NO328846B1 - Bioadhesive sammensetninger og fremgangsmate for fremstilling derav, samt sammensetning for a administrere ett eller flere aktive agens. - Google Patents
Bioadhesive sammensetninger og fremgangsmate for fremstilling derav, samt sammensetning for a administrere ett eller flere aktive agens. Download PDFInfo
- Publication number
- NO328846B1 NO328846B1 NO20001567A NO20001567A NO328846B1 NO 328846 B1 NO328846 B1 NO 328846B1 NO 20001567 A NO20001567 A NO 20001567A NO 20001567 A NO20001567 A NO 20001567A NO 328846 B1 NO328846 B1 NO 328846B1
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Classifications
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- A61K9/0012—Galenical forms characterised by the site of application
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- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0015—Medicaments; Biocides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/043—Mixtures of macromolecular materials
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
- A61L2300/608—Coatings having two or more layers
Description
1. Bakgrunn for oppfinnelsen
Foreliggende oppfinnelse omhandler generelt bioadhesive sammensetninger og metoder for den topiske administreringen av aktive agens til et pattedyr. Mer spesielt omhandler foreliggende oppfinnelse sammensetninger som er istand lii å bli benyttet i våte eller fuktige omgivelser, spesielt på slimete membraner, i en forlenget tidsperiode. Det er ingen begrensning på typen av medikament som kan bli benyttet i den foreliggende oppfinnelsen, gitt at den kan bli topisk administrert. Følgelig inkluderer det aktive midlet både medikamenter som påføres topisk for lokale effekter, og de som kan bli administrert topisk for systemiske effekter. Nærmere bestemt angår således oppfinnelsen bioadhesive sammensetninger og fremgangsmåte for fremstilling derav, samt sammensetning for å administrere ett eller flere aktive agens.
2. Beskrivelse av beslektet teknikk
Slimete membraner slike som slimhinnene i kinnhulen har flere fysiske fordeler, slik som rik blodtilførsel, som gjør dem til et ønsket mål for topisk administrering av aktive agens for systemisk avlevering. Avlevering over slimhinnene av aktive agens sørger videre for at man unngår en første passasjemetabolisme i leveren, såvel som dårlig opptak eller inaktivering via gastrointestinalveien. Eksempler på slike agens inkluderer steroider, slike som østrogener, progestiner og beslektede forbindelser; androgener og anabole steroider; ikke-steroid anti-inflammatoriske agens slike som ketoprofan; diklofenak; propranolol; tyroidhormoner; pH-sensitive peptider og små proteiner slike som insulin og ACTH; fysostigmin; skopolamin; verapamil; og gallopamil.
Videre er det ofte ønskelig eller nødvendig å avlevere farmasøytiske agens lokalt, slik som for å lindre smerte i munnhulen.
Munn og/eller slimhinneavleverende sammensetninger, anordninger og metoder er beskrevet, f.eks. i US patent nr. 3 972 995 til Tsuk et al., US 4 593 053 til Jevne et al., US patent nr. 4 755 396 til Hsiao et al., US patent nr. 4 764 378 til Keith et al., US patent nr. 4 740 365 til Yukimatsu et al., US patent nr. 4 889 720 til Konishi et al., US patent nr. 5 047 244 til Sanvordeker et al., og RE 33 093 til Schiraldi et al.
Anvendelsen av bioadhesiver i administreringen av aktive agens til slimhinnemembraner har vært kjent i noe tid. De vanligste benyttede bioadhesive sammensetningene har "ikke-begrensede" (dvs. spredningssubstanser som ikke beholder sin form) og væske eller semi-væske bærestoffer slike som pasta, geler, hudvann, emulsjoner, kremer, sprayer, dråper eller salver. I den senere tid har man i økende grad begynt å anvende "begrensede" bærestoffer (dvs. ikke-spredende substanser som beholder sin form) slike som filmer, forbindinger og bandasjer, eller som starter som begrensede og som deretter løser seg opp, slik som pastiller og tabletter. Slike sammensetninger og anvendelser har vært mindre enn tilfredsstillende til å oppnå kontrollert frigivelse av slike agens, og til å opprettholde adhesjon (dvs. ganske enkelt holdes på plass), eller i virkningsfullhet i forlengede tidsperioder. Videre etterlater de ofte uakseptable klebrige rester ved fjerning.
Det er beskrevet i US patent nr. 5 446 070 til Mantell, at konsentrasjoner så høye som 50 % regnet på vekt av i det vesentlige oppløste bedøvende midler og andre medikamenter, kan oppnås i et system som inneholder en bioadhesiv bærer der adhesjonen av bæreren ikke er hindret. Ikke desto mindre eksisterer det et behov for å øke den tiden slike sammensetninger kan forbli på administrasjonsstedet for å oppnå en maksimal forlengelse av terapeutiske effekter, både systemisk og lokalt.
En suksessrik bioadhesiv anordning for topisk administrering av aktive agens for forlengede tidsperioder må tilfredsstille flere fysiske karakteristika. F.eks. bør frigivelsesenheten være lett å ta av fra den bioadhesive delen, og likevel må den sistnevnte både være tilstrekkelig adhesiv og kohesiv til å opprettholde nær eller intim kontakt med applikasjonssetet i lange tidsperioder, vanligvis mellom 1 og 2 timer, og til og med opptil 24 timer med visse aktive agens. Den bioadhesive sammensetningen må videre holde tilbake det aktive midlet i en passende hastighet for vedvarende eller kontrollert avlevering under forholdene som råder i de våte og fuktige miljøene assosiert med slimhinner. I tillegg må den bioadhesive sammensetningen være ikke-toksisk, ikke føre til kjemisk irritasjon, og må være lett å fjerne med minimal mekanisk irritasjon eller skade til applikasjonsstedet.
I denne betraktningen er sammensetninger som angitt i den foreliggende
oppfinnelsen i stand til å klebe seg fast i lange tidsperioder slik som, f.eks. mer enn 1 time, fortrinnsvis 2 timer, mer fortrinnsvis 4 timer, enda mer fortrinnsvis mer enn 8 timer, opptil til og med 24 timer, for å fukte vev slik som slimhinner, og derved er de ønskede terapeutiske effektene sikret ved den høye graden av adhesjon tilveiebrakt av sammensetningene i den foreliggende oppfinnelsen.
Foreliggende oppfinnelse tilveiebringer en bioadhesiv sammensetning i en fleksibel, endelig form for topisk applikasjon av én eller flere aktive agens som er resultatet av en tilblanding, kjennetegnet ved(a) 2,5 - 40 vekt% av ett eller flere aktive agens; (b) 10-40 vekt% av minst ett bioadhesiv som er en naturlig gummi; (c) 10 - 40 vekt% av minst én løselig polyvinylpyrrolidonpolymer (PVP); (d) 10 - 60 vekt% av ett eller flere løsningsmidler; og (e) et støttelag som forhindrer tap av aktivt agens, hvori sammensetningen inneholder mindre enn omtrent 10 vekt% vann; sammensetningen er av en endelig, fleksibel form og enten omfatter adhesivlaget 2,5 - 40 vekt% av en eller flere aktive agens; eller sammensetningen omfatter et lag som er separert fra adhesivlaget og som omfatter 2,5 - 40 vekt% av en eller flere aktive agens (lag med aktiv agens) og i) adhesivlaget er tilstøtende til og i kontakt med en første store overflate til laget med aktiv agens, ii) støttelaget er i kontakt med en andre store overflate til laget med aktiv agents som er motsatt til den første store overflaten til laget med aktivt agens.
I følge et aspekt er den naturlige gummien er valgt fra karayagummi, guargummi, okragummi, arabingummi, pectinagummi, ghattigummi, tragakantgummi, canthangummi, johannesbrødgummi, loppefrøgummi, tamarindgummi, destriagummi og caseingummi. 1 følge et foretrukket aspekt av oppfinnelsen inneholder bioadhesivet i følge oppfinnelsen kayaragummi. 1 følge et annet aspekt av den foreliggende oppfinnelse inkluderer ett eller flere av løsningsmidlene et separat løsningsmiddel og et separat bløtgjøringsmiddel.
I følge en foretrukket utførelsesform inneholder minst ett bioadhesiv kayaragummi, og hvori det separate løsningsmidlet inneholder en polyhydrisk alkohol, og det separate bløtgjøringsmidlet inneholder glyserin.
I følge enda et aspekt ved oppfinnelsen er minst én løselig PVP er til stede i en mengde på fra 7-15 vekt%, kayaragummien er til stede i en mengde på fra 20-40 vekt%, den polyhydriske alkoholen er tilstede i en mengde på fra 15-35 vekt%, og glyserinet er tilstede i en mengde på fra 20-40 vekt%, alt basert på den kombinerte vekten til minst én løselig PVP, kayaragummien, den polyhydriske alkoholen og glyserinet.
I følge en annen foretrukket utførelsesform i følge oppfinnelsen er vektforholdet mellom minst én PVP og kayaragummi er fra 1:3 til 1:4. I ytterligere en annen foretrukket utførelsesform i følge oppfinnelsen er vektforholdet mellom kayaragummi og glyserin er fra 10:1 til 1:2.1 ytterligere en annen foretrukket utførelsesform i følge oppfinnelsen er vektforholdet mellom kayaragummi og propylenglykol er fra 10:1 til 1:1.
I følge et annet aspekt ved oppfinnelsen inneholder den polyhydriske alkoholen propylenglykol.
I følge enda et annet aspekt ved oppfinnelsen har den løselige polyvinylpyrrolidonpolymeren en molekylvekt på omkring 1000000 til omkring 1500000.
Det ene eller de flere aktive agensene er i følge et aspekt ved oppfinnelsen valgt fra gruppen bestående av anestesimidler, anti-inflammatoriske midler, smertestillende midler, antimigrenemidler, antimikrobemidler, tannmidler, antibiotika, anoreksimidler, polypeptidmedikamenter, proteinmedikamenter, opioidagonister, opioidantagonister, antibrekningsmidler, antineoplastiske midler, antiparkinson-midler, antidiuretiske midler, hormoner, bronkiodilatorer, sentralnervesystemstimulerende midler og agens, oksyotiske midler og vasodilatorer.
Videre tilveiebringer den foreliggende oppfinnelse en sammensetning for å administrere ett eller flere aktive agens, kjennetegnet ved (a) 2,5 - 40 vekt% av ett eller flere aktive agens; og (b) et adhesivt lag tilpasset for å klebe til hud eller slimhinnevev, og som er resultatet av en blanding som inneholder: (i) 10 - 40 vekt% av minst én løselig polyvinylpyrrolidonpolymer (PVP); (ii) 10 - 40 vekt% av minst ett bioadhesiv som er naturlig gummi; og (iii) 10-60 vekt% av ett eller flere løsningsmidler; (c) et støttelag som forhindrer tap av aktivt agens; hvori kilden (a) er forskjellig fra det adhesive laget (b); og hvori sammensetningen inneholder mindre enn omtrent 10 vekt% vann; sammensetningen er av en endelig, fleksibel form og enten omfatter adhesivlaget 2,5 - 40 vekt% av en eller flere aktive agens; eller sammensetningen omfatter et lag som er separert fra adhesivlaget og som omfatter 2,5 - 40 vekt% av en eller flere aktive agens (lag med aktiv agens) og i) adhesivlaget er tilstøtende til og i kontakt med en første store overflate til laget med aktiv agens, ii) støttelaget er i kontakt med en andre store overflate til laget med aktiv agents som er motsatt til den første store overflaten til laget med aktivt agens.
I følge et aspekt ved oppfinnelsen inkluderer kilden (a) i nevnte sammensetning et separat lag som inneholder den eller de aktive agensene, og hvori den første hovedoverflate til det adhesive laget er nærliggende til og i kontakt med en første hovedoverflate til det separate laget. I følge enda et foretrukket aspekt ved nevnte sammensetning i følge oppfinnelsen inneholder sammensetningen videre (c) et belegglag som er i kontakt med en annen hovedoverflate til det separate laget som er motstående til den første overflaten til det separate laget; og (d) en fjernbar frigivelsesforing som er i kontakt med en annen hovedoverflate til det adhesive laget som er motstående til den første hovedoverflaten til det separate laget. 1 følge et annet aspekt ved nevnte sammensetning inkluderer kilden (a) et aktivt agensreservoar, og at det adhesive laget er perifert til det aktive agensreservoaret. Adhesivlaget i sammensetningen for å administrere ett eller flere aktive agens i følge oppfinnelsen inkluderer i en foretrukket utførelsesform ett eller flere løsningsmidler, hvori nevnte ene eller flere løsningsmidler inneholder et separat løsningsmiddel og et separat bløtgjøringsmiddel, og hvori nevnte minst ene bioadhesiv inneholder kayaragummi. I følge en foretrukket utførelsesform av den foreliggende oppfinnelse inneholder det separate løsningsmidlet en polyhydrisk alkohol, og hvori det separate bløtgjøringsmidlet inneholder glyserin.
Endelig tilveiebringer den foreliggende oppfinnelse en fremgangsmåte for fremstilling av sammensetningen i følge oppfinnelsen kjennetegnet ved å blande (a) 2,5 - 40 vekt% av én eller flere aktive agens; (b) 10-40 vekt% av minst ett bioadhesiv som er en naturlig gummi; (c) 10-40 vekt% av minst én løselig polyvinylpyrrolidonpolymer; og (d) 10-40 vekt% av ett eller flere løsningsmidler for å danne en sammensetning.
I følge en utførelsesform av fremstilles sammensetningen i følge oppfinnelsen ved (a) å lage en aktiv agenskilde som inneholder 2,5 - 40 vekt% av én eller flere aktive agens; og (b) å lage et separat adhesivt lag tilpasset for å klebe seg til hud eller slimhinnevev, som omfatter å blande; (i) 10 - 40 vekt% av minst én løselig polyvinylpyrrolidonpolymer; (ii) 10-40 vekt% av minst ett bioadhesiv som er en naturlig gummi; og (iii) 10-40 vekt% av ett eller flere løsningsmidler.
Bioadhesiv sammensetningen i følge oppfinnelsen er av en type som er passende for forlenget klebing til våte eller fuktige overflater for kontrollert frigivelse av et aktivt middel derfra, en blanding av et polysakkarid, fortrinnsvis en naturlig gummi slik som karayagummi, og en løselig PVP.
Bioadesiv sammensetningen i følge oppfinnelsen er egnet for topisk administrering av to eller flere aktive agens med forskjellige flukshastigheter, for å oppnå forlenget og/eller multiple terapeutiske effekter.
Videre fungerer også den bioadhesive sammensetningen som et trykksensitivt klebemiddel passende for forlenget klebing til enten våte/fuktige overflater eller tørre overflater, slik som hud, for kontrollert frigivelse av et aktivt middel derfra. Foreliggende oppfinnelse omhandler også metoder for å administrere de førnevnte sammensetningene.
Støttemateriale og en frigivelsesenhet i den bioadhesive sammensetningen i følge oppfinnelsen kan tilpasses størrelsen og formen på en individuell doseenhet eller avleveringssystem.
Den bioadhesive sammensetningen i følge oppfinnelsen kan anvendes for for forlenget topisk administrering av ett eller flere aktive agens til et subjekt ved at det en bioadhesiv sammensetning i en fleksibel, endelig form i følge oppfinnelsen bringes i kontakt med et område med hud eller en slimhinnemembran, fortrinnsvis de orale slimhinnene med nevnte bioadhesive sammensetning for å administrere én eller flere aktive agens, hvori sammensetningen enten inkluderer minst et aktivt agens eller alternativt, blir benyttet sammen med et aktivt agens, eventuelt alternativ blir brukt sammen med et aktivt agens..
Videre hensikter, trekk og fordeler ved den foreliggende oppfinnelsen vil være åpenbare ut fra vurderingen av den detaljerte beskrivelsen av foretrukne utførelsesform er som følger.
Foreliggende oppfinnelse omhandler bioadhesive sammensetninger for avlevering av et aktivt agens som har lokal eller systemisk virkning, og metoder og anvendelse derav. Fordelen med disse bioadhesive sammensetningene ligger i deres evne til å opprettholde direkte eller intim kontakt med applikasjonsstedet i forlengede tidsperioder, slik som f.eks. mer enn 1 time, fortrinnsvis 2 timer, mer fortrinnsvis 4 timer, enda mer fortrinnsvis mer enn 8 timer, opptil til og med 24 timer. Det antas at anvendelsen av en løselig PVP-polymer sammen med en annen bioadhesiv, spesielt et løselig bioadhesiv, slik som naturlig gummi, i et løsningsmiddel som inkluderer et bløtgjøringsmiddel for bioadhesivene, tillater hver av dem å svelle (dvs. absorbere fuktighet) uavhengig av hverandre, og etter hverandre heller enn på samme tid, slik at når de påføres slimhinner tilveiebringer de øket og forlenget klebing til våte eller fuktige overflater slik som slimhinnemembraner og tenner, og derved øker den effektive penetrasjonen eller absorpsjonen, og forlengede avleveringen, av det aktive midlet.
Selv om det ikke ønskes å være bundet av noen teori, tror oppfinnerne at kombinasjonen av PVP og andre bioadhesiver tilveiebringer en fremragende adhesjon som ikke kan oppnås ved enten PVP eller andre bioadhesiver alene. Det antas at nærværet av et bioadhesiv, slik som kayaragummi, innehar effekten å fortrinnsvis absorbere og svelle med væsker, slik som løsningsmiddel, bløtgjørings-midler og spytt, som ellers kan interferere med de bioadhesive egenskapene til PVP. Følgelig tilveiebringer tilsetningen av det andre bioadhesivet en raskere virkning og lengre varighet av adhesjon.
Sammensetningene tilveiebringes videre i en endelig, fleksibel form for hensikts-messig topisk applikasjon av det aktive midlet. De foreliggende sammensetningene degraderes ikke i det vesentlige under anvendelse, og fører ikke til unødvendig irritasjon eller bieffekter som har blitt erfart med andre transslimhinnesammen-setninger i den kjente teknikken.
Begrepet "bioadhesiver" eller "slimhinneadhesiver" som benyttet heri, betyr naturlige, syntetiske eller semi-syntetiske materialer som kleber seg til, og fortrinnsvis kleber seg sterkt til, overflater slik som hud, tenner eller slimhinnemembran når de blir våte eller hydrert. For at et materiale skal kvalifisere som et bioadhesiv, må det være i stand til å opprettholde nær eller intim kontakt med en våt eller fuktig overflate i et minimumstidsrom.
Den bioadhesive sammensetningen i den foreliggende oppfinnelsen er endelig og "selvadhesiv" i betydningen av at den er i stand til å klebe seg til applikasjonssetet uten behovet for å forsterke en slik kobling ved hjelp av anvendelsen av andre adhesiver som påføres den, eller som en støtte.
Et bioadhesiv blir ofte karakterisert som ett som absorberer et visst antall ganger sin egen vekt i vann (dvs. er vann-svellende). Avhengig av bioadhesivet kan dette være så lite som omkring 10 eller så mye som omkring 1000 ganger dets egen vekt i vann. Eksempler på bioadhesiver er naturlige plantegummier som absorberer fra 30 til omkring 50 ganger sin egen vekt i vann, avhengig av gummien som velges. Bioadhesjon er ofte et vanskelig fenomen å måle. Den bioadhesive styrken for hensikten med den foreliggende oppfinnelsen kan bli målt ved standardtester for å måle kraft, f.eks. i dyn pr. cm<2>, som beskrevet i Robinsun, US patent nr. 4 615 697, og er minst 50 dyn pr. cm<2>, og mer fortrinnsvis 100-500 dyn pr. cm<2>, eller til og med 1000 dyn pr. cm<2>.
Begrepet "polyvinylpyrrolidon" eller "PVP" refererer til en polymer, enten en homopolymer eller kopolymer, som inneholder vinylpyrrolidon (også referert til som N-vinylpyrrolidon, N-vinyl-2-pyrrolidon og N-vinyl-2-pyrrolidinon) som en monomerenhet. PVP-polymerer inkluderer løselige og uløeslige homopolymere PVP'er) og kopolymerer slike som vinylpyrrolidon/vinylacetat og vinylpyrrolidon/dimetylamino-etylmetakrylat. Tris-bindende homopolymerer er uløselige og er generelt kjent i den farmasøytiske industrien under begrepene polyvinylpoly-pyrrolidon, krospovidon og PVP. Det kopolymere vinylpyrrolidon-vinylacetatet er generelt kjent i den farmasøytiske industrien under betegnelsen Copolyvidon(e), Copolyvidonum eller VP-VAc.
Begrepet "løselig" når det benyttes med referanse til PVP, betyr at polymeren er løselig i vann og generelt ikke er vesentlig krysskoblet, og har en molekylvekt på mindre enn omkring 2000000. Se generelt Buhler, KOLLI DON®: POLYVINYLPYRROLIDON FOR DEN FARMASØYTISKE INDUSTRIEN, BASF Aktien-gesellschaft (1992). Løselige PVP-polymerer har blitt identifisert under i den farmasøytiske industrien under forskjellige navn, der de mest vanlige som benyttes inkluderer povidon, polyvidon(e), polyvidonum, polyvidonum, poly (N-vinyl-2-pyrrolidinon, poly (N-vinylbutyrolaktam), poly (l-vinyl-2-pyrrolidon), poly [l-(2-okso-1 -pyrrolidinyl)etylen].
Begrepet "slimhinnemembran" eller "slimhinne" som benyttet heri betyr oral, kinn, vaginal, rektal, nese, intestinal eller øyneoverflater.
Begrepet "kinn" eller "oral" som benyttet heri, betyr munnen og det omkring-liggende spiseområdet inkludert gommene, tenner, gane, tunge, mandler og penodontalvev.
Begrepet "adhesiv" som benyttet heri betyr et naturlig eller syntetisk materiale som er i stand til å klebe seg til stedet for topisk applikasjon eller administrering.
Begrepet "topisk" blir benyttet heri i sin tradisjonelle betydning, og refererer til direkte kontakt med et sted på et pattedyr som kan være ethvert anatomisk sted eller overflateareal inkludert hud, slimhinnemembraner eller hardt vev slik som ben, tenner eller negler.
Begrepet "å administrere" eller "administrering" er ment å bety enhver måte med applikasjon til et vev som resulterer i den fysiske kontakten mellom sammensetningen og det anatomiske setet eller overflatearealet.
Begrepet "subjekt" er ment å inkludere alle varmblodige pattedyr, spesielt mennesker.
Som benyttet heri refererer begrepet "forlenget" eller "utvidet" til en tidsperiode på mer enn 30 min. Den foreliggende sammensetningen er i stand til å opprettholde kontakt med slimhinnene, slik som kinnslimhinner, for en tidsperiode på opptil 24 timer, fortrinnsvis i perioder som strekker seg fra omkring 30 min. til omkring 24 timer, mer fortrinnsvis fra omkring 1 time til omkring 16 timer, og mest fortrinnsvis fra omkring 1 time til omkring 12 timer.
Som benyttet heri er begrepet "fluks" definert som absorpsjonen av det aktive midlet gjennom huden eller slimhinnene, og er beskrevet ved Ficks første lov for diffusjon: J = -D(dCm(dx), der J er fluksen i g/cm<2>/sek., D er diffusjonskoeffisienten til medikamentet over huden eller slimhinnene i cm<2>/sek. og dCm/dx er konsentrasjonsgradienten til det aktive midlet over huden eller slimhinnen.
Frasen "fleksibel, endelig form" er ment å bety en fast form som er i stand til å tilpasse seg til en overflate som den kommer i kontakt med, og som er i stand til å opprettholde kontakten i en slik fast form slik at topikal applikasjon fasiliteres uten noen uønsket fysiologisk respons, og uten å bli vesentlig dekomponert av vandig kontakt under administreringen til et subjekt.
En viktig karakteristikk ved utførelsesformen i den foreliggende oppfinnelsen omhandler den i det vesentlige vannfrie og vannuløselige egenskapen til sammensetningen. Ved begrepet "vesentlig vannfri" er det ment at sammensetningen inneholder mindre enn omkring 10 % vann regnet på vekt, og fortrinnsvis mindre enn 5 %, og mer fortrinnsvis mindre enn 5 % og mer fortrinnsvis mindre enn 3 % før den blir topisk påført. Generelt er det ønskelig å fullstendig unngå tilsetningen av vann, og å eliminere så langt som mulig nærværet av vann i de andre bestand-delene i sammensetningen. Ved begrepet "i det vesentlige vannuløselig" menes det at sammensetningen forblir "endelig" og at den ikke generelt løsner fra applikasjonsstedet og under forholdene med regulær, tiltenkt anvendelse i en periode på minst 3 timer. Fordelene som kan trekkes frem fra den i det vesentlige vannfrie og vannuløselige egenskapen til sammensetningene i den foreliggende oppfinnelsen, inkludere det å oppnå høyere konsentrasjoner av aktivt middel. En annen fordel ved disse sammensetningene er minimaliseringen av utfylling av det aktive midlet, ettersom utfelling påvirker prosesseringen av sammensetningen, påvirker hastigheten av avlevering av det aktive midlet, og i noen tilfeller kan påvirke sensitiviteten til subjektet for det aktive midlet.
Den foreliggende sammensetningen kan i én utførelsesform inkludere anvendelsen av to aktive agens som kan være like eller forskjellige, f.eks. kan ett agens være i baseform, og det andre agenset kan være i syre- eller saltform. 1 tillegg kan et agens være tilstede som avleveres raskt og har en relativt høy flukshastighet, sammen med et annet agens som avleveres over en forlenget tidsperiode og som har en lavere flukshastighet.
Spesielt tillater den foreliggende sammensetningen doseringen av to eller flere aktive agens samtidig. F.eks. kan et første agens være tilstede i sammensetningen slik at det blir fullstendig eller i det vesentlige avlevert etter en tidsperiode på f.eks. mellom 1 time og 90 min., spesielt i en periode som strekker seg fra omkring 5 til omkring 60 min. På den samme tiden kan et annet aktivt agens være tilstede i sammensetningen slik at det andre aktive agenset blir avlevert over en lengre tidsperiode, f.eks. opptil en periode på 24 timer, spesielt i en periode som strekker seg fra omkring 5 min. til omkring 16 timer. Det vil si at i en utførelsesform av den foreliggende oppfinneslen vil det første agenset ha en totalt høyere flukshastighet enn det andre agenset, noe som resulterer i en tidligere uttømming av det første agenset fra den bioadhesive sammensetningen.
Tidsperioden for å avlevere de aktive agensene vil avhenge av mange faktorer, dvs. doseringsforholdene, forbindelsene som ble avlevert osv. F.eks. vil det, i samsvar med den foreliggende oppfinnelsen, være mulig å inkludere et topisk bedøvende agens som blir avlevert raskt, la oss si innen 20 min., og også å inkludere et sekundært bedøvende agens som er det samme som, eller forskjellig fra, det første bedøvende midlet, og som eventuelt kan være systemisk, som ville kunne bli avlevert over en forlenget periode, f.eks. over en periode på opptil 8 timer eller til og med 24 timer. Et slikt arrangement ville være passende for multiple applikasjoner, slik som under tannbehandlinger.
Alternativt kan to eller flere aktive agens bli topisk administrert for å oppnå enten en forlenget terapeutisk effekt, eller multiple terapeutiske effekter, eller begge deler. F.eks. kan et ikke-steroid anti-inflammatorisk middel bli topisk administrert sammen med et bedøvelsesmiddel slik at den bioadhesive sammensetningen tilveiebringer en reduksjon i smerte ved hjelp av både henholdsvis den smertestillende effekten og anestien ved slike agens. De tiltenkte effektene ved en slik sammensetning av forbindelser, eller andre multiple sammensetninger av agens, kan være for en tidsperiode på opptil 24 timer for de multiple agensene, eller for varierende tidsperioder over en 24 timers periode.
Hastigheten på avleveringen av de aktive agensene kan bli kontrollert enten ved konsentrasjonen og/eller løseligheten til slike agens i den bioadhesive sammensetningen, pH til sammensetningen, graden av tykkhet på sammensetningen eller størrelsen på systemet som en endelig doseform, eller permeabiliteten eller løseligheten til hele sammensetningen.
Som benyttet heri er begrepet "aktiv agens" (og dens ekvivalenter, "agens", "bioaktive agens", "medikament", "medikament" og "farmasøytisk") ment å ha den bredeste betydningen, og inkluderer minst én av enhver terapeutisk profylaktisk, farmakologisk eller fysiologisk aktiv substans eller blanding derav, som blir avlevert til et pattedyr for å gi en ønsket, vanligvis fordelaktig, effekt.
Mer spesifikt er ethvert aktivt agens som er i stand til å gi en farmakologisk respons, lokal eller systemisk, uavhengig av hvorvidt den er terapeutisk, diagnostisk eller profylaktisk av natur, innen betraktningen av oppfinnelsen. Det bør bemerkes at de aktive agensene eller medikamentene kan bli benyttet enkeltvis eller som en blanding av to eller flere agens eller medikamenter, og i mengder som er tilstrekkelig til å hindre, kurere, diagnostisere, dempe eller behandle en sykdom eller tilstand, som i tilfellet kan være: 1. a-adrenerge agonister slik som adrafinil, adrenolon, amidefrin, apraklonidin, budralazin, klonidin, cyklopentamin, detomidin, dimetofrin, dipivefrin, efedrin, epinefrin, fenoksazolin, guanabenz, guanfacin, hydroksyamfetamin, ibopamin, indanazolin, isomethepten, mefentermin, metaraminol, metoksamin, hydroklorid, metylheksanamin, metizolen, midodrin, naftazolin, norepinefrin, norfenefrin, oktodrin, oktopamin, oksymetazolin, fenylefrinhydroklorid, fenylpropanolaminhydroklorid, fenylpropylmetylamin, foledrin, propylheksedrin, pseudoefedrin, rilmenidin, synefrin, tetrahydrozolin, tiamenidin, tramazolin, tuaminoheptan, tymazolin, tyramin og xylometazolin. 2. P-adrenerge agonister slik som albuteron, bambuterol, bitolterol, karbuterol, klenbuterol, klorprenalin, denopamin, dioksetedrin, dopeksamin, efedrin, epinefrin, etafedrin, etylnorepinefrin, fenoterol, formoterol, heksoprenalin, ibopamin, isoetarin, isoproterneral, mabuterol, metaproterenol, metoksyfenamin, oksyfedrin, pirbuterol, prenalterol, prokaterol, protokylol, reproterol, rimiterol, ritodrin, soterenol, terbuterol og xamoterol. 3. a-adrenerge blokkerere slik som amosulalol, arotinolol, dapiprazol, doksazosin, ergoloid, mesylater, fenspirid, indoramin, labetalol, nicergolin, prazosin, terazosin, tolazolin, trimazosin og yohimbin. 4. P-adrenerge blokkerere slik som acebutolol, alprenolol, amosulalol, arotinolol, atenolol, befunolol, betaksolol, bevantolol, bisprolol, bopindolol, bukumolol, befetolol, bufuralol, bunitrolol, bupranolol, butidrin hydroklorid, butofilolol, karazolol, karteolol, carvedilol, celiprolol, cetamolol, kloranolol, dilevalol, epanolol, esmolol, indenolol, labetalol, levobunolol, mepindolol, metipranalol, metoprolol, moprolol, nadoksolol, nifenalol, niradilol, oksprenolol, penbutolol, pindolol, prastolol, pronetalol, propanolol, sotalol, sulfinalol, talinolol, tertatolol, timolol, tolipropol og xibenolol. 5. Alkoholavskrekkende midler slik som kalsiumcyanamidcitratet, disulfiram, nadid og nitrefazol. 6. Aldosereduktaseinhibitorer slik som epalrestat, ponalrestat, sorbinil og tolrestat. 7. Anaboler slike som androisoksazol, androstenediol, bolandiol, bolasteron, klostebol, etylestrenol, formyldienolon, 4-hydroksy-19-nortestosteron, metandiol, metenolon, metyltnenolon, nandrolon, nandrolon dekanoat, nandrolon, p-heksyl-oksyfenylpropionat, nandrolonfenpropionat, norboleton, oksymesteron, pizotylin, kinbolon, stenbolon og trenbolon.
8. Smertestillende midler (tann) slike som klorbutanol, clove og eugenol.
9. Smertestillende midler (bedøvelse) slike som alfentanil, allylprodin, alfa-prodin, anileridin, benzylmorfin, bezitramid, buprenorfin, butorfanol, klonitazen, kodein, kodeinmetylbromid, kodeinfosfat, kodeinsulfat, desomorfin, dekstromor-amid, dezocin, diampromid, dihydrokodein, dihydrokodeinonenolacetat, dihydro-morfin, dimenoksadol, dimeftanol, dimetyltiambuten, dioksafetylbutyrat, dipianon, eptazosin, etoheptazin, etylmetylytiambuten, etylmorfin, etonitazen, fentanyl, hydrokodon, hydrokodonbitartrat, hydromorfon, hydroksypetidin, isometadon, ketobemidon, leverfanol, lofentanil, meperidin, meptazinol, metazosin, metadon-hydroklorid, metopon, morfin, morfinderivater, myrofin, nalbufin, narcein, niko-morfm, norlevorfanol, normetadon, normorfin, norpipanon, opium, oksykodon, oksymorfon, papaveretum, pentazocin, fenadokson, fenazocin, feoperidin, piminodin, pintramid, profeptazin, promedol, properidin, propiram, propoksyfen, sufentanil og tilidin. 10. Smertestillende midler (ikke-bedøvelse) slike som acetaminofen, acetaminosalol, acetanilid, acetylsalicylsyre, alklofenak, alminoprofen, aloksiprin, aluminium bis(acetylsalicylat), aminoklortenoksazin, 2-amino-4-pikolon, amino-propylon, aminopyrin, ammoniumsalicylat, antipyrin, antipyrinsalicylat, antrafenin, apazon, aspirin, benorylat, benoksaprofen, benzipiperylon, benzydamin, p-bromacetanilid, 5-bromsalicylsyre, acetat, bucetin, bufeksamak, bumadizon, butacetin, kalsiumacetylsalicylat, karbamazepin, karbetidin, karbifen, karsalam, kloralantipyrin, klortenoksazin, cholin, salicylat, cinchofen, ciramadol, clometasin, kropropamid, crotetamid, deksoksadrol, difenamizol, diflunisal, dihydroksy-aluminium acetylsalicylat, difyrocetyl, difyron, emorfazoh, enfenaminsyre, epirizol, etersalt, etenzamid, etoksazen, etodolak, felbinak, fenoprofen, floktafenin, flufenaminsyre, fluoreson, flupirtin, fluproquazon, flurbiprofen. fosfosal, gentisin-syre, flafenin, ibufenak, imidazolsalicylat, indometacin, indoprofen, isofezolak,
isoladol, isoniksin, ketoprofen, ketorolak, p-laktofenetid, lefetamiri, lokoprofen, lysinacetylsalicylat, magnesiumacetylsalicylat, metotrimeprazin, metofolin, miroprofen, morazon, morfolinsalicylat, naproksen, nefopam, nifenazon, 5' nitro-2' propksyacetanilid, parsalmid, perisoksal, fenaktin, fenazopyridin, hydroklorid, fenokoll, fenopyrazon, fenylacetylsahcylat, fenylsalicylat, fenyramidol, pipbuzon, piperylon, prodilidin, propacetamol, propyfenazon, proksazol, kinin, salicylat, ramifenazon, rimazoliummetylsulfat, salacetamid, salicin, salicylamid, salicylamid O-eddiksyre, salicylsvovclsyre, salsalt, salverin, simetrid, natriumsalicylat, sulfamipyrin, suprofen, talniflumat, tenoksikam, tramadol, viminol, xenbucin og zomepirac. 11. Androgene midler slike som andosteron, boldenon, dehydropiandrosteron, fluksymesteron, metanolon, mesterolon, metandrostenolon, 17-metyltestosteron, 17a-metyltestosteron, 3-cyklopentylenoleter, noretandrolon, normetandron, oksandrolon, oksymesteron, oksymetolon, prasteron, stanlolon, stanozolol, testosteron, testosteron 17-kloralhemiketal, testosteron 17P-kypionat, testosteron-enantat, testosteronnikotinat, testosteronfenylacetat, testosteronpropionat og timesteron. 12. Anestesimidler slike som acetamidoeugenol, alfadolon, acetat, alfaksalon, amucain, amolanon, amylokain, hydroklorid, benoksinat, benzokain, bifenamin, bupivakain, butakain, butaben, butanilikain, buretamin, butalitalnatrium, butoksy-kain, kartikain, 2-klorprokainhydroklorid, kokaetylen, kokain, cyklometykain, dibukainhydroklorid, dimetisokin, dimetokain, diperadonhydroklorid, dyklonin, ekgonidin, ekgonin, etylaminobenzoat, etylklorid, etidokain, etokadrol, P-eukain, europrocin, fenalkomin, fomokain, heksobarbital, heksylkainhydroklorid, hydroksy-dionnatrium, hydroksyprokain, hydroksytetrakain, isobutyl, p-aminobenzoat, kentamin, leukinokainmesylat, levokadrol, lidokain, mepivakain, meprylkain, hydroklorid, metabutoksykainhydroklorid, metoheksitalnatrium, metylklorid, midazolam, myrtekain, neapain, oktakain, ortokain, oksetazain, paretoksykain, penakainhydroklorid, fencyklidin, fenol, piperokain, pindokain, polydokanol, pramoxin, prilokain, prokain, propanidid, propanokain, proparakain, propipokain, propofol, propoksykainhydroklond, pseudokokain, pyrrokain, kininureahydroklond, risokain, salicylalkohol, tetrakainhydroklorid, tialbarbital, timylal, tiobutabarbital, tiopentalnatrium, tolykain, trimekain og zolamin. 13. Anoreksimidler slike som aminoreks, amfekloral, amfetamin, bezafetamin, klorfentermin, klobenzoreks, kloforeks, klortermin, cykloeksedring, destro-amfetaminsulfat, dietylpropion, difemetoksidin, N-etylamfetamin, fenbutrazat, fenfluramin, fenproporeks, furfurylmetylamfetamin, levofacetoperat, mazindol, mefenoreks, metamfeproamon, metamfetamin, norpseudoefedrin, fendimetrazin, fendimetrazintartrat, fenmetrazin, fenpentermin, fenylpropanolaminhydroklorid og piciloreks. 14. Anthelmintica (cestoder) slik som arekolin, aspidin, aspidinol, diklorofen, embelin, kosin, naftalen, niklosamid, pellertierin, pellertierintannat og kinakrin. 15. Anthelmintica (nematoder) slike som alantolakton, amoskanat, askaridol, befenium, bitoskanat, karbontetraklorid, karvakrol, cyklobendazol, dietyl-karbamazin, difenan, ditiazininiodid, dymantin, gentianfiolett, 4-heksylresorcinol, kaininsyre, mebendazol, 2-naftol, okantel, papain, piperazin, piperazinadipat, piperazincitrat, piperazinedetatkalsium, piperazintartrat, pyrantel, pyrvinium-pamoat, a-santonin, stilbaziumiodid, tetrakloretylen, tetramisol, tiabendazol, tymol, tymyl N-isomylkarbamat, triklofenolpiperazin og ureastibamin.
16. Anthelmintica (onkocerca) slike som ivermektin og suraminnatrium.
17. Anthelmintica (schistosoma) slike som amoskanat, amfotalid, antimon-kaliumtartrat, antimonnatriumglukonat, antimonnatriumtartrat, antimonnatrium-tioglykollat, antimontioglykollamid, bekanton, hykanton, lukantonhydroklorid, niridazol, oksaminikin, prazikantel, stibokaptat, stibofen og ureastibamin.
