SYLLABUSCOPYFORFINALYEARB.

PHARM SEMSETERVII PHARMACEUTICALMEDICINALCHEMISTRYIII

S.No. Topic Discussion of the following classes of drugs including classification, chemical nomenclature, structure including stereochemistry, generic names, chemistry, physicochemical properties, SAR, metabolism, molecular mechanism of action and synthesis, introduction to rational developmentifanyoftheclassofdrugs. 1. CholinergicDrugs: (i) cholinergic agonists (methocholine, carbochol*, bethanechol, pilocarpine) (ii) Ach esterase inhibitors (physostigmine, neostigmine*,tacrine*, ambenoniumchloride,isofluorphate,pralidoxime) (iii)Cholinergic antagonists (atropine, scopolamine, homatropine hydrobromide, ipratropium bromide) synthetic cholinergic antagonists (cyclopentolate*, dicyclomine*, ben/otropine mesylate, procyclidinehydrochloride,isopropamideiodide,tropicamide) (iv)Ganglionblockingagents(trimethaphan,camsylate,mecamylamine) (v) Neuromuscularblockingagents(tubocurarine,gallamine,triethiodide, succinylcholinechloride) AdrenergicDrugs: (i) adrenergic agonists (phenylephrine, naphazoline, xylometazoline, oxymetazoline,methyldopa,clonidine*,guanabenz,guanfacine) (ii) adrenergicagonists(isoproternol,terbutaline*,albuterol,salmeterol, isoxsuprine,ritodrine) (iii)adrenergic antagonists (tolazine, phentolamine, phenoxybenzamine,prazosin,doxazosin) (iv) adrenergic antagonists (propranolol*, atenolol, metoprolol, acebutalol,alprenolol,timolol,labetalol*) other adrenergic agents (amphetamine, pseudophedrine, ephedrine, guanethidine*,propylhexedrine,reserpine). CVSDrugs: (i) antianginal agents (amyl nitrite, isosorbide dinitrate, pentaerythritol tetranitrate, verapamil, bepridil, diltiazem, nifendipine*, amlodipine, nimodipine,dipyridamole) (ii) antiarrhythmic agents (quinidine, procainamide*, disopyramide, lidocaine, tocainide, mexilitine, encainide, amiodarone, pro[afenone, verapamil,diltiazen,propranolol,sotalol*). (iii)Antihypertensiveagents(a)reviewofadrenergicagents(b)reviewof Ca channel blockers (c) ACE inhibitors (captopril*, enalapril, benzepril, ramipril) (d) angiotensin II receptor antagonists (losartan, valsartan*,candersartan) (iv) VasodilatorsandKchannelagonists(diazoxide,minoxidil) (v) Antihyperlipidemic agents (clofibrate*, gemfibrozil, niacin, lovastatin, 70 |P a g e 9

3hrs/week
Hours

2.

3.

atorvastatin) *Indicatessynthesistobediscussed ReferenceBooks: 1. 2. 3. 4. 5. 6.

WilsonandGisvoldsTextbookofOrganicMedicinalandPharmaceuticalChemistry, th 11 Ed.Eds.JohnH.BlockandJohnM.Beale,LippincottWilliams&Wilkins,2004 Foyes Principals of Medicinal Chemistry, Eds. T. L. Lemke and D. A. Williams. Williams&Wilkins,Baltimore,2002. th Medicinal Chemistry, Ashutosh Kar, 4 Edition, New Age International Publishers, 2007. The Art of Drug Synthesis, Eds. Douglas S. Johnson and Jie Jack Li, Wiley Interscience,2007. PharmaceuticalChemistry,Vol.EDrugSynthesisEds.H.J.Roth,A.KleemanandT. Beissewenger,EllisHorwoodLtd.1988. TheOrganicChemistryofDrugSynthesis,DanielLednicer,Vols1to7,Wiley.

PHARMACEUTICALANALYSISIV
S.No. 1. Topic

3hrs/week
Hours 3

Chromatography Principals, terminologystationery phase, mobile phase, classification of chromatography methods, migrationrate of species (partition coefficient, retentiontime,adjustedretentiontime),Rateofsolutemigration(capacity factor,selectivityfactor),Columnefficiencyandbandbroadening(shape of peakGausssian, plate height, number of theoretical plates, van Deemeter equation), Optimisation of column performance (Column resolution, capacity factor, selective factor, tailing factor, peak width), Qualitative analysis, Quantitative analysis (Peak height, peak areas, calibrationandinternalstandard,externalstandard,areanormalization). Gaschromatography(GSC&GLC) Introduction,Principal,Instrumentationcarrier,columns,injectionsystem, detectors(advantage,disadvantage,applicationsofThermalconductivity, electron capture, thermionic, flame ionization, nitrogen phosphorus, photoionisation),headspaceanalysis,applications. HPLC Introduction, Principal, Instrumentationmobile phase reservoir, pumps (reciprocating, displacement, pneumatic, isocratic elution, gradient elution), solvent treatment system, Injection systems (Rheodyne injector indetail,directsampleintroduction,samplingloops),columnsandfittings (for reverse and normal phase, analytical and guard columns. Thermostats, column packing), detectors advantages, disadvantages, (UVsingle wavelength, variable wavelength, phtotodiode array), fluorescence,refractiveindex,electrochemical. Ionexchangechromatography Principal,ionexchangeresins,mobilephases,applications. 71 |P a g e

2.

3.

4.

5. 6.

Ionpairchromatography Principal,applications Sizeexclusionchromatography Principal for gel permeation and gel filtration method, support media, mobilephases,applications Paperchromatography Introduction,choiceoffilterpapers,solvents,chromatographicchambers, development techniques (descending, ascending, radial multiple chromatography, twodimensional chromatography), qualitative analysis locationofspots,Quantitativeanalysis(directandelutionmethod),factors affectingretentionfactor,applications. Thinlayerchromatography Introduction, Principal, different absorbents different methods for preparation of plates, solvents, development techniques cascending, descending, horizontal, multiple development two dimensional development, preparative TLC, Qualitative evaluation visualization of spots,Quantitativeevaluation(Area,weight,densitometryelutionfactors affectingRF,applications) Highperformancethinlayerchromatography Introduction, Principal, preparation of plates, development techniques Qualitative evaluation, Quantitative evaluation Instrumentation (adsorbents,solvents,sampleapplication,scanninganddocumentation), applications.

