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    Antiviral Face Mask and filter material.

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    Antiviral Face Mask and filter material.

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    26 views15 pages

    Us 2009 0320849 A1

    Uploaded by

    Leví Canales
    Antiviral Face Mask and filter material.

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    IMO A US 200903208491 c») United States c2) Patent Application Publication (10) Pub. No.: US 2009/0320849 AI Biedermann (43) Pub. Date: Dee. 31, 2009 ($4) ANTL-VIRAL FACE MASK AND FILTER G0) Foreign Application Priority Data MATERIAL Jul. 18,2006 (GB) 0614251.7 « Apr 2,2007 (GB) 7064355, (76) inventor: Kimberly Bledermann, (US) Publication Classification Consapninee Adres op mer SMITHKLINE BEECHAM CORPORATION con Ds gosony CORPORATE INTELLECTUAL Property. C2IK-S92 (205.01 Us/uwaa) , bso} Ropes born Seae (anon) 0, BOX 18 hosp S00 (oso) KING OF PRU A, PA 19406-0939 (US) 129/206.28; £24/320; 524/599 96/11; 96/13; 95/45; 427723 (21) Appl.No. 12n74,t04 ca ABSTRACT (2) PCT Fite Va A face mask comprising a filler material being a fibrous 2) ei eae substrate, especially non-woven polypropylene or polyester, having an aide polymer, especially of the Cabopol of Ga (86) PCTNo. PCTIEPOTIST298 tees type, deposited on the fbees. The mask has an anti-viral fsctvity against inhaled or exhaled ai filter material suit 5371 (000. able for such a mask, and a process for making it are also (2),()Date: Fan. 16,2009 ‘eseribed 12 Patent Application Publication Dec. 31, 2009 Sheet 1 of 2 US 2009/0320849 A1 Patent Application Publication a 2 Ny Percentage Virus Reduction control O} Virus O} iO} Percentage reduction in Viral Titre of Avian Influenza A NIBRG-14 HSN1 virus Dec. 31, 2009 Sheet 2 of 2 Cell only control eS 888SSS8 Fig.8. Log Reduction (-log C1050) 1 2 3 Test Articles Log reduction in Viral Titre of Avian Influenza A NIBRG-14 HSN1 virus 4 1 2 3 Test Articles US 2009/0320849 AI = Test Articles a Test Articles 15 Test Articles = Test Articles US 2009/0320849 AL [0001] This invention relates o anovel device being an oral ‘andlor nasal ar filer able to remove and neutralize harm, ‘ins rom inhaled sir contaminated with such vir, and from contaminated air exhaled from patients infected with such Virus. In particular the invention relates to sucha devicein the form of face mask, The invention also relates to novel filter materials stable for use in such a deviee 0002] In the past contury three pandemics of Influenza have been witnessed, of which the“Spanish Mu” of 1918 was the lagest pandemic of any infectious disease known to medial science (Oxford, JS, 2000). The three tains which ‘cased these pandemics belong to group A of the influenza Vins and, unlike the other two groups (2 and C), this group infects a vast variety of animals (poultry, swine, horses, humans and other mammals) Influenza A virus continue 0 ‘cause global problems, bath economically and medically (Hayden, FG. & Palese, P2000). The curret global con- ‘cerns the avian lflucnza.A HISNI vinws, which fist demon- strated itsabilty to infeetbinds in China in 1997 and has since Spread to other conateis in South East Asia, Burope and Aiea (Enserink, M, 2006: Guan, ¥. eta, 2004; Peiis, JS. ‘etal, 2004), Is ability w cause severe disease in beds was ‘docuimeated by the World Health Organisation during mild ‘outbreak in South Bast Asian bids during 2003-2004. HSNI mutates rapidly and is highly pathogenic. lis co-existence ‘with other avian influenza virus increases the likelihood of ‘concurrent infections in birds, Such evens would provide the “mixing vessel” forthe emergence of a novel subtype with sifficent avian genes tobe easily transmitted between svian Species, which would mack the start ofan influenza epidemic (WHO Foct she’, 10003] _ Much hss been done to contol and prevent another pandemic from occurring with many aniinfluensa products {eeines and treatments) curently on the market. Presently, Amaniadine is the principal antiviral compound against Influenza infections, butts activity isresticted lnfluenza.A vinis- Anti-netraminidase inhibitors, such as Zanamivir(Re- Jeaza) and Oselamivr Tamiflu) area new elas of antiviral gents licensed for ose inthe treatment of oth Inflaenza A and B infections (Cant, 1, et al, 2002). The role of these ‘antivirals in a pandemie may be limited