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Aerosol pptx
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FORMULATIONANDMANUFACTURINGOFAEROSOL
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INTRODUCTION
Aerosol is defined as a system thatdepends on the power of a compressed orliquefied gas to expel the contents from the
container. It is also known as canister/pressure
package/pressurized package.
In mid 1950 the pharmaceutical aerosolintroduced in market.
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ADVANTAGES
Convenience,speed&easeofapplication. Itcanavoidthehepaticmetabolismofdrugs.
Avoidanceofmanualcontactwithmedicament
Controlled & uniform dosage delivered by
meteredvalves.
Absenceofair incontainerpreventsoxidationof
susceptibledrugs.
Itdirectlyappliedtotheaffectedareainadesiredfoam.
It produce local & systemic effect(due to large
surfaceareaoflungandbloodcapillary)
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Costlierthantraditionalpack.
Disposalmaydifficult.
Packshouldnotbesubjectedtoheat.
Ifthedrugisnotsolubleinpropellantformulation
difficultiesarised. Theremaybepropellanttoxicitywheninhalation
therapylastforalongperiod.Heartpatientmay
beatriskifpropellantsareinhaled.
Somepropellants(CFCS)causeenvironmental
problem.
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1.Productconcentrate
2.Propellant
3.Container
4.Valveandactuator
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Containersusedformanufacturingofaerosolmustwithstandpressureashighas140to
180psig
Typesofcontainers:
consistsofsheetofsteelplatethathasbeen
electroplatedonbothsideswithtin
Greaterresistancetocorrosion,Lightweight,
notfragile
Goodforlightsensitivedrugs
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Contd
3.
Limitedforsmallersize
Extremelystrongandresistanttomostmaterials
Pressurestand
Availablewithplasticorwithoutplasticcoating
Compatiblewithmanyadditives
Nocorrosionproblems
Canhavevariousshapebecauseofmolding
Fragile
Notforlightsensitivedrugs
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Actuator
Ferruleormountcap
Valvebodyorhousing
Stem
Gasket
Spring
Diptube
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Actuators: Thesearespeciallydesignedbuttonplacedon
thevalvesystemwhichhelpsineasyopening
andclosingofthevalve.
Ithelpsindelivertheproductinthedesiredform.
Therearedifferenttypeofactuatorsareused,
SprayActuators-orifices0.016-0.040inch.
FoamActuators-orificediameter0.070-0.125inch
SpecialActuators-todeliverthemedicamenton
thespecificsites
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VALVES
Regulatetheflowofproductanddischargethe
content.
Valveisassociatedwiththehelpofactuautor(if
thefoampresentinthecontainer)toemittedthe
productaswetorsprayTYPESOFAEROSOLVALVES
1.Continuoussprayvalve
MountingCup/Ferrule,ValvebodyorHousing
Stem,Gasket,Spring,DipTube
2.Meteringvalve
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AnAerosolformulationconsistsofthreeessentialcomponents:
Propellant
Productconcentrate
TypesofsystemParametersconsideration:
Physical,chemicalandpharmacologicalpropertiesofactive
ingredient,surfactant,solventtogivetheproperHLB
valueforanemulsion.Propellantisselectedtogivethedesiredvapourpressure,
solubility,andparticlesize.
Typesofsystemrequiredtodispensedasfinemist,wet
spray,foam.
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Therearefivetypesofaerosolsystem
1.Solutionsystem/Twophasesystem
2.Waterbasedsystem/Threephasesystem
3.SuspensionorDispersionsystem
4.Foamsystem
Aqueousstablefoam
Non-Aqueousstablefoam
QuickBreakingFoam
Thermalfoam
5.Intranasalfoam
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SOLUTIONSYSTEM
Whichconsistsoftwophases:avapour
phaseandliquidphase.
Whentheactiveingredientsaresolubleinthepropellant,noothersolventisrequired.
Dependingonthetypeofsprayrequired
Propellantareused.
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Theseareapplicableforthosedrugwhichisnot
solubleinpropellant.
SincewaterandpropellantarenotmisciblesoIt
formthreephasesystemcontainingvapour
phase,propellant,water. Ethanolusedasacosolventtosolubilisethe
propellantinwater.