1 1

7.

8.

9.

10. ValidationofanalyticalmethodsasperU.S.P. 11. Statistics&StatisticalQualitycontrol Normaldistribution,ttest,Ftest,linearregressioncorrelationcoefficient, confidencelimits. 12. Samplingprocedures Objectives,differentkindsofsamples,samplingplan,samplingschemes, sampling equipments, methods of statistical analysts as applied to samplingandinterpretationofresults. 13. Thermalmethodsofanalysis Theory, introduction, instrumentation, factors affecting analysis, pharmaceutical applications of: Thermogravimetry (TG), Differential thermalanalysis(DTA),DifferentialScanningCalorimetry(DSC). ReferenceBooks: 1. 2. 3. 4. 5.

1 3

th SkooghPrincipalsofInstrumentalAnalysis,4 edition,SaundersCollegePublishing, 1992,USA. BrowningChromatography,1969,McGrawHill,London. th WillardH.H.,L.L.Merrit&JohnA.DeanInstrumentalMethodofAnalysis6 edition, 1986,CBSPublishers&Distributors,NewDelhi. th Beckett & StenlakePractical Pharmaceutical Chemistry, 4 edition, 1988, CBS Publishers&Distributors,India. I.P.,U.S.P.,B.P.EuropeanPharmacopeia.

72 |P a g e

6.

James W. MunsonPharmaceutical Analysis, Modern methods, Marcel Dekker Inc. 1981,USA.

PHARMACOGNOSYIII
Drugmentionedinboldareordetailedstudy S.No. 1. Topic

3hrs/week

Hours 12

Alkaloids:Chemistry,Classificationandoccurrenceofalkaloidingeneral. Detailed study of the following plants containing alkaloids Ephedra, Colchicum, cocoa, & tea, coffee, lobelia, tobacco, belladonna, datura stramonium, hyoscyamus, cinchona, opium, ashwagandha, ipecac, rauwolfia,vinca,nuxvomica,vasaka,aconite,kurchi,pilocarpus,cola, coca,pepper,curare,alkaloids,ergot. Biosynthesis of lysergic acid, opium alkaloids, tropane, alkaloids, colchicines,emethine,quinine.

2.

OccurrencestructureandapplicationsoffollowingGlycosides a) Anthroquinone Rubia, cochineal, aloes, hyperieum, cascara, andira,senna,rhubiarb. b) IsothiocyanateBrassica c) CyanogeneticAlmonds,wildcherry d) NapthoquinonePlumbago,alkanna,henna,walnut Biosynthesisofaloeemodin,amygdaline,juglone. BriefintroductiontoPlantallergens Definition,classification(inhalant,injectant,infestantsetc.)withexample. Plantscausinghayfever&dermatitis,mouldcausingallergy. Sources,preparationandusesoffollowingenzymes: Papain, bromelain, malt extract, serratiopeptidase, urokinase, streptokinase,pepsin. Studyoflectinsandsnakevenom,Preparationofpolyvalentantivenins Studyoffollowingherbsashealthfood(Neutraceuticals): Alfaalfa, arnica, apricot, pits, bran, chamomic, chicory, cucumber, fenugreek, onion, garlic, gentian, hydrocotyle, hibiscus, hops, honey, marigold, amla. Ginseng, ashwagandha, ginko biloba, spirulina, gymnema,momordica,tinospora. Occurrence, composition, preparation and uses of following drugs of mineralorigin: Diatomic,chalk,bentonite,talc. Study of sulphur containing naturally occurring compounds (sulphide, thiophenes).

2 2

3.

4.

5.

6.

ReferenceBooks: 1. 2. TreaseD.&EvansW.CTextbookofPharmacognosyW.B.Saunders. TylerV.E.BradyL.R.&RobbersJ.E.PharmcognosyLeaFeibger,USA. 73 |P a g e

3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

WallisI.E.TextbookofPharmacognosyCBSPublishers,Delhi. Kokate C. K. Purohit A. P. & Gokhale S. B. Pharmacognosy: Nirali Publications, Pune. HarboneJ.B.PhytochemicalMethods:Aguidetomoderntechniquesof PlantAnalysisChapmann&Hall,London. BrunctonJ.Pharmacognosy,Phytochemistry,MedicinalPlants:InterceptLimited. Vasudevan I. N. & Buddha K. S. A textbook ofPharmacognosy, Vrinda Publication House,Jalgaon. TheIndianPharmacopeia.TheControllerofPublicationDelhi. BrainK.R.&FurnerL.D.ThePracticalEvaluationofPhytopharmaceuticalsWright Sceintica,Bristol. Lyenger M. A. & Nayak S. G. Anatomy of Crude Drugs: Manipal Power Press, Manipal. LyengerM.A.PharmacognosyofPowderedDrugs:ManipalPowerPress,Manipal. KokateC.K.PracticalPharmacognosy,VallabhPrakashan. Wagner,Bladi&zagainskit:PlantDrugAnalysis:SpringerVerlag. Khandelwal K. R.: Practical Pharmacognosy Techniques and Experiments: Nirali Prakashan,Pune. Vasudevan L. N. Laddha K. S.: Practical Pharmacognosy: New Vrinda Publishing House,Jalgaon.

PHARMACEUTICSVI
S.No. 1. Topic

3hrs/week
Hours 12

Introductiontosteriledosageforms Parentalproducts Various routesofparental administration, pyogens,vehicle,WFI preparation, purity, storage and distribution, vehicles other than WFI,additivesinparentalproducts, types offormulations,freeze drying , containers glass and plastics types and evaluation, conceptofFFS,rubberclosuresand testing,personnel,facilities layout, environmental control cleanliness classes, air handling (HVAC systems), HEPA filters, laminar flow, production procedures, QA & QC sterility test, pyrogen/ endotoxin test, particulateevaluation,leakertest. Ophthalmicproducts Anatomy and physiology of eye lachrymal system, tears, precorneal tear film, cornea, ocular bioavailability, types of ophthalmicproductssolutions,suspension,ophthalmicointments and gels, preservatives and efficacy test, additives, QA and QC sterilitytest,clarity,particlesizeforsuspension,testsonointments andcollapsibletubes,packaging. Contact lens solutions: types of lensescleaning solution, disinfection solution, lubricants, multipurpose solutions and packages. Oralsustainedandcontrolledreleasesystems AdvantagesofSRsystems,biopharmaceuticalconsiderationand 74 |P a g e

2.