18. Anthelmintica (trematoder) slike som antiolimin og tetrakloretylen.
19. Anti-aknemedikamenter slike som adapelen, algeston, ecetofenid, azelinsyre, benzoylperoksid, cyktol, cyproteron, motretinid, resorcinol, retinoidsyre, tetrakinon og tretinonin. 20. Anti-allergimidler slike som amleksanoks, astemizol, azelastin, kromolyn, fenpipran, histamin, ibudilast, nedokromil, okatomid, pentigetid, giftig eføy ekstrakt, giftig eik ekstrakt, giftig sumakekstrakt, repirinast, tranilast, traksanoks og urushiol. 21. Anti-amøbemidler slike som arstinol, bialamikol, karbarson, sefalin, klor-betamid, klorokin, klorfenoksamid, klortetracyklin, dehydrometin, dibrompropa-midin, diloksanid, deftarson, emitin, fumagillin, flaukarubin, glykobiarsol, 8-hydroksy-7-jod-5-kinolinsulfosyre, jodklorhydroksykin, jodkinon, paromomycin, fankinon, fearsonsulfoksylat, polybenzarsol, propamidin, kinfamid, seknidazol, sulfarsid, teklozan, tetracyklin, tiokarbamizin, tiokarbarson og tinidazol. 22. Anti-androgene midler slike som bifluranol, cyoktol, cyoroteron, delmadinonacetat, flutimid, nilutamid og oksendolon. 23. Anti-anginamidler slike som acebutolol, alprenolol, amiodaron, amlodipin, arotinolol, atenolol, bepridil, bevantolol, bukomolol, bufetolol, bufuralol, bunitrolol, bupranolol, karozolol, karteolol, karvedilol, celiprolol, cinepazetmaleat, diltiazem, epanolol, felodipin, gallopamil, imolamin, indenolol, isisorbiddinitrat, isradipin, limaprost, mepindolol, metoprolol, molsidomin, nadolol, nikardipin, nifedipin, nifenalol, nilvadipin, nipradilol, nisoldipin, nitroglyserin, oksprenolol, oksyfedrin, ozagrel, penbutolol, pentaerytritoltetranitrat, pindolol, pronetalol, propanolol, sotalol, terodilin, timolol, toliprolol og verapamil. 24. Anti-hjerterytmemidler slike som acebutol, acekain, adenosin, ajmalin, alpreolol, amidoraron, amopoksan, aprinidin, arutinolol, atenolol, bevantolol, bretyliumtosylat, bubumolol, bufetolol, bunaftin, bunitrolol, bupranolol, butidrinhydroklorid, butobendin, kapobensyre, karazolol, karteolol, kifenilin, kloranolol, disoyramid, enkamid, esmolol, flekainid, gallopamil, hydrokinidin, indekainid, indenolol, ipratropiumbromid, lidokain, lorajmin, lorkainid, meobentin, metiprnolol, meksiletin, morisizin, nadoksolol, nifenalol, oksprenolol, penbutolol, pindolol, pirmenol, praktolol, prajmalin, prokainamidhydroklorid, pronetalol, propafenon, propranolol, pyrinolin, kinidinsulfat, kinidin, sotalol, talinolol, timolol, tokainid, verapamil, viquidil og xibenolol.
25. Anti-arteriosklerosemidler slik som pyridinolkarbamat.
26. Anti-artritt/revmatiske midler slike som allokupreidnatrium, auranofin, aurotioglukose, aurotioglykanid, azatioprin, kalsium, 3-aurotio-2-propanol-l-sulfonat, celecoxib, klorokin, klobuzarit, kuproksolin, diacerein, glukosamin, gullnatriumtiomalat, gullnatriumtiosulfat, hydroksyklorkin, kebuzon, lobenzarit, melittin, metotreksat, myoral og penicillamin.
27. Anti-bakterielle (antibiotika) medikamenter inkludert:
aminoglykosider slike som amikacin, apramycin, arbekacin, bamermyciner, butyrosin, dibekacin, dihydrostreptomycin, fortimicin(er), gentamicin, ispamicin, kanamycin, mikronomicin, neomycin, neomycinundecylenat, netilmicin, paromomycin, ribostamycin, sisomicin, spektinomycin, streptomycin, streptonikozid og tobramycin;
Amfenikoler slike som azidamfenokol, kloramfenikol, kloramfenikolpalmitat, kloramfenikolpantotenat, florfenikol og tiamfenikol;
Ansamyciner slike som rifamid, rifampin, rifamycin og rifaksimin;
P-laktamer, inkludert:
karbapenemer slike som imipenem; cefalosvoriner slike som cefaktor, cefadroksil, cefamandol, cefatrizin,
cefazedon, cefazolin, cefiksim, cefmenoksim, cefodizim, cefonicid, cefoperazon, ceforanid, cefotakim, cefotiam, cefpimizol, cefpirimid, cefpodoksim, proksetil, cefroksamdin, cefsulodin, ceftazidim, cefteram, ceftezol, ceftobuten, ceftizoksim, ceftriakson, cefuroksim, cefuzonam, cefacetrilnatrium, cefaleksin, cefaloglysin, cefaloridin, cefalosporin, cefalotin, cefapirinnatnum, cefradin og pivcefalexin; cefamyciner slike som cefbuperazon, cefmetazol, cefminoks, cefetan og cefoksitin; monobaktamer slike som aztreonam, carumonam og tigemonam: okacefemer slike som flomoksef og moksolaktam;
penicilliner slike som amidinocillin, amidonocillin, pivoksil, amoxicillin, amfecillan, apalcillin, aspoksicillin, azidocillan, azlocillan, bakampicillin, benzyl-penicillinsyre, benzylpenicillinnatrium, karbenicillin, karfecillinnatrium, karndacillin, klometocillin, klokacillin, cyklacillin, dikloksillin, difenicillinnatrium, epicillin, fenbenicillin, floksicillin, hetacillin, lenampicillin, metampicillin, meticillinnatnum, mezlocillin, nafcillinnatrium, oksacilhn, penamecillin, penetamathydriodid, penicillin G benetamin, penicillin benzatin, penicillin G benzhydralamin, penicillin G kalsium, penicillin G hydrabamin, penicillin G kalium, penicillin G prokain, penicillen N, penicillin O, penicillin V, penicillin V benzatin, penicillin V hydrabamin, penimepisyklin, feneticillinkalium, piperacillin, pivapicillin, propicillin, kinacillin, sulbenicillin, talampicillin, temocillin og tikarcillin;
linkosamider slike som klindamycin og linkomycin;
makrolider slike som azitromycin, karbomycin, klaritromycin, erytromycin, erytromycin, acistrat, erytromycinestolat, erytromycinglykoheptonat, erytromycin-laktobionat, erytromycinpropionat, erytromycinstearat, josamycin, leukomycin, midekamyciner, miokamicin, oleandomycin, primycin, rokitamycin, rosaramicin, roksitromycin, spiramycin og troleandomycin;
polypeptider slike som amfomycin, baktitracin, kapreomycin, kolistin, enduracidin, enviomycin, fusafungine, gramicidin(er), gramicidin S, mikamycin, polymyksin, polymyksin B.metansulfonsyre, pristinamycin, ristocetin, teikoplanin, tiostrepton, tuberktinomycin, tyroksidin, tyrotricin, vankomycin, viomycin, viomycinpantotenat, virginiamycin og zinkbakitracin;
tetracykliner slike som apicykhn, klortetracyklin, klomocylin, demeklo-cyklin, doksycyklin, guamecylin, lymecyklon, meklocyklin, metacyklin, mino-cykliner, oktetracyklin, penimepicyklin, pipacyklin, rolitetracyklin, sancyklin, seociklin og tetracyklin; og
andre antibiotika slike som cykloserin, mupirocin og tuberin.
28. Antibakterielle medikamenter (syntetiske), inkludert: 2,4-diaminpyrimidiner slike som brodimoprim, tetroksoprim og trimetoprim;
nitrofuraner slike som furaltadon, furazoliumklorid, nifuraden, nifuratel, nifurfolin, nifurpirinol, nifurprazin, nifurtoinol og nitrofurantoin;
kinoloner og analoger slike som amfloksacin, cinoksacin, ciprofloxacin, difloxacin, enoxacin, fleroksacin, flumekin, lomefloksain, milksacin, nalidiksinsyre, norfloksacin, ofloksacin, okolinsyre, peflokacin, pipemidinsyre, piromidinsyre, rosoksacin, temafloksacin og tosulflokacin;
sulfonamider slike som acetyl sul fametoksypyrazin, acetyl sul fisoksazol, azosulfamid, benzylsulfamid, kloramin-B, kloramin-T, dikloramin-T, formo-sulfatiazol, N<2>formylsulfisomidin, N<2->(3-D-glukosylsulfanilamid, mafenid, 4'-(metylsulfamoul)sulfanilanilid, p-nitrosulfatiazol, noprylsulfamid, ftalyl-sulfacetamid, ftalylsulfatiazol, salazosulfadimidin, succinylsulfatiazol, sulfa-
benzamid, sulfacetamid, sulfaklorpyridazin, sulfakrysoidin, sulfacytin, sulfadiazin, sulfadikramid, sulfadimetoksin, sulfadoksin, sulfaetidol, sulfaguariidin, sulfaguanol, sulfalen, sulfalokssyre, sulfamerzin, sulfameter, sulfametazin, sulfametizol, sulfametomidin, sulfametoksazol, sulfametoksypyridazin, sulfametrol, sulfa-midokrysoidin. Sulfamoksol, sulfanilamid, sulfanilamidometansulfonsyretrietanol-aminsalt, 4-sulfanilamidosalicylsyre, N-sulfanilylsulfanilamid, sulfanilylurea, N-sulfanilyl-3.4-xylamid, sulfamtran, sulfaperin, sulfafenazol, sulfaproksylin, sulfa-pyrazin, sulfapyridiri, sulfasomizol, sulfasymazin, sulfatiazol, sulfatiourea, sulfatolamid, sulfisomidin og sulfisoksazol;
sulfoner slike som acedapson, acediasulfon, acetosulfonnatrium, dapson, diatymosulfon, glukosulfonnatrium, solasulfon, succisulfon, sulfanilsyre, p-sulfa-nilylbenzylamin, p,p'-sulfonyldianilin-N,N' diagalaktosid, sulfoksonnatrium og tiazolsulfon; og
andre slike som klofoktol, heksedin, metanamin, metanaminanhydrometylen-citrat, metenaminhippurat, metanaminmandelat, metanaminsulfosalicylat, nitroksolin og zibornol. 29. Anti-kolinerge midler slike som adifeninhydroklorid, alvenn, amutonomiumbromid, aminopentamid, amiksetnn, amprotropinfosfat, anisotropinmetylbromid, apoatropin, atropin, atropin N-oksid, benactyzin, benapryzin, benzetimid, benziloniumbromid, benztropinmesylat, bevoniummetylsulfat, biperiden, butropiumbromid, N-butylskopolammoniumbromid, buzepid, kamylofin, karamifenhydroklorid, klorbenzoksamin, klorfenoksamin, cimetropiumbromid, klidiniumbromid, cyklodrin, cykloniumiodid, cykrimin-hydroklorid, deptropin, deksetimid, dibutohnsulfat, dicyklominhydroklorid, dietazin, difemnerin, diheksyverin, difemanilmetylsulfat, N-(l,2-difenyl-etyl)nikotinamid, dipiproverin, diponiumbromid, emeproniumbromid, endo-benzylinbromid, etopropazin, etybenztropin, etylbenzhydramin, etomidohn, eukatropin, fenpiveriniumbromid, fentoniuumbromid, flutropiumbromid, glykopyrrolat, heteroniumbromid, heksocykliummetylsulfat, homatropin, hysocyamin, ipratropiumbromid, isopropamid, levomepat, mekloksamin, mepenzolatbromid, metkarafen, metantelinbromid, metiksen, metskopolamin-bromid, oktamylamin, oksybutyn inkl ori d, oksyfencyklimin, oksyfenoniumbromid, pentapiperid, pentienatbromid, fenkarbamid, fenglutarimid, pipenzolatbromid, piperidolat, piperilat, poldinmetylsulfat, pridinol, prifiniumbromid, procyklidin, propantelinbromid, propenzolat, propyromazin, skopolamin, skopolamin N-oksid, stiloniumiodid, stramonium, sultroponium, tiheksinol, tifenamil, tiemoniumiodid, timepidiumbromid, tiquiziumbromid, tridiheketyliodid, triheksyfenidylhydroklorid, tropacin, tropenzil, tropikamid, trospiumklorid, valetamatbromid og xenytropiumbromid. 30. Anti-krampemidler slike som acetyl fen etyrid, albutoin, aloksidon, aminoglutetimid, 4-amino-3-hydroksysmørsyre, atrolaktamid, beklamid, buramat, kalsiumbromid, karbamazepin, kinromid, klometiazol, klonazepam, decimemid, dietadion, dimetadion, doksenitoin, eterobarb, etadion, etosuksimid, etotoin, fluoreson, garbapentin, 5-hydroksytryptofan, lamotrigin, lomaktil, magnesiumbromid, magnesiumsulfat, mefenytoin, mefobarbital, metarbital, metetoin, metsuksimid, 5-metyl-5-(3-fenantryl)hydantoin, 3-metyl-5-fenylhydantoin, narkobarbital, nimetazepam, nitrzepam, parametadion, fenacemid, fenetarbital,
feneturid, fenobarbital, fenobarbitalnatrium, fensuksimid, fenylmetylbarbituratsyre, fenytoin, fetenylatnatrium, kaliumbromid, pregabatin, primidon, progabid, natriumbromid, natriumvalproat, solanum, strontiumbromid, suklofenid, sultiam, tetrantoin, tiagabin, trimetadion, valproatsyre, valpromid, vigabatrin og zonisamid.
31. Antidepressive midler inkludert:
bicykliske slike som binedalin, karboksazon, citalopram, dimetazan,
indalpin, fencamin, fluvokaminmaleat, indeloksazinhydroklorid, nefopam, nomifensin, oksitriptan, okypertin, paroksetin, sertralin, tiazesim, trazodon, venlafaksin og zometapin;
hydrazider/hydraziner slike som benmoksin, iproklozid, iproniazid, isokarboksazid, nialamid, oktamoksin og fenelzin;
pyrrolidoner slike som kotinin, rolikyprin og rolipram;
tetracykliner slike som maprotilin, metralindol, mianserin og oksaprotilin.
tricykliske slike som adinazolam, amitriptylin, amitriptylinoksid, amokapin, butriptylin, klomipramin, demeksiptilin, desipramin, dibenzepin, dimetracrin, dotiepin, doksepin, fluacizin, imipramin, imipramin N-oksid, iprindol, lofepramin, melitracen, metapramin, nortriptylin, noksiptilin, opipramol, pizotylin, propizepin, protriptylin, kinupramin, tianeptin og trimiprmin; og
andre slike som adrafinil, benaktyzin, bupropion, butacetin, deanol, deanolaceglumat, deanolacetamidobenzoat, dioksadrol, etoperidon, febarbamat, femoksetin, fenpentadiol, fluoksetin, fluvokamin, hematoporfyrin, hypercinin, levofacetoperan, medifoksamin, minaprin, moklobemid, oksaflozan, piberalin, prolintan, pyrisuccideanol, rubidiumklorid, sulpirid, sultoprid, teiloksazin, tozalinon, tofenacin, tolokaton, tranylcypromin, L-tryptofan, viloksazin og zimeldin.
32. Anti-diabetesmidler inkludert:
biguanider slike som buformin, metforming og fenformin;
hormoner slike som glukagon, insulin, insulininjeksjon, insulinsinksuspensjon, isofaninsulinsuspensjon, protaminsinkinsulinsuspensjon og sinkinsulinkrystaller;
sulfonylureaderivater slike som acetoheksamid, l-butyl-3-metanilylurea, karbutamid, klorpropamid, glibornurid, gliklazid, glipizid, gliquidon, glisoxepid,
glyburid, glybutiazol(er), glybuzol, glyheksamid, glymidin, glypinamid, fenbutamid, tolazamid, tolbutamid og tolcyklamid; og
andre slike som akarbose, kalsiummesoksalat og miglitol.
33. Antidiarémedikamenter slike som acetylgarvesyre, albumintannat, alkofanon, aluminmmsalicylater - basisk, katekin, difenoksin, difenoksylat, lidamidin, loeramid, mebikin, trillium og uzarin. 34. Antivanndrivende midler slike som desmopressin, felypressin, lypressin, ornipressin, oksycinchofen, hypofyse - posterior, terlipressin og vasopressin. 35. Antiøstrogenmidler slike som delmadinonacetat, etamokytrifetolm, tamoksifen og toremifen.
36. Antisoppmedikamenter (antibiotika), inkludert:
polyener slike som amfotericin-B, kandicidin, dermostatin, filipin, fungikromin, hakimycin, hamycin, lukensomycin, mepartricin, natamycin, nystatin, pecilocin og perimycin; og
andre slike som azaserin, griseofulvin, oligomyciner, neomycin, undecylenat, pyrrolnitrin, siccanin, tubercidin og viridin.
37. Antisoppmedikamenter (syntetiske), inkludert:
allylaminer slike som naftifin og terbinafin;
imidazoler slike som bifonazol, butoksonazol, klordantoin, klormidazol, klokonazol, klotrimazol, ekonazol, enilkonazol, fentikonzol, isokonazol, ketokonazol, mikonazol, omokonazol, oksikonazol, nitrat, sulkonazol og tiokonazol;
triazoler slike som flukonazol, itrakonazol og terkonazol; og
andre, slike som aknsorcin, amorolfin, bifenamin, bromsalicylkloranilid, buklosamid, kalsiumpropionat, klofenesin, ciklopiroks, kloksykin, koparaffinat, diamtazol, dihydroklorid, eksalamid, flucytosin, haletazol, heketidin, loflukarban, nifuratel, kalsiumiodid, propionsyre, pyrition, salicylanilid, natriumpropionat, sulbentin, tenonitrozol, tolciklat, tolindat, tolnaftat, tncetin, ujotion, undercylensyre og sinkpropionat.
38. Anti-grønn stærmedikamenter slike som acetazolamid, befunolol, betaksolol, bupranolol, karteolol, dapiprazok, diklorfenamid, dipivefrin, epinefrin, levobuolol, metazolamid, metipranolol, pilokarpin, pindolol og timolol. 39. Anti-gonadotrofinmidler slike som danazol, gestrinon og paroksypropion. 40. Anti-giktmedikamenter slike som allopurinol, karprofen, kolchisin, probenecid og sulfinpyrazon.
41. Atihistaminer, inkludert:
alkylaminderivater slike som akrivastin, bamipin, bromfeniramin, klorfeniramin, dimetinden, metron S, feniramin, pyrrobutamin, tenaldin, tolpropamin og triprolidin;
aminoalkyletere slike som bietanautin, bromodifenydramin, karbinoksamin, klemastin, difenylypyralin, doksylamin, embramin, medrylamin, mefenfydramin, p-metyldifenydramin, ofrenadrin, fenyltoloksamin, piprinhydrinat og setasin;
etylendiaminderivater slike som alloklamid, p-bromtripelennamin, kloropyramiri, kloroten, histapyrrodin, metafurylen, metafenilen, metapyrilen, fenbenzamin, pynlamin, talastin, tenyldiamin, tonzylaminhydroklorid, tripelennamin og zolamin;
piperaziner slike som cetirizin, klorcyklizin, cinnarizin, klocinizin og hydrokzin;
tricykliske, inkludert:
fenotiaziner slike som ahistan, etymemazin, fenetazin, N-hydroksyetyl-prometazin, klorid, isoprpmetazin, mequitazin, promoetazin, pyratiazin og tiazinamiummetylsulfat; og
andre slike som azatadin, klobenzepam, cyproheptadien, deptropin, isotipendyl, loratadin og protipendyl; og
andre antihistaminer slike som antazolin, astemizol, azelastin, cetoksim. klemizol, klobenztropin, difenazolin, difenhydramin, fluticason, propionat, mebhydrohn, fenindamin, terfenadin og tritoqualin.
42. Antihyperlipoproteinmidler, inkludert:
aryloksyalkansyrederivater slike som beklorbrat, bazafibrat, binifibrat, kiprofibrat, klinofibrat, klofibrat, klofibrilsyre, etonfibrat, fenofibrat, gemfibrozil, nikofibrat, pirifibrat, ronifibrat, simfibrat og teofibrat: gallesyrekompleksdannere slike som kolestyraminresin, kolestipol og polideksid;
HMG CoA reduktaseinhibitorer slike som fluvastatin, lovastatin, pravastatinnatrium og simvastatin;
nikotinsyrederivater slike som aluminiumnikotinat, acipimoks, nikeritrol, nikoklonat, nikomol oksiniacinsyre;
tyroidhormoner og analoger, slike som etiroksat, tyropropsyre og tyroksin; og
andre, slike som akifran, azakosterol, benfluoreks, (3-benzalbutyramid, karnitin, kondroitinsulfat, klomeston, dekstran, dekstransulfatnatrium, 5, 8, 11, 14, 17-eikosafpentaensyre, eritadenin, furazbol, meglutol, melinamid, mytatrienedol, ornitin, y-oryzanol, pantetin, penataerytritoltetraacetat, cc-fenulbutyramid, pirozadil, probukol, a-sitosterol, sultosilsyre, piperazinsalt, tiadenol, triparanol og xenbucin.
