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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Aerosol pptx