3.

dose calculation ofdrug, propertiesof drug with referenceto the designoforalSRsystems,matrixand reservoirtypeofsystems, dissolution controlled systems, diffusion controlled systems, ion exchangecontrolledsystems. 4. Stabilitystudies Kinetic principles, Arrhenius equation and derivation of shelf life based on Arrhenius equation, limitations and advantages equation,degradationpathways hydrolysis,oxidation,photolytic degradation,methodstoenhancestabilitystudies,introductionto ICHguidelines. 8

ReferenceBooks: 1. 2. 3. 4. 5. 6. 7. 8. 9. Pharmaceuticaldosageforms:Parentalmedications,Vol.I,II,III,ed.byKennethA. Avis,LeonLachmanandH.A.Liberman,MarcelDekkerInc.,1986. nd Pharmaceutics The Science of dosage form design ed. by M. E. Aulton, 2 ed., ChurchillLivingstone,2002. th ModernPharmaceutics,4 ed.RevisedandExpandeded.byGilbertS.Bankerand ChristopherT.Rhodes,MarcelDekkerINC.,2002. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. rd Liberman,J.I.Kanig,3 ed.,VerghesePublishinghouse,1987. st Remington, The science and practice of Pharmacy, 21 ed., Vol. I and II, B. L. PublicationsPvt.Ltd.,2005. Ophthalmicdrugdelivery,ed.byAshimK.Mitra,1993,MarcelDekkerINC. rd TurcoandKings,SterileDosageforms,3 Edn.,Lea&Febiger,Philadelphia,1985. MichaelJ.Akers,QualityControlofParenterals,MarcelDekker Controlled drug delivery Fundamentals and Applications, Robinson Joseph R., LeeVincentH.,Vol.29,MarcelDekkerInc.

BIOPHARMACEUTICSANDPHARMACOKINETICS
Topic

3hrs/week
Hours 1 2 2 2 2 2 2

IntroductiontothesubjectofbiopharmaceuticsandPharmacokinetics.Emphasis ontheimportanceindrugdiscovery,developmentandclinicalpharmacy. Definitions,differentmechanismsofdrugtransport,physiologyofcellmembrane andpassageofdrugsacrosscellmembrane. ModifiedpHpartitiontheoryanditslimitations.Zerov/sfirstordertransport. Ratelimiting steps in drug absorption, Theoriesofdissolution,Physicochemical factorsaffectingthebioavailabilityofdrugs. Physiology of GH and oral bioavailability Formulation, dosage form related factorsandphysiologicalfactorsaffectingoralbioavailability Different routes of drug administration as alternative to oral route Factors affectingbioavailabilityofdrugsfromparentalroutese.g.insulinzincsuspension Dissolutionrateandmethodsofenhancingdissolutionrate.Officialandunofficial methodsofdissolution.Applicationtodifferentdosageforms 75 |P a g e

Invitroinviewcorrectionanditssignificance Distribution Definition relationship of drug transport to distribution process, perfusion limitation permeability limitation. Plasma protein and tissue protein binding,introductiontotheconceptofvolumeofdistributionandfactorsaffecting distribution. Elimination, Definition, introduction to elimination via metabolism and excretion Hepatic clearance drugs,firstpass effectanddependenceofhepatic extraction ratio.Introductiontorenalclearanceandfactorsaffectingrenalclearance. Pharmacokinetics: Introduction to compartmental and physiological models. Introductiontothecompartmentalopenmodelanditsassumptions. Mathematical treatment of Pharmacokinetics upon IV bolus dosing and extravasculardosing.Importanceofvolumeofdistribution.Clearance,elimination rateconstant,halflife,absorptionrateconstant,bioavailability.Introductionofthe conceptofareaunderthecurve,thetrapezoidalruleandthemethodresiduals IntroductiontotheratemethodandsigmaminusmethodforurineanalysisforIV. Introductiontomethodforestimatingbioavailabilityandbioequivalence. Discussionoflinearandnonlinearkineticsanddescriptionoffactorsresultingin nonlinearkinetics. ApplicationofPKprinciplesthroughsimpleproblems. ReferenceBooks: 1. 2. 3.

1 3

1 9

2 2 2

4. 5. 6.

Brahmankar, D. M. Jaiswal, Sunil B., Biopharmaceutics and Pharmacokinetics: a st treatise,1 Edition,1995,VallabhPrakashan,Delhi. Banakar, Umesh, Pharmaceutical Dissolution Testing, Volume 49, Marcel Dekker Inc.,NewYork,1992. Malcom Rowland, Thomas Tozer, Clinical Pharmacokinetics: Concept and rd Application, 3 Edition, 1996. A LeaFebiger book, B. L. Baverly Books Pvt. Ltd. USA. th RobertE.Notari,BiopharmaceuticsandPharmacokineticsAnIntroduction,1971,4 Edition,MarcelDekkerInc.,NewYork. Leon Shargel, Susanna WuPong, Andrew B. C. Yu. Applied Biopharmaceutics & th Pharmacokinetics5 Edition,2005,Singapore. th MiloGibaldi,BiopharmaceuticsClinicalPharmacokinetics4 Edition,1991,USA.

PHARMACOLOGYIV
S.No. 1. Topic Drugsactingoncentralnervoussystem Aliphaticalcohols Generalanaesthetics Localanaesthetics Sedativehypnotics&anxiolyticagents Antidepressants Antipsychotics 76 |P a g e

3hrs/week
Hours 18

DrugsusedinNeurodegenerativedisorders Antiparkinsons DrugsusedinAlzheimersdisease Analgesics,antipyreticandantiinflammatorydrugs CNSstimulants&Psychotomimeticdrugs (Convulsions and respiratory stimulants, Psychomotor stimulants andPsychotomimeticdrugs) 6

2.