43. Medikamenter mot høyt blodtrykk inkludert:
aryletanolaminderivater slike som amosulalol, bufuralol, dilevalol, labetalol, pronetalol, sotalol og sulfinalol; aryloksypropanolaminderivater slike som acebutolol, alprenolol, arotinolol,
atenolol, betaksolol, bevantolol, bisoprolol, bopindolol, bunitrolol, bupranolol, butofilolol, karazolol, kartezolol, karvedilol, celiprolol, cetamolol, epanolol, indenolol, mepindolol, metipranolol, metoprolol, moprolol, nadolol, nipradilol, oksprenolol, penbutolol, pindolol, propranolol, talinolol, tetraolol, timolol og toliprolol; benzotiadiazinderivater slike som altuiazid, bendroflumetiazid, benztiazid, benzylhydroklorotiazid, butiazid, klorotiazid, klorlalidon, cyklopentiazid, cyklo-tiazid, diazoksid, epitiazid, etiazid, fenquizon, hydroklorotiazid, hydroflumetiazid, metylklotiazid, metikran, metolazon, paraflutizid, polytiazid, tetrakl orm etiazid og triklormetiazid; N-karboksylalkyl (peptid/laktam) derivater slike som alacepril, kaptopril, cilazapril, delapnl, enalapril, enalaprilat, fosinopnl, lisinopril, moveltipril, perindopril, kinapril og ramipril; dihydropyridindenvater slike som amlodipin, felodipin, isradipin, nikardipin, nifedipin, nilvadipin, nisoldipin og nitrendipin; guanidinderivater slike som betanidin, debrisokin, guanabenz, guanaklin, guanadrel, guanazodin, guanetidin, guanfacin, guanklor, guanoksabenz og guanoksan; hydraziner og ftalaziner slike som budralazin, kadralazin, dihydralzin, endralazin, hydrakarbazin, hydralazin, feniprazin, pildralazin og todralazin; imidazolderivater slike som klonidin, lofeksidin, fentolamin, fentol-aminmesylat, tiamenidin og tolonidin; kvaternære ammoniumforbindelser azametoniumbromid, klorisondaminklorid, heksametonium, pentacynium bis(metylsulfat), pentametoniumbromid, pentolimumtartat, fenaktopiniumklorid og trimetidiunummetosulfat; kinazolinderivater slike som alfuzosin, bunazosin, dokazosin, prasosin, tetrazosin og trimazosin; reserpinderivater slike som bietaserpin, desrpidin, rescinnamin, reserpin og syrosingopin; sulfonamidderivater slike som ambusid, klopamid, furosemid, indapamid, kinetazon, tripamid og xipamid; og andre, slike som ajmalin, y-aminosmørsyre, bufeniod, kandesartan, klor-talidon, cicletain, ciclosidomin, kryptenamintannater, eprosartan, fenoldopan, flosekinan, indoramin, irbesartan, ketanserin, losartan, metbutamat, mecamylamin, metyldopa, metyl 4-pyridylketontiosemikarbarzon, metolazon, minoksidil, muzolimin, pargylin, pempidin, pinacidil, piperoksan, primaperon, protoveratriner, raubasin, reskimetol, rilmeniden, saralsin, natriumnitroprussid, tikrynafen, trimetafankamsylat, tyrosinase, urapidil og valsartan. 44. Antihypertyroidmidler slik som 2-amino-4-metyltiazo1, 2-aminotiazol, karbimazol, 3,5-dibrom-L-tyrosin, 3,5-diiodotyrosin, hinderin, iodin, iotiural, metiamazol, metyltiouracil, propyltioyracil, natnumperklorat, tibenzazolin, tiobarbital og 2-tiouracil. 45. Antihypolensive medikamenter slike som ameziniummetylsulfat, angiotensinamid, dimetofrin, dopamin, etifelmin, etilferin, gepefrin, metaraminol, midodrin, norepinefrin, foledrinead og syneprin. 46. Anti-hypotyroidmedikamenter slike som levotyroksinnatrium, liotyronin, tyroid, tyroidin, tyroksin, tiratrikol og TSH. 47. Anti-inflammatoriske (ikke-steroid) medikamenter, inkludert: aminoarylkarboksylsyrederivater slike som enfenamsyre, etofenamat, flufenamsyre, isoniksin, meklofenamsyre, mefansyre, niflumsyre, talniflumat, terofenamat og tolfenamsyre;
aryleddiksyrederivater slike som acemetacin, alkofenak, amfenak, bufeksamak, cinmetacin, klopirak, d i kl ofenakn atrium, etodolak, felbinak, fenklofenak, fenklorak, fenclozsyre, fentiazak, glukametacin, ibufenac, indometacin, isofezolak, isoksepak, lonazolak, metiazinsyre, oksametacin, proglumetacin, sulindak, tiaramid, tolmetin og zomepirak;
arylsmørsy reden vater slike som bumadizon, butibufen, fenbufen og xenbucin;
arylkarboksylsyrer slike som klidanak, ketorolak og tinoridin;
arylpropionsyrederivater slike som alminoprofen, benoksaprofen, buklokssyre, karprofen, fenoprofen, flunokaprofen, flurbiprofen, ibuprofen, ibuproksam, indoprofen, ketoprofen, loksoprofen, miroprofen, naproksen, oksaprozin, piketoprofen, pirprofen, pranoprofen, protizinsyre, suprofen og tiaprofensyre;
pyrazoler slike som difenamizol og epirizol;
pyrazoloner slike som apazon, benzpiperylon, feorazon, mofebutazon, morazon, oksyfenbutazon, fenybutazon, pipebuzon, propyfenazon, ramifenazon, suksibuzon og tiazolinobutazon;
salicylsyrederivater slike som acetaminosalol, aspirin, benorylat, bromsaligenin, kalsiumacetylsalicylat, diflunisal, etersalat, fendosal, gentisyre, glykolsalicylat, imidazolsalicylat, lysinacetylsalicylat, mesalamin, morfolinsalicylat, 1-naftyl, salicylat, olsalazin, parsalmid, fenylacetylsalicylat, fenylsalicylat, salacetamid, salicylamin O-acetiksyre, salicylsvovelsyre, salsalat og sulfasalazin;
tiazinkarboksamider slike som droksikam, isoksikam, piroksikam og tenoksikam; og
andre, slike som e-acetamidokaprosyre, S-adenosylmetionin, 3-amino-4-hydroksysmørsyre, amiksetrin, bendazak, benzydamin, bukolom, difenpiramid,
ditazol, emorfazon, guaiazulen, nabumeton, nimesulid, orgotein, oksaceprol, paranylin, perisoksal, pifoksim, proquazon, proksazol og tenidap. 48. Anti-malariamedikamenter slike som acedapson, amodiakin, arteeter, artemeter, artemisinin, artesunat, bebeerin, berberin, chirata, klorguanid, klorokin, klorproguanil, cinchona, cinchonidin, cinchonin, cykloguanil, gentiopikrin, halofantrin, hydroksyklorokin, meflokinhydroklond, 3-metylarsacetin, pamakin, plasmocid, primakin, pyrimetamin, kinakrin, kinin, kininbisulfat, kininkarbonat, kinindihydrobromid, kinindihydroklorid, kininetylkarbonat, kininformat, kinin-glukonat, kininhydrodid, kininhydroklorid, kininsalicylat, kininsulfat, kinintannat, kininreahydroklond, kinocid, kinolin og natnumarsenatdiabasik. 49. Anti-migrenemedikamenter slike som alpiroprid, dihydroergotamin, eletriptan, ergokornin, ergokorninin, ergokryptin, ergot, ergotamin, flumedrokson-acetat, fonazin, lisurid, metysergid(er), naratriptan, oksetoron, pizotylin, nzatriptan og sumatriptan. 50. Anti-kvalmemedikamenter slike som acetylleucinmonoetanolamin, alizapnd, benzkinamid, bietanautin, bromoprid, buclizin, klorpromazin, kleboprid, cyklizin, dimenhydrinat, difeniodol, domperidon, granisetron, meklizin, metalltal, metoklopramid, metopimazin, nabilon, ondansteron, oksypendyl, pipamazin, piprinhydrinat, proklorperazin, skopolamin, tetrahydrokannabinoler, tietylperazin, tioproperazin og trimetobenzamid.
51. Anti-neoplastiske medikamenter, inkludert:
alkylerende agens, inkludert:
alkylsulfonater slike som busulfan, improsulfan og piposulfan;
azindiner slike som benzodepa, karbokon, meturedepa og uredepa;
etyleniminer og metylmelaminer slike som altretamin, trietylenmelamin, trietylenfosforamid, trietylentiofosforamid og trimetylolomelamin;
nitrogensenneper slike som klorambucil, klornafazin, cyklofosfamid, estramustin, ifosfamid, mekloretamin, mekloretaminoksidhydroklorid, melfalan, novembichin, fenesterin, predinimustin, trofosfamid og uracilsennep;
nitrosoureaforbindelser slike som karmustin, klorozotocin, fotemustin, lomustin, nimustin og ranimustin; og
andre, slike som kamptotecin, dakarbazin, mannomustin, mitobronitol, mitolaktol og pipobroman;
antibiotika slike som aklacinomyciner, aktinomycin Fi, antramycin, azaserin, bleomyciner, dakinomycin, daunorubicin, 6-diazo-5-okso-L-norleucin, doksorubicin, epirubicin, mitomyciner, mykofenolsyre, nogalamycin, olivomyciner, peplomycin, plikamycin, porfiromycin, puromycin, streptonigrin, streptozocin, tunercidin, ubenimeks, zinostatin og zorubicin;
antimetabolitter, inkludert:
folsyreanaloger slike som denoterin, metotreksat, pteropterin og trimetrekat;
purinanaloger slike som fludarabin, 6-merkaptopurin, tiamiprin og tioguanain; og
pyridinanaloger slike som ancitabin, azacitidin, 6-azayridin, karmofur, cytarabin, doksifluridin, enocitabim, floksuridin, fluroouracil og tegafur;
enzymer slike som aceglaton, amsakrin, bestrabucil, bisantren, bryostatin 1, karboplatin, cisplatin, defofamid, demekolcin, diaziquon, elfornitin, elliptinium-acetat, etoglucid, etoposid, gal Hum nitrat, hydroksyurea, interferon-a, interferon-|3, interferon-y, interleukin-2. lentinan, letrozol, lonidamin, mitoguazon, mitoksantron, mopidamol, nitracnn, pentostatin, fenamet, pirarubicin, podofyllinsyre, 2-etylhydrazid, polynitrokubaner, prokarbazin, PSK7, razoksan, sizofiran, spirogermanium, taksol, teniposid, tenuazonsyre, triaziquon, 2,2',2"-trikolrotri-etylamin, uretan, vinblastin, vinkristin, vindesin og vinorelbin.
52. Anti-neoplastiske (hormonelle) medikamenter, inkludert:
androgener slike som kalusteron, dromostanolonpropionat, epitiostanol, mepitiostan og testolakton; anti-binyreforbindelser slike som aminoglutetimid, mititan og trilostan; anti-endrogene forbindelser, slike som flutamid og nilutamid; og anti-lstrogene forbindelser slike som tamoxifen og toremifen. 53. Anti-neoplastiske adjuvantia inkludert folsyrepåfyllere slike som frolinsyre. 54. Anti-parkinsonmedikamenter slike som amantadin, benserazid, bietanautin, biperiden, bromkriptin, budipin, kabergolin, karbidopa, deprenyl (a/k/a L-deprenyl, L-deprenil, L-deprenalin og selegilin), dekstimid, deitazin, difenhydramin, droksidopa, etopropazin, etylbenzhydramin, levodopa, nakagolid, pergolid, piroheptin, pramipeksol, pridinol, prodipin, kinpirol, remacemid, ropinirol, tergund, tigloidin og triheksyfenidylhydroklorid. 55. Antifeokromocytom medikamenter slike som metyrosin, fenoksybenzamin og fentolamin. 56. Anti-lungecystiske medikamenter slike som effornitin, pentamidin og sulfametoksazol. 57. Anti-prostata hypertrofiske medikamenter slike som kaproat, mepartricin, oksendolon og proskar 7. 58. Anti-protozomedikamenter (leshmania) slike som antimonnnatriumglukonat, etylstibamin, hydroksystilbamidin, N-metylglukamin, pentamidin, stilbamidin og ureastilbamin. 59. Anti-proteozomedikamenter (trikomonas) slike som acetarson, aminitrozol, anisomycin, azanidazol, forminitrazol, furazolidon, hachimycin, lauroguadin, mepartiricin, metronidazol, nifuratel, nifuroksim, nimorazol, secnidazol, sølvpikrat, tenonitrozol og tinidazol. 60. Anti-protozomedikamenter (trypanosma) slike som benznidazol, eflornitin, melarsoprol, nifurtimoks, oksofenarsin, hydroklorid, pentamidin, propamidin, puromycin, kinapyramin, stilbamidin, suraminnatrium, trypan rød og tryparasmid. 61. Antirensemidler (puritics) slike som kamfer, cyproheptadin, diklorison, glycin, halometason, 3-hydroksykamfer, mentol, mesulfen, metdilazin, fenol, polidokanol, risokain, kamfersprit, tenaldin, tolpropamin og trimeprazin. 62. Anti-psoriasismedikamenter slike som acitretin, ammoniumsalicylat, anralin, 6-azauridin, bergapten(er), krysarobin, etretinat og pyrogallol.
63. Anti-psykotiske medikamenter inkludert:
butyrofenoner slike som benperidol, bromperidol, droperidol, fluanison, haloperidol, melperon, moperon, pipamperon, sniperon, timiperon og trifluperidol; fenotiaziner slike som acetpfenazin, butaperazin, karfenazin, klorproetazin,
klorpromazin, klospirazin, cyamemazin, dikyrazin, flufenazin, imiklopazin, mepazin, mesoridazin, metoksypromazin, metofenazat, oksaflumazin, perazin, pericyazin, perimetazin, perfenazin, piperacetazin, pipotiazin, proklorperazin, promazin, sulforidazin, tioproazat, tioridazin, trifluoperazin og triflupromazin; tioksantener slike som klorprotiksen, klopentiksol, flupentiksol og tiotiksen; andre tricykliske midler slike som benzkinamid, karpipramin, klokaprimin, klomacran, klotiapin, klozapin, opipramol, protipendyl, tetrabenazin, og zotepin; og andre, slike som alizaprid, amisulprid, buramat, fluspinlen, molindon, penfluridol, pimozid, spirilen og sulpirid. 64. Anti-febermidler slike som acetaminofen, acetaminosalol, acetanilid, aconin, aconit, aconitin, alkofenak, aluminium bis(/acetylsalicylatl, aminoklortenoksazin, aminopyrin, aspirin, benorylat, benzydamin, berberin, p-brom-acetanilid, bufeksamak, bumadizon, kalsiumacetysalicylat, klortenokazin(er), cholinsalicylat, klidanak, dihydroksyaluminumacetylsalicylat, dipyrocetyl, dipyron, epirizol, etersalat, imidazolsalicylat, indometacin, isofezolak, p-laktofenetid, lysinacetylsalicylat, magnesiumacetylsalicylat, meklofenamsyre, morazon, morfolinsalicylat, naproksen, nifenazon, 5'-nitro-2'-propoksyacetanilid, fenaktin, fenikarbazid, fenokoll, fenopyrazon, fenylacetylsalicylat, fenylsalicylat, pipebuzon, propacetamol, propyfenazon, ramifenazon, salacetamid, salicylamid O-eddiksyre, natriumsalicylat, sulfamipyrin, tetrandrin og tinoridin. 65. Anti-rickettsiamedikamenter slike som p-aminobenzosyre, kloramfenikol, kloramfenikolpalmitat, kloramfenikolpantotenat og tetracyklin. 66. Anti-seborré medikamenter slike som kloroksin, 3-O-lauroylpyridoksoldi-acetat, pirocton, pyntion, resorcinol, seleniumsulfider og tioksolon.
67. Antiseptika, inkludert:
guanidiner slike som aleksidin, ambazon, klorheksidin og pikloksydin; halogener og halogenforbindelser slike som bismut, lodidoksid, bismutiodosubgallat, bismuttribromofenat, bornylklorid, kalsiumiodat, klorinert kalk, kloflukarban, flurosalan, iodsyre, iodin, iodinmonoklorid, iodintriklorid, iodoform, metenamintetraiodin, oksyklorosen, povidon-iodin, natriumhypoklorit, natriumiodat, symklosene, tymoliodin, triklokarban, triklosan og troklosenkalium; kvikksølvforbindelser slike som hydragafen, meraleinnatnum, merbromin, kvikksølvklorid, kvikksølvklorid, ammoniated, kvikksølvnatrium p-fenolsulfonat, kvikksølvsuksinimid, kvikksølvsulfid, rød, merkurofen, kvikksølvacetat, kvikksølv-klorid, kvikksølviodid, nitromersol, kaliumtetraiodkvikksølv(ll), kalium-tniodokvikksølv(II) oppløsning, timerfonatnatrium og timerosal; nitrofuraner slike som furazolidon, 2-(metoksymetyl)-5-nitrofuran, nidrokyzon, nifuroksim, nifurzid og nitrofurazon; fenoler slike som acetomeroktol, bitionol, kadmiumsalicylat, carvacrol, kloroksylenol, klorofen, kresot, kresol(er), p-kresol, fentiklor, heksaklorofen, 1-naftylsalicylat, 2-naftylsalicylat, 2,4,6-tribromo-m-kresol og 3',4',5-trikloro-salicylanilid; Kinoliner slike som aminokinurid, benzoksikin, broksykinolin, kloroksin, klorkinaldol, kloroksykin, etylhydrokuprein, euprocin, halkinol, hydrastin, 8-hydroksykinolin, 8-hydrokskinolinsulfat og iodoklorhydroksykin; og andre slike som aluminiumsulfat, 3-amino-4-hydroksysmørsyre, borsyre, klorheksidin, kloroazodin, m-kresylacetat, kupriksulfat, dibromopropamidin, lchthammol, negatol7, noksytiolin, ornidazol, |3-propiolaktin, a-terpineol. 68. Anti-spasmemedikamenter slike som alibendol, ambucetamid, amino-promazin, apoatropin, bevoniummetylsulfat, bietamiverin, butaverin, butropiumbromid, N-butylscopolamminiumbromid, karoverin, cimetropiumbromid, cinnamedrin, kleboprid, coniinhydrobromid, coniinhydroklorid, cukloniumiodid, diferamin, diisopromin, dioksafetylbutyrat, diponiumbromid, drofenin, emeproniumbromid, etaverin, feklemin, fenalamid, fenoverin, fenpipran, fenpiverinumbromid, fentoniumbromid, flavoksat, flopropion, glukonsyre, guaiaktamin, hydramitrazin, hymekromon, leiopyrrol, mebeverin, moksaverin, nafiverin, oktamylamin, oktaverin, pentapiperid, fenamacidhydroklorid, floro-glucinol, pinaveriumbromid, piperilat, pipoksolanhydroklorid, pramiverin, prifiniumbromid, properidin, propivan, propyromazin, prozapin, racefemin, rociverin, spasmolytol, stiloniumiodid, sultroponium, tiemioniumiodid, tiquiziumbromid, tirporamid, trepibuton, trikromyl, trifolium, trimebutin,
N,N-ltrimetyl-3,3-difenyl-propylamin, tropenzil, trospiumklorid og xenytropiumbromid. 69. Anti-trombosemedikamenter slike som anagrelid, argatroban, cilostazol, krysoptin, daltroban, defibrotid, enoksaparin, fraksiparin7, indobufen, lamoparan, ozagrel, pikotamid, plafibrid, reviparin, tedelparin, tiklopidin, triflusal og warfarin. 70. Anli-hostemedikamenter slike som allokamid, amicibon, benproperin, benzonatat, bibenzoniumbromid, bromoform, butamirat, butetamat, karamifenetan-disulfonat, karbetapentan, klofedianol, klobutinol, kloperastin, kodein, kodeinmetylbromid, kodein N-oksid, kodeinfosfat, kodeinsulfat, cykleksanon, dekstrometorfan, dibunatnatrium, dihydrokodein, dihydrokodeinonenolacetat, dimemorfan, dimetoksanat, a,a-difenyl-2-pipendinpropanol, dropropizin, drotebanol, eprazinon, etyldibunal, etylmorfin, fominoben, guiaiapat, hydrokodon, isomainil, levopropoksyfen, morklofon, narcein, normetadon, noskapin, okseladin, oksolamin, folkodin, pikoperin, pipazeat, piperidion, prenoksidiazinhydroklorid, racemetorfan, taziprinonhydroklorid, tipepidin og zipeprol. 71. Anti-ukerøsemedikamenter slike som aceglutamidaluminiumkompleks, e-acetamidokaproinsyresinksalt, acetoksolon, arbaprostil, beneksathydroklorid, bismutsubcitratsol (tørket), karbenoksolon, cetraksat, cimetidin, enprostil, esaprazol, famotidin, ftaksilid, gefarnat, guaiazulen, irsogladin, misoprostol, nizatidin, omeprazol, ornoprostil, y-oryzanol, pifarnin, pirenzepin, plaunotol, ranitidin, rioprostil, rosaprostol, rotraksat, roksatidinacetat, sofalkon, spizofuron, sukralfat, teprenon, trimoprostil, tritiozin, triksipid og zolimidin. 72. Anti-urologiske medikamenter slike som acetohydroksamsyre, allopurinol, kaliumcitrat og succinimid.
