused by preservatives, detergents or drugs in topically used cosmetic, pharmaceutical or veterinary compositions.
  • a non-irritant topical cosmetic or pharmaceutical composition for mucous cells or for the skin as defined above, further comprising at least one pharmaceutically active agent in solution, or in suspension but not in emulsion.
  • a non-irritant topical cosmetic or pharmaceutical composition for mucous cells or for the skin as defined above, further comprising at least one viscosity enhancing agent.
  • Glycerol 1.3 gm. Xylitol 2.2 gm. Benzalkonium Chloride 0.01 gm. NaOH q.s. to pH 7.0 H 2 O to 100 ml.
  • Glycerol 1.3 gm. Xylitol 2.2 gm. Sodium diclofenac 0.1 gm. Benzalkonium chloride 0.01 gm NaOH q.s. to pH 7.2 H 2 O to 100 ml.
  • Glycerol 1.0 gm. Mannitol 1.6 gm. Xylitol 1.6 gm. Sodium diclofenac 0.1 gm. NaOH q.s. to pH 7.2 H 2 O to 100 ml.
  • Glycerol 10.0 gm. Xylitol 8.0 gm. Urea 5.0 gm. Glycine 5.0 gm Methylparaben 0.1 gm. Propylparaben 0.01 gm. Polyacrylate 980 adjusted to pH 4.5 0.7 gm. H 2 O to 100 ml.
  • Glycerol 8.0 gm. Myoinositol 4.5 gm. Xylitol 3.5 gm Urea 5.0 gm. Glycine 5.0 gm Methylparaben 0.1 gm. Propylparaben 0.01 gm. Polyacrylate 980 adjusted to pH 4.5 0.7 gm. H 2 O to 100 ml.
  • Glycerol 8.0 gm. Xylitol 7.0 gm Polyethylene glycol 3350 2.0 gm Phospholipids 0.25 gm Phytosphingosine in suspension 0.2 gm. Polyacrylate 980 or 974 1.0 gm. Methylparaben 0.1 gm. Propylparaben 0.01 gm. H 2 O to 100 ml.
  • Suitable preservatives, suspending agents, excipients and other additives can be incorporated.
  • the preferred pH (to be adjusted) of the compositions of examples 6 to 9 is pH 4.0 to 6.0.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Birds (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
US11/914,429 2005-05-16 2006-05-07 Topical Compositions Abandoned US20080207771A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL168603A IL168603A (en) 2005-05-16 2005-05-16 Pharmaceutical or cosmetic composition for the prevention and treatment of irritation of mucous cells or skin cells
IL168603 2005-05-16
PCT/IL2006/000537 WO2006123324A1 (en) 2005-05-16 2006-05-07 Topical compositions

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2006/000537 A-371-Of-International WO2006123324A1 (en) 2005-05-16 2006-05-07 Topical compositions

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US15/286,578 Continuation-In-Part US10183076B2 (en) 2005-05-16 2016-10-06 Topical compositions for treatment of irritation of mucous membranes
US15/687,600 Division US10660961B2 (en) 2005-05-16 2017-08-28 Method of treatment of irritation of skin or mucous cells

Publications (1)

Publication Number Publication Date
US20080207771A1 true US20080207771A1 (en) 2008-08-28

Family

ID=36952425

Family Applications (2)

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US11/914,429 Abandoned US20080207771A1 (en) 2005-05-16 2006-05-07 Topical Compositions
US15/687,600 Active US10660961B2 (en) 2005-05-16 2017-08-28 Method of treatment of irritation of skin or mucous cells

Family Applications After (1)

Application Number Title Priority Date Filing Date
US15/687,600 Active US10660961B2 (en) 2005-05-16 2017-08-28 Method of treatment of irritation of skin or mucous cells

Country Status (8)

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US (2) US20080207771A1 (pl)
EP (2) EP2465493B1 (pl)
DK (2) DK2465493T3 (pl)
ES (2) ES2433271T3 (pl)
IL (1) IL168603A (pl)
PL (2) PL2465493T3 (pl)
PT (2) PT1888024E (pl)
WO (1) WO2006123324A1 (pl)

Cited By (9)

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US20090123550A1 (en) * 2007-11-13 2009-05-14 Meritage Pharma, Inc. Corticosteroid compositions
US20090181099A1 (en) * 2005-11-12 2009-07-16 The Regents Of The University Of California, San Diego Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
US20090264392A1 (en) * 2008-04-21 2009-10-22 Meritage Pharma, Inc. Treating eosinophilic esophagitis
US20100216754A1 (en) * 2007-11-13 2010-08-26 Meritage Pharma, Inc. Compositions for the treatment of inflammation of the gastrointestinal tract
US8324192B2 (en) 2005-11-12 2012-12-04 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US20130045940A1 (en) * 2010-03-04 2013-02-21 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Composition comprising as active ingredient l-carnitine in combination with a solar filter, for the prevention and/or treatment of pathologies of the eye due to ultraviolet radiation
US8497258B2 (en) 2005-11-12 2013-07-30 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US9511144B2 (en) 2013-03-14 2016-12-06 The Proctor & Gamble Company Cosmetic compositions and methods providing enhanced penetration of skin care actives
US10293052B2 (en) 2007-11-13 2019-05-21 Meritage Pharma, Inc. Compositions for the treatment of gastrointestinal inflammation

Families Citing this family (6)

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Publication number Priority date Publication date Assignee Title
US10183076B2 (en) 2005-05-16 2019-01-22 Resdevco Research And Development Co. L Topical compositions for treatment of irritation of mucous membranes
EP2667853A4 (en) 2011-01-25 2014-08-20 Procter & Gamble LIPOSOME AND BODY HYGIENE COMPOSITION CONTAINING SAME
IL212725A (en) 2011-05-05 2016-06-30 Resdevco Res And Dev Co Glycerol Preparation for Non-surgical Conjunctivochalysis
CA2937213A1 (en) * 2014-01-28 2015-08-06 Resdevco Research And Development Co. Ltd. Composition comprising xylitol and cholecalciferol for topical treatment of skin and mucous membranes
ITUB20153104A1 (it) * 2015-08-13 2017-02-13 Sooft Italia S P A Contrada Molino 17 68333 Montegiorgio Fm Composizione ed uso di collirio a base di inositolo per migliorare l'accomodazione visiva dei pazienti
MX2019010471A (es) * 2017-03-05 2020-02-12 Resdevco Res And Development Co Ltd Gotas oculares para el tratamiento de la irritacion no causada por infeccion.

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US5817323A (en) * 1993-06-28 1998-10-06 R.P. Scherer Corporation Soft gelatin capsule shell compositions
US5597559A (en) * 1993-11-12 1997-01-28 Ciba Geigy Corporation Ophthalmic formulation
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EP1393721A1 (en) * 1997-03-20 2004-03-03 Schering Corporation Dosage form of powder agglomerates
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US6361806B1 (en) * 2000-02-23 2002-03-26 Michael P. Allen Composition for and method of topical administration to effect changes in subcutaneous adipose tissue
US20020022668A1 (en) * 2000-05-19 2002-02-21 Welsh Michael J. Use of xylitol to reduce ionic strength and activate endogenous antimicrobials for prevention and treatment of infections
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Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11413296B2 (en) 2005-11-12 2022-08-16 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US8679545B2 (en) 2005-11-12 2014-03-25 The Regents Of The University Of California Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
US11197822B2 (en) 2005-11-12 2021-12-14 The Regents Of The University Of California Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
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ES2393927T5 (es) 2015-12-21
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US20170354735A1 (en) 2017-12-14
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