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PARENTERALS
V.MANIMARAN
LECTURER
DEPARTMENT OF PHARMACEUTICS
SRM COLLEGE OF PHARMACY
INTRODUCTION
Theadministrationofdrugsthroughthepatientbyinjectionunder
throughoneormorelayeroftheskinormucousmembrane.
Thetermparenteralderivesfromthegreekword
1.Para(outside)
2.Enteron(Intestine)
Itdenotesthatrouteofadministrationotherthanoralroute.
ADVANTAGES
Itprovidesrapidonsetofaction
Itprovidesimmediatetherapeuticaction
Itcanbeadministeredaccuratedose.
Itcanbegiventopatientswhocannottakeoralmedication.
Itminimizethefirstpasseffect.
Itprovidesmorebioavailability
disadvantage
Itshouldbeadministredaseptically
Itproducespainatthesiteofinjection
Theadministredofdrugthroughwrongroutemayprovefataleffect
Selfadministrationisnotpossible
Ifpyrogenicpreparationsleadtoveryharmfuleffect.
Routes of administration
IntraMuscular(IM)
Intradermal(ID)
Intravenous(IV)
Subcutaneous/Hypodermic(SC)
Intraarticular
Intrasynovial
Intraspinal
Intrathecal
Intrarterial
Intracardiac
Intracisternal
Intraperitonial
Intraplueral
TYPES OF PARENTERALS
9 PowderforinjectionEg.Cefuroximeforinjection
9 Colloidalsolution Eg.Irondextran
9 InjectableemulsionEg.PropofolUSP
9 InjectablesuspensionEg.Methylprednisoloneacetate
9 Oilyinjection(solution)Eg.Dimercaprolinjection.
9 Infusionfluid
PREFORMULATION FACTORS:
Itisstudyaboutphysical&chemicalpropertiesofdrugsubstance
priorformulationiscalledaspreformulation.
Theyare
pH
Solubilty
pka
Dissociationconstant
Compatabiltystudies FTIR/DSC
Oxidation&reduction
particlesize
FORMULATION OF PARENTERALS
1.Solutes
2.Addedsubstance
Antimicrobialagent
Buffers
Antioxidants
Tonicityagent
Cryoprotectant
Suspendingagent
Emulsifyingagent
3.Vehicle
AqueousWFI
Non aqueousEg.arachisoil
GENERAL PROCEDURE
Cleaning&washingofcontainer,closures
Preparationofsolutions
Sterilizaation(Filteration)
Filling
Packaging
Lyophilization techniques
9 Itisaprocessofremovalofsolventfromtheproductorsubstancesiscalled
aslyophilization.
9 Itconsistofthreesteps
Freezing
Primarydrying
Secondarydrying
Creteria for parenterals
9 Sterility
9 Pyrogen
9 Isotonicity
9 Stability
9 Ph
9 Osmoticpressure
Containers & closures
1.Glass
2.Plastic
Ampoules(singledose)
Vials(multipledose)
Cartridges
Automaticinjector
3.Rubberclosurewithaluminiumcaps
Smallvolumeparenterals:lessthan100ml
Largevolumeparenterals:morethan100ml
Evaluation test for parenterals
9 Testforpyrogen
9 Steriltytesting
9 Rabbittest
9 Claritytest
9 LALtest
9 Leakertest
thank you