Submitted By: JUBER KHAN

QUALITY CONTROL AND MANUFACTURING PROCESS OF TABLETS

Dissertation submitted to Rajasthan University of Health Sciences, Jaipur,

in the partial fulfillment of the requirements For the degree of

!"H#$%R %F &H!R'!"(

Submitted by
'r) JU #R *H!+ )&H!R'!"( &!R,- ./

0123-0124
!$5!R &H!R'!"( "%$$#6# +%R,H #7,#+S.%+, ').)!) !$5!R-312131 8R!J!S,H!+9

This treatise is

Dedicated to My family member #uide $ho E%coura#ed a%d flared &assio% i% me to lear% more al'ays A%d My !rofessio% (&harmacist is the fou%der sto%e of the medici%e) my !ro"ect

JUBER KHAN

Sr. No. 1. 2. 3. ". %. (. ). +. ,. Company Profile Introduction ru! Profile Plan of #or$

TITAL

PAGE NO.

Li&t& of e'uipment u&ed Proce&& of manufacturin! *uality Control Summary and Conclu&ion -eference&

CONTENTS:

COMPANY PROFILE
#e are a rapidly !ro.in! Indian p/armaceutical company0 producin! a .ide ran!e of 'uality medicine&0 tru&ted 1y /ealt/care profe&&ional& and patient& acro&& !eo!rap/ie&.

Our earne&t attempt i& to en&ure t/e a2aila1ility of .orld cla&& 'uality medicine& at afforda1le price&0 acro&& t/e !lo1e. #e are /ead'uartered at Ne. el/i 3India40 and /a2e t.o manufacturin! plan. near1y 5/i.adi Indu&trial Area in National Capital Territory 6L0 .it/ a &tron! t/ru&t on e7po.0 produce& a &i8a1le num1er 0 'uality product& of different cate!orie& 9 do&a!e form& ran!in! from :ulti2itamin& 0 Antio7idant& to &pecial product& &uc/ a& Artemi&inin deri2ati2e& .it/ &pecialty in &oft !elatin cap&ule&. #e are committed to .or$ to.ard& a /ealt/ier 9 /appier .orld.

Our capa1ilitie& and intent are &tron!ly reflected in t/e product& t/at .e manufacture. 6L /a& internationally appro2ed manufacturin! facilitie& appro2ed 1y leadin! dru! re!ulatory aut/oritie& for t/e compliance .it/ International &tandard& and /a2e re!i&tered it& product& for &afety0 'uality and efficacy in num1er of countrie&. After t/e &ucce&&ful e&ta1li&/ment of /i!/ly &peciali8ed Soft Gelatin Plant0 6L /a& &prouted anot/er :anufacturin! plant t/at i& dedicated for Cep/alo&porin& cla&& of anti1iotic&. 6L manufacture& o2er 1%; formulation& repre&entin! 2ariou& t/erapeutic &e!ment& and do&a!e form&. T/e do&a!e form& include ta1let&0 cap&ule&0 Sac/et&0 Oral li'uid&0 dry po.der& for &u&pen&ion and &peciali8ation in Soft Gelatin Cap&ule&.

Core Value
< #E A-E E ICATE TO#A- S :A=ING A 5ETTE- #O-L . #E #ILL AC>IE?E

T>IS T>-O@G>< Inno2ation Our product& are a re&ult of continuou& inno2ation0 offerin! e7cellence and conