Date post: | 05-Apr-2018 |
Category: |
Documents |
Upload: | ranjeet-singh |
View: | 234 times |
Download: | 0 times |
of 39
7/31/2019 Aerosol pptx
1/39
Submittedby
FORMULATIONANDMANUFACTURINGOFAEROSOL
7/31/2019 Aerosol pptx
2/39
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.
7/31/2019 Aerosol pptx
3/39
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)
7/31/2019 Aerosol pptx
4/39
Costlierthantraditionalpack.
Disposalmaydifficult.
Packshouldnotbesubjectedtoheat.
Ifthedrugisnotsolubleinpropellantformulation
difficultiesarised. Theremaybepropellanttoxicitywheninhalation
therapylastforalongperiod.Heartpatientmay
beatriskifpropellantsareinhaled.
Somepropellants(CFCS)causeenvironmental
problem.
7/31/2019 Aerosol pptx
5/39
1.Productconcentrate
2.Propellant
3.Container
4.Valveandactuator
7/31/2019 Aerosol pptx
6/39
Containersusedformanufacturingofaerosolmustwithstandpressureashighas140to
180psig
Typesofcontainers:
consistsofsheetofsteelplatethathasbeen
electroplatedonbothsideswithtin
Greaterresistancetocorrosion,Lightweight,
notfragile
Goodforlightsensitivedrugs
7/31/2019 Aerosol pptx
7/39
Contd
3.
Limitedforsmallersize
Extremelystrongandresistanttomostmaterials
Pressurestand
Availablewithplasticorwithoutplasticcoating
Compatiblewithmanyadditives
Nocorrosionproblems
Canhavevariousshapebecauseofmolding
Fragile
Notforlightsensitivedrugs
7/31/2019 Aerosol pptx
8/39
Actuator
Ferruleormountcap
Valvebodyorhousing
Stem
Gasket
Spring
Diptube
7/31/2019 Aerosol pptx
9/39
Actuators: Thesearespeciallydesignedbuttonplacedon
thevalvesystemwhichhelpsineasyopening
andclosingofthevalve.
Ithelpsindelivertheproductinthedesiredform.
Therearedifferenttypeofactuatorsareused,
SprayActuators-orifices0.016-0.040inch.
FoamActuators-orificediameter0.070-0.125inch
SpecialActuators-todeliverthemedicamenton
thespecificsites
7/31/2019 Aerosol pptx
10/39
VALVES
Regulatetheflowofproductanddischargethe
content.
Valveisassociatedwiththehelpofactuautor(if
thefoampresentinthecontainer)toemittedthe
productaswetorsprayTYPESOFAEROSOLVALVES
1.Continuoussprayvalve
MountingCup/Ferrule,ValvebodyorHousing
Stem,Gasket,Spring,DipTube
2.Meteringvalve
7/31/2019 Aerosol pptx
11/39
AnAerosolformulationconsistsofthreeessentialcomponents:
Propellant
Productconcentrate
TypesofsystemParametersconsideration:
Physical,chemicalandpharmacologicalpropertiesofactive
ingredient,surfactant,solventtogivetheproperHLB
valueforanemulsion.Propellantisselectedtogivethedesiredvapourpressure,
solubility,andparticlesize.
Typesofsystemrequiredtodispensedasfinemist,wet
spray,foam.
7/31/2019 Aerosol pptx
12/39
Therearefivetypesofaerosolsystem
1.Solutionsystem/Twophasesystem
2.Waterbasedsystem/Threephasesystem
3.SuspensionorDispersionsystem
4.Foamsystem
Aqueousstablefoam
Non-Aqueousstablefoam
QuickBreakingFoam
Thermalfoam
5.Intranasalfoam
7/31/2019 Aerosol pptx
13/39
SOLUTIONSYSTEM
Whichconsistsoftwophases:avapour
phaseandliquidphase.
Whentheactiveingredientsaresolubleinthepropellant,noothersolventisrequired.
Dependingonthetypeofsprayrequired
Propellantareused.
7/31/2019 Aerosol pptx
14/39
Theseareapplicableforthosedrugwhichisnot
solubleinpropellant.
SincewaterandpropellantarenotmisciblesoIt
formthreephasesystemcontainingvapour
phase,propellant,water. Ethanolusedasacosolventtosolubilisethe
propellantinwater.
Itisdifficulttoachievedesiredfineparticlesize
withproductcontainiglargeamountsofwaterand
lowproportionofpropellant,amechanical
breakupactuatormustbeusedalongwitha
vapourtapevalve.
7/31/2019 Aerosol pptx
15/39
Toovercomethedifficultiesarisesfromwater
basedsystemoradditionofcosolventsuspensionsystemisused.
Itispreparedbydispersingactiveingredientsin
mixtureofpropellantbyusingsuspendingagent. Thephysicalstabilityofsuspensioncanbe
increasedbyusingminimumsolubilityofAPI.
Eg.Ephedrinebitartarateislesssolublethan
Hcl.
ByUseofsurfactanttoreducetheagglomeration
Eg.Sorbitanmonolaurate,sorbitan
monooleate,sorbitantrioleate,isopropylmyristae.