73. Antivenin medikamenter slik som lyovac7,antivenin.
74. Antivirale medikamenter, inkludert:
puriner og pyrimidioner slike som acyklovir, cytarabin, dideoksyadenosin, dideoksycytidin, dideoksyinosin, edoksudin, floksuridin, ganciklovir, idoksuridin, inosinpranobex, MADU, penciklovir, trifluridin, vidrarbin og zidovudiin; og
andre slike som acetylleucinmonoetanolamin, amantadin, amidinomycin, kosalan, kuminaldehydtiosemikarbzon, foskarnetnatrium, imiquimod, interferon-a, interferon-P, interferon-y, ketoksal, lysozym, metisazon, moroksydin, podofyllo-toksin, ribavirin, rimantadin, stallimycin, statolon, tromantadin og xenazoisyre.
75. Beroligende medikamenter inkludert:
arylpiperaziner slike som buspiron, gepiron, ipsapiron og tondospiron.
benzodiazepinderivater slike som alprazolam, bromazepam, kamazepam, klordiazepoksid, klobazam, korazepat, chotiazepam, kloksazolam, diazepam,
etylloflazepat, etizolam, fluidazepam, flutazolam, flutoprazepam, halazepam, ketazolam, lorazepam, loksapin, medazepam, metaklazepam, meksazolam, nordazepam, oksazepam, oksazolam, pinazepam, prazepam og tofisopam;
karbamater slike som cyklarbamat, emylkamat, hydroksyfenamat, mepro-bamat, fenoprobamat og tybamat; og
andre slike som alpidem, benzoktamin, kaptodiamin, klormezanon, etifoksin, flesinoksan, fluoreson, glutaminsyre, hydroksyzin, lesoptiron, mekloralurea, mefenoksalon, mirtrazepin, oksanamid, fenaglykodol, suriklon og zatosetron.
76. Benzodiazepinantagonister slik som flumazenil.
77. Bronkodilatorer, inkludert:
efedrinderivater slike som albuterol, bambuterol, bitolterol, karbuterol,
klenbuterol, klorenalin, dioksetedrin, efedrin, epinifrin, eprozinol, etafedrin, etylnorepinprin, fenoterol, heksoprenalin, isoetarin, isoproterenol, mabuterol, metaproterenol, N-metylefedrin, pirbuterol, prokaterol, protokylol, reproterol, nmiterol, salmeterol, soterenol, terbutalin og tulobuterol;
kvaternære ammoniumforbindelser slike som bevoniummetylsulfat, kl utropi umbromid, ipratropiumbromid og oksitropiumbromid;
xantinderivater slike som acefyllin, acefyllinpiperazin, ambufyllin, aminofyllin, bamifyllin, kolin, teofyllinat, doksofyllin, dyfyllin, enprofyllin, etamifyllin, etofyllin, guaithyllin, proksyfyllin, teobromin, 1-teobromineddik syre og teofyllin; og
andre slike som fenspirid, medibazin, montekulast, metoksyfenanim, tretokinol og zafirkulast.
78. Kalsiumkanalblokkere, inkludert:
arylalkylaminer slike som bepridil, ditiazem, fendilin, gallopanil, prenylamin, terodilin og verapamil; dihydropryridinderivater slike som felodipin, isradipin, nikardipin, nifedipin, nilvadipin, nimodipin, nisoldipin og nitrendipin; piperazinderivater slike som cinnarizin, flunarisin og lidoflazin; og andre slike som benzyklan, etefenon og perheksilin. 79. Kalsiumregulatorer slike som kalcifediol, kalcitonin, kalsitriol, klodronsyre, dihydrotakysterol, elkatonin, etidronsyre, ipriflavon, pamidronsyre, paratyroid-hormon og teriparatidacetat. 80. Hjertestyrkende midler slike som acefyllin, acetyldigititoksiner, 2-amino-4-pikolin, amrinon, benfurodilhemisuksinat, buklasdesin, cerberosid, kampfotamid, konvallatoksin, cymarin, denopamin, deslanosid, ditalin, digitalis, digitoksin, digoksin, dobutamin, dopamin, dopeksamin, enoksimon, erytroflein, fenalkomin, gitalin, gitoksin, glykocyamin, heptaminol, hydrastinin, ibopamin, lanotodiser, metamivam, milrinon, neriifolin, oleandrin, ouabain, oksyfedrin, prenalterol, proscillaridin, resibufogenin, scillaren, scillarenin, strofantin, sulmazol, teobromin og xamoterol. 81. Chelaterende agens slike som deferozmin, ditiokarbnatrium, edetat, kalsiumdinatrium, edetatdinatrium, edetatnatrium, edetattrinatrium, penicillamin, pentetatkalsiumtrinatrium, pentektinsyre, succimer og trientin;
82. Gallecystokininantagonister slik som proglumid.
83. Gallesteinoppløsende agens slik som chenodiol, metyltertbutyleter, monooktanoin og ursodiol. 84. Gallemidler slike som alibendol, anetol, trition, azintamid, kolsyre, cicrotosyre, klanobutin, cyklobutyrol, cyklovalon, cynarin(er), dehydrokolsyre, deoksykolsyre, dimetkrotsyre, a-etylbenzylalkohol, eksiproben, feguprol, fencibutirol, fenipentol, florantyron, hymekromon, menbuton, 3-(o-metoksyfenyl)-2-fenylakrylsyre, metoochalkon, moquizon, osalmid, oksbilleekstrakt, 4,4'-oksydi-2-butanol, piprozolin, prozapin, 4-salicyloylmorfolin, sincalid, taurocholsyre, timonacic, tokamfyl, trepibuton og vanitiolid. 85. Kolinerge agens slike som aceklidin, acetylkolin, bromid, acetylkolidklorid, aklatoniumnapadisilat, benzpyriniumbromid, betankolklorid, karbakol, karpronium-klorid, demekariumbromid, dekspantenol, diisopropylparaokson, ekotiofatiodid, edrofomiumklorid, esendin, furtretonium, isoflurofat, metakolinklorid, muskarin, neostigmin, oksapropaniodid, fysostigmin og pyridostigminbromid. 86. Kolinesteraseinhibitorer slike som ambenoniumklorid, distigminbromid og galantamin. 87. Kolinesterasereaktivatorer slike som obidoksiminklorid og pralidoksim-klorid. 88. Sentralnervesystemstimulerende midler og agens slike som amineptin, amfetimin, amfetaminil, beegrid, benzfetamin, brucin, kaffein, klorfentermin, klofenciclan, klortermin, koka, emanylfosfat, deksoksadrol, dekstroamfetaminsulfat, dietlorpion, N-etylamfetamin, etamivan, etifelmin, etryptamin, fenkamfamin, fenetyllin, fenosolon, flurotyl, galantamin, heksacyklonatnatrium, homokamfin, mazindol, megeksamid, methamfetamin, metylfenidat, niketamid, pemolin, pentylentetrazol, fenidimetrazin, fenmetrazin, fentermin, pikrotoksin, pipradrol, prolintan og pyrovaleron. 89. Avsvellende midler slike som amidefrin, kafaminol, cyklopentamin, efedrin, epinefrin, fenoksazolin, indanazolin, metizolin, nafazolin, nordefrinhydroklorid, oktodrin, oksymetazolin, fenylprinhydroklorid, fenylpropanol-aminhydroklorid, fenylpropylmetylamin, propylheksidrin, pseudoefedrin, letrahydrozohn, tymazolin og xylometazolin.
90. Tannmidler, inkludert:
bisfosfonater (anti-periodontal sykdom og benresorpsjon) slike som alendronat, klodronat, etidronat, pamidronat og tiludronat; karriesprofylaktiske midler slike som arginin og natrium fluorid;
desensitiserende agens slike som kaliumnitrat og citratoksalat.
91. Avpigmenterende midler slike som hydrokinin, hydrokionon og monobenzon.
92. Vanndrivende midler inkludert:
organiske kvikksølvmidler slike som klormerodnn, merallurid, merkamfamid, merkaptomerinnatrium, merkumallylsyre, merkumatilinnatrium, merkurousklorid og mersalyl; pteridiner slike som furterende og triamterende; puriner slike som acefyllin, 7-morfolinometylteofyllin, pamabrom, proteobromin og teobromin; steorider slike som canrenon, oleandrin og spironolakton; sulfonamidderivater slike som acetazolmid, ambusid, azosemid, bumetanid, butazolamid, kloraminofenamid, klofenamid, klopamid, kloreksolen, difenylmetan-4,4'-disulfonamid, disulfamid, etoksyzolamid, furosemid, indapamid, mefrusid, metazolamid, piretanid, kinetazon, torasemid, tripamid og zipamid; uraciler slike som aminometradin og amisometradin; andre slike som amanozin, amilorid, arbutin, klorazanil, etakrynsyre, etozolin, hydrakarbazin, isosorbid, mannitol, metokalkon, muzolimin, perheksilin, trikrynafen og urea. 93. Dopaminreseptoragonister slike som bromokntin, dopeksamin, fenoldopam, ibopamin, lisurid, naksagolid og pergolid. 94. Ektoparasittmidler slike som amitraz, benzylbenzoat, karbaryl, krotamiton, DDT, dikantogen, isobornyltiocyanoacetat.teknisk, sitronsvovelholdig løsning lindan, malation, kvikksølvoleat, mesulfen og svovel-farmasøytiske midler.
95. Enzymer inkludert:
fordøyelsesenzymer slike som a-amylase (svinepankreas), lipase, pankrelipase, pepsin og rennin;
mucolyttiske enzymer slik som lysozym;
penicillininaktiverende enzymer slik som penicillinase; og
proteolytiske enzymer slike som kollagenase, kymopapain, kymotrypsiner, papain og trypsin.
96. Enzyminduserende midler (hepatiske) slik som flumecinol.
97. Østrogener, inkludert:
ikke-steroide østrogener slike som benzastrol, broparoestrol, klorotrianisen, dienestrol, dietylstilbestrol, dietylstilbestroldiproprionat, dimestrol, fosfestrol, heksestrol, metallenstril og metestrol; og
steroide østrogener slike som kolpormon, konjugerte østrogenhormoner, equilenin, equilin, estradiol, estradiolbenzoat, estradiol 17(3-cypionat, estriol, estron, etinyl, estradiol, mestranol, moksestrol, mytatriendiol, kinestradiol og kinestrol.
98. Magesekresjonsinhibitorer slike som enterogastron og oktreotid.
99. Glukokortikoider slike som 21-acetoksyprefnenolon, aalklometason, algeston, amicinonid, beklometason, betametason, budesonid, kloropredinison, klobetasol, blovetason, klokortolon, kloprednol, kortikosteron, kortison, kortivazol, deflazakort, desnid, desoksimetason, deksametason, diflorason, diflukortolon, difluprednat, enoksolon, fluazakort, lukloronid, flumetason, flunisolid, flukinolon-acetonid, fluocinonid, fluokortinbutyl, fluokortolon, fluorometolon, fluperolonacetat, fluprednidenacetat, flupredmsolen, fluperolonacetat, fluprednidenacetat, fluprednisolen, flurandrenolid, formokortal, halcinonid, halometason, halopredon-acetat, hydrokortamat, hydrokortison, hydrokortisonacetat, hydrokortisonfosfat, hydrokortison 21-natriumsuksinat, hydrokortisontebutat, mazipredon, medryson, mepredison, metyolprednisolen, mometasonfuroat, parmaetason, prednikarbat, predisolon, prednisolon 21-dietylaminoacetat, prednisonnatriumfosfat, prednisolon-natriumsuksinat, prednisolonnatrium 21-m-sulfobenzoat, prednisolon 21-stearoylglykolat, prednisolontebutat, predninsolon 21-trimetylacetat, prednison, prednival, prednyliden, prednyliden 21-dietylaminoacetat, tiksokortal, triamkonolon, triamcinolonacetonid. triacinolonbenetonid og triamcinolonheksacetonid.
100. Gonadestimulerende prinsipper slike som buserelin, klomifen, cyklofenil, epimestrol, FSH, HCG og LH-RH.
101. Gonadotropiske hormoner slike som LH og PMSG.
102. Veksthormoninhibitorer slike som oktreotid og somatostatin.
103. Vekststimulerende midler slik som semorelin.
104. Vekststimulerende midler slik som somatotropin.
105. Hemolytiske agens slike som fenylhydrazin og fenylhydrazinhydroklorid.
106. Heparinantagonister slike som heksadimetrinbromid og protaminer.
107. Leverbeskytlende midler slike som S-adenosylmetionin, betain, katekin, kitolon, malotilat, orazamid, fosforylkolin, protoporfyrin IX, silymannøgruppe, tiotsyre og tiopronin.
108. Immunmodulerende midler slike som amiprilose, busillamin, ditiokarbnatrium, inosinpranobeks, inlerferon-y, interleukin-2, lentinan. muroktasin, platonin, prokodazol, tetramisol, tymompdulin, tymopentin og ubenimeks.
109. Immunsupressive midler slike som azatioprin, cyklosponner og mizoribin.
110. Ioneutbytterharpikser slike som karbakrylharpikser, kolestyraminharpiks, kolestipol, polydeksid, resodek og natriumpolystyrensulfonat.
Ul. Laktasjonsstimulerende hormon slik som prolaktin.
112. LH-RH agonister slike som buserelin, goserelin, leuprolid, nafarelin og triptorelin.
113. Lipotropiske agens slike som N-acetylmetionin, kolinklorid, kolindehydrokolat, kolindihydrogencitrat, inositol, lektin og metionin.
114. Lupus erytematosus undertrykkere slike som bismutnatriumtnglykollamat, bismutsubsalicylat, klorokin og hydroksyklorokin.
115. Mineralkortikoider slike som aldosteron, deoksykortikosteron, deoksykortikosteronacetat og fludrokortison.
116. Miotiske medikamenter slike som karbakol, fysostigmin, pilokarpin og pilokarpus.
117. Monoaminoksidaseinhibitorer slike som deprenyl, iproklozid, iproniazid, isokarboksasid, moklobemid, oktomoksin, pargylin, fenelzin, fenoksypropazin, pivalylbenzhydrazin, propidin, tolokaton og tranylkypromin.
118. Mukolytisk agens slike som acetylcystein, bromheksin, karboksystein, domiodol, letostein, lysozym, mecysteinhydroklorid, mesna, sobrerol, stepronin, tiopronin og tyloksapol.
119. Muskelavslappende midler (skjelett) slike som afloqualon, alkuronium, atrakurium, besylat, baklofen, benzooktamin, benzokinoniumklorid, C-kalebassin, karisoprodol, klormezanon, klorfenesin, karbamat, klorproetazin, klozoksazon, kurare, cyklarbamat, cyklobenzaprin, dantrolen, dekametoniumbromid, diazepam, eperison, fazadiniumbromid, flumetramid, gallamintrietiodid, heksakarbakolin-bromid, heksafluoreniumbromid, idrocilamid, laueksiummetylsulfat, leptodaktylin, memantin, mefenesin, mefenoksalon, metaksalon, metokarbamol, metokuriniodid, nimetazepam, orfenandrin, pankuroniumbromid, fenprobamat, fenyramidol,
pipekuriumbromid, promoksolan, kininsulfat, styramat, succinylkolinbromid, succinylkolinklorid, succinylkolinopdin, suksetoniumbromid, tetrazepam, tiokolkikosid, tizanidin, tolperison, tubokurarinklond, vekuroniumbromid og zoksolamin.
120. Narkotiske antagonister slike som amifenazol, cyklazocin, levallorfan, nadid, nalmfen, nalorfin, nalorfindinikotinat, nalokson og naltrekson.
121. Nervebeskyttende agens slik som dizocilpin.
122. Nootropiske agens slike som aceglutamid, acetylkarnitin, aniracetam, bifematlan, eksifon, fipeksid, idebenon, indeloksazunhydroklorid, nizofenon, oksiracetam, piracetam, propentofyllin, pyritinol og takrin.
123. Øyeagens slik som 15-ketoprostaglandiner.
124. Eggstokkhormon slik som relaksin.
125. Oksytoksiske medikamenter slike som karboprost, kargutocin, deaminooksytocin, ergonovin, gemeprost, metylergonovin, oksytocin, hypofyse (posterior), prostaglandin E2, prostaglandin F2a og spartein.
126. Pepsininhibitorer slik som natriumamylosulfat.
127. Peristaltikkstimulerende midler slik som kisaprid.
128. Progestogener slike som allylestrenol, anageston, klormadinonacetat, delmadinonacetat, demegeston, desogestrel, dimetisteron, dydrogesteron, etisteron, etynodiol, flurogestonacetat, gestodon, gestonoronkaproat, haloprogesteron, 18-hydroksy-16-metylenprogesteron, 17a-hydroksygesteronkaproat, lynestrenol, medrogeston, medroksyprogesteron, megestrolacetat, melengestrol, noretindron, noretynodrel, nprgesteron, norgestimat, norgestrel, norgestrienon, norvinisteron, pentagestron, progesteron, promegeston, kingestron og trengeston.
129. Prolaktininhibitorer slik som metergolin.
130. Prostaglandiner og prostaglandinanaloger slike som arbaprostil, karboprost, enprostil, bemeprost, limaprost, misoprostol, ornoprostil, prostacyklin, prostaglandin Ej. prostaglandin E2, prostaglandin i F2a, rioprostil, rosaprostol, sulproston og tnmoprostil.
131. Proteaseinhibitorer slike som aprotinin, kamostat, gabeksat og nafamostat.
132. Respiratorisk stimulerende midler slike som almitrin, bemegrid, karbon-dioksid, kropropamid, krotetamid, dimeflin, dimorfolamin, doksapram, etamivan, fominoben, lobelin, mepiksanoks, metamivam, niketamid, pikrotoksin, pimeklon, pyridofyllin, natriumsuksinat og tacrin.
133. Skleroseagens slike som etanolamin, etylamin, 2-heksyldekariosyre, polidokanol, kininbisulfat, kininyreahydroklorid, natnumricinoleat, natriumtetradekylsulfat og tnbenosid.
134. Beroligende og søvndyssende midler inkludert:
asyklisk ureider slike som acekarbromal, apronalid, bomisovalum, kapurid, karbromal og ectylurea;
alkoholer slike som klorheksadol, etklorvynol, meparfynol, 4-metyl-5-tiazoletanol, tert-pentylalkohol og 2,2,2-trikloretanol;
amider slike som butoktamid, dietylbromacetamid, ibrotamid, isovaleryldietylamid, niaprazin, tricetamid, trimetozin, zolpidem og zopiklon;
barbitursyrederivater slike som allobarbital, amobarbital, aprobarbital, barbital, brallabarbital, butabarbitalnatnum, butalbital, butallylonal, butetal, karbubarb, cyklobarbital, cyklopentobarbital, enallylpropymal, 5-etyl-5-(l-pipeidyl) barbitursyre, 5-furfuryl-5-isopropylbarbitursyre, heptabarbital, heksetalnatrium, heksobarbital, mefobarbital, metitural, narkobarbital, nealbarbital, pentobarbitalnatrium, fenallymal, fenobarbital, fenobarbitalnatrium, fenylmetyl-barbitursyre, probarbital, propallylonal, proksibarbal, reposal, sekobarbitalnatrium, talbutal, tetrabarbital, vinbarbitalnatrium og vinylbital;
benzodiazepinderivater slike som brotizolam, doksefazepam, estazolam, flunitrazepam, flurazepam, halokazolam, loprazolam, lormetazepam, nitrazepam, quazepam, temazepam og triazolam;
bromider slike som ammoniumbromid, kalsiumbromid, kalsiumbromo-laktobionat, litiumbromid, magnesiumbromid, kaliumbromid og natriumbromid;
karbamater slike som amylkarbamat - tertiary, etinamat, heksapropymat, meparfynolkarbamat, novonal og trokolorouretan;
kloralderivater slike som karbokloral, kloralbetain, kl oral form am id, klorhydrat, kloralantipyrin, dikloralfenazon, pentaerytrotpøløpraø og triklofos;
piperidindioner slike som glutehimid, methyprylon, piperidion, pyrityldion, taglutimid og talidomid;
kinazolonderivater slike som etaqualon, mekloqualon og methaqualon; og
andre slike som acetal, acetopenon, aldol, ammoniumvalerat, amfenidon, d-bornyl a-bromoisovalerat, d-bornylisovalerat, bromoform, kalsium 2-etyl-butanoat, karfinat, a-klorose, klometiazol, kypripedium, doksylamin, etodroksizin, etomidat, fenadiazol, homofenazin, hydrobromsyr, mekloksamin, mentylvalerat, opium, paraldehyd, perlapin, propiomazin, rilmazafon, natriumoksybat, sulfonetylmetan og sulfonmetan.