Autocoids Histamine,Antithistaminics 5HTandAntagonists Kinins,Ecosonides,Cytokines,PAF PharmacotherapyofBronchialasthma Immunology Regulation of Immune system physiological and pathological states, Signaling Pathways for activation and inhibition, Immunology of diseases like HIV and Cancer and their modulation & Immunomodulators. Principalsoftoxicology Heavymetalpoisoninganditstreatment Pesticidepoisoninganditstreatment Opiumalkaloidpoisoninganditstreatment

3. 4.

2 6

5.

ReferenceBooks: 1. Goodman & Gilmans Pharmacological Basis of Therapeutics Joel G. Hardman, th Lee E, Limbird, Alfred Goodman Gillman 11 Edition, The McGraw Hill Companies Inc.,2001. th Satoskar, R. S.BhandarkarS. D.& Rege N. N. Pharmacology & Therapeutics 20 Edition,PopularPrakashan,2007. th Rang&DalePharmacology5 Edition,ChurchillLivingstone,2003. rd Lippincotts Illustrated Reviews: Pharmacology Lippincott Raven 3 Edition Howland&NycetsPublishersNY,2006. th LewisPharmacologyByCrossland5 Edition,ChurchillLivingstone. th LaurenceD.R.&BennetClinicalPharmacology9 Edition,Elsevier,NY,2006. rd Kulkarni, S. K. Handbook of Experimental Pharmacology, 3 Edition, Vallabh Prakashan,NewDelhi,2005. th B. G. Katzung Basic and Clinical Pharmacology 9 Edition Appleton and Lange publication,2004. rd Gosh M. N. Fundamentals of Experimental Pharmacology, 3 Edition, Hilton & Company,Calcutta,2005.

2. 3. 4. 5. 6. 7. 8. 9.

PHARMACOLOGYLABORATORYII
S.No. 1. Experiments Bioassayof Acetylchoine 77 |P a g e Topic

4hrs/week

 2.

Histamine

Demonstration bioassayofoxytocin bioassayofpancuronium(WithGraphorActual) Demonstration/SimulatedCDs To study the CNS depressant activity of chlorpromazine on locomotor activityofmiceusingactophotometer To study the effect of diazepam on the muscle grip strength of mice usingrotarodapparatus. Analgesiceffectofasprinusinganalgesiometer To study phenothiazine induced catatonia in rats and to study anticatatonic(antiparkinsons)effectofscopolamine Tostudytheanticonvulsantpropertyofdiazepamonpentylenetetrazole inducedconvulsionsinmiceoranticonvulsanteffectofphenytoinagainst maximalelectroshockinducedconvulsioninmice Toxicitystudies(CPCSEA,OCEDguideline) briefintroductiontoacute,subacuteandchronictoxicitystudies.

3.

4.

ReferenceBooks: 1. 2. 3. 4. 5.
rd Kulkarni, S. K. Handbook of Experimental Pharmacology 3 Edition Vallabh PrakashanNewDelhi,2005. rd Gosh M. N. Fundamentals of Experimental Pharmacology, 3 Edition, Hilton & Company,Calcutta,2005. st S.B.Kasture.AHandbookofExperimentsinPreClinicalPharmacology1 Edition, CareerPublications,2006. W.L.M.Perry,PharmacologicalExperimentsOnIsolatedPreparations,2bndEdition, E&SLivingstone,Edinburgh&London,1970. Websites:IndianJournalofPharmaceuticaleducationandresearch,Vol.41(1)Jan Mar,20075261.(www.ipper.org)

PHARMCEUTICALCHEMISTRYLABORATORYII 1. 2. 3. 4. 5. 6. 7. 8. 9.

4hrs/week

Synthesis ofheterocyclics: a) Benzimidazole from 0phenylenediamine, b) 4methyl carbostyrilfromAcetoacetanilide. Perkinreaction:Cinnamicacidfrombenzaldehyde Claisen/AldolCondensationacidfrombenzaldehyde. Benzilicacidrearrangement:Benzilicacidfrombenzyl. Holfmannrearrangement:AnthranilicacidfromPhthalimide. Reductionreaction:PABAfrompnitrobenzoicacid. Esterification:BenzocainefromPABA. Condensation:Phenytoin. Multistepreaction:Sulfanilamidefromacetanilide.

78 |P a g e

PHARMACOGNOSYLABORATORYII
S.No. 1. 2. Topic

4hrs/week
Hours 8 2

Morphology, microscopeand chemical testfor identificationof cinchona, vasaka,ephedra,kurchi,datura,nux,vomica,senna,rauwolfia,ipeca. TLCanalysis: 1) Alkaloidsofnuxvomicacinchona 2) Glycosidesofsenna/aloe Morphological identification of drugs covered in theory (alkaloids and glycosides)any20samples Total

3.

2 12

PHARMACEUTICSLABORATORYIV 1. 2. 3. PreparationandmonographictestingWFI(IP) Processing&testingofglasscontainers&rubberclosures(asperIP) Preparationanddocumentationoffollowing: A)Injections(official) SodiumchlorideandDextroseinjection Calciumgluconateinjection Ascorbicacidinjection Oneinjectionwithoilyvehicle Onesuspensioninjection B)Ophthalmicpreparations Sulphacetamideeyedrops OneAntibioticeyeointment Contactlenssolution CalculationofPharmacokineticparameters(plasmasamplesprovided)

4.

