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Part1pharmacology
Theword"pharmacology“derivesfromtheGreekwordfordrug,pharmakon.Itisthebranchofmedicineand
biologyconcernedwiththestudyoftheactions,uses,mechanisms,andadverseeffectsofdrugs.Morespecifically,
itisthestudyoftheinteractionsthatoccurbetweenalivingorganismandchemicalsthataffectnormalorabnormal
biochemicalfunction.Ifsubstanceshavemedicinalproperties,theyareconsideredpharmaceuticals.Thefieldof
pharmacologyencompassesdrugcompositionandproperties,interactions,toxicology,therapy,andmedical
applicationsandanti-pathogeniccapabilities.
Thetwomainareasofpharmacologyarepharmacodynamicsandpharmacokinetics.Theformerstudiesthe
effectsofthedrugsonbiologicalsystems,andthelatterstudiestheeffectsofbiologicalsystemsonthedrugs.In
broadterms,pharmacodynamicsdiscussestheinteractionsofchemicalwithbiologicalreceptors,and
pharmacokineticsdiscussestheabsorption,distribution,metabolism,andexcretionofchemicalsfromthebiological
systems.
Pharmacokineticsdescribestheeffectofthebodyonthedrug.Whendescribingthepharmacokinetic
propertiesofadrug,pharmacologistsareofteninterestedinLADME:
•Liberation-disintegration,dispersalanddissolution
•Absorption-Isthemedicationabsorbedthroughtheskin,theintestine,ortheoralmucosa
•Distribution-Howdoesitspreadthroughtheorganism?
•Metabolism-Isthemedicationconvertedchemicallyinsidethebodyandintowhichsubstances?Are
theseactive?Couldtheybetoxic?
•Excretion-Isthemedicationeliminatedthroughthebile,urine,breath,orskin?
Pharmacologyisnotsynonymouswithpharmacyandthetwotermsarefrequentlyconfused.Pharmacology
dealswithhowdrugsinteractwithinbiologicalsystemstoaffectfunction.Itisthestudyofdrugs,ofthereactions
ofthebodyanddrugoneachother.Incontrast,pharmacyisabiomedicalscienceconcernedwithpreparation,
dispensing,dosage,andthesafeandeffectiveuseofmedicines.Thestudyofpharmacologyisofferedinmany
universitiesworldwideinprogramsthatdifferfrompharmacyprograms.Studentsofpharmacologyaretrainedas
researchers,studyingtheeffectsofsubstancesinordertobetterunderstandthemechanismswhichmightleadto
newdrugdiscoveries.Whereasapharmacystudentwilleventuallyworkinapharmacydispensingmedicationsor
someotherpositionfocusedonthepatient.
Part2Pharmaceuticalchemistry
Medicinalorpharmaceuticalchemistryisadisciplineattheintersectionofchemistryandpharmacology,and
involvestheidentification,synthesisanddevelopmentofnewchemicalentitiessuitablefortherapeuticuse.The
contentofmedicinalchemistryalsoincludesthestudyofexistingdrugs,theirchemicalstructure,physicaland
chemicalproperties,chemicalstability,biologicalproperties,structure-activityrelationships(SAR),metabolism,
chemicalmechanismofinteractionbetweendrugsandbiologicaltarget,etc.
Thescienceofmedicinalchemistryinvolvesthedesignandsynthesisofnoveldrugs.Therearetwomajor
considerationsthathavetobetakenintoinanydrugdesignproject.Firstofall,drugsinteractwithmolecular
targetsinthebody,andsoitisimportanttochoosethecorrecttargetforthedesiredpharmaceuticaleffect.Itisthen
acaseofdesigningadrugwillinteractaspowerfullyandselectivelyaspossibleforthattarget-anareaof
medicinalchemistryknownaspharmacodynamics,Secondly,adrughastotravelthroughthebodyinorderto
reachitstarget,soitisimportanttodesignthedrugsothatitisabletocarryoutthatjourney.Thisisanareaknown
aspharmacokinetics.
Thechiefroleofthemedicinalchemististodesignandsynthesizethetargetstructuresrequired.Therefore,
themedicinalchemistisanessentialmemberofanydrugdesignteamsinceheorshehastoidentifywhether
proposedtargetstructuresarelikelytobestableandwhethertheycanbesynthesizedornot.