Itisdifficulttoachievedesiredfineparticlesize
withproductcontainiglargeamountsofwaterand
lowproportionofpropellant,amechanical
breakupactuatormustbeusedalongwitha
vapourtapevalve.
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Toovercomethedifficultiesarisesfromwater
basedsystemoradditionofcosolventsuspensionsystemisused.
Itispreparedbydispersingactiveingredientsin
mixtureofpropellantbyusingsuspendingagent. Thephysicalstabilityofsuspensioncanbe
increasedbyusingminimumsolubilityofAPI.
Eg.Ephedrinebitartarateislesssolublethan
Hcl.
ByUseofsurfactanttoreducetheagglomeration
Eg.Sorbitanmonolaurate,sorbitan
monooleate,sorbitantrioleate,isopropylmyristae.
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TheycontainDispersionofA.I,Aqueousornonaqueous
Vehicle,surfactantandpropellant. Liquefiedpropellantisemulsifiedandfoundintheinternal
phase.
Aqueousstablefoam
A.Ingredientsoilwaxes
O/Wsurfactant
Water
HydrocarbonNonaqueousstablefoam:
ThesearepreparedbyusingGlycols
EmulsifyingagentusedthistypePEGEsters
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Quickbreakingfoam:
Inthissystemthepropellantisintheexternalphase.whendispensed,theproductisemittedasafoamwhichthen
collapsedintoliquid.
Usefulfortopicalmedication.
Thermalfoam:
Usedtoproduceawarmfoamforshaving.
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Theaerosolconcentrateconsistsofdrugor
combinationofdrugs,solvents,antioxidantsandsurfactantsformulatedassolution,suspension.
Theaerosolconcentrateisfirstpreparedandfilled
intothecontainer. Thepropellantisthenfilledintothecontainer.
Therefore,partofthemanufacturingoperation
takesplaceduringthefillingoperationmeasures
toensurethatbothconcentrateandpropellantarebroughttogetherintheproperproportion.
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Coldfillingprocess
Pressurefillingprocess Compressedgasfillingprocess
Automaticfillingprocess
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Coolingchamber
Hoke
valve
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Evacuatetheairandsealthevalveinplace
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Singleheadormultipleheadrotaryunitcapableof
vacuumcrimpingupto120can/minareavailable.
Avalveisplacedeithermanuallyorautomatically
dependingontheproductionraterequired.
Thevalveiscrimpedinplacebyusingvalvecrimper.
Aqueousproducts,emulsionsandthoseproducts
adverselyaffectedbycoldtemperaturecannotbe
filledbythismethod.
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ADVANTAGES
Itisthepreferredmethodforsolutions,emulsionsandsuspension.
Lesschancesforcontaminationofproduct
withthemoisture.
Norefrigerationisrequired,canbecarried
outatRT.
DISADVANTAGES
Notsuitableforinhalationaerosolfitedwith
meteredvalve
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COMPRESSEDFILLING
Compressedgasesarepresentunderhighpressureincylinders.Thesecylindersarefittedwithapressurereducingvalveandadeliverygauge.
1.Theconcentrateisplacedinthecontainer
2.Thevalveiscrimpedinplace 3.Airisevacuatedbymeansofvacuumpump
4.Thefillingheadisinsertedintothevalveopening,
valvedepressedandgasisallowedtoflowintothe
container5.Toobtainmaximumsolubilityofthegasintheproduct,
thecontainerisshakenmanuallyduringandafterthe
fillingoperationbymechanicalshakers.
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video
http://e/m.pharma/Aerosol/High%20Speed%20Net%20Weight%20Aerosol%20Filler%20-%20YouTube.FLVhttp://e/m.pharma/Aerosol/High%20Speed%20Net%20Weight%20Aerosol%20Filler%20-%20YouTube.FLV -
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Thistestindicatestheeffectofanaerosolformulationon
theextensionofanopenflame.
Productissprayedfor4sec.intoflame.
Dependingonthenatureofformulation,theflameisextended,andexactlengthwasmeasuredwithruler.
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FLASHPOINT
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Determinedbypressuregauge
Pressurevariationfromcontainertocontainerbe
determined,sinceexcessivevariationin
pressureindicatesthepresenceofairin
headspace.