79 |P a g e

SYLLABUSCOPYFORFINALYEARB.PHARM. SEMESTERVIII PharmaceuticalMedicinalChemistryIV

S.No. Topic Discussion of the following classes of drugs including, classification, chemical nomenclature, structure including stereochemistry, generic names, chemistry, physicochemical properties, SAR. Metabolism, molecular mechanism of action, and synthesis, introduction to rational developmentifanyoftheclassofdrugs: 1. CNSDrugs 1. Sedatives and hypnothics (mephobarbital, Phenobarbital pentobarbital, secobarbital, diazepam, nitrazepam*. Oxazepam. Alprazolam. Midazolam, cholorodiazepoxide, choral hydrate, gluthethimde*,zolpidem,zopiclone) 2. Anticonsulvants (Phenobarbital, chlordizepoxide, diazepam, clonazepam*, phenytoin, trimethadione, paramethadione, ethosuximide*, phenosuximide, primidone, sodium valproate, carbamazepine*,progabide,lamotrigine,vigbatrin 3. Antipyschotics (chlorpromazine*, triflupromazine, thioridazine, fluphenazine, chlorprothixene, loxapine, clozapine, haloperidol*, droperiodol,risperidone*,pimozide,molindone 4. Antianxiety agents (meprobamate, tybamate, hydroxyzine, buspirone) 5. Antidepressants (imipramine, chlorimipramine, amitryptyline, nortriptyline, doxepine*, fluoxetine*, paroxetine, trazodone, iproniazid,pargline,isocarboxazide,tranylcypromine) 6. Antiparkinsons (carbidopa*, levodopa, selegiline, amantadine, bromocriptine, benzotropine*, procyclidine, trihexyphenidyl, orphenadrine) 7. Analgesics (opioids) (morphine, codeine, levophanol, dextromethorphan,phenazocine,pentazocine,meperidine*,and prodine, pheniridine, anileridine, fentanyl, methadone*, phenadoxone, racemoramide, dextropropoxyphene*, nalorphine, naloxone,naltrexone) NSAIDs(aspirin,paracetamol,phenylbutazone*,oxyphenbutazone, indomethacine,sulindac,mefenamicacid,ibuprofen,naproxen*, ketoprofen,nabumetone,diclofenac*,nimesulide,celecoxib,rofecoxib, piroxicam*,colchicines,sulfinpyrazone,allopurinol). *indicatessynthesistobediscussed 5

3hrs/week
Hours

1 5

2.

80 |P a g e

ReferenceBooks: 1. 2. 3. 4. 5. 6. WilsonandGisvoldsTextbookofOrganicMedicinalandPharmaceuticalChemistry, th 11 Ed.,Eds.,JohnHBlockandJohnMBeale,LippincottWilliams&Wilkins,2004. Foyes Principles of Medicinal Chemistry, Eds., T. L. Lemke and D. A. Williams, Williams&Wilkins,Baltimore,2002. th Medicinal Chemistry, Ashutosh Kar, 4 Edition, New Age International Publishers, 2007. The Art of Drug Synthesis, Eds., Douglas S Johnson and Jie Jack Li, Wiley Interscience,2007. PharmaceuticalChemistry,Vol.1:DrugSynthesis,Eds.,H.J.Roth,A.Kleeman,and T.Beissewenger,EllisHorwoodLtd.,1988. TheOrganicChemistryofDrugSynthesis,DanielLednicer,Vols.1to7,Wiley.

PHARMACEUTICALANALYSISV
S.No. Topic

3hrs/week
Hours 3

1. AtomicabsorptionandEmissionspectroscopy Principle,differencebetweenatomicabsorptionspectroscopyandflame emission spectroscopy, Instrumentation Radiation sources, Flame atomization (types of flames, flame structure, flame atomizers), single anddoublebeamspectrophotometers,advantagesanddisadvantages, Pharmaceuticalapplications. 2. NuclearMagneticResonanceSpectroscopy Introduction, Phenomenon (Spinning nucleus, effect of an external magnetic field, precessional motion, precessional frequency, energy transitions), theory, Chemical shift and its measurement (factors influencing chemical shiftshielding, deshielding, Vander Waals deshielding,anisotropiceffect.e.g.alkanes,alkenes,carbonyl,aromatic and cyclohexane), solvents used in NMR (Choice of solvents, solvent shiftsconcentration,temperature,hydrogenbondingeffects),Spinspin coupling constants and splitting (splitting of NMR signals, theory, coupling, constants, multiplicities, of signal, chemical and magnetic equivalence),spinspindecoupling,Instrumentation(Magnets,magnetic field sweep, radiofrequency oscillator, receiver, recorder and integrators,applications. 3. Massspectrometry Introduction,Basicprinciples,Instrumentation(singlefocusingand doublefocusingmassspectrometer,quadrupolemassspectrometer GCMS,HPLCMS),Electronimpact,chemicalionisation,Field ionisationmassspectrometry,fastatombombardmentspectrometry), basepeak,Molecularion,metastableions,Fragmentationprocesses, Applications. 4. RadiochemistryandRadiopharmaceuticals Fundamentalsofradioactivity(radionuclide,Isotope,radioactive,decay, 81 |P a g e

halflifeofradionuclide,specificactivity,Bccquerel,Curie),Propertiesof radiation,Radiationprotection,measurementofradioactivity(Geiger Mullercounter,liquidscintillatingcounting,gammascintillation detector),Radiopharmaceuticals(Propertiesofradionuclide, pharmaceuticalproperties,chemicalproperties),99mTcgenerator, Qualitycontrolofradiopharmaceuticals(Physical,chemicalandsterility control,radionuclidepurityandradiochemicalpurity),Isotopedilution analysis. 5. NearIRspectroscopy Introduction,Principles,Advantages,QualitativemeasurementsNIR overtonebandsoforganicfunctionalgroups,Quantitativeabsorption Absorbancemeasurements,diffusereflectancemeasurements, InstrumentationRadiationsource,Wavelengthselection,Detectors, Sampleinterface,Samplepreparation,pharmaceuticalapplicationsof NIR. 6. XRaymethodsIntroduction,Instrumentation,identificationof crystallinecompound,Xraypowderdiffraction,Braggreflections, diffractionmethods,Pharmaceuticalanalyticalapplications. 7. StructuralelucidationproblemsbasedonUV,IR,NMR,Mass spectroscopy(simpleproblemswithmolecularformulagiven). 8. HyphenatedTechniquesGCMS,LCMS(Interfacesand Applicationsonly). ReferenceBooks: 1. 2. 3. 4. 5. 6. 7.
th SkooghPrinciplesofInstrumentalAnalysis,4 edition,SaundersCollegePublishing, 1992,USA. BrowningChromatography,1969,McGrawHill,London. th WillardH.H.,L.L.Merritt&JohnDeanInstrumentalMethodofAnalysis,6 edition, 1986,CBSPublishers&Distributors,India. th Beckett&StenlakePracticalPharmaceuticalChemistry,4 edition,1988,CBS Publishers&Distributors,India. I.P.,U.S.P.,B.P.,EuropeanPharmacopoeia. rd WilliamKempOrganicSpectroscopy,3 edition,Reprinted2005,Palgrave PublishersLtd.,NewYork. CliveWhistonAnalyticalChemistrybyopenlearning,1987,JohnWiley&SonsNew York,Toronto.

8 2

PHARMACOGNOSYIV
S.No. Topic

3hrs/week
Hours 6

1. Glycosides Saponinglycosides(liquorice,quillaia,asparagus,ginseng,dioscorea, agave,fenugreek,bacopa,hydrocotyle,alpine,smilaxAcaciaconcinna, sapiandus) 82 |P a g e

Cardiac(digitalis,strophanthus,squill,nerium,thevetia) Biosynthesisofsteroidalglycosidemolecule. 2. Volatileoils:withrespecttosources,composition&preparationof volatileoilsanduses. Umbelliferousfruits(anise,caraway,dill,ajowan,fennel,coriander), clove,cardamom,cinnamon,Saussurealappa,eucalyptus, sandalwood,staranise,patchoulioil,lemongrase,wintergreen, palmrosa,rose,abolmescus,rasana,nutmeg,lemonpeeloil,orange peeloil,spearmintoilandpeppermintoil,jatamansi,valerian,artmesia, vetiver. 3. Resinsturpentine,cannabishops,(Colophony,niyrrh,shellac,benzoin, balsams(tolu,peru),turmeric,guggulu,ginger,colocynth,guaiacum, asafetida,capsicum. 4. Flavonoids Quercetin,Rutin,hesperidin&Flavonoidsfromorangepeelpowder. 5. Phenylpropanoids&Lignans Podophyllum,psoralea,Ammimajus,phyllanthus 6. Polyketidesmalefern,podophyllum 7. Terpenoids&iridoids(Structure,occurrenceanduses) Quassia,piccrorhiza,tinospora,Artemisia,taxus,carrot,gentian,chirata, andrographs 8. Biosynthesisofterpenoids(mono,sesqui,diandtriterpenoids)(skeleton only) 9. Phytotoxins Abrusprecatorius,aconite,belighiasapida,curare,datura,lilyofthe valley,ergot,poisonhemlock,poisonivy,yew,mushrooms,psoralea. 10. IntroductiontomarineDrugs Cytotoxinswithanytwoexamples. 11. SpecialaspectsofpreparationofAyurvedicformulationsandherbal formulations. PreparationandEvaluationofplantextractsandformulationswith respecttophytoconstituents. ReferenceBooks: 1. 2. 3. 4. 5. 6. 7. TreaseD.&EvansW.C.:TextbookofPharmacognosyW.B.,Saunders. TylerV.E.BradyL.R.&RobbersJ.E.:PharmacognosyLeaFeibger,USA. WallisT.E.:TextbookofPharmacognosyCBSPublishers,Delhi. Kokate C. K. Purohit A. P. & Gokhale S. B.: Pharmacognosy Nirali Publications, Pune. Harbone J. B.: Phytochemical Methods: A guide to modern techniques of Plant Analysis:Chapman&Hall,London. BrunetonJ.:Pharmacognosy,Phytochemistry,MedicinalPlantsInterceptLimited. VasudevanT.N.&LaddhaK.S.:ATextbookofPharmacognosy,VrindaPublication House,Jalgaon 83 |P a g e 9

2 2 1 4

2 2

2 2

8. 9. 10. 11. 12. 13. 14. 15.

TheIndianPharmacopoeia:TheControllerofPublicationDelhi. BrainK.R.&TurnerT.D.:ThePracticalEvaluationofPhytopharmaceuticals:Wright, Scientica,Bristol. Iyenger M. A. & Nayak S. G.: Anatomy of Crude Drugs: Manipal Power Press, Manipal. IyengerM.A.:PharmacognosyofPowdereddrugs:ManipalPowerPress,Manipal. KokateC.K.:PracticalPharmacognosy:VallabhPrakashan. Wagner,Bladi&Zgainski:PlantDrugAnalysisSpringerVerlag. Khandelwal K. R.: Practical Pharmacognosy Techniques and Experiments Nirali Prakashan,Pune. Vasudevan T. N., Laddha K. S. Practical Pharmacognosy New Vrinda Publishing House,Jalgaon.

PHARMACEUTICSVII

3hrs/week

Note: References to latest amendments of schedule M and Schedule U of Drugs and CosmeticsAct1940tobemadewhereveritisappropriate. S.No. 1. Topic Qualityassurance(discussspecimendocuments) Raw material control, actives and inactive, in process control, sanitization, environmental and microbiological control, packaging and labelingcontrol,finishedproductcontrol,standardoperatingprocedures, cGMP. Q. C. standards of identity, purity, quality and potency, Q. C. Charts,sampling&samplingplans. Documentationneed/importance,batchmanufacturingrecords,SOPs, Maintenance&RetrievalofDocuments. Pilot plant scale up techniques groups responsibilities, facilities, exampleofscalingupofmanufacturingoftablets,liquidsandsemisolids. ValidationDefinition,Types,Qualification Process Validation steps & documentation (Brief), Examples Raw Materials, mixing and granulation, mixer, granulator, Validation of sterilization process and equipment microbial death kinetic terms, F Valueapplications,stepsforvalidatingsteamsterilizationmethod Productionmanagement Pharmaindustrycurrentscenario Siteselectionanddevelopmentfactorstobeconsideredindesigninga facility, layout of manufacturing facilities, environmental aspects, materials of construction, equipment selection, handling of components and containers, vendor audit, warehousing, maintenance and service aspects,Personnel qualifications, selection, responsibilities& training. Materials management, sales forecasting, inventory control, production planning,elementsofcost&costcontrols. Factory Layout considerations/ steps, Examples of Typical layout schemesforTablets,capsule,liquids,sterileformulationsmanufacturing areas. 84 |P a g e Hours 8

2. 3. 4.

3 5 5

5.

6.

ReferenceBooks: 1. 2. 3. 4. 5. The theory and practice of industrial pharmacy, ed., by Leon Lachman, H. A. rd Liberman,J.L.Kanig,3 ed.,VerghesePublishinghouse,1987. st The science and practice of Pharmacy, 21 ed., Remington, Vol. I and II, B. L. PublicationsPvt.Ltd.,2005. Cole,Graham,PharmaceuticalProductionFacilities:DesignandApplication,1990. nd PharmaceuticalProcessValidation,2 Edition,NashRobertA.BerryIraR.Volume 57,1992,MarcelDekkerInc.,NewYork. Pharmaceuticaldosageformsparenteralmedications,Vol.I,II,III,ed.,byKenneth A.Avis,LeonLachmanandH.A.Liberman,MarcelDekkerINC.,1986.

