HPH209 = Fundamental “Therapevtics, 2044 -2016 PRACTICE QUESTIONS 1. Describe the S main qualities fa GMP campuant product. C40 mares) Ans: SISPQ @ Sogety: the product remains free from ANy unexpected) side effects when ub is USed Appropriately by the patent Taentity: the product is exacty what the label + related Materials Say th ts. Every MEENA , COMPONENE , siqnipicannt piece SF equipment + cperation are Usbeled + documented so that ae history can be Accurately reconstrucled gram start to finish. Strength: the product delivers the corect dose + US potency is Maintained over the shele-~Upe ce the product WPrity: product ts free prom physical, biologie! + chemical contaminaions © Guatity: product meets the standards + PropessiGnAls + requiatory agencies aro performs @s claims + can be manner. expecksiicns of medical mond the Worid . “The. product made successpolly WY A@ “consistent 2. The Long-term stAouty of @ local anaesthehe scwnen intended for TV injechon was assessed by Stonng the product at the temperatures, Snow BEIGE + MEABUNNg the RUNEKC rate CCNStNL & the degradanon feAchon. 30 C.OC4K4S LO o.0o9L 50 o-0158 €O o- S844 2 Seely ¢ cage Rae the RWEHC fale consceants mane be determined 5) Use the dota. to suggest & storage temperature winch woud ensure &) USe 3 year shel-ufe based on a lower Um of IO% gp ene staied os f dcse. Ans: sag Uncone ¥S “he Rinekic Ole constant can be determined by plotking 9 en Se a Unear Slope, From which the. gradient ,-R, SiMe ES ge worked cub and We fate constane deremined con NOTE: This is a Fist order reaction, with We vo its of the rae constants being weerB) @ TAO) shele upe = tn C.400/90) / e@ R= NC4100/90) help ure Cs2 ws 8 ke WCACO/AG) / 256 EF HAE ESE weeks gear) k = 6.75x10 ‘ueek™*, eo nk = ww C678 xtO) = - 7-3 Temp @o) RGeawa) a CKelwa) Te 30. ©, CO44R 0.0033 - 5.40813 40 0- 0084 0.00319 =e 644k 50 Jo.0158 | 0-CO3086 =| — + ATS 60 ©. 0344 © .003003 3 as55E8 \ o.008> saltt o.0082 010038 Ocal T p08 0.0036 @ Plot graph ue vs 4/7 @ Extrapoiae tO -7.30 on the WR oocts and determine the corresponding = 4/T value Sow wis case 4/T We=-7.3 = 0.003848 A(T= O° CO8KS Te soomt = 287.356 C27 = 14.3 .C ——— ae shelp Ure OF 2 Years CPourl's ANSWEL was G.W"C - depends how accuraely yoo daw the graph) + BONUS QUESTION” e Ge given whe LempPyrature , Need to wore cue ene Snell ale ROS @ Say, ok AO'C ,convert to K and do aT. @ Do ~ table, as enousiy. e@ Plot graph extrapolate to A0T: Wes 1-14 x 1073 3 T(QO)=_ ULllO0/A) 71-4107 = 4k vores —BaPescrise how shape CIANGOPMABEN CUS MOM extrcae peuer Cr mares b) Breply cuscuss the Factors afPecbng ehis crensformagon. CE Marked) Fens: @ Process’ outline : Soud(s) + Uquid \ Conxeng) Bue wet powder Mass | Shaping and densification Cextrestod Extrodatte 2) are SUbdivision >> > Shaping, Csphernisatics) . e Drying of pellet screking Copy rad Soud drug is i e placed Wa binder added to form a Bera bul mace Wis Buus, mat ree 7 placed uo an extruder to produce an extrudale , so eeeers Sphaghete -ties Strocture. is permed Ths process is “known as extruston. The extrudiale Csphaghett) ts pla. SxS RUG eransporms che exemaaie ub sy NO, E Srna This process is Rnown As spheronisabon. These pellets are then es darned Wa drying oven to remove morsture, b) The factors oggecking bhis Eransformation include extrusion pr es Ss aS plasticity, fluidity » selp- lubricating + rgiclty of the extrudate. also play a role, iNndeding the water FOrmutaion com, content cf the wet mass and Meluston mucrocrystadune ceuuiose . The feed rate the wet mass ; die also curibule qi S stength anc) cusmeler Sphererisacion also affects the qualty Ff the peUets , paying particular attention to mechanical strength »plastctty , L/D Clengh/ diameter) ratio , and Non-adhesion properties. she sphemizer size,chage generation, disc speed ancl residence me also play a role.1H Ourune O manufacturing process for hard gelatin capsues , Cadluding the APPOpAle W-Process quAUEY cont! checks C40 marks) Ans: First ,a. stock solution ts pared by dtssoi | Or Wi) in not sessed MME Ceo! FORGING geleatin (20-40 @a vacuum (Ss appuied bo remove alr bubbles Csmau batches are prepared lcecmUSe UN FOE sAIUtION , getatin hydolyses and viscosity gradvally decreases ,so & becomes nany we wank it truce!) a (3) cotourants + additves added if) Viscosity is checked Cp ESO Chicke, more hot water acicled) G) Lubricated stainless steel Movid pins are then lowered into the saivtion CSO-~SS°Q + brought back up again © Capsule shell ends an’ capered at the loattam @) Surpace of capsle Film coated by geting @ Pins removed prom solution + rotated Above & horizontal axcis for AN EVEN combing of gelatin over the pins 9) Stream of cool air blown cabo che capsule te set the gel Pin bors then passed through & sertes cf AYING Rims to decrease moisture content. Nd rotates Against R metat ous the capsule of the pis aI @: Ramte wo cuk the capsule at the cormect fength GD Tremmings are removed “loy suckon + reused @) Two halves of capsule then ettied Eagether on & central jointng block , and ected. ° Pins then deaned & lvoncaled for use AQGSUL @ Output typically 4m capsvies 724 hous double Wa be done as weil as doves == Tn-process visual Nspecken CAN apie “eam fal mocstors ey ss_ Ohedes 5 Length ; capsvie Morstore 4 GBRDE Ur pocess query cones TRORS