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MEASUREMENTOFDENSITY
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Methodused G.Chasalsobeenused
1.G.C
2.I.Rspectrophotometry
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AEROSOLVALVEDISCHARGERATE
Determinedbytakinganaerosolknownweight
anddischargingthecontentsforgiventimeusing
standardapparatus.
Byreweighingthecontaineraftertimelimit,thechangeinweightpertimedispensedis
dischargerate.Itisexpressedasgramper
seconds.
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Spraytheproductonthecoated(dye+talc)Paper.Dependinguponthenatureofaerosol,water/oilsoluble
dyeisused.Theparticlesthatstrikethepapercausethe
dyetogointosolutionandtobeabsorbedontothe
paper.Thisgivesarecordofspray.
Valve
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Particlesize(cascadeimpactor)
AEROSOL
Impaction slide
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BIBLIOGRAPHY
formulation
Url:www.google.com/patents/US7090831.Accessed on 08/05/2012, 7.30 p.m.
Url: http://www.china-pharmaceutical-
machine.com/product/47-semi-auto-aerosol-
propellant-filler-pqgbi-14c9/Accessed on 08/05/2012, 7.31p.m.Url: http://www.aerosolindia.in/aerosol
machines.htmlAccessed on 09/05/2012, 5.30 p.m.
Url:http://www.pharmacopeia.cn/v29240/usp29nf24
s0_c1151s8.html
Accessed on 08/05/2012, 5.33 p.m.
http://www.google.co.in/url?sa=t&rct=j&q=pharmaceutical+aerosol+pdf&source=web&cd=32&ved=0CFcQFjABOB4&url=http://www.google.com/patents/US7090831.pdf&ei=z3WqT47jOZCsrAfataHgAQ&usg=AFQjCNG1Ne1HA8pvNyFcXdtAmete38nhqwhttp://www.google.com/patents/US7090831.pdfhttp://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.aerosolindia.in/aerosol-machines.htmlhttp://www.aerosolindia.in/aerosol-machines.htmlhttp://www.pharmacopeia.cn/v29240/usp29nf24s0_c1151s8.htmlhttp://www.pharmacopeia.cn/v29240/usp29nf24s0_c1151s8.htmlhttp://www.pharmacopeia.cn/v29240/usp29nf24s0_c1151s8.htmlhttp://www.pharmacopeia.cn/v29240/usp29nf24s0_c1151s8.htmlhttp://www.pharmacopeia.cn/v29240/usp29nf24s0_c1151s8.htmlhttp://www.pharmacopeia.cn/v29240/usp29nf24s0_c1151s8.htmlhttp://www.aerosolindia.in/aerosol-machines.htmlhttp://www.aerosolindia.in/aerosol-machines.htmlhttp://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.china-pharmaceutical-machine.com/product/47-semi-auto-aerosol-propellant-filler-pqgbi-14c9/http://www.google.com/patents/US7090831.pdfhttp://www.google.com/patents/US7090831.pdfhttp://www.google.com/patents/US7090831.pdfhttp://www.google.co.in/url?sa=t&rct=j&q=pharmaceutical+aerosol+pdf&source=web&cd=32&ved=0CFcQFjABOB4&url=http://www.google.com/patents/US7090831.pdf&ei=z3WqT47jOZCsrAfataHgAQ&usg=AFQjCNG1Ne1HA8pvNyFcXdtAmete38nhqwhttp://www.google.co.in/url?sa=t&rct=j&q=pharmaceutical+aerosol+pdf&source=web&cd=32&ved=0CFcQFjABOB4&url=http://www.google.com/patents/US7090831.pdf&ei=z3WqT47jOZCsrAfataHgAQ&usg=AFQjCNG1Ne1HA8pvNyFcXdtAmete38nhqwhttp://www.google.co.in/url?sa=t&rct=j&q=pharmaceutical+aerosol+pdf&source=web&cd=32&ved=0CFcQFjABOB4&url=http://www.google.com/patents/US7090831.pdf&ei=z3WqT47jOZCsrAfataHgAQ&usg=AFQjCNG1Ne1HA8pvNyFcXdtAmete38nhqw -
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