NOVELDRUGDELIVERYSYSTEMS
S.No. 1. Topic

3hrs/week
Hours 2

OralControlledDrugDeliverySystems a) Multiparticulate drug delivery systems (Pellets) need and significance of pelletization, techniques pan coating, extrusion and spheronization,equipments,evaluation b) Osmotic Systems Basic principles, classification, oral osmotic pumps,applications&evaluation c)Gastroretentivedrugdeliverysystems(GRDDS) Regional variability in intestinal absorption and concept of absorption window, Design of GRDDS technologies low density (Floating systems), Swelling and expanding systems, Mucoadhesive systems, highdensitysystems,EvaluationofGRDDS. Mucoadhesivedrugdeliverysystems Mucoadhesionandtheories,factorsinfluencingmucoadhesion,invitro in vivo methods to study mucoadhesion, bioadhesive polymers and systems. Oculardrugdeliverysystems Limitations of conventional systems, ophthalmic insectsnonerodible anderodibleinserts,pilocarpineocularinsert,Lacrisert,SCDI,Minidisc, NODS, polymers, particulates, enhancers, intraocular solutions, ocular iontophoresis,evaluation. Transdermaldrugdeliverysystems(TDDS) Skin and skin permeation, modes of percutaneous penetration, components of TDDS, different types of TDDS and release control mechanisms, production, evaluation of PSA and TDDS in vitro, in vivo. Introductiontotargeting,Passiveandactivetargeting a)Targetingtolymphaticsystems Anatomyoflymphaticsystem,lymphaticsinintestine,factorsenhancing intestinal drug uptake, approaches, prodrug and delivery systems examples,parentaldrugadministrationforlymphatictransport 85 |P a g e

1 2

2.

3.

4.

5.

1 2

b)Liposomes Structural components and classification, methods of preparation, size reduction,characterization,stability,applications. c)Drugtargetingtobrain The blood brain barrier, transport through blood brain barrier, factors affecting drug permeation through BBB, strategies for brain drug delivery d)Nanoparticles Preparation techniques, characterization, biodistribution, evaluation andapplications. e)ColonictargetingPhysiologyofcolon,difficultiesincolonictargeting, approaches prodrug, pH sensitive polymers, polysaccharides, time releasesystems,osmoticsystems,azopolymers,evaluation. ReferenceBooks: 1. 2. 3. 4. 5. 6. 7. 8.

9. 10. 11. 12. 13. 14. 15.

Advances in controlled and novel drug delivery, ed. by N. K. Jain, CBS publishers anddistributors,2001. th ModernPharmaceutics,4 ed.RevisedandExpandeded.byGilbertS.Bankerand ChristopherT.Rhodes,MarcelDekkerINC.,2002. Targettedandcontrolleddrugdelivery,Novelcarriersystems,S.P.VyasandR.K. Khar,CBSpublishersanddistributors,2002. Controlled and Novel drug delivery, ed. by N. K. Jain, CBS publishers and distributors,1997. Controlleddrugdelivery,conceptsandadvances,S.P.VitasandR.K.Khar,Vallabh Publishers,2002. The theory and practice of industrial pharmacy, ed. by Leon Lachman, H. A. rd Liberman,J.L.Kanig,3 ed.,VerghesePublishinghouse,1987. st The science and practice of pharmacy, 21 ed., Remington, Vol. I and II, B.L. PublicationsPvt.Ltd.,2005. Bioadhesive Drug Delivery Systems Fundamentals, Novel Approaches, and Development, Mathiowitz Edith, Chickening III, Donald E., Lehr ClausMichael, Volume98,MarcelDekkerINC,NewYork,1995. Nanoarticulate Drug Delivery Systems, Thassu Deepak, Dellers Michael, Pathak Yashwant,Volume166,MarcelDekkerInc.,NewYork,2007. nd MicroencapsulationMethodsandIndustrialApplications,BenitaSimon,2 Edition, MarcelDekkerInc.,NewYork,2006. st Controlled and Novel Drug Delivery, Jain N. K. 1 Edition, CBS Publishers and Distributors,NewDelhi,2004. TargetedandControlledDrugDeliveryNovelCarrierSystems,VyasS.P.KharR. st K.,1 Edition,CBSPublishersandDistributors,NewDelhi,2002. OphthalmicDrugDeliverySystems,Mitra,AshimK.,Volume58,MarcelDekkerInc., NewYork,1993. Encyclopedia of Pharmaceutical Technology, Swabrick, Boylan, Volumes 1,6,8,9,10,12,13,14,15,16,17,18,19,20.MarcelDekkerInc.,NewYork. OralMucosalDrugDelivery,RathboneMichaelJ.,Volume74,1996,MarcelDekker Inc.,NewYork,1996. 86 |P a g e

FORENSICPHARMACYANDJURISPRUDENCE
S.No. 1. 2. Topic

3hrs/week
Hours 1 5

Historical perspective including details of Chopra Committee and Hathi Committee An objective study of the following Acts mearporating the latest amendmentsPharmacyAct1948 Definition PCIandStateCouncils,CompositionandFunction PreparationofRegistersandqualificationsforentryintoregisters EducationalRegulationandApprovalofCoursesandInstitutions OffencesandPenalties DrugsandCosmeticAct1945 Definitions AdvisorbodiesDLABandDCCCompositionandfunction DrugControlLaboratoriesandGovernmentAnalysts Drug inspectors,LicensingAuthorities, Controlling Authorities and CustomsCollectors ProvisionsGoverningImport,ManufactureandSaleofDrugs. LabelingandPackagingofDrugs ProvisionsapplicabletomanufactureandSaleofAyurvedicDrugs Provisions Governing Import, Manufacture and Sale of HomeopathicDrugs. VariousoffencesandcorrespondingPenalties BroadcontentofvariousSchedulesoftheDrugsandCosmeticAct andRules. DrugsandMagicRemedies(ObjectionableAdvertisements)Act1954. Definitions,ProhibitedAdvertisement,Savings. NarcoticDrugsandPsychotropicSubstancesAct Definitions NarcoticsCommissionerandotherofficers IllicitTrafficandmeasurestopreventillicittrafficofopium. Offencesandcorrespondingpenalties. DrugPriceControlOrder1995andnewDrugPolicy MedicinaladToiletPreparations(ExciseDuties)Act. Definitions,restrictedandunrestrictedpreparations Manufacturinginbondandoutsidebond PreventionofFoodAdulterationAct1954 Definitions Central board of food standards, central food laboratory, compositionsandfunctions Publicanalysisandfoodinspectors IndianPatentsAct1975 87 |P a g e

3.

