Jawaharlal Nehru Technological University KAKINADA School of Pharmaceutical Sciences & Technologies SY A!US "#$ %&P'A$%A(Y !

ranch) Pharmaceutics

M.PHARM PHARMACEUTICS I SEMESTER Paper CEU 101 Paper CEU 102 Paper CEU 103 Paper CEU 10! Paper CEU 10$ I SEMESTER Paper CEU 201 Paper CEU 202 Paper CEU 203 Paper CEU 20! Paper CEU 20$ AD&ANCES IN DRUG DELI&ERY SYSTEMS AD&ANCED PHARMACEUTICAL TECHNOLOGY INDUSTRIAL PHARMACY AD&ANCES IN DRUG DELI&ERY SYSTEMS PRACTICALS E#PERIMENTS BASED ON THEORY AD&ANCED PHARMACEUTICAL TECHNOLOGY PRACTICALS E#PERIMENTS BASED UPON THEORY B10-PHARMACEUTICS & PHARMACOKINETICS PHYSICAL PHARMACEUTICS DRUG REGULATORY A AIRS B"O PHARMACEUTICS & PHARMACOKINETICS PRACTICAL E#PERIMENTS BASED ON THEORY. PHYSICAL PHARMACEUTICS PRACTICALS% PRACTICALS BASED UPON THEORY&

III SEMESTER & I& SEMESTER Paper CEU 301 Paper CEU !01 Paper CEU !02 Paper CEU !03 Paper CEU !0! Se'()ar-I *O) +,e pr-p-.e/ pr-0e1+ 2-r3 2(+, a('. a)/ -40e1+(5e.6 Se'()ar-II *O) +,e e7per('e)+a+(-) a)/ re.8"+. -4+a()e/ () +,e pr-0e1+ 2-r36 T,e.(. e5a"8a+(-) De9e)1e *&(5a-&-(1e6 C-'pre,e).(5e &(5a 5-(1e

M.PHARM *PHARMACEUTICS6 I Se'e.+er CEU 101 B10-PHARMACEUTICS & PHARMACOKINETICS *& 0 3 4 !io+availa,ility !ioe-uivalence an. Thera/eutic e-uivalence) Designing of ,ioavaila,ility stu.ies an. inter/retation of results& Physicochemical /ro/erties affecting ,ioavaila,ility1 /'+/artition theory1 .issolution1 surface area a.sor/tion1 com/le2ion1 /olymor/hism an. techni-ues of enhancing .issolution rate& "ormulation factors affecting ,ioavaila,ility of .rugs in .osage forms of Ta,lets1 ca/sules1 /arenterals1 li-ui. orals an. to/ical .osage forms& !asic conce/ts of Pharmaco5inetics) (om/artmental mo.els) #ne1 Two an. non+ com/artmental a//roaches to Pharmaco5inetics& $ecent tren.s1 merits an. limitations of these a//roaches& A//lication of these mo.els to .etermine the various /harmaco5inetic /arameters /ertaining to) a6 A,sor/tion) 7wherever a//lica,le6 a,sor/tion rate constant1 A,sor/tion half time1 lag time an. e2tent of a,sor/tion1 AU(& ,6 Distri,ution) A//arent volume of .istri,ution an. its .etermination& c6 %eta,olism) %eta,olic rate constant .6 8limination) #ver all a//arent elimination rate constant an. half life un.er the following con.itions) i& Intravenous ,olus in9ection& ii& Intravenous infusion& iii& Single .ose oral a.ministration& iv& %ulti/le .ose in9ections& v& %ulti/le .osage oral a.ministration e6 Non invasive metho.s of estimating Pharmaco5inetic /arameters with em/hasis on salivary an. urinary com/artments& f6 (once/t of clearance) #rgan clearance1 total clearance1 he/atic clearance1 lung clearance an. renal clearance& Non+linear Pharmaco5inetics) (once/ts of linear an. non linear /harmaco5inetics1 %ichaelis + %enton 5inetics characteristics& !asic 5inetic /arameters1 /ossi,le causes of non in.uction1 non linear ,in.ing1 non linearity of /harmacological res/onses& Time .e/en.ent /harmaco5inetics) Intro.uction1 classification1 /hysiologically in.uce. time .e/en.ency) (hrono/harmaco5inetics1 chemically in.uce. .e/en.ency& Drug %eta,olism + sites of meta,olism1 factors affecting .rug meta,olism 7genetic1 s/ecies an. environmental6& (linical /harmaco5inetics) Altere. 5inetics in /regnancy1 chil. ,irth1 infants an. geriatrics& Kinetics in >I .isease1 mala,sor/tion syn.rome1 iver1 car.iac1 renal an. /ulmonary .isease states&

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Drug interactions) Kinetics of .rug interaction1 stu.y of .rug+.rug interactions me.iate. through a,sor/tion1 .istri,ution1 meta,olism an. elimination1 mechanisms of interaction an. conse-uence& Influence of alcohol1 smo5ing1 foo. an. ,everages on .rug action&

Re9ere)1e.% *& !io/harmaceutics an. clinical Pharmaco5inetics ,y %ilo >i,al.i& 0& $emington@s Pharmaceutical Sciences ,y %ac5 /u,lishing com/any1 Pennsylvania& 3& Pharmaco5inetics ,y %ilo >i,al.i1 Donal. PerrierA %arcel De55er1 Inc& 4& 'an.,oo5 of clinical Pharmaco5inetics ,y %ilo >i,al.i an. aurie Prescott ,y ADIS 'ealth Science Press& :& !io/harmaceutics an. Pharmaco5inetics ,y $o,ert 8& Notari& ;& !io/harmaceutics ,y Swar,ric5& <& !io/harmaceuties an. Pharmaco5inetics+ A Treatise ,y D&%&!rahman5ar an. Sunil !&Jaiswal&1 Balla,h Pra5ashan Pitam/ura1 Delhi& =& (linical Pharmaco5inetics1 (once/ts an. A//lications ,y %alcolm $owlan. an. Thomas N&ToCer& ea an. "e,iger1 Phila.el/hia1 *??:& ?& Dissolution1 !ioavaila,ility an. !ioe-uivalence ,y A,.ou& '&%&1 %ac5 Pu,lishing (om/any1 Pennsylvania1 *?=?& *D& !io/harmaceutics an. (linical Pharmaco5inetics+ An intro.uctionA 4th e.ition1 $evise. an. e2/an.e. !y $o,ert& 8& Notari1 %arcel De55er Inc1 New Yor5 an. !asel1 *?=<& **& 8ncyclo/e.ia of Pharmaceutical Technology1 Bol *31 James Swar,ric51 James& (&!oylan& %arcel De55er Inc1 New Yor51 *??;&

CEU-102 PHYSICAL PHARMACEUTICS% *& Particle science an. /ow.er technology) (rystal structure1 Amor/hous state1 Polymor/hism1 /article siCe .istri,ution1 /article siCe analysis metho.s& Soli. .is/ersionsEsoli. solutions& 0& Physics of ta,let com/ression) (om/ression1 consoli.ation strength of granules1 com/ression an. consoli.ation un.er high loa.s1 effect of friction1 .istri,ution of forces in com/action1 force volume relationshi/s1 'ec5el /lots1 com/action /rofiles1 energy involve. in com/action1 strength of ta,let1 crushing strength1 fria,ility1 lamination1 instrumentation of ta,let machines& 3& Dissolution an. solu,ility) Solu,ility an. solu,ilisation of non electrolytes1 solu,ilisation ,y the use of surfactants1 cosolvents1 com/le2ation1 .rug .erivatisation an. soli. state mani/ulation1 .issolution rates of soli.s in li-ui.s1 measurement of .issolution rates 4& Theories on sta,ility of .is/erse systems) A.sor/tion1 wetting1 crystal growth mechanisms1 /hysical sta,ility of sus/ensions an. emulsions1 sta,ility testing of emulsions an. sus/ension an. release of .rugs from sus/ensions an. emulsion formulations& !io/harmaceutical as/ects of .is/erse systems& :& $heology) Theoretical consi.eration1 instrumentation1 rheological /ro/erties of .is/erse systems an. semi soli.s& ;& Polymer science) Pro/erties of /olymers1 thermo.ynamics of /olymer solution1 /hase se/aration1 /olymers in soli. state1 a//lications of /olymers in /harmaceutical formulations <& Kinetics an. .rug sta,ility) sta,ility calculations1 rate e-uation1 (om/le2 or.er Kinetics1 5inetics of some .ecom/ositions1 strategy of sta,ility testing1 metho.s of sta,iliCation1 metho.s of accelerate. sta,ility testing in .osage forms1 "reeCe+Thaw metho.s1 centrifugal metho.s1 tem/erature an. humi.ity control1 Physical sta,ility testing of /harmaceutical /ro.ucts& =& Physical /ro/erties1 instrumental analysis of .rug molecules1 Differential Thermal Analysis1 Differential Scanning (alorimetry1 Diffusive $eflective S/ectro/hotometry1 F+$ay Diffraction Analysis& Re9ere)1e.% *& 0& 3& 4& :& ;& <& Physical PharmacyA !y Alfre. martin $emington@s Pharmaceutical Sciences& Theory an. Practice of In.ustrial Pharmacy !y achmann an. i,ermann& Pharmaceutical PreformulationsA !y J&J& Gells& %o.ern PharmaceuticsA !y >ill,ert an. S& !an5er& Instrumental %etho.s of (hemical Analysis H !& K& Sharma + ?th 8.ition& Princi/les of Instrumental Analysis ,y Donglas A& S5oog1 James1 J& eary1 4th 8.ition&

CEU 103 DRUG REGULATORY A

AIRS%

*& "ormulation .evelo/ment) $egulatory re-uirements involve. in the /reformulation stu.ies1 soli.1 li-ui. an. semi+soli. .osage forms1 controlle. release /re/arations1 in9ections1 ocular /re/arations as /er the 8uro/ean community1 Unite. States an. In.ian regulatory authorities 0& %anufacturing) $egulatory re-uirements as /er 8uro/ean community1 Unite. States an. In.ian regulatory authorities for manufacturing information1 manufacturing formula1 /rocess1 vali.ation of manufacturing /rocess1 e-ui/ment1 .ocumentation1 ins/ection re-uirement of regulatory gui.elines for active ingre.ients1 .ata re-uirement for new .rug1 International as/ects of 82ci/ients1 a//roval as /er gui.elines of all the territories& $egulatory gui.elines for /ac5aging materials1 test an. evaluation of /ac5aging materials1 ,iological test1 elastometer test1 micro,iological test an. evaluation of closures& 3& Sta,ility testing) Scientific an. technical ,ac5groun. to the .esign of sta,ility testing regulatory re-uirements as /er 8uro/ean community1 Unite. States an. In.ian regulatory authorities for testing of new active su,stances1 ,ul5 active .rug su,stances1 .osage form in their final /ac5aging& 82tension of shelf+life after authoriCation of .rug international harmoniCation an. current gui.elines& $egulatory affairs in res/ect of resi.ual solvents as /er the I(' gui.elines1 analytical metho. vali.ation1 /harmaco5inetic an. to2ico5inetic vali.ation& 4& !io/harmaceutics) Different testing /arameters an. stan.ar.s as /er regulatory re-uirements of 8uro/ean community1 Unite. States an. In.ian regulatory authorities with res/ect to factors relate. to formulation1 .osage form1 manufacturing /rocess1 sta,ility an. storage& :& Preclinical as/ects of !io/harmaceutics) (urrent gui.elines an. .evelo/ments as /er regulatory re-uirements of 8uro/ean community1 Unite. States an. In.ian regulatory authorities in res/ect of clinical ,ioavaila,ility 1 stu.y .esign1 /resentation .ocumentation an. statistical analysis ;& (linical /harmacology an. Pharmaco.ynamics) $egulatory gui.elines as /er 8uro/ean community1 Unite. States an. In.ian regulatory authorities on clinical stu.y .esign1 .ocumentation1 /resentation an. inter/retation& (linical trials) Definition1 /hase I1 /hase II1 /hase III an. /hase IB stu.ies1 .esign .ocumentation1 /resentation an. inter/retation1 statistical analysis of clinical .ata an. factorial .esign& <& Intellectual /ro/erty rights an. /atents) Intro.uction1 /ur/ose1 international scenario an. In.ian scenario1 gui.elines as /er 8uro/ean community1 Unite. States an. In.ian regulatory authorities1 .ocumentation1 /resentation an. a//lication1 /roce.ure for o,taining an. writing a /atent an. /atenting rules an. regulations Re9ere)1e% *& Iuality Assurance >ui.e ,y #rganiCation of Pharmaceutical /ro.ucers of In.ia& 0& Drug formulation manual ,y D&P&S& Kohli an. D&'&Shah& 8astern /u,lishers1 New Delhi& 3& 'ow to /ractice >%Ps ,y P&P&Sharma& Ban.hana Pu,lications1 Agra&

4& Pharmaceutical Process Bali.ation ,y "ra& $& !erry an. $o,ert A& Nash& :& Pharmaceutical Preformulations ,y J&J& Gells& ;& A//lie. /ro.uction an. o/erations management ,y 8vans1 An.erson1 Sweeney an. Gilliams& <& !asic Princi/les of (linical $esearch an. %etho.ology ,y >u/ta& =& !io/harmaceutics an. (linical Pharmaco5inetics+An intro.uctionA 4th e.ition1 $evise. an. e2/an.e. ,y $o,ert& 8& Notari1 %arcel De55er Inc1 New Yor5 an. !asel1 *?=<&

CEU 10! B"O PHARMACEUTICS & E#PERIMENTS BASED ON THEORY.

PHARMACOKINETICS

PRACTICAL

CEU -10$ PHYSICAL PHARMACEUTICS PRACTICALS% PRACTICALS BASED UPON THEORY&

2)/ SEMESTER CEU 201 AD&ANCES IN DRUG DELI&ERY SYSTEMS *& "un.amentals of controlle. .rug .elivery systems1 use of /olymers in controlle. .rug .elivery1 /harmaco5inetic an. /harmaco.ynamic ,asis of controlle. .rug .elivery& Design1 fa,rication1 evaluation an. a//lications of the following controlle. release systems& a6 (ontrolle. release oral .rug .elivery systems ,6 Parenteral controlle. release .rug .elivery systems c6 Im/lanta,le thera/eutic systems .6 Trans.ermal thera/eutic systems an. Ionto/horesis e6 #cular an. intrauterine .elivery systems f6 !ioa.hesive .rug .elivery systems g6 Proteins an. /e/ti.e .rug .elivery 0 !iochemical an. molecular ,iology a//roaches to controlle. .rug .elivery a6 %icro /articulate .rug carriersA i/osomes1 Niosomes1 %icros/heres1 Nano/articles an. $eseale. erythrocytes& ,6 %onocional anti,o.ies 3 Drug targeting to /articular organs) a6 Drug .elivery to res/iratory system ,6 Pro,lems of .rug .elivery to the ,rain an. targeting to ,rain c6 Drug .elivery to eye .6 Drug targeting in Neo/lastic .iseases 4 Drug carrier systems targete. to wi.ely .is/erse. cells a6 Delivery to %acro/hages ,6 Delivery to lym/hoi. cells of immune networ5 c6 Delivery to lysosomal storage .iseases Re9ere)1e.% *& 8ncyclo/e.ia of controlle. .eliveryA ,y 8.ith %athiowitC1 Pu,lishe. ,y Giley Interscience Pu,lication1 John Giley an. sons1 Inc1 New Yor5 E (hichester E Geinheim& 0& (ontrolle. an. Novel Drug Delivery ,y N&K&Jain1 (!S Pu,lishers an. Distri,utors1 New Delhi1 "irst e.ition1 *??< 7re/rint in 0DD*6& 3& (ontrolle. Drug Delivery + (once/ts an. A.vances ,y S&P&Byas an. $&K&Khar1 Balla,h Pra5ashan1 New Delhi1 "irst e.ition1 0DD0& 4& $emington@s Pharmaceutical Sciences& :& Novel .rug .elivery system ,y Y&%&(hien1 %arcel De55er1 Inc& ;& (ontrolle. Drug Delivery + "un.amentals an. A//lications1 0n. e.ition ,y Jose/h $&$o,inson an. Bincent '& & ee& <& Pharmaceutical Dosage forms1 .is/erse system) Bolume *1 ,y 'er,ert A& i,ermann et&al1 %arcel De55er1 Inc&

=& Pharmaceutical Dosage forms) Ta,lets Bolume II1 'er,ert A& i,ermann et&al1 %arcer De55er1 Inc& ?& !entley@s Te2t,oo5 of Pharmaceutics ,y 8&A&$awline1 8 !S Pu,lications& *D& %icroenca/sulation an. $elate. Drug Process ,y Patric !&Deasy& CEU-202 AD&ANCED PHARMACEUTICAL TECHNOLOGY% *& Preformulation stu.ies) >oal of /reformulation1 /reformulation /arameters1 %etho.ology1 Soli. state /ro/erties1 Solu,ility & /artition coefficient1 Drug+82ci/ient com/ati,ility& 0& "ormulation Develo/ment) a6 Soli. .osage forms) Im/rove. /ro.uction techni-ues for ta,lets) New materials1 /rocessess1 e-ui/ments im/rovements1 high shear mi2ers1 com/ression machines1 coating machines1 (oating techni-ues in ta,let technology for /ro.uct .evelo/ment1 Physics of ta,let com/ression an. com/uteriCation for in /rocess -uality control of ta,lets& ,6 Pow.er .osage forms) "ormulation .evelo/ment an. manufacture of /ow.er .osage from for internal an. e2ternal use inclu.ing inhalation .osage forms& c6 i-ui. an. Semi+soli. .osage forms) $ecent a.vances in formulation as/ects an. manufacturing of mono/hasic .osage forms1 recent a.vances in formulation as/ect an. manufacturing of sus/ensions an. semi+soli. .osage forms& .6 Parenteral .osage forms) A.vances in materials & /ro.uction techni-ues1 filling machines1 steriliCers & ase/tic /rocessing e6 Aerosols) A.vances in /ro/ellants1 metere. .ose inhaler .esigns1 .ry /ow.er inhalers1 selection of containers & formulation as/ects in aerosol formulation1 %anufacture & -uality control& 3& Ase/tic /rocessing o/eration) Intro.uction1 (ontamination control1 %icro,ial environmental monitoring1 %icro,iological testing of water1 %icro,iological air testing1 (haracteriCation of ase/tic /rocess1 %e.ia an. incu,ation con.ition1 Theoretical evaluation of ase/tic o/erations& Re9ere)1e.% *& 0& 3& 4& :& Theory an. Practice of In.ustrial Pharmacy ,y achmann an. i,ermann& %o.ern Pharmaceutics ,y >ill,ert an. S& !an5er& $emington@s Pharmaceutical Sciences& Pharmaceutical Preformulations ,y J&J& Gells& A.vances in Pharmaceutical Sciences Bol& *+: ,y '&S& !ean & A&'& !ec5ett&

CEU 203 INDUSTRIAL PHARMACY * A .etaile. stu.y involving machinery an. theory of /harmaceutical unit o/erations li5e %illing1 %i2ing1 "iltration1 Drying an. SteriliCation& 0 %aterials of construction of /harmaceutical e-ui/ment an. /ac5aging materials& Stu.y of the /rinci/les1 /ro.uction techni-ues an. scale u/ techni-ues in the large scale /ro.uction of ta,lets1 ca/sules1 emulsions1 sus/ensions1 sterile /ro.ucts1 Semisoli.s an. li-ui. /harmaceuticals1 o/hthalmic /ro.ucts& 3 Pro.uction %anagement) Pro.uction organiCation1 o,9ectives an. /olicies1 goo. manufacturing /ractices1 layout of ,uil.ings1 services1 e-ui/ment an. their maintenance1 materials management1 han.ling an. trans/ortation1 inventory management an. control1 /ro.uction an. /lanning control& Sales forecasting1 ,u.get an. cost control1 in.ustrial an. /ersonal relationshi/& 4 Iuality control1 Process an. Dosage form) Process control1 control of manufacturing /rocess1 statistical -uality control1 control charts of automate. /rocess control1 .osage form control1 testing /rogramme an. metho.1 /ro.uct i.entification system1 a.ulteration an. mis,ran.ing 1 .rug information /rofile& : Process Bali.ation) $egulatory ,asis1 Bali.ation of soli. .osage forms1 sterile /ro.ucts1 li-ui. .osage forms& Process vali.ation of raw materials1 Bali.ation of analytical metho.s1 8-ui/ment an. Process& Re9ere)1e.% *& Theory an. Practice of In.ustrial Pharmacy ,y achmann an. i,ermann& 0& Pharmaceutical .osage forms) Ta,lets Bol& *+3 ,y eon achmann& 3& Pharmaceutical Dosage forms) Dis/erse systems1 Bol1 *+0 ,y eon achmann& 4& Pharmaceutical Dosage forms) Parenteral me.ications Bol& *+0 ,y eon achmann& :& %o.ern Pharmaceutics ,y >ill,ert an. S& !an5er& ;& $emington@s Pharmaceutical Sciences& <& A.vances in Pharmaceutical Sciences Bol& *+: ,y '&S& !ean & A&'& !ec5ett& =& Physical Pharmacy ,y Alfre. martin ?& !entley@s Te2t,oo5 of Pharmaceutics H $aw,ins& *D& >oo. manufacturing /ractices for Pharmaceuticals) A /lan for total -uality control1 Secon. e.ition ,y Si.ney '& Gillig& **& Iuality Assurance >ui.e ,y #rganiCation of Pharmaceutical /ro.ucers of In.ia& *0& Drug formulation manual ,y D&P&S& Kohli an. D&'&Shah& 8astern /u,lishers1 New Delhi& *3& 'ow to /ractice >%PsA !y P&P&Sharma& Ban.hana Pu,lications1 Agra& *4& Pharmaceutical Process Bali.ation ,y "ra& $& !erry an. $o,ert A& Nash& *:& Pharmaceutical Preformulations ,y J&J& Gells& *;& A//lie. /ro.uction an. o/erations management ,y 8vans1 An.erson1 Sweeney an. Gilliams&

CEU 20! AD&ANCES IN DRUG E#PERIMENTS BASED ON THEORY

DELI&ERY

SYSTEMS

PRACTICALS PRACTICALS

CEU-20$ AD&ANCED PHARMACEUTICAL E#PERIMENTS BASED UPON THEORY

TECHNOLOGY