7/31/2019 Aerosol pptx
16/39
TheycontainDispersionofA.I,Aqueousornonaqueous
Vehicle,surfactantandpropellant. Liquefiedpropellantisemulsifiedandfoundintheinternal
phase.
Aqueousstablefoam
A.Ingredientsoilwaxes
O/Wsurfactant
Water
HydrocarbonNonaqueousstablefoam:
ThesearepreparedbyusingGlycols
EmulsifyingagentusedthistypePEGEsters
7/31/2019 Aerosol pptx
17/39
Quickbreakingfoam:
Inthissystemthepropellantisintheexternalphase.whendispensed,theproductisemittedasafoamwhichthen
collapsedintoliquid.
Usefulfortopicalmedication.
Thermalfoam:
Usedtoproduceawarmfoamforshaving.
7/31/2019 Aerosol pptx
18/39
7/31/2019 Aerosol pptx
19/39
Theaerosolconcentrateconsistsofdrugor
combinationofdrugs,solvents,antioxidantsandsurfactantsformulatedassolution,suspension.
Theaerosolconcentrateisfirstpreparedandfilled
intothecontainer. Thepropellantisthenfilledintothecontainer.
Therefore,partofthemanufacturingoperation
takesplaceduringthefillingoperationmeasures
toensurethatbothconcentrateandpropellantarebroughttogetherintheproperproportion.
7/31/2019 Aerosol pptx
20/39
Coldfillingprocess
Pressurefillingprocess Compressedgasfillingprocess
Automaticfillingprocess
7/31/2019 Aerosol pptx
21/39
Coolingchamber
Hoke
valve
7/31/2019 Aerosol pptx
22/39
Evacuatetheairandsealthevalveinplace
7/31/2019 Aerosol pptx
23/39
Singleheadormultipleheadrotaryunitcapableof
vacuumcrimpingupto120can/minareavailable.
Avalveisplacedeithermanuallyorautomatically
dependingontheproductionraterequired.
Thevalveiscrimpedinplacebyusingvalvecrimper.
Aqueousproducts,emulsionsandthoseproducts
adverselyaffectedbycoldtemperaturecannotbe
filledbythismethod.
7/31/2019 Aerosol pptx
24/39
7/31/2019 Aerosol pptx
25/39
ADVANTAGES
Itisthepreferredmethodforsolutions,emulsionsandsuspension.
Lesschancesforcontaminationofproduct
withthemoisture.
Norefrigerationisrequired,canbecarried
outatRT.
DISADVANTAGES
Notsuitableforinhalationaerosolfitedwith
meteredvalve
7/31/2019 Aerosol pptx
26/39
COMPRESSEDFILLING
Compressedgasesarepresentunderhighpressureincylinders.Thesecylindersarefittedwithapressurereducingvalveandadeliverygauge.
1.Theconcentrateisplacedinthecontainer
2.Thevalveiscrimpedinplace 3.Airisevacuatedbymeansofvacuumpump
4.Thefillingheadisinsertedintothevalveopening,
valvedepressedandgasisallowedtoflowintothe
container5.Toobtainmaximumsolubilityofthegasintheproduct,
thecontainerisshakenmanuallyduringandafterthe
fillingoperationbymechanicalshakers.
7/31/2019 Aerosol pptx
27/39
7/31/2019 Aerosol pptx
28/39
7/31/2019 Aerosol pptx
29/39
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.FLV7/31/2019 Aerosol pptx
30/39
Thistestindicatestheeffectofanaerosolformulationon
theextensionofanopenflame.
Productissprayedfor4sec.intoflame.
Dependingonthenatureofformulation,theflameisextended,andexactlengthwasmeasuredwithruler.
7/31/2019 Aerosol pptx
31/39
FLASHPOINT
7/31/2019 Aerosol pptx
32/39
Determinedbypressuregauge
Pressurevariationfromcontainertocontainerbe
determined,sinceexcessivevariationin
pressureindicatesthepresenceofairin
headspace.
7/31/2019 Aerosol pptx
33/39
MEASUREMENTOFDENSITY
7/31/2019 Aerosol pptx
34/39
Methodused G.Chasalsobeenused
1.G.C
2.I.Rspectrophotometry
7/31/2019 Aerosol pptx
35/39
AEROSOLVALVEDISCHARGERATE
Determinedbytakinganaerosolknownweight
anddischargingthecontentsforgiventimeusing
standardapparatus.
Byreweighingthecontaineraftertimelimit,thechangeinweightpertimedispensedis
dischargerate.Itisexpressedasgramper
seconds.
7/31/2019 Aerosol pptx
36/39
Spraytheproductonthecoated(dye+talc)Paper.Dependinguponthenatureofaerosol,water/oilsoluble
dyeisused.Theparticlesthatstrikethepapercausethe
dyetogointosolutionandtobeabsorbedontothe
paper.Thisgivesarecordofspray.
Valve
7/31/2019 Aerosol pptx
37/39
Particlesize(cascadeimpactor)
AEROSOL
Impaction slide
7/31/2019 Aerosol pptx
38/39
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=AFQjCNG1Ne1HA8pvNyFcXdtAmete38nhqw7/31/2019 Aerosol pptx
39/39