14

4. 5.

2 2

6. 7.

2 2

8.

9.

10. 11. 12.

BombayShopsandEstablishmentsAct DefinitionsandProvisions FactoriesAct1954 DefinitionsandProvisions IndianPenalCodeandCodeofCriminalProcedures ProvisionspertainingtodifferentCourts,jurisdictionandpower Provisions governing entry, search, arrest, bailable and non bailableoffences,Cognizableandnoncognizableoffences InsecticidesAct Definitions ProcedureforlicensingandregistrationofInsecticides Savings

1 1 1

13.

ReferenceBooks: 1. 2. 3. 4.
th ForensicPharmacy,KuchekarandKadtareandItkar,NiraliPrakashan,5 edition, 2005. th TextbookofForensicPharmacyN.K.Jain,Vallabhprakashan,4 edition,1999. D & C Acts, 1940 and Rules, 1945, S. W. Deshpande and Nilesh Gandhi, Sumit Publishers2006,Mumbai. Govt.ofIndiaPublicationofaboveActsandRules.

CLINICALPHARMACYANDDRUGINTERACTION
S.No. 1. 2. 3. 4. Topic

3hrs/week
Hours 6 6 3 16

Concept of clinical pharmacy, community pharmacy and hospital pharmacy(definition,scopeandobjectives) Conceptoftherapeuticdrugmonitoringandpatientcompliance RoleofPharmacistasapatientcouncilor Rationaluseofdrugs Drugdruginteractions possiblemechanismsandexamples Druginteractionwithfood,alcohol,tobacco AdversedrugreactionsTypesandexamples DetectionandPreventionofADR Drugsusedingeriatrics,pediatricsandpregnancy Irrationaldrugcombination Doseadjustmentinrenalandhepaticdysfunction General Introduction to drug discovery and development PreClinical Stages Clinicaldevelopmentphasesofclinicaltrials CommercialAspects

5.

ReferenceBooks: 1.
st ClinicalPharmacyDr.Tipnis,Dr.Bajaj,1 Edition,CareerPublications,2003.

88 |P a g e

2. 3. 4.

th ClinicalPharmacologyP.N.Benett,M.J.brown,9 Edition,ChurchillLivingstone, 2006. TextBookofClinicalPharmacyPracticeG.Parthisarathi,KarinNyfortHansen,Milap C.Nahata,Orientlongman,2004. rd ClinicalPharmacyandTherapeuticsRogerWalker,CliveEdwards,3 Edition, ChurchillLivingstone,2003.

PHARMACEUTICSLABORATORYV
1.

4hrs/week

S.R.oraltabletsuseofhydrophobicandhydrophilicmatrixmaterials(monolithicand reservoir)preparationandinvitroreleaseevaluation. Dissolutiontesting Marketedformulationsofconventionaltablets solubledrug& poorlysolubledrug(selectionofmedium) OphthalmicDDSMucoadhesivegelandevaluation. Acceleratedstabilitytestingofanysuitabledrug/formulation Demonstrationofsugarandfilmcoatingoftablets. Microencapsulation by coacervation phase separation technique of a liquid (volatile oil)&asolid(Charcoal/Paracetamol),evaluationoftheproducts. SRsuppositoriesPEGbaseandHydrogelbaseevaluationofinvitrorelease.

2.

3. 4. 5. 6.

7.

PHARMACOGNOSYLABORATORYIII
S.No. 1. 2. Topic

4hrs/week
Hours 8 2

Macroscopy microscopy of liquorice, clove, fennel, dill, cardamom, cinnamon,coriander,quassia,kalmegh,picrorrhiza,asparagus. Extractionanddetectionofphytoconstituentsoffollowingclasses(Anytwo examplesofeachclass) Flavonoids,glycosides(liquorice),volatileoils(clove,fennel,anise,dill) Qualitativeanalysisofunorganizeddrugsascovereddrugsascoveredin theory(asafetida,myrrh,benzoin,guggul,andaloes). MicroscopicevaluationofAyurvedicchurnaformulation&analysisoftotal tanninsfromTriphalachurna. Morphological identification of drugs covered in theory (volatile oils and glycosides)any20samples Total

3. 4. 5.

2 1 1 14

89 |P a g e

PHARMACEUTICALANALYSISLABORATORYIII 1. 2. 3.

4hrs/week

Determinationofpka1andpka2ofphosphoricacid. DeterminationofHClandphosphoricacidinagivenmixturepotentiometrically. Assay of paracetamol tablets, propanolol tablets, albendazole tablets, Rifampicin capsulesasperI.P. 4. Assayofquininesulphatebyfluorimetry. 5. Studyofquenchingeffectsofiodideionsonfluorescenceofquininesulphate. 6. Assay of phenylephrine hydrochloride ophthalmic solution by difference spectroscopy. 7. Assay of caffeine and sodium benzoate injection by simultaneous equation method andabsorbancerationmethod. 8. AssayoftrimethoprimincotrimoxazoletabletsasperI.P. 9. AssayofnifedipineandatenololtabletsbyUV. 10. DeterminationofstreptomycinbasecolorimetricallyfromInjection. 11. IdentificationofsamplebyTLC. Demonstrationexperiments: 1. 2. 3. 4. 5. AssayofsamplebyHPLC/HPTLC/GC. QualitativeanalysisbyI.R. DeterminationofK+fromKCIbyflamephotometry. SelectionofmobilephaseforTLC. Identificationofaminoacidsbypaperchromatography.

90 |P a g e