135. Trombolytiske agens slike som APS AC, plasmin, pro-urokinase, strepto-kinase, vevsplasminogenaktivator og urokinase.
136. Tyrotropiske hormoner slik som TRH og TSH.
137. Uricosuriske midler slike som benzbromaron, etebenecid, orotsyre, oksycinkopen, probenecid, sulfinpyrazon, tikrynafen og zokazolamin.
138. Vasodilatorer (cerebrale) slike som bencyklan, kinnarizin, citikolin, cyklandelat, ciklonikat, diisopropylamindikloracetat, eburnamonin, fenoksedil, flunarizin, ibudilast, ifenprodil, nafronyl, nikametat, nikergolin, nimodipin, papaverin, pentifyllin, tinofedrin, vinkamin, vinpoketin og viquidil.
139. Vasodilatorer (hjerte) slike som amotrifen, bendazol, benfurodilhemisuksinat, benziodaron, kloacizin, kromonar, klobenfurol, klonitrat, dilazep, dipyndamol, droprenilamin, efloksat, erytritol, erytrityltetranitrat, etafenon, fendilin, floredil, ganglefen, heksastrol bis(P-dietylaminoetyleter), heksobendin, itramintosylat, khellin, lidoflazin, mannitol, heksanitrat, medibazin, nikorandil, nitroglyserin, pentaerytritoltetranitrat, pentrinitrol, perheksilin, pimefyllin, prenylamin, propatylnitrat, pyridofyllin, trapidil, trikromyl, tnmetazidin, trolnitratfosfat og visnadin.
140. Vasodilatorer (perifere) slike som aluminiumnikotinat, bametan, bencyklan, betahistin, bradykinin, brovinkamin, bufoniod, buflomedil, butalamin, cetiedil, ciklonikat, kinepazid, cinnarizin, cyklandelat diisopropylamindikloracetat, eledoisin, fenoksidil, flunarisin, heronikat, ifenprodil, inositolniacinat, isoksuprin, kallidin, kallikrein, moksylyt, nafronyl, nikametat, nikergolin, nikofuranose, nikotinylalkohol, nylidrin, pentifyllin, pentoksifyllin, piribedil, protaglandin Ei, suloktidil og xantinalniacinat.
141. Vasobeskyttere slike som benzaron, bioflavonoider, kromkarb, klobeosid, diosmin, dobesilatkalsium, eskin, rolescutol, leukocyanidin, meteskufyllin, quercetin, rutin og trokserutin.
142. Vitaminer, vitaminkilder og vitaminekstrakter slike som vitamin A, B, C, D, E, og K og derivater derav, kalsiferoler, glysyrriza og mekobalamin.
143. Sårlegende agens slike som acetylcystein, allantoin, asiatikosid, kadeksomeriodin, kitin, dekstranomer og oksakreprol.
144. Anti-koagulerende midler slik som heparin.
145. Forskjellige midler slike som erytropoietin (Hematinic), filgrastim, finasterid (benign prostata hyoertrofy) og interferon beta 1 - alfa (multippel sklerose).
Den ovenfor nevnte listen av aktive agens er basert på de kategoriene og artene av medikamenter som er satt frem på sidene THER-l til THER-28 i Merck Index, 12. utgave, Merck & Co. Rahway, N.J. (1996). Denne referansen er inkorporert ved referanse i sin helhet.
De aktive agensene som er inneholdt i den bioadhesive sammensetningen kan være i forskjellige former avhengig av løseligheten og frigivelseskaraktertristikkene som ønskes, såsom nøytrale molekyler, komponenter av molekylkomplekser og farmasøytisk akseptable salter, frie syrer eller baser, eller kvaternære salter av det samme, eller som kombinasjoner av disse. Enkle derivater av medikamentene slik som farmasøytisk akseptable etere, estere, amider og lignende, som har ønskelig retensjon og frigivelseskarakteristika, men som blir enkelt metabolisert ved kropps pH, enzymer, pro-aktive former, pro-medikamenter og lignende, kan også bli benyttet.
Det aktive agenset kan inneholde lokale anestesibaser, inkludert svake organiske baser som er lipofile i natur og derved lite løselig i vann. Imidlertid vil slike baser vanligvis reagere med organiske eller uorganiske syrer for å danne sure, vann-løselige syretilsetningssalter. Derfor vil begrepet "base" når det benyttes med referanse til et anestesimiddel, bety den ikke-ioniserte formen av et anestesimiddel som kan bringe til veie et elektronpar for å danne en kovalent binding. Begrepet "syre" når det benyttes med referanse til et anestesimiddel, betyr en substans som kan ta opp et elektronpar for å danne en kovalent binding. Begrepet "salt" når det benyttes med referanse til et anestesimiddel, betyr formen som dannes av en anestesibase når den reagerer med en organisk eller uorganisk syre.
Lokale anestesiagens som er passende for anvendelse i utførelsen av foreliggende oppfinnelsen inkluderer amider og estere. Eksempler på amider er lidokain, prilokain, mepivakain, bupivakain, dibukain og etidokain. Estere inkluderer prokain, tetrakain, propoksykain, klorprokain, benzokain, butambenpikrat, kokain, heksylkain, piperokain, oksyprokain og proparakain. Andre passende lokale anestesimidler for anvendelse i utførelsen av foreliggende oppfinnelse inkluderer cyklometikain, dimetisokin, ketokain, diperodon, diklonin og pramoksin, alle vanligvis administrert i form av syretilsetningshydrokloridene eller sulfatsaltene.
Syreaddisjonssaltene til anestesiagens som er passende for den foreliggende oppfinnelsen inkluderer ethvert ikke-toksisk farmasøytisk akseptabel organisk eller uorganisk salt som i visse utførelsesformer er ikke-salicylat. Vanlige uorganiske salter er hydrogenhalogenider, spesielt hydrokloridene, karbonatene, boratene, fosfatene, sulfatene, hydrogensulfatene, hydrobromidene, nitratene, sulfidene og arsenatene. Vanlige organiske salter er salter av mono- og polykarboksylsyrer såsom citrat, tartrat, maleat, cinnamat, oksalat, format, suksinat og ftalater. Baseformen og saltformen av et passende anestesiagens inkorporert i den foreliggende sammensetningen bør fortrinnsvis være forskjellige anestesiagens for å oppnå maksimum varighet av den kombinerte anestesieffekten. Begrepet "forskjellig" når det benyttes med referanse til et anestesiagens, betyr at saltformen i en hvilken som helst kombinasjon ikke er et salt av baseformen som benyttes i den gitte kombinasjonen.
Anestesimiddelet som kan anvendes som aktivt agens i sammensetningen i følge oppfinnelsen kan vRe en fri base som er valgt fra gruppen som omfatter lidokain, prokain, propoksykain, mepivakain, prilokain, dyklonin, pramoksin, benzokain og klorprokain, i kombinasjon med saltformen til et annet anestesimiddel. Saltformen er fortrinnsvis en som er valgt fra gruppen som omfatter prilokain, tetrakain, bupivakain, dyklonin, dibukain, etidokain og lidokainsalter.
Sammensetningen i følge oppfinnelsen kan inneholde en kombinasjon av både en fri baseform og en saltform av et anestesimiddel, vil forholdet mellom den frie baseformen og saltformen i sammensetningen avhenge av flere faktorer: nemlig (1) identiteten til saltet og basen som benyttes; (2) den ønskede varigheten av hendelsen; og (3) den ønskede hastigheten av anestesieffekt. Som en generell regel i tilfellet med slimhinneapplikasjon, er forholdene mellom base og salt slik at den fri baseformen fortrinnsvis bør penetrere slimhinnen og være på toppen av sin effektivitet innen en omkring 2-30 min. periode, mens saltformen fortrinnsvis bør penetrere slimhinnen og ha sin høyeste effektivitet innen en periode på omkring 10-75 min. Varigheten av anestesi vil strekke seg fra omkring 2 min. til flere timer, til og med opptil 24 timer, avhengig av base/saltkombinasjonen som er valgt, og lengden på applikasjonstiden. For å oppnå denne effekten i praksis vil mengden vekt av baseformen normalt være i overskudd i forhold til mengden vekt av saltformen.
Begrepet "start av anestesi" er ment å bety tiden som er nødvendig for å få effekt i de individuelle nervene. Starten på anestesi avhenger i prinsippet av fettløselig-heten, molekylstørrelse og tilgjengelig mengde av ikke-ionisert form av det lokale anestesimidlet. Følgelig vil anestesimidler med en høy fettløselighet eller en lav pKa, eller begge deler, ha en raskere anestesistart.
Begrepet "varigheten av anestesi" som benyttet hen, betyr tidsperioden som det lokale anestesimidlet på en målbar måte blokkerer nerveledning. Det foregående avhenger av alle faktorene som er listet opp for starten på anestesi, såvel som på mengden av proteinbinding av anestesiagenset.
Et anestesiagens som er en fri base kan penetrere intakt hud i en begrenset grad, og vil raskere penetrere huden dersom keratinlagene er skrapet av. I tilfellet med slimhinner vil anestesimidlet i form av fri base penetrere mye raskere som en følge av den forskjellige keratinsammensetningen og den resulterende forskjellen i hydrofilisitet sammenlignet med stratum corneum til intakt hud.
Som en generell regel penetrerer ikke saltformene av anestesiagens i en tilfredsstillende grad intakt hud, men de ikke-ioniserte baseformene penetrerer i en begrenset grad. Begge formene, salt og base, vil penetrere avskrapede keratinlag. Saltformen såvel som baseformen, vil penetrere i forskjellig grad slimhinner som en følge av slimhinnenes hydrofilisitet, sammenlignet med stratum corneum til intakt hud. Generelt vil det gjelde at jo høyere lipidinnholdet i slimhinnemembranen er, jo raskere vil baseformen til anestesiagenset bli absorbert. Derfor må de forskjellige lipidinnholdene i gommen (gingiva) og de alveolære slimhinnene ligge i minnet når den bioadhesive sammensetningen blir benyttet for applikasjon på munnhuleslimhinnene, for å oppnå den optimale penetrasjonshastigheten.
Selv om søkere ikke har til hensikt å bli bundet av noen teori eller foreslått mekanisme for handling, antas det at baseformen til et anestesiagens som er lipidløselig, har en raskere start på anestesi siden den trenger inn i lipoproteinnervemembranen og derved hindrer depolariseringen og ioneutbyttet som er involvert i stimulioverføring. På den annen side vil saltformen av et anestesiagens som ikke er lipidløselig penetrere til lipoproteinnervemembranen kun etter at bufringskapasiteten til huden eller slimhinnevevet omdanner saltet til basen, og sluttresultatet er en forsinket start på anestesi.
Saltformene til anestesiagensene blir valgt på basis av start av anestesi og varighet av anestesi. Å tilpasse forholdet mellom base og salt påvirker den relative starten, såvel som varigheten av anestesi. Jo større mengde av anestesiagens som har en rask start på aktivering, jo kortere tid tar det før start av anestesi. På tilsvarende måte følger at dess større mengden av anestesiagens som har en forlenget varighet på anestesi, jo mer forlenget blir varigheten av anestesi. Videre kan sammensetningen inkluderer andre medikamenter som benyttes samtidig.
Tabell 1 under viser toppen og varighet av virkningen av utvalgte lokale anestesimidler primært basert på applikasjon på hud eller slimhinnemembraner:
Generelt er den relative hastigheten og starten på anestesi, og varigheten av anestesi for en gitt form av et anestesiagens, tilgjengelig i litteraturen eller kan bli beregnet ved standardtester for transmucosadose.
Starttidspunkt, såvel som varighet av anestesi, vil variere fra individ til individ, såvel som basisen for applikasjonssetet. Når sammensetningen blir påført til svært keratinisert dermalt vev, kan starten på antestesi ta så lenge som 2-4 timer.
Begrepet "terapeutisk effektiv mengde" som benyttet heri, med referanse til det aktive agenset, er ment å bety mengden av aktivt agens som er tilstrekkelig til å gi den ønskede effekten, lokal eller systemisk, når den påføres topisk over varigheten av tiltenkt anvendelse. Mengden som er nødvendig er kjent i litteraturen, eller kan bli beregnet ved metoder som er kjent i faget, men varierer vanligvis fra omkring 0,1 til 20000 mg, og fortrinnsvis omkring 0,1 til omkring 1000 mg, og mer fortrinnsvis varierer fra omkring 0,1 til omkring 500 mg pr. menneskelig voksen person på omkring 75 kg kroppsvekt, avhengig av de aktive agensene som er valgt, og applikasjonsstedet. Den eneste øvre grensen for mengden av det aktive agenset er at sammensetningen fortrinnsvis i det vesentlige bør være fri for krystaller av det aktive agenset, og at mengden av løsningsmiddel som benyttes ikke er tilstrekkelig til på en uønsket måte å påvirke de bioadhesive egenskapene til sammensetningen.
Terapeutiske doser og doseenhetsmengder kan bli estimert ved in vitro fluksdata ved å benytte hud fra døde mennesker, eller alternativt ved å benytte dyrehud som beskrevet i US patent nr. 4 751 087.
Konsentrasjonen, såvel som mengden av det aktive agenset pr. enhet areal, nemlig pr. cm 2 eller cm 3, kan variere uavhengig for å oppnå den ønskede terapeutiske effekten. F.eks. vil høyere konsentrasjoner av anestesibase som er inneholdt i en doseform med redusert tykkhet, resultere i anestesi med raskere start og kortere varighet. Høye konsentrasjoner av anestesibasen som er inneholdt i en doseform med øket tykkhet (høyere mg med anestesimiddel pr. cm<2> eller cm<3>), vil resultere i kraftig anestesi med rask start og lang varighet. Lave konsentrasjoner av anestesibasen i en doseform med redusert tykkhet vil resultere i mild anestesi med lengre start og kortere varighet. Lave konsentrasjoner av anestesibasen inneholdt i en doseform med øket tykkhet vil ha mild anestesieffekt med lengre start og lengre varighet. Som vist i den ovenfor nevne forklaringen tillater muligheten til å variere konsentrasjonen av aktive agens fra svært lave (omkring 1 %) til høye (40 % eller mer) av den totale sammensetningen i kombinasjon med muligheten til å dekke tynne (ca. 0,025 mm (0,001 ") eller tykke (ca. 13 mm (0,5 ") eller mer) den som praktiserer oppfinnelsen til å variere dosen etter behov for et spesielt sted for topisk applikasjon og terapeutiske effekter.
De bioadhesive sammensetningene i den foreliggende oppfinnelsen kan også inneholde én eller flere løsningsmidler eller koløsningsmidler. Slike løsningsmidler og koløsningsmidler er de som er kjent i faget, og er ikke-toksiske, farmasøytisk aksepterbare substanser, fortrinnsvis væsker, som ikke i det vesentlige negativt påvirker de bioadhesive egenskapene eller løseligheten til de aktive agensene i konsentrasjonene som benyttes. Løsningsmidlet og koløsningsmidlet kan enten være for det aktive agenset eller for de bioadhesive materialene, eller begge deler. Løsningsmidlet er fortrinnsvis en polyhydrisk alkohol, eller kombinasjon av polyhydriske alkoholer. Løsningsmidlet bør inkludere fra omkring 5 % til omkring 50 °/o, og mer fortrinnsvis fra omkring 10 % til omkring 30 % regnet på vekt, av den tørre vekten til den totale bioadhesive sammensetningen av et løsningsmiddel kjent for å mykgjøre den bioadhesive sammensetningen. Spesielt nyttige bløtgjøringsmidler er glykoler såsom dipropylenglykol og propylen, fettsyrer såsom olinsyre og linolinsyre, fettsyreestere såsom isopropylmyristat, grønnsak, dyre- og fiskeoljer såsom hydrogenerte kastoroljer, kanola, torskelever og lanolin, mineraloljer, glyserin, lektin, tokoferol og tokoferylacetat. Alternativt kan medikamenter som er væsker ved romtemperatur, såsom nitroglyserin, nikotin, selegilin og lignende, bli benyttet som bløtgjøringsmidler.
Anvendelsen av et løsningsmiddel (som omfatter både løsningsmidler og bløtgjøringsmidler) har også blitt funnet å bedre utseendet og teksturen på sluttsammensetningen, spesielt for PVP og kayaragummiutførelsesformer. Spesielt antas det at ved å inkludere et løsningsmiddel i den bioadhesive sammensetningen fører til at de pudderaktige kayaragummipartiklene sveller eller gelerer når de tilsettes en blanding eller sammensetning som inneholder PVP, løsningsmidler og aktivt agens (dersom den bioadhesive sammensetningen ikke blir benyttet som et separat adhesivt lag). Til sist vil den bioadhesive sammensetningen ha en mykere, bløtere finish enn en bioadhesiv sammensetning som ikke inneholder et løsnings-middel. En bioadhesiv sammensetning som ikke inneholder noe løsningsmiddel vil generelt ha adekvate påføringsegenskaper, og er derfor ikke utenfor målet ved den foreliggende oppfinnelsen, imidlertid er anvendelsen av løsningsmidler å foretrekke av grunnene som er bemerket over.
Begrepet "polyhydrisk alkohol" betyr enhver organisk polyalkohol og inkluderer dipropylenglykol, propylenglykol, polyetylenglykol, glyserin, butyrert glykol, heksylenglykol, polyoksyetylen, polypropylenglykol, sorbitol, etylenglykol og lignende. Andre passende løsningsmidler inkluderer fettsyrer såsom oleinsyre, linolinsyre, kaprisyre og lignende, polyetylen, polypropylen og etere av fettsyrer, såvel som fettsyreestere eller alkoholer. Andre passende løsningsmidler inkluderer andre ikke-toksiske, ikke-flyktige løsningsmidler som vanligvis benyttes i transdermal eller transglukosasammensetninger for å løse opp aktive agens.
De ovenfornevnte polyhydriske alkoholene kan inkludere de som har 2-6 alkoholhydroksylgrupper. Slike polyhydriske alkoholer inkluderer glykoler, trioler og polyoler som har 4-6 alkoholhydroksylgrupper. Typisk for nevnte glykoler er glykoler som inneholder 2-6 karbonatomer, f.eks. etylenglykol, propylenglykol, butylenglykol, polyetylenglykol (gjennomsnittelig molekylvekt omkring 200-8000, fortrinnsvis omkring 200-6000), osv. Eksempler på nevnte trioler inkluderer glyserin, trimetylolpropan, osv. Nevnte polyoler er eksemplifisert ved sorbitol (sorbit), polyvinylpyrrolidon osv. Disse polyhydriske alkoholene kan bli benyttet enten enkeltvis eller i kombinasjon (fortrinnsvis med to eller tre). Følgelig kan f.eks. glyserin eller dipropylenglykol alene, eller en blanding av enten glyserin eller dipropylenglykol med butylenglykol bli benyttet.
Blant disse polyhydriske alkoholene kan de som tilfredsstiller kravene relevante for tilpasningen og opprettholdelsen av mykheten av den ytre overflaten av oppfinnelsen, kompatibilitet eller kodispersibilitet med de andre komponentene, og tilveiebringer en passende konsistens av sammensetningen, fritt bli benyttet. De som har en lav flyktighet er generelt å foretrekke, og i denne hensikt er dipropylenglykol, glyserin, propylenglykol, butylenglykol og sorbitol passende løsningsmidler, ifølge oppfinnelsen.
Selv om den eksakte mengden av de polyhydriske alkoholene eller fettsyrene, estrene, etrene eller alkoholene som kan bli benyttet i sammensetningen avhenger av egenskapen og mengden av andre komponenter, og derfor ikke kan bli satt frem i generelle termer, kan andelen variere fra omkring 30 % regnet på vekt, og fortrinnsvis fra omkring 5 % til omkring 20 % ved vekt, og mer fortrinnsvis fra omkring 5 % til omkring 10 % regnet på vekt basert på tørrvekten til den totale bioadhesive sammensetningen.
