美國藥典氣霧劑檢測

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時間:2018-07-09

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1、AerosolsPharmaceuticalaerosolsareproductsthatarepackagedunderpressureandcontaintherapeuticallyactiveingredientsthatarereleaseduponactivationofanappropriatevalvesystem.Theyareintendedfortopicalapplicationtotheskinaswellaslocalapplicationintothenose(nasalaerosols),mouth(lingualaeroso

2、ls),orlungs(inhalationaerosols).Theseproductsmaybefittedwithvalvesenablingeithercontinuousormetered-dosedelivery;hence,terms”[DRUG]MeteredTopicalAerosols,””[DRUG]MeteredNasalAerosols,”etc.Theterm”aerosol”referstothefinemistofspraythatresultsfrommostpressurizedsystems.However,theter

3、mhasbeenbroadlymisappliedtoallself-containedpressurizedproducts,someofwhichdeliverfoamsorsemisolidfluids.InthecaseofInhalationAerosols,theparticlesizeofthedeliveredmedicationmustbecarefullycontrolled,andtheaveragesizeoftheparticlesshouldbeunder5μm.Theseproductsarealsoknownasmetered

4、-doseinhalers(MDIs).Otheraerosolspraysmaycontainparticlesuptoseveralhundredmicrometersindiameter.Thebasiccomponentsofanaerosolsystemarethecontainer,thepropellant,theconcentratecontainingtheactiveingredient(s),thevalve,andtheactuator.Thenatureofthesecomponentsdeterminessuchcharacter

5、isticsasparticlesizedistribution,uniformityofdoseformeteredvalves,deliveryrate,wetnessandtemperatureofthespray,spraypatternandvelocityorplumegeometry,foamdensity,andfluidviscosity.TypesofAerosolsAerosolsconsistoftwo-phase(gasandliquid)orthree-phase(gas,liquid,andsolidorliquid)syste

6、ms.Thetwo-phaseaerosolconsistsofasolutionofactiveingredientsinliquefiedpropellantandthevaporizedpropellant.Thesolventiscomposedofthepropellantoramixtureofthepropellantandcosolventssuchasalcohol,propyleneglycol,andpolyethyleneglycols,whichareoftenusedtoenhancethesolubilityoftheactiv

7、eingredients.Three-phasesystemsconsistofasuspensionoremulsionoftheactiveingredient(s)inadditiontothevaporizedpropellants.Asuspensionconsistsoftheactiveingredient(s)thatmaybedispersedinthepropellantsystemwiththeaidofsuitableexcipientssuchaswettingagentsand/orsolidcarrierssuchastalco

8、rcolloidalsilicas.Afoamaer

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