due tothe time and ‘cost involved in production and the current listed supply. With the recent news ofa probable HSNI pandemic the need to prevent any opportunities of transmission of the Virus brwoen avian species hs risen 10004] The iahalation of sircontamsinated by harmful vinas and/or oer miero-organismsisacommon route for infection ‘of human beings, particularly health workers and others ‘case to work with infected humans or animals. Airexhaled by infected patients is a source of contamination. At the present time te risk of infection by the socalled “bird ” HISNI vin is of particular eoncem, Masks incorporating suitable filter material would he ideal foe use a baie proven! species-o-spocies transmission of the vir. 10005] Air filters believed to remove such virus andior ‘other micro-organisms are known, One type of such a filter ‘comprises a fibrous or particulate substrate on which is ‘deposited, upon the surface andor into te bulk of such bees ‘or particles, «substance which captures andlor neutralizes Dec. 31, 2009 viris and/or other micro-organisms of concer. Examples of Aisclosues of such filters are Fisted below [0006] US. Pat.No.3,871.950 and US. Pat.No.4,181,604 Aisclose hollaw fibres of acrylonitrile polymers for ultrafilter use, primarily for fering agueous media. U.S. Pat. No. 4,886,500 dselosesa facemask wherein solect portions ofthe ‘mask contain vial destroying agent such as citric acid, US, at. No. 8.767.167 discloses aerogel foams suited for filtering ‘iia for eapure of micro organisms suc as virus ete U1. Pat, No, 5,783,502 discloses fabric substrate with ati viral molecules, particularly cationic groups such as quaternary mnium eationie hydrocarbon groups bonded tothe fabs Fic. US, Put. No. 5,851,395 discloses virus filter comprising ‘filter material onto which is deposited « view=-capturing material based on sia aid (9-carbon monostecharideshav- ing a carboxylic acd substituent on the ring), US, Pat, No. 6,182,659 discloses a virs-removing filter based on a Srep- ‘ococeus agalactiae culture product US, Pa. No. 6.190437 discloses an aie filer for removing vis from the zie com: prising # eatier substrate impregnated with “iodine resins” US. Pat, No. 6,379,794 discloses fiers based on glass and boler high modulus fibres impregnated with an acrylic US. Pat. No. 6,551,608 discloses @ porous thermoplastic ‘material substrate and a ativiral substance made by sinter- jing at least one antiviral agent with the thermoplastic sub- stance. US. Pat. No. 7.029.516 diseloses a filter system for removing particles fom a id comprising a non-woven polypropylene base upon which is deposited an acidic poly- Inet such as polyacrylic acid, US-A-2004/0250683 discloses aflter material comprising a network of fibres with an acidic Substance deposited thereon, which may he an acrylic poly rier US-A-2005/0247608 disclose a filter block which my be tested with various ani viral polymers, prineipally cat ionie polymers. [0007] WO-A-2001/07000 discloses a filter for removi ‘nicto-organisms comprising a substrate having reactive surface and a polymer oa its surfee which includes cationic troupe for attracting micro onznisms. WO-A-2002/0S8812 Aiscloses_an_ai filter with micro-encapsulated biocides ‘WO-A-20031039713 discloses filer material sido havean antipathogenic effect, including an effect against virus, based ‘ma fibrous substrate partly coated with polymer network containing pendant functional groups which may be acidic groups. WO-A-2005/070242 dlsclses an inhalation filter ‘made of fibres treated to impart an eletrical charge to catch particles such as vinss Toons] GiB-4-2085133 discloses membrane filter witha \Waternsoluble polymer, preferably a PVA, on is surface Use of such a filter material in gas mask cartridges issu gested. {0009} 3P-4-2001/162116 discloses an antibacterial flea tion medium in which a sef-eross-linking acrylic resin is used 1o bind a slverorganie idine antibacterial agent 10 {Ahrous substrate, JP-A-2008/198676 discloses the use of @ water-hardenable resin emulsion to bind citric acid to an Antiviral face mask. [0010] Three papers in Jouraal of Virology: September 1968, p 878-885; March 1970, p 313.320 and p 321-328, disclose antiviral activity of vations polyearboxylic acids Including polyacrylic aid, polymethaeryli aid and polyac~ cial carboxylic acids, The antiviral activity reported therein appears to be a cell-mediated