Inmedicinalchemistry,thesearchofleadcompoundanditsstructuralmodificationareimportanttwosteps
forlookingfornewdrugs.Theleaddiscoveryprocessesincluderandomscreening,drugmetabolismstudies,
clinicalobservationsofdrugaction,rationalapproachestoleaddiscoveryandcomputer-assisteddrugdesign
techniques,etc.Manyapproachescanbeusedforoptimizationofleadcompound,suchasleadoptimizationby
pro-drugdesign,bybioisosterism,bysoftdrugorharddrugdesign,byQSARmethod,etc.Computeraideddrug
design(CADD),asophisticdrugdiscoveringtechniques,isatopicareainmodernmedicinalchemistryforthe
discoveryofleadcompoundanditspharmaceuticaldevelopment.
Part3Pharmaceutics
Pharmaceuticsisabranchofpharmacyofstudyinghowtogeteffectiveandstablepharmaceuticaldosage
formswithoutdisturbingitsqualitybythesystematicapproach.Primitively,itisconcernedwiththescientificand
technologicalaspectsofthedesignandmanufactureofdosageforms.Meanwhile,pharmaceuticsisthescienceof
drugdeliverysystemforseekingtheoptimaldrugdeliveryproductordeviceanditssubsequentperformanceinthe
deliveryofthedrugformsfollowingitsadministrationtoapatient.Thestudyinvolvespreparationandstabilityof
suitabledosageforms,designandmanufactureofdosageformsthatovercomethephysiologicbarrierandoptimize
thedrugaction,quantitativecharacterizationofboththedrugconcentration-effectrelationshipandthe
concentration-timerelationshipafterthedrugentersthebodyandevaluatingthedosageregimen,avoidanceand
eliminationofmicroorganismsinthemedicines.
Pharmaceuticsisamultidisciplinaryarea,withsignificantunderpinningsfromsuchbasicscientificdisciplines
asphysicalchemistry,biochemistry,analyticalchemistry,mathematics,chemicalengineering,molecularand
cellularbiology,pharmacology,anatomyandphysiology.IttriestogathertheknowledgeofpharmacyfromChina
towesterncountries,runthroughthewholehistoryofpharmacyandtouchupontheintroductionofthemost
importantpharmacysubjects.
Arguably,itisthemostdiverseofallthesubjectareainpharmaceuticalscienceandencompasses.Specifically,
thestudyincludesthephysicalpharmaceutics(applicationofthebasicphysicalchemistrynecessaryforthe
efficientdesignofdosageforms),biopharmaceutics(studyofrelevantdrugdeliverysystemsandhowdrugsarrive
therefollowingthedrugadministration),drugdosageformsdesignandcompounding,pharmaceuticaltechnology
andpharmaceuticalmicrobiology(avoidanceandeliminationofmicroorganismsinmedicines).Thecoursealso
includesthenewpharmaceuticaltechniquesandnewdosageformssuchastransdermaldrugdeliverysystem,
nanoparticledrugdeliverysystems,traditionalChinesemedicinedrugdeliverysystems,soliddispersiontechnique,
inclusiontechniquesandapplicationtechniquesofnewexcipients.
Pharmaceuticsspecificallyexplainsthemajorconsiderationsinthedesignofdosageforms:Physicochemical
propertiesconsideration-Theabsorptionofthedruginthebodyisstronglydependentontheresolutionproperties
ofthedrug,suchasdegreeofdissociationandspeedofdiffusionofthedrugmolecules.Knowledgeoftheflow
propertiesofliquidsisusefulinsolvingcertainproblemsrelatingtothemanufactureandperformancesolutions
andsemi-solidsasdosageformsintheirownright.Byfarthemajorityofdrugsaresolid(mainlycrystalline)
powdersand,unfortunatelymostofthesehavenumerousadversecharacteristics,themacroscopicpropertiesof
powdersinfluencetheirperformanceofdosageforms.So,thecharacteristicmustbeconsideredduringthedesign
ofmedicinestoenabletheirsatisfactorymanufactureandsubsequentperformanceindosageforms.
Biopharmaceuticalconsideration-Theadministrationrouteofadosageformaffectstheabsorptionrateintothe
body,andtherapeuticconsiderationsofthediseasestatetobetreated,whichinturnindecidethemostsuitabletype
ofdosageform,possibleroutesofadministrationandthemostsuitabledurationofactionanddosefrequencyfor
thedrug.Thefactorsinfluencingthebioavailabilityofadrugandmethodsofitsassessmentaredescribed.Itis
concernedwithaconsiderationofthemannerinwhichthefrequencyofdrugadministrationandtherateatwhichit
isreleasedaffectitsconcentrationinthebloodplasmaatanygiventime.Microbiologyconsideration——Itis
necessarytoeliminatemicroorganismsfromtheproductbothbeforeandduringmanufacture.Microbiologyisa
verywide-rangingsubject.Pharmaceuticsconcentratesonlyonthoseaspectsofmicrobiologythataredirectly
relevanttothedesign,productionanddistributionofdosageforms.Thismainlyinvolvesavoiding(asepsis)and
eliminating(sterilization)themicroorganisminmedicines,andpreventingthegrowthofanymicroorganismwhich
mightentertheproductduringmanufacture,storageanduseofthemedicine.Theprinciplesandtechniquesof
sterilizationarediscussedinpharmaceutics.
Pharmaceuticswillalsotellusaboutthedevelopmentofpharmacy,theresponsibilityandmissionofa
pharmaceuticalpractitionerandthedirectiontopharmacyprofessionalsubjects.Thecoursefitsallstudentswho
majorpharmacyandteachthestudentshowtomastertheirprofessionstudy.Havinggatheredthisunderstandingof
thebasicsofpharmaceutics,theformulationscientistshouldnowbeequippedtobeginaconsiderationofthe
designandmanufactureofthemostsuitabledosageformforthedruginquestion.
Part4Druganalysis
Druganalysishasevolvedfromatechniqueofthe20thcenturyintoanever-maturingscience-thescienceof
pharmaceuticalanalysis.Byutilizingthemethodologiesandtechniquesinphysics,chemistry,biologyand
microbiology,pharmaceuticalanalysisfocusesonqualitativeandquantitativeanalysisofdrugs,qualitycontroland
developmentofnewdrugs.Thissciencerelatestoawiderangeofstudies,includingqualitycontrol,clinical
pharmacy,analysisoftraditionalChinesemedicineandnaturaldrugs,drugmetabolicanalysis,forensic
toxicologicalanalysis,dopingcontrolandformulationanalysis,etc.
Pharmaceuticalscienceassumesthemostimportanttaskindrugqualitycontrol,whichinvolvesphysicaland
chemicalinspectionoffinisheddrugs,qualitycontrolindrugproduction,qualityobservationinstorage,quick
analysisofpreparationsformulatedinhospitals,establishmentofqualitystandardsintheR&Dofnoveldrugsas
wellastheanalysisofdrugsinvivo.
Inthefirstaspect,itrelatestophysicalandchemicaltesting,throughwhichitispossibletojudgewhetherthe
drugisincompliancewiththequalitystandardsbeforebeingmarketedandused.Duringdrugproduction,raw
material,intermediateandby-productsshouldbeanalyzedandmonitoredtoensurethequalityofthefinalproducts.
Qualityexaminationshouldbeperformedondrugsinstorageonaregularbasissothatappropriatestorage
conditionsandmethodscanbeemployedtoguaranteethestabilityofthedrugsinstorageanduse.Techniquesof
pharmaceuticalanalysisarealsoneededinquickanalysisofthepreparationsformulatedinhospitalstosafeguard
theirquality.
Inthesecondaspect,apartfromthestudiesonsynthesizingroute,pharmacologyandtoxicologyaswellas
drugmanufacturingtechnologies,studiesonqualitystandardsandstabilityareneverthelessnecessaryinthe
developmentofnewdrug.Basedonthechemicalstructures,physicochemicalpropertiesandthepotentialnegative
impactsonquality,itispossibletodesignmethodsfortheidentificationofcounterfeitmedicines,puritytestand
contentassayandtoestablishqualitystandardsfornewdrugs.
Furthermore,inpharmacokinetics,bioavailabilitytestofpreparations,clinicalpharmacologyandclinical
monitoringandadjustmentofplasmaconcentration,methodsandmeansofdruganalysisarealsoneededto
conductqualitativeandquantitativeanalysisofdrugsinblood,tissuesandorgans,tounderstandin-vivoabsorption,
distribution,metabolismandexcretionofdrugs,andtoinvestigatecharacteristicsandmechanismsofaction,
therebyprovidingnecessaryinformationforrationaldruguse,detectionofactivemetabolitesanddiscoveryoflead
compounds.
Thusitcanbeseenthatthemethodsandmeansofpharmaceuticalanalysisareindispensableinthe
development,production,storage,supplyandapplicationofdrugsaswellasclinicalmonitoringofplasma
concentration.Withthevigorousdevelopmentofpharmaceuticalsciences,thescienceofpharmaceuticalanalysisis
facingincreasingchallengesfromvariousrelatedsciences.Insteadofbeingonlylimitedtostaticqualitycontrolof
drugs,ithasdevelopedintoacomprehensiveanddynamicanalyticalstudyondrugmanufacturing,in-vivo
dynamicsandmetabolism.
Part5Pharmacognosy
Theword"pharmacognosy“isderivedfromtheGreekwords“pharmakon”(drug),and“gonsis”or
“knowledge".
Pharmacognosyisastudyofdrugsthatoriginateintheplantandanimalkingdoms.Modemaspectsofthe
scienceincludenotonlythecrudedrugsbutalsotheirnaturalderivatives.Digitalisleafanditsisolatedglycoside,
digitoxin;rauwolfiarootanditspurifiedalkaloid,reserpine;andthyroidglandwithitsextractedhormone,thyroxin;
areallpartofthesubjectmatterofpharmacognosy.
Inabroadsense,pharmacognosyembracesknowledgeofthehistory,distribution,cultivation,collection,
selection,preparation,commerce,identification,evaluation,preservation,anduseofdrugsandeconomic
substancesthataffectthehealthofhumansandotheranimals.Sucheconomicsubstancesextendbeyondthe
categoryofcrudeandtheirderivativestoincludeavarietyofcommercialandmedicinalproductsoftenrequiring
complicatedmethodsofpreparation:allergens,allergenicextracts,antibiotics,immunizingbiologies,flavoring
agents,andcondiments.Inarestrictedsense,thedefinitiononpharmacognosyimpliesaparticularknowledgeof
methodsofidentificationandevaluationofdrugs.
Part6Biopharmacy
Biopharmacyisthestudyofbiopharmaceuticalsofthosemedicaldrugsproducedwiththeaidifbiotechnology
orderivedfromlifeforms.Theseincludeproteinsandnucleicacidsthatareusedfortherapeuticpurposesamong
others.Thetermbiopharmacologydescribesafieldofresearchcloselyrelatedtopharmacokinetics,sometimes
calledbiopharmacy.
Biopharmaceuticalsaremedicaldrugsproducedusingbiotechnology.Theyareproteins(includingantibodies),
nucleicacids(DNA,RNAorantisenseoligonucleotides)usedfortherapeuticorinvivodiagnosticpurposes,and
areproducedbymeansotherthandirectextractionfromanative(non-engineered)biologicalsource.Thefirstsuch
substanceapprovedfortherapeuticusewasbiosynthetic"human5insulinmadeviarecombinantDNAtechnology.
Thelargemajorityofbiopharmaceuticalproductsarepharmaceuticalsthatarederivedfromlifeforms.Small
moleculedrugsarenottypicallyregardedasbiopharmaceuticalinnaturebytheindustry.
Howevermembersofthepressandthebusinessandthefinancialcommunityoftenextendthedefinitionto
includepharmaceuticalsnotcreatedthroughbiotechnology.Thatis,thetermhasbecomeanoft-usedbuzzwordfor
avarietyofdifferentcompaniesproducingnew,apparentlyhigh-techpharmaceuticalproducts.
Whenabiopharmaceuticalisdeveloped,thecompanywilltypicallyapplyforapatent,whichisagrantfor
exclusivemanufacturingrights.Thisistheprimarymeansbywhichthedeveloperofthedrugcanrecoverthe
investmentcostfordevelopmentofbiopharmaceutical.ThepatentlawsintheUnitedStatesandEuropediffer
somewhatontherequirementsforapatent,withtheEuropeanrequirementsareperceivedasmoredifficultto
satisfy.Thetotalnumberofpatentsgrantedforbiopharmaceuticalshasrisensignificantlysincethe1970s.In1978
thetotalpatentsgrantedwas30.Thishadclimbedto15,600in1995,andby2001therewere34527patent
applications.
WithintheUnitedStates,theFoodAdministration(FDA)exertsstrictcontroloverthecommercialdistribution
ofapharmaceuticalproduct,includingbiopharmaceuticals.Approvalcanrequireseveralyearsofclinicaltrials,
includingtrialswithhumanvolunteers.Evenafterthedrugisreleased,itwillstillbemonitoredforperformance
andsafetyrisks.
Themanufactureofthedrugmustsatisfythe"currentGoodManufacturingPractices^^regulationsoftheFDA.
Theyaretypicallymanufacturedinacleanroomenvironmentwithsetstandardsoftheamountofairborne
particles.
Classificationofbiopharmaceuticals:
Bloodfactors(FactorVIDandIX);
Thrombolyticagents(tissueplasminogenactivator);
Hormones(insulin,glucagon,growthhormone,gonadotrophins);
Hematopoieticgrowthfactors(Erythro
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