Betegnelsen "oppløst" er ment å bety at i oppløsningsmidlet og det påfølgende i den bioadhesive sammensetning, er det en intim dispersjon av det aktive middel og krystallinsk, molekylært eller ionisk nivå, slik at krystallene til det aktive midlet ikke kan detekteres ved å bruke et mikroskop som har en forstørrelse på 25X. Som sådan blir det aktive middel deri betegnet å være "ikke-krystallisert" form når den er i sammensetningen i henhold til foreliggende oppfinnelse.
Generelt kan konsentrasjonen av det oppløste farmasøytiske aktive middel variere fra ca. 1% til ca. 50%, mer fortrinnsvis fra ca. 2,5% til 40%, og optimalt fra ca. 5% til ca. 30% regnet på vekten av tørrvekten til den totale bioadhesive sammensetning. I en foretrukket utforming av oppfinnelsen for topisk administrering av et enkelt aktivt middel, ketoprofen i den frie syreform blir brukt i en konsentrasjon mellom 2% og 30% regnet på vekt av tørrvekten til den totale bioadhesive sammensetningen.
For topisk administrering av en forbindelse av anestesiagens er forholdet regnet på vekt mellom fri base og saltformene generelt omkring 90:10 til omkring 40:60, fortrinnsvis omkring 75:25 til omkring 50:50, og mer fortrinnsvis omkring 70:30 til omkring 60:40. For andre salter er forholdene sammenlignbare basert på relative molare mengder. Generelt er forholdet regnet på vekt mellom base og salt mellom omkring 1:2 til omkring 4:1. I en foretrukket utførelsesform av oppfinnelsen for en forbindelse av anestesiagens er forholdet mellom base og salt henholdsvis 2:1, basen som blir benyttet er idokain og saltet som blir benyttet er et salt av prilokain, butyvakain, dyklonin, mepivakain, eller tetrakain, fortrinnsvis hydrokloridsaltet.
Høyere konsentrasjoner av aktive agens, nemlig opptil 50 % regnet på vekt kan typisk bli oppnådd ved å blande slike agens med et passende løsningsmiddel, fortrinnsvis ved en forhøyet temperatur, f.eks. omkring 70-100°C, for å oppnå en blanding, fortrinnsvis en løsning, av de aktive agensene som deretter blir tilsatt til bioadhesive materialene. Å unnlate løsningsmidlet vil typisk gi en slutt-sammensetning fylt med krystaller eller en krystallinsk masse.
Valg av løsningsmiddel for en forbindelse av aktive agens avhenger blant annet av formen til agenset, dvs. hvorvidt det er en fri base, fri syre eller syretilsetnings-saltform.
Passende løsningsmidler for saltformen til anestesiagens er typisk polare organiske løsningsmidler. Polare organiske løsningsmidler er fortrinnsvis polyhydriske alkoholer, som diskutert over. Andre passende løsningsmidler for enten den frie base eller syretilsetningsformen til anestesiagens er de løsningsmidlene som er kjent å løse opp enten én eller begge disse to typene av former, inkludert cykliske ketoner slike som 2-pyrrolidon; N-(2-hydroksyetyl) pyrrolidon, N-metylpyrrolidon, 1-dodecylazacykloheptan2-on og andre n-substituerte alkyl-azacykloalkyl-2-oner (azoner) dimetylformamid, og dimetylsulfoksid. Andre passende løsningsmidler for den fri baseformen til et anestesiagens inkluderer forbindelser som er kjent for å være nyttige i topiske farmasøytiske prepareringer som ødelegger cellekappen, forbindelser som antas å bidra til slimhinnepenetrering vd å ødelegge lipid-strukturen til stratum corneum cellekappene. Noen av disse forbindelsene kan generelt skrives på formelen: Pv-X hvori R er en rettkjedealkyl på omkring 7-16 karbonatomer, et ikke-terminal alkenyl på omkring 7-22 karbonatomer, eller et forgrenet kjedealkyl på fra omkring 13-22 karbonatomer, og X er -OH, -COOCH3, -COOC2H5, -OCOCH3,
-SOCH3, -P(CH3)20, -COOCH2H4OC2H4OH,
-COOH (CHOH)4CH2OH, -COOCH2CHOHCH3, -COOCH2CH(OR")CH2OR", -(OCH2CH2)mOH, -COOR<1>, eller -CONR'2 hvor
R; er -H, -CH3, -C2H5, -C3H7 OR -C2H4OH; R" er -H, eller et ikke-terminalt alkenyl på omkring 7-22 karbonatomer; og m er et positivt tall fra 2-6; gitt at når R" er en alkenyl og X er -OH eller -COOH, er minst en dobbeltbinding i cis-konfigurasjonen.
Den bioadhesive sammensetningen kan også inneholde agens som er kjent å akselerere avleveringen av de aktive agensene gjennom huden eller slimhinnen. Disse agensene har blitt referert til som penetrerings- eller permeabilitetsøkere, akseleranter, hjelpestoffer og absorpsjonspromotere, og er kollektivt referert til om "forsterkere".
Noen eksempler på forsterkere er monohydriske alkoholer såsom etanol og isopropylbutyl og benzylalkoholer, eller dihydriske alkoholer såsom etylenglykol, dietylenglykol eller propylenglykol, dipropylenglykol og trimetylenglykol, eller polyhydriske alkoholer såsom glyserin, sorbitol og polyetylenglykol, som øker medikamentløseligheten; polyetylenglykoletere av alifatiske alkoholer (såsom cetyl, lauryl, oleyl og stearyl) inklydert polyoksyetylen (4) lauryleter, polyoksyetylen (2) oleyleter og polyoksyetylen (10) oleyleter kommersielt tilgjengelig under varemerket BRU<®> 30, 93, og 97 fra ICI Americas, Inc., og BRU<®> 35, 52, 56, 58, 72, 76, 78, 92, 96, 700 og 721; grønnsaker, dyre- og fiskefett og oljer såsom oliven og kastoroljer, squalene og lanolin; fettsyreestere såsom propyloleat, decyloleat, isopropylpalmiatat, glykolpalmitat, glykollaurat, dodecylmyristat, isopropylmyristat og glykolstearat som øker medikamentdiffusjonsevnen, fettsyrealkoholer såsom oleylalkohol og dens derivater; fettsyreamider såsom oleamid og dens derivater; urea og ureaderivater såsom alantoin som påvirker keratinens evne til å forbli fuktig; polare løsningsmidler såsom dimetyldecylfosfoksid, metyloktylsulfoksid, dimetyllaurylamid, dodecylpyrrolidon, isosorbitol, dimetylacetonid, dimetylsulfoksid, decylmetylsulfoksid og dimetylformamid som påvirker keratinets permeabilitet; salicylsyre som mykner keratinet; aminosyrer som hjelper til med penetrasjon; penzylnikotinat som er en hårfolikkelåpner; og høyere molekylvekt alifatiske overflatestoffer såsom laurylsulfatsalter som forandrer overflatetilstanden til huden, og medikamenter administrert og estere av sorbitol og sorbitolanhydrid såsom polysorbat 20 kommersielt tilgjengelig under varemerket Tween<®> 20 fra ICI Americas, Inc., såvel som andre polysorbater såsom 21, 40, 60, 61, 65, 80, 81 og 85.
Andre forsterkere inkluderer olein og linolinsyrer, askorbinsyre, pantenol, butylert hydroksytoluen, tokoferol, tokoferolacetat, tokoferyllinoleat.
Spesielt har det uventet blitt funnet at når karayagummi blir benyttet som poly-sakkaridbioadhesivet, og løselig PVP blir benyttet som det vannløselige bioadhesivet, med et farmasøytisk akseptabelt løsningsmiddel som inneholder et løsningsmiddel kjent for å bløtgjøre den totale bioadhesive sammensetningen, blir det dannet en bioadhesiv sammensetning som også er en trykksensitiv adhesiv. Dette resultatet er fullstendig uventet fordi hverken karayagummi eller løselig PVP alene er et trykksensitivt adhesiv. Tillagingen av et bioadhesiv/trykksensitivt adhesiv sammensetning blir dannet når karayagummi og PVP blir benyttet i et forhold på mellom 1:10 og 10:1.
Generelt kan den bioadhesive sammensetningen ha de følgende typer og mengder av ingredienser:
Mengden og typen av PVP som kreves i de foretrukne utførelsesformene vil avhenge av kvantiteten og typen medikament som er tilstede i den bioadhesive sammensetningen, såvel som typen av bioadhesiv, men kan enkelt bli bestemt ved rutineeksperimentering.
Vanligvis er PVP til stede i en mengde fra omkring 5 % til omkring 50 % regnet på vekt, fortrinnsvis fra omkring 10 % til omkring 40 % regnet på vekt av tørrvekten til den totale bioadhesive sammensetningen. Imidlertid kan mengden PVP bli høyere enn 20 %, f.eks. opptil 40 %, avhengig av det spesielle medikamentet som blir benyttet og de ønskede egenskapene til blandingen.
Nevnte PVP har fortrinnsvis en molekylvekt på omkring 2000 til 1200000, mer fortrinnsvis 5000 til 100000, og mest fortrinnsvis 7000 til 54000. PVP som har en molekylvekt på omkring 1000000 til omkring 1500000 er også foretrukket.
PVP'er blir solgt til den farmasøytiske industrien under varemerket KOLLIDON av BASF AG, Ludwigshafen, Tyskland; PLASDONE, POLYPLASDONE og COPOLYMER 958 av ISP Technologies, Waynem New Jersey. Foretrukne PVP'er er KOLLIDON 12PF, 17PF, 25, 30, 90 og VA-64.
Sammensetningen i følge oppfinnelsen kan inkludere et trykksensitivt adhesiv. Begrepet "trykksensitivt adhesiv" som benyttet heri, refererer til et viskøst elastisk materiale som umiddelbart kleber seg til de fleste overflater når det blir påført et svært lett trykk, og som permanent forblir klebrig. En polymer er et trykksensitivt adhesiv innenfor betydningen av begrepet som benyttet heri, dersom det har egenskapene til et trykksensitivt adhesiv som sådann, eller fungerer som et trykksensitivt adhesiv når det blir blandet med klebemidler, bløtgjørelsesmidler eller andre additiver.
Passende trykksensitive adhesiver inkluderer alle de ikke-toksiske naturlige og syntetiske polymerene kjent for, eller som passer til, anvendelse i transdermale innretninger, som hydrofobe adhesiver inkludert naturlige eller syntetiske elastiske forbindelser, såsom polysobutylen, styren, polybutadien, styrenisopropen-blokkerende kopolymerer, polyuretaner, polykrylater, polysiloksaner og styren/b utad i en-ko pol ym erer.
Spesielt foretrukne trykksensitive adhesiver er akrylpolymerer, og mer spesielt løsningsmiddelbaserte akrylpolymerer. Begrepet "akrylpolymer" er ment å bli benyttet om hverandre med begrepene akrylatpolymerer, polyakrylat og poly-akryladhesivpolymerer som benyttet heri, og som er kjent i faget. Begrepet "løselighetsbasert" blir benyttet heri for å bety i det vesentlige fri for overflatestoffer.
Akrylpolymerene som er nyttige for å utføre oppfinnelsen er polymerer av én eller flere monomerer av akrylsyrer og andre kopolymerbare monomerer. Akrylpolymerene inkluderer også kopolymerer av alkylakrylater og/eller metakrylater og/eller kopolymeriserbare sekundære monomerer, eller monomerer med funksjonelle grupper. Ved å variere mengden av hver type monomer som tilsettes, kan de kohesive egenskapene til den resulterende akryliske polymeren bli forandret, som det er kjent i faget. Generelt består den akryliske polymeren av minst 50 % regnet på vekt av et akrylat eller alkylakrylatmonomer, fra 0-20 % av en funksjonell monomer kopolymeriserbar med akrylatet, og fra 0-40 % av andre monomerer.
Akrylatmonomerer som kan bli benyttet inkluderer akrylsyre, metakrylsyre, butyl-akrylat, butylmetakrylat, hesksylakrylat, heksylmetakrylat, 2-etylbutylakrylat, 2-etylbutylmetakrylat, isooktylakrylat, isooktylmetakrylat, 2-etylheksylakrylat, 2-etylheksylmetakrylat, decylakrylat, decylmetakrylat, dodecylakrylat, dodecyl-metakrylat, tridecylakrylat og tridecylmetakrylat.
Funksjonelle monomerer, kopolymeriserbare med de ovenfornevnte akrylatene eller metakrylatene som kan bli benyttet inkluderer akrylsyre, metakrylsyre, malesyre, maleanhydrid, hydroksy etyl akrylat, hydroksypropylakrylat, akrylamid, dimetyl-akrylamid, akrylonitril, dimetylaminoetylakrylat, dimetylaminoetylmetakrylat, tert-butylaminoetylakrylat, tert-butylaminoetylmetakrylat, metoksyetyl akryl at og metoksyetylmetakrylat og andre monomerer som har minst én umettet dobbeltbinding som deltar i kopolymeriseringsreaksjonen i et molekyl, og en funksjonell gruppe på sin sidekjede slik som en karboksylgruppe, en hydroksyl-gruppe, en sulfoksylgruppe, en aminogruppe, en amidogruppe og en alkoksy, såvel som flere forskjellige andre monomere enheter inkludert alkylen, hydroksy-substituerte alkylener, karboksylsyresubstituerte alkylener, vinylalkanoat, vinylpyrrolidon, vinylpyridin, vilylpirazin, vinylpyrol, vinylimidazol, vinylkaprolaktam, vinyloksasol, vinylacetat, vinylpropionat og vinylmorfolin.
Ytterligere detaljer og eksempler på akryladhesiver som er passende i utførelsen av oppfinnelsen er beskrevet i Såtas, "Acrylic Adhesives", Handbook of Pressure-Sensitive Adhesive Technology, 2. utgave, pp. 396-456 (D. Såtas, red.), Van Nostrand Reinhold, New York (1989).
Passende akryladhesiver er kommersielt tilgjengelig og inkluderer polyakrylat-adhesivene solgt under varemerkene DURO-TAK av National Starch Company, Bridgewater, New Jersey; GELVA ved Monsanto, St.Louis, Missouri, HRJ ved Schenectady International, Inc., Schenectady, New York; MORSTIK ved Morton International, Inc., Chicago, Illinois; og EUDRAG1T RL og RS ved Roehm Pharma GmbH, Darmstadt, Tyskland.
Mengden av det trykksensitive adhesivet som benyttes avhenger av konsentrasjonen av aktivt agens som benyttes for å oppnå en terapeutisk effekt. Vanligvis er det trykksensitive adhesivet i en mengde på omkring 10 % til omkring 60 % regnet på vekt av tørrvekten til den totale bioadhesive sammensetningen, og fortrinnsvis omkring 15 % til omkring 50 %, og mest fortrinnsvis omkring 20 % til omkring 40 % regnet på vekt basert på tørrvekten til den totale bioadhesive sammensetningen.
I tillegg til de ovenfornevnte ingrediensene kan det også være inkorporert forskjellige farmasøytiske aksepterbare additiver og tilsetningsstoffer som er tilgjengelig for dem med kunnskaper i faget. Disse additivene inkluderer klebrige agens, som er spesielt nyttige i de utførelsesformene der det aktive midlet ikke bløtgjør den bioadhesive sammensetningen, såsom alifatiske hydrokarboner, blande alifatiske og aromatiske hydrokarboner, aromatiske hydrokarboner, substituerte aromatiske hydrokarboner, hydrogenerte estere, polyterpener og hydrogenerte treharpikser. Ytterligere additiver inkluderer bindemidler såsom lecitin som "binder" de andre ingrediensene, eller reologiske agens (tykningsmiddel) som inneholder silikon såsom røyket silika, sand av reagenskvalitet, presippitert silika, amorf silika, kollodial silikondioksid, sammenføyet silika, silikagel, kvarts og partikkelsilikamaterialer kommersielt tilgjengelig som Syloid<®>, Cabosil<®>, Aerosil<® >og Whitelite<®>, som har til hensikt å øke den uniforme konsistenten eller kontinuerlige fasen til sluttsammensetningen. Andre additiver og tilsetningsstoffer inkluderer fortynnere, stabiliserere, fyllmiddel, leirer, buffringsagens, biocider, fuktighetsmidler, anti-irntasjonsmidler, antioksidanter, bevaringsmidler, aroma-stoffer, fargestoffer, pigmenter og lignende. Slike additiver eller tilsetningsstoffer blir typisk benyttet i mengder opptil 25 % regnet på vekt av den bioadhesive sammensetning og fortrinnsvis fra omkring 0,1 % til omkring 10 % regnet på vekt.
Sammensetningene som angitt i den foreliggende oppfinnelsen kan bli dannet ved å blande den ene eller flere bioadhesiver i pudder- eller væskeform, med PVP og aktivt agens, med eller uten et trykksensitivt adhesiv, fortrinnsvis i et passende flyktig løsningsmiddel ved lav molekylvekt. Når et trykksensitivt adhesiv blir benyttet er det flyktige løsningsmidlet med lav molekylvekt fortrinnsvis et organisk løsningsmiddel som er supplert med det trykksensitive adhesivet, f.eks. akryladhesivet. Vanlige væsker å anvende som slike flyktige løsningsmidler, som skiller seg fra emulsjon (vanligvis vandig) polymerisering, singulært eller i kombinasjon med andre flyktige og ikke-flyktige løsningsmidler, er flyktige polare og ikke-polare organiske væsker såsom alkanoler med lavere molekylvekt (f.eks. isopropanol og etanol), aromatiske såsom benzenderivater (f.eks. xylen og toluen), alkaner og cykloalkaner med lavere molekylvekt (f.eks. heksan, heptan og cykloheksan) og alkanosyreestere såsom etyl eller butylacetat.
Fortrinnsvis blir blandingen støpt ved omgivelsestemperatur og trykk, etterfulgt av fordamping av de flyktige løsningsmidlene f.eks. ved å fordampe ved lett forhøyede temperaturer, for å danne den bioadhesive blandingen. Løsningsmidlene som er ikke-flyktige eller som har høyere kokepunkt, såsom polyolene som benyttet i sammensetningen, forblir deri.
En individuell enhet eller anordning (ofte referert til som et "avleveringssystem") som inneholder den foreliggende oppfinnelsen kan bli dannet på et hvilket som helst vis som er kjent for en med kunnskaper i faget. Eksempel på en generell metode for dannelse er som følger: 1. passende mengder av PVP-polymeren, trykksensitivt adhesiv(er), løsningsmiddel/midler og/eller ko-løsningsmiddel/midler, forsterker(e), additiv(er) og tilsetningsstoffer) blir slått sammen og utførlig blandet sammen i en beholder. 2. Den eller de aktive agensene blir deretter tilsatt til blandingen og forsiktig rønng blir utført inntil agens(ene) er uniformt mikset deri, dersom den bioadhesive sammensetningen blir benyttet som kilden til både adhesivet og det aktive agenset. Dersom dette ikke er tilfellet blir det ikke tilsatt noe aktivt agens. 3. Passende mengder av andre bioadhesive material(er), såsom kayaragummi, kan deretter bli tilsatt til blandingen som inneholder det aktive agenset, og nøye blandet. 4. Sammensetningen blir deretter overført til en beleggingsoperasjon der den blir overtrukket på en frigivelsesforing (lag) i en kontrollert og spesifikk tykkelse. Den overtrukne sammensetningen blir deretter plassert i en ovn for å fjerne alle flyktige prosesseringsløsningsmidler. 5. Sammensetningen som er overtrukket med frigivelsesforingen blir deretter bragt i kontakt med et baklag og kveilet til ruller. 6. Passende størrelse og form av leveringssystemer blir utstanset fra rullmaterialet og deretter plassert i poser.
Antall trinn, mengden av ingredienser og tiden for røring eller blanding kan være viktige prosessvariabler som avhenger av de spesifikke polymerene, aktive agensene, løsningsmidler og/eller koløsningsmidler, forsterkere og additiver og tilsetningsstoffer som benyttet i sammensetningen. Disse faktorene kan justeres av personer med kunnskaper i faget, mens de bærer i minnet hensikten med å oppnå et oppløst aktivt agens og tilveiebringe et uniformt produkt. Det antas at et antall av andre metoder, f.eks. andre metoder for å overtrekke baklag som er velkjent i faget, såsom Mayerstav, dyptrykk, rulle over avskraper, ekstrusjon, fristøping, kalandrering og støping, eller å forandre rekkefølgen av visse trinn, f.eks. ved i en utførelsesform å la anestesiagensene løses opp i et løsningsmiddel, fortrinnsvis en polyhydrisk alkohol, og deretter la den resulterende blandingen bli tilsatt til andre bioadhesive komponenter før overtrekkingen, kan bli gjort og vil også gi ønskede resultater.
De foreliggende oppfinnerne har imidlertid funnet at ved å tilsette ikke-PVP bioadhesiv, såsom kayaragummi, til en blanding som inneholder PVP og løsningsmidler, vil den resulterende bioadhesive sammensetningen ha en mykere og glattere finish.
Belegget som vanligvis beskytter mot vanngjennomtrengning sørger for å bevare og opprettholde den bioadhesive sammensetningen som er anbragt derpå i en definert størrelse og form, hindre tap av aktivt agens og/eller forsterkere til miljøet, etterlate den individuelle enheten eller avleveringssystemene (sammen med frigjørings-foringen) transportabel, og generelt tilveiebringe beskyttelse både før og etter applikasjon av enheten eller systemet til et subjekt.
Passende materialer som kan bli benyttet, enkeltvis, i kombinasjon som laminater eller som ko-kryssformende for å danne belegglaget er vel kjent i faget, og inkluderer filmer eller flak av polyetylen, polyester, polypropylen, polyuretan, polyolefin, polyvinylalkohol, polyvinylklorid, polyvinyliden, polyamid, vinyl-acetatharpikser, BAREX<®>, etylen/vinylacetatkopolymerer, etyl en/etyl akryl at-kopolymerer, metalldampavsatte filmer eller flak derav, gummiflak eller filmer, ekspanderte syntetiske harpiksflak eller filmer, ikke-vevede stoffer, strikkede stoffer, klær, foiler og papir.
Belegglaget har generelt en tykkelse i området mellom 2-1000 mikrometer, og den bioadhesive sammensetningen blir generelt avsatt på belegglaget i en tykkelse som varierer fra omkring 12 til 250 mikrometer. Belegglaget kan være pigmentert, f.eks. farget for enten å matche med eller på en enkel måte å skille det fra applikasjonssetet, og/eller inneholde skrift, merking og andre måter å identifisere og/eller oppspore enheten eller systemet selv på. Belegglaget kan videre være laget opakt eller i det vesentlige opakt (dvs. å hindre lys.av gitte energibølgelengder fra å penetrere eller å passere), såsom metallisering, fyllere, blekk, fargestoffer og lignende, med den hensikt å beskytte fotosensitive aktive agens, såsom ketoprofen, fra degradering og/eller å hindre fotoallergiske reaksjoner eller irritasjoner på subjektet.
Fngjøringsforingen eller avskallingsstripen er også ment å hindre tap av det aktive agenset og/eller enhancere til omgivelse, og å etterlate den individuelle enheten eller avleveringssystemet (i forbindelse med belegglaget) transportabelt, såvel som generelt å beskytte den bioadhesive sammensetningen fra forurensning og lignende inntil den appliseres på et subjekt. Frigivelsesforingen er vanligvis også impermeabel og avstøtende, og må være kompatibel med partikkel bioadhesiver og/eller aktive agens slik at den ikke interfererer med deres ultimate topiske applikasjon og terapeutiske effekt.
Passende materialer som kan bli benyttet, enkeltvis, i kombinasjon, som laminater eller som kopressformere, for å danne frigivelsesforingen er også velkjent i faget og inkluderer ethvert materiale som er passende for belegglaget. Når frigivelsesforingen er dannet av et materiale som vanligvis ikke på en enkel måte frigir (dvs. ikke på en enkel måte kan fjernes eller separeres fra den bioadhesive sammensetningen), f.eks. papir, kan et overtrekksmateriale såsom silikon bli påført til frigivelsesforingen ved en hvilken som helst tradisjonell måte. Foretrukne frigivelsesforinger er filmer som er kommersielt tilgjengelige fra DuPont, Wilmington, Delaware, under varemerket Mylar<®>, og fluorpolymer (silikon) overtrukkede filmer kommersielt tilgjengelige fra Rexam Release, Oak Brook, Illinois, under varemerket FL2000<®> og MRL2000, og fra 3M Corporation, St.Paul, Minnesota under varemerket ScotchPak<®> 1022.
Konfigurasjonen av en individuell enhet eller avleveringssystem i den foreliggende oppfinnelsen kan være i en hvilken som helst form, fortrinnsvis en definert geometrisk form, og størrelse (dvs. overflatearealet for applikasjon) som er nødvendig eller ønskelig. Formen blir oppnådd ved tradisjonelle teknikker, f.eks. å kutte eller å stanse, og slike teknikker er beskrevet f.eks. i US patent nr. 5 032 207, 5 405 486 og 5 656 285. Det påtenkte applikasjonsstedet er en viktig faktor når størrelsen og formen på en individuell enhet eller avleveringssystem i den foreliggende oppfinnelsen skal bestemmes, og kan bli tilpasset av den med kunnskaper i faget ettersom det er nødvendig for å utføre terapi. Vanligvis bør størrelsen ikke overskride 100 cm<2>. Foretrukne størrelser varierer fra omkring 0,1
2*2 2 ;cm til omkring 60 cm , og mer foretrukket varierer fra omkring 1,5 cm til omkring 30 cm<2>, og optimalt fra omkring 2,0 cm<2> til omkring 10 cm<2>. ;De bioadhesive sammensetningene i den foreliggende oppfinnelsen inneholder fortrinnsvis de aktive agensene oppløst deri, og fester direkte til huden eller slimhinnene etter fjerning av frigivelsesforingen. ;Alternativt kan den bioadhesive sammensetningen bli benyttet uten et aktivt agens, i et multilagavleveringssystem som et "underlag" adhesivt lag (dvs. kobler seg direkte til huden eller slimhinnen etter fjerning av frigivelses"hner") der det aktive agenset er oppløst eller inneholdt i én eller flere andre separate lag, og der de andre lagene inneholder eller ikke inneholder utførelsesformer av de bioadhesive sammensetningene i den foreliggende oppfinnelsen. ;Den bioadhesive sammensetningen i følge den foreliggende oppfinnelsen bli benyttet uten et aktivt agens, i et reservoartype avleveringssystem som et underlagsadhesiv eller et perifert adhesivt lag eller ring, der det aktive agenset er oppløst eller inneholdt i et separat reservoar eller depot, og der reservoaret eller depotet kan inneholde eller ikke inneholde utforminger av de bioadhesive sammensetningene i den foreliggende oppfinnelsen. ;Dersom den bioadhesive sammensetningen blir benyttet som en adhesiv ring rundt det aktive agensreservoaret eller medikamentdepotet, er det bioadhesive laget perifert til det aktive agensreservoaret. Dersom den bioadhesive sammensetningen blir benyttet som et separat underliggende adhesivt lag i forhold til laget som inneholder det aktive agenset, er det adhesive laget ved siden av, og i kontakt med, den første hovedoverflate av det aktive agenslaget. Sammensetningen kan da inkludere et belegglag som er i kontakt med en hovedoverflate nr. 2 til det aktive agenslaget, som er overfor den første hovedoverflaten til det aktive agenslaget; og en fjernbar frigivelsesforing som er i kontakt med en sekundær hovedoverflate til det adhesive laget som er overfor den første hovedoverflaten til det aktive agenslaget. ;Dersom det bioadhesive laget blir benyttet uten et aktivt agens som et separat underliggende lag, er tykkheten på det underliggende laget generelt i området fra (25,4-254) • 10"<3>mm (1-10 mil), mer fortrinnsvis (50,8-203,3) • I0"<3>mm (2-8 mil) og mest fortrinnsvis (101,6-151,6) • 10 3 mm (4-6 mil) tykt. ;Mengden av hver komponent (aktiv agens er ikke inkludert) i vekt% basert på den kombinerte tørre vekten til minst én løselig polyvinylpyrrolidonpolymer, kayaragummien, den polyhydriske alkoholen og glyserinet er vist under: ;Dersom den bioadhesive sammensetningen inneholder den ene eller flere aktive agens, kan mengdene av de førnevnte komponentene bli tilpasset av personer med ;kunnskaper i faget avhengig av mengden og type av den ene eller flere aktive agens. ;Et foretrukket vektforhold mellom kayaragummi og glyserin er fra 10:1 til 1:2, mer fortrinnsvis omkring 1:1. Et foretrukket vektforhold mellom kayaragummi og polypropylenglykol er fra 10:1 til 1:1, mer fortrinnsvis omkring 1:0,8. Et foretrukket vektforhold mellom PVP og kayaragummi er fra 1:1 til 1:7, fortrinnsvis 1:3 til 1:4. ;Det har blitt funnet at dersom den spesielt foretrukkede sammensetningen i tabellen over blir benyttet som et separat adhesivt lag, er sammensetningen istand til å redusere tiden som kreves for adhesjon av en sammensetning til slimhinnevev i en slik grad at sammensetningen kleber seg til shmhinnevevet i det vesentlige i det samme øyeblikket som de kommer i kontakt, uten ytterligere trykk. ;De følgende eksemplene vil ytterligere beskrive den foreliggende oppfinnelsen, og blir benyttet kun i den hensikt å illustrere, og må ikke anses på noen måte å begrense oppfinnelsen som er beskrevet heri. ;Prosent (%) som benyttet i eksempel 1 refererer til % av væskeformuleringen på en vekt til vekt basis, og temperaturer er gitt i grader celsius (°C). ;Eksempel 1 ;;Sluttproduktet blir produsert ved først å blande lidokainbasen, prilokainhydroklorid, propylenglykol, PVP og glyserin ved omkring 70-90°C, til alt medikamentet er oppløst. Løsningen blir deretter kjølt ned til 20-35°C før det tilsettes karayagummi. Straks karayagummien har blitt tilsatt blir sluttsammensetningen påført et passende beleggmateriale såsom en ikke-vevet polyesterfilm (f.eks. filmen som selges under varemerket Sontara 8100, produsert av DuPont de Nemours, E.l. og co., Wilmington, Delaware) og varmet til omkring 100°C for å akselerere dannelsen til dets endelige sluttform. ;Eksempel la ;1 eksempel 1 a blir det fremstilt en sammensetning på følgende måte uten et medikament. Sammensetningen kan deretter bli benyttet alene som et underliggende adhesivt lag, eller det kan tilsettes et aktivt agens før fjerningen av flyktige prosesseringsløsningsmidler. ;Eksempel 2 ;En bioadhesiv sammensetning blir dannet ved å kombinere 20,59 % vekt/vekt våt vekt av karayagummi, 10,59 % vekt/vekt våtvekt av løselig PVP (PLASDONE K90), 7,94 % vekt/vekt våtvekt av oleinsyre, 45,0 % vekt/vekt av etanol og 15,88 % vekt/vekt våtvekt av ketoprofen i en passende beholder og blande utførlig inntil blandingen er fullstendig homogen. Den resulterende sammensetningen har ingredienskonsentrasjonene på en tørrvektbasis, dvs. etter fjerning av det flyktige prosessløsningsmidlet (etanol). ;EKSEMPEL 2 ;1 de følgende eksemplene er metoden i eksempel 2 benyttet med de passende mengder av utgangsmaterialet for å gi sammensetninger som har de følgende ingredienskonsentrasjonene, på en vekt% i tørrvekt av den totale bioadhesive sammensetningen. Flyktige løsningsmidler, der de er indikert ved (), er ikke tilstede i sluttsammensetningen. ;Videre er medikamentene i eksempler 21-29 dispergert i sluttsammensetningen i stedet for å være oppløst. ;*
Claims (20)
1. Bioadhesiv sammensetning i en fleksibel, endelig form for topisk applikasjon av én eller flere aktive agens som er resultatet av en tilblanding, karakterisert ved: (a) 2,5 - 40 vekt% av ett eller flere aktive agens; (b) 10-40 vekt% av minst ett bioadhesiv som er en naturlig gummi; (c) 10 - 40 vekt% av minst én løselig polyvinylpyrrolidonpolymer (PVP); (d) 10 - 60 vekt% av ett eller flere løsningsmidler; og (e) et støttelag som forhindrer tap av aktivt agens
hvori
sammensetningen inneholder mindre enn omtrent 10 vekt% vann; sammensetningen er av en endelig, fleksibel form og
enten omfatter adhesivlaget 2,5 - 40 vekt% av en eller flere aktive agens;
eller sammensetningen omfatter et lag som er separert fra adhesivlaget og som omfatter 2,5 - 40 vekt% av en eller flere aktive agens (lag med aktiv agens) og i) adhesivlaget er tilstøtende til og i kontakt med en første store overflate til laget med aktiv agens, ii) støttelaget er i kontakt med en andre store overflate til laget med aktiv agents som er motsatt til den første store overflaten til laget med aktivt agens.
2. Sammensetning ifølge krav 1, hvori den naturlige gummien er valgt fra karayagummi, guargummi, okragummi, arabingummi, pectinagummi, ghattigummi, tragakantgummi, canthangummi, johannesbrødgummi, loppefrøgummi, tamarindgummi, destriagummi og caseingummi.
3. Sammensetning som angitt i krav 2,
karakterisert ved at bioadhesivet inneholder kayaragummi.
4. Sammensetning som angitt i krav 1,
karakterisert ved at ett eller flere av løsningsmidlene inkluderer et separat løsningsmiddel og et separat bløtgjøringsmiddel.
5. Sammensetning som angitt i krav 4,
karakterisert ved at minst ett bioadhesiv inneholder kayaragummi, og hvori det separate løsningsmidlet inneholder en polyhydrisk alkohol, og det separate bløtgjøringsmidlet inneholder glyserin.
6. Sammensetning som angitt i krav 5,
karakterisert ved at minst én løselig PVP er til stede i en mengde på fra 7-15 vekt%, kayaragummien er til stede i en mengde på fra 20-40 vekt%, den polyhydriske alkoholen er tilstede i en mengde på fra 15-35 vekt%, og glyserinet er tilstede i en mengde på fra 20-40 vekt%, alt basert på den kombinerte vekten til minst én løselig PVP, kayaragummien, den polyhydriske alkoholen og glyserinet.
7. Sammensetning som angitt i krav 5,
karakterisert ved at vektforholdet mellom minst én PVP og kayaragummi er fra 1:3 til 1:4.
8. Sammensetning som angitt i krav 5,
karakterisert ved at vektforholdet mellom kayaragummi og glyserin er fra 10:1 til 1:2.
9. Sammensetning som angitt i krav 5,
karakterisert ved at vektforholdet mellom kayaragummi og propylenglykol er fra 10:1 til 1:1.
10. Sammensetning som angitt i krav 5,
karakterisert ved at den polyhydriske alkoholen inneholder propylenglykol.
11. Sammensetning som angitt i krav 1,
karakterisert ved at den løselige polyvinylpyrrolidonpolymeren har en molekylvekt på omkring 1000000 til omkring 1500000.
12. Sammensetning som angitt i krav 1,
karakterisert ved at én eller flere av de aktive agensene er valgt fra gruppen bestående av anestesimidler, anti-inflammatoriske midler, smertestillende midler, antimigrenemidler, antimikrobemidler, tannmidler, antibiotika, anoreksimidler, polypeptidmedikamenter, proteinmedikamenter, opioidagonister, opioidantagonister, antibrekningsmidler, antineoplastiske midler, antiparkinson-midler, antidiuretiske midler, hormoner, bronkiodilatorer, sentralnervesystemstimulerende midler og agens, oksyotiske midler og vasodilatorer.
13. Sammensetning for å administrere ett eller flere aktive agens, karakterisert ved : (a) 2,5 - 40 vekt% av ett eller flere aktive agens; og (b) et adhesivt lag tilpasset for å klebe til hud eller slimhinnevev, og som er resultatet av en blanding som inneholder: (i) 10 - 40 vekt% av minst én løselig polyvinylpyrrolidonpolymer (PVP); (ii) 10-40 vekt% av minst ett bioadhesiv som er naturlig gummi; og (iii) 10 - 60 vekt% av ett eller flere løsningsmidler, (c) et støttelag som forhindrer tap av aktivt agens;
hvori kilden (a) er forskjellig fra det adhesive laget (b); og hvori sammensetningen inneholder mindre enn omtrent 10 vekt% vann; sammensetningen er av en endelig, fleksibel form og enten omfatter adhesivlaget 2,5 - 40 vekt% av en eller flere aktive agens; eller sammensetningen omfatter et lag som er separert fra adhesivlaget og som omfatter 2,5 - 40 vekt% av en eller flere aktive agens (lag med aktiv agens) og i) adhesivlaget er tilstøtende til og i kontakt med en første store overflate til laget med aktiv agens, ii) støttelaget er i kontakt med en andre store overflate til laget med aktiv agents som er motsatt til den første store overflaten til laget med aktivt agens.
14. Sammensetning som angitt i krav 13,
karakterisert ved at kilden (a) inkluderer et separat lag som inneholder den eller de aktive agensene, og hvori den første hovedoverflate til det adhesive laget er nærliggende til og i kontakt med en første hovedoverflate til det separate laget.
15. Sammensetning som angitt i krav 14,
karakterisert ved at det videre inneholder: (c) et belegglag som er i kontakt med en annen hovedoverflate til det separate laget som er motstående til den første overflaten til det separate laget; og (d) en fjernbar frigivelsesforing som er i kontakt med en annen hovedoverflate til det adhesive laget som er motstående til den første hovedoverflaten til det separate laget.
16. Sammensetning som angitt i krav 13,
karakterisert ved at kilden (a) inkluderer et aktivt agensreservoar, og at det adhesive laget er perifert til det aktive agensreservoaret.
17. Sammensetning som angitt i krav 13,
karakterisert ved at det adhesive laget inkluderer ett eller flere løsningsmidler, hvori nevnte ene eller flere løsningsmidler inneholder et separat løsningsmiddel og et separat bløtgjøringsmiddel, og hvori nevnte minst ene bioadhesiv inneholder kayaragummi.
18. Sammensetning som angitt i krav 17,
karakterisert ved at det separate løsningsmidlet inneholder en polyhydrisk alkohol, og hvori det separate bløtgjøringsmidlet inneholder glyserin.
19. Fremgangsmåte for fremstilling av sammensetningen i følge krav 1, karakterisert ved å blande (a) 2,5 - 40 vekt% av én eller flere aktive agens; (b) 10-40 vekt% av minst ett bioadhesiv som er en naturlig gummi; (c) 10-40 vekt% av minst én løselig polyvinylpyrrolidonpolymer; og (d) 10-40 vekt% av ett eller flere løsningsmidler for å danne en sammensetning.
20. Fremgangsmåte for fremstilling av sammensetningen i følge krav 13, karakterisert ved : (a) å lage en aktiv agenskilde som inneholder 2,5 - 40 vekt% av én eller flere aktive agens; og (b) å lage et separat adhesivt lag tilpasset for å klebe seg til hud eller slimhinnevev, som omfatter å blande: (i) 10 - 40 vekt% av minst én løselig polyvinylpyrrolidonpolymer; (ii) 10 - 40 vekt% av minst ett bioadhesiv som er en naturlig gummi; og (iii) 10-40 vekt% av ett eller flere løsningsmidler.
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US6115597P | 1997-09-26 | 1997-09-26 | |
PCT/US1998/020091 WO1999015210A2 (en) | 1997-09-26 | 1998-09-25 | Bioadhesive compositions and methods for topical administration of active agents |
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ES (1) | ES2252865T3 (no) |
IL (1) | IL135258A0 (no) |
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1998
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- 1998-09-25 AU AU95813/98A patent/AU750809B2/en not_active Ceased
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- 1998-09-25 DK DK98949505T patent/DK1021204T3/da active
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AU750809B2 (en) | 2002-07-25 |
DE69833000D1 (de) | 2006-02-02 |
US6562363B1 (en) | 2003-05-13 |
WO1999015210B1 (en) | 1999-08-19 |
WO1999015210A2 (en) | 1999-04-01 |
NZ504108A (en) | 2002-06-28 |
WO1999015210A3 (en) | 1999-06-17 |
CA2304958C (en) | 2008-12-30 |
DE69833000T2 (de) | 2006-09-07 |
DK1021204T3 (da) | 2006-05-08 |
AU9581398A (en) | 1999-04-12 |
JP2001517493A (ja) | 2001-10-09 |
ES2252865T3 (es) | 2006-05-16 |
EP1021204A2 (en) | 2000-07-26 |
NO20001567L (no) | 2000-05-25 |
RU2234337C2 (ru) | 2004-08-20 |
CA2304958A1 (en) | 1999-04-01 |
ATE314092T1 (de) | 2006-01-15 |
NO20001567D0 (no) | 2000-03-24 |
IL135258A0 (en) | 2001-05-20 |
EP1021204B1 (en) | 2005-12-28 |
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