effet, and the conclusion is expressed that "PMA (polymethaerylic acid) did not inae tivate the vis particle in ts extracellular state” US 2009/0320849 AL {0011} ‘There isan ongoing need to impro parca in view of perception of isk fom: Prescot inventors have ideale Ser materials which may Facilitate an increased level of removal of harm vis a ‘orether mier-crzanisns rom inhaled air and newwatisation Dfthesame enabling tic use oF such materials inan improved nasal andor mouth ite. [0012] According to fit aspect of this invetion thee is Provided an airpermesble mask of shape suitable fo be Placed over wees mouth and nose at sealing contact theuscr fie, prvided wth meinsto bold the maskin place ‘onthe users fate and comprising one or more layer ofa iter tmaterl positioned such hat inhaled andor exhaled airof the scr pasts tho he ier material wherein the iter mat= Fal comprises an air pemeble substrate combined with an ‘ie polymer 10013] ‘Theoverl shape ofthe fice mask maybe generally ‘conventional inthe dof face asks, and the means ol the maskin place on the ers lace may fr example come pris one ormore laste strap to be passed behind the user's head 10014) ‘Thesie-pemeable substrate may comprises fibrous Substrate, which an either he a woven or aon-woven mate al, Examples of woven materials include hose sar td Synthetic thers such a eoton,eolulose, woo, polyoletins, polyester, polyamide (ea nylon), rayon, polyacslonitie, Ealllose atte, polystyrene, polwinysand anyother syn theicpolymersthatcanbe processed int ters. Examples non-woven materials inelide polypropylene, polyethylene, polyester, nylon, PET and PLA. Torts invention, non-wo= tenis preferred. Such # material may be i the form of a non-woven sheet orp [0015] Non woven polyester is «prefered sirpemeatie Substrate because is ound that te aide polyenes ofthe types described herein adhere beter o polyester materia “Thee appear abe less tendency foe the sce polymer 0 ‘isl Make or ub off a polyester substrate, Paes bes nd fabrics made therefrom are wall known. The term “poly ‘se a used herein is a generic name fora manufactured fie being polymer with wns linked by ester groups. A ‘common polyester used for woven and nonwoven fibre nanufatue is poly lee eephhslte,compesing 060 C1, C00 C1, unis, [0016] ‘The grade of fibrous substrate which may be used may be determined by practice to achieve a suitable through- ow of ait, and the density may be as known from the face- mask at to provide 2 mask ofa comfortable weight 10017] Non-woven polypropylene ofthe type conveation- ally used for surgical masks andthe likes widely available in sheet form. Suitable grades of non-woven polypropylene include the well known grades commonly used for surgical face masks and the ike. Typical non-woven polypropylene ‘materials found suitable foruse inthis invention have weights 10-40 gi although othr suitable material weights can be dsermined empiriealy, 10018] Typical non-woven polyester materials found sui able for use in this invention have weights 10-200 ‘although materials toward the upper end ofthis range may be rather heavy foruse ina face mask. For example materials of weizht 20-100 g/m" are prefered, eg. ca. 60 im". Such materials are commercially avaiable. Ober suitable matei- als ean be determined empirically Dec. 31, 2009 {0019} Alvematvely the substrate may be in other forms suet as an open-cell foam, eg. polyurethane foam ass also ted for ie filters, for example as in nasal air pligs. [0020 Ithas heen found tht acidic polymers are effective tearing and neutralising vies inairpassing through such ‘material Without being Timted toa spevifi theory of action itis belived that upon contact with the surface of the sub- sirate the virus interact with the polymer, are entrapped and {he localised low pl environment (eg. ca. pl12.8 08) ofthe acidic polymer inactivates the vinis 0 theesby nevtealise the, Iris believed that the filter material ofthis inveation ‘nay be effective inthis manner against the vgs that cause colds intluenza, SARS, RSV; bird fu snd mutated serotypes ofthese [0021] Asused herein the tem “seidie polymer” includes polymer having acidic groups along its backbone, eas side troupe, Suitable acidic groups are carboxylic acid groups. ‘The acidic polymer may be crosslinked or linea. Generally forte preseat application non-eross linked, eg, near poy= srs are prefered, This sinter alia because relative to crose- linked polymers noa-cros inked linear structure ean provide ‘more available —COOH groups, nd also non-eross linked polymers are eaierto dissolve and consequently to use inthe preparative process dislosed herein, [0022] Theacidie polymer may comprivea poly-(carboxy- Tie sci) polymer. {0023} _Poly.(carboxylic aid) polymers ae typically poly- mers which include —COOH groups in their stricture, oF erivative groups svch as acid-anhydride groups, readily cleavable carboxylic acid ester groups or salified COOH ‘groups which readily cleave to yiekd COOH groups. [0024] "A°poly-(carboxylic acid) polymer may have its COOH groups (or derivative proups) diretly linked tits backbone, ote polymer may be a so-called grafted or den- Artic polymers in which the COOH (or derivative) groups ‘reattached fo side chains branching off from the backbone. [oas) "or cxample ply crboy lic act) polymers may ‘units in their structure, wherein R is preferably hydrogen, oF RE may be, alkyl C,. alkoxy orC, hydroxy alkyl [0026] One type of such a poly-earboxylie aid) polymer comprises a polymer having tits: [-c2?c2.cooH {nits structure wherein R? and Rare independently prefer- ably hydrogen, or may be Cy, alkyl or C;,, alkoxy. For ‘examplesuch polymer may comprise a poly-Cearboxy¥ins)) polymer, forexample a polymer of@ monomer compound of formula CR2R?—CR',COOH wherein the substituents areas efined above. Such a polymer may comprise a polymer of terylic acid or methacrylic acid, ie. polyacrylic or poly ricthaerylic acid, eg, linear polyacrylic and polymethocrylic avid homo- and co-polymers. An example of such a polyiner is carboxypolymethylene. An example of a commercially vailable polyacrylic acid is the material Good-Rite™ K-702 ‘whieh has a molecular weight of around 30,000. An exemple of a commercially available polyacrylic acid, as its sodium salt is the material Good-Rite™ K-765 which also has ‘molecular weight of around 30,000, Polyacrylie acid poly ‘ers are commercially available under the trade mame Cat- bomer™ classified asa synthetic polymer and is otherwise usedas.an emulsion stabilizer as wellas.anaqueous Viscosity increasing agent. US 2009/0320849 AL [0027] Polymers ofthis type are for example disclosed in US. Pat. No 2,798,083 viz “a carboxylic monomer such as ‘serylic acid, maleic aed or anhydride and the like, copoly rized with cern proportions of polyalkenyl polyether ‘ofa polyhydrie acolo! containing more than one alkenyl tether grouping per molecule, the pareat polyhydre aleokol ‘containing at fest 4 earbon atoms anda leas three hydroxyl proups”” 10028] Examples of crosslinked poly-(carhonylic acid) polyners include homopolymers of arylic acid crosslinked With an ally] ether, eg. of pentaerythritol, of sucrose or of propylene, e. the material available from B.F. Goodrich ‘Company under the trade name “Carbopo, such asthe spe cific Carbopols inchude Carbopol 934, 940, 980 1382, Car- bopol ETD 2020, ETD 2050, Ulrez 20 and 2. [0029] Another type of sucha poly-(carboxylic acid) poly- mer may include adjocent units (where Ris defined above) in its structure, for example polymers based on maleic acid moieties which typically include —[--CH.COOH-CH.COOH—]— units, andlor salisor esters of such units, oF such units in anydrie form in Which COOH groups on adjacent carbon atoms may be eye- lised to form a—CHLCO—0—CO.CH— ring system, such derivatives being sisceptible wo hydrolysis o form the corre sponding free acid [0030] "One type of sucha poly-(carboxylic ac) polymer ray comprise units with pags of earboxylic acid groups on ‘adjacent polymer chain carbon atoms, For example such polymers may comprise units [cal cwet_ cx cooncRE coon in its structure wherein R, R?, RY, R4, RY and RY are inde- pendently hydrogen (preferred) oF C,. alkyl or, alkoxy, preferably Rand R” being hydrogen, R being hydrogen R* beingmethoxy. and Rand R"being hydrogen, oraderivative ‘hereof retaining COOH groups in its strcture, oF groups readily hydrolysable (© COOH groups. Such 2 poly.(ear- hoxslicacid) polymeris the polymer based ona copolymerar methyl vinyl ether and maleic anhydride. Such polymers are ‘commercially avilable unde the trade name Gantrez™ 0031] An example of such a polymer comprises: cH, coc, ex.cooH-ces coon} 10032] Such polymers may be liner polymers, or eros lke polymers. Linear, noo-ross inks polymers ofthis Iype are commercially avaiable unde the tad name Gan trea § (CAS # 251534-69), eg. Ganeez™ S96 having a molecule weight 700,000, Gantrez™ S.97 having. a nolectlar Weight ea. 1,200000. Such Gantz polymers ae prefered In experiments tas found ha that filter mat Fal comprising such Gantz polymer retained its surface pl of below pl1 3.5, suitble w kill viruses, even afer 4 hors of immersion in water. [0033] Cros inked polymers ofthis type arealsocommer- ‘ally available under the Gantez™ trade ma. [0034] "An example ofa derivative of such an acid is an ankydrid, cin whic the twoadjacent—COOH groups are ‘elise 16 form a CH.COO~CO.CH — ring system, Sch an anydedeissuscepblew ydiolis wo Form the ‘comexponding fe aids. Such polymers ae commervially Dec. 31, 2009 available under the trade name Gantre™ AN (CAS # 9011 16-9), eg. Gantrez™ AN-119, Gantrez™ AN-903, Gan twez'™ AN-139, Gantrez™ AN-169. {0038} Another example ofa derivatives a paral sale. ‘were some ofthe free — COOH groups sre converted into a metal sat ofa Group for Group Hf meta such as espetvely citer sodium oe caleum, oe mixed sodumafetum salt Soch a polymer is commercially available under the tade name Gantez™¥ MS, eg Gantez™ MS.955 (CAS # 62386- 55.2, [0036] Another ewmple of adervatve of suck an acid isa pata ester in which some of the frve COOH proups are esterified With, alkyl eg. ethyl orn-butyl. Such polymers ‘xe commevaly available under the tradename Gante?™ FS, eg. Gantz 15.225 (CAS # 25087-0603) or Gan- tee E3428 (CAS # 25119-68.0. Typically polymers of this second type have molecule weighs ia the range 200, (00.2,000.00 [0037] Other poly-(caboxslic act) polymers ofthis ype Include eopolymers of Cally acrylates and one or more ‘monomer compound of formula R'R'C—CR™—COO ‘wherein each oF RR, and Ris independently selected Irom hydrogen or C,. ally. in parieular methyl, ethyl or propyl Examples of sich monomer compounds include ster of eric acid and methacrylic acd {0038} Osher suitable poly-arboxylic acid) polymers Jnclude anionic polymers based on compotiads of Formula R,RC—CR,—COOR, wherein each of R,, Re Ry and Ry, is independently selete fom hydrogen oF Cys alk in Particular nets ethyl oF propyl Examples of sic poly nets are thowe Based on mstherylie ack and etylacrylstos ‘with carbone aid funetonal oops availabe from Rehm Gmbll & Co under the tre name “Eudmait™ Specific aades include Eadrgit 100-85, L30-D-55, 100, S100 and ¥8300. 10039} Other suitable cide polymers may he polymers incorporating other seid groups sich as sulphonic acid stoupe, Example of acidic polymecs incorporating sulphonic Sci groups ar co-polymers ofanaerylic methacrylic aid ‘itha sulphonic ed, eg inca copelyiners. Sich polymers ‘ncorporatng sulphonic aid groups may be wed inthe fom oftheiesals,eg. thoi sodium salts. An example ofa copoly- tuerof acrylic acid ad sulphonic acid iscommercaly ale ble under the trade name Good: Rie! K-776, Other acc polymers may compeise copolymers of acrylic aid and Spon acid. For example the ace polymir may come prise copolymers and terpolymers of male aid, poly !erglamide-2-methylpropane sulfonic aid) polyAMPS"), tnd copolymers of atic aid and 2-arylamido-2-methy propane sulfonic aid [0040] Polystyrene sulphone acids may be suitable, for example a commerially available plystyeene sulphone acid fn the form of it sodium salt available oder the name Flexan®™Ttwith a molecular weight of around 120,000 may be auitable [0041] Other suitable acide polymers are belived to Jnclude polyvinyl phosphonic sci {002} Acidic polymers which have boon found wsel for the purposes herein have boen found to have molecular \wejghts ia the range 30.000 to 2,000,000 but molecular ‘ej does notappenrto be val, an his may be simply fn exemplary range, US 2009/0320849 AL [0043] _Ackitonal substances may be incomporated into the filter material, for example adtional substances to optimize the properties and anti-viral eectiveness of the filter mate- rial [0044] For example the acidic polymer may be used in ‘combination with plasticser material to encourage the for- mation ofa film ofthe acidic polymer on the fibres of the substrate material. In particular plasticiser material may be Useful in combination wit the anionie polymers based on ‘compounds of formula R, R,C—CR,—COO R,, mentioned tbove, such as the above-mentioned “Fudagit” polymers Suitable pasticisers include Wiethsl citrate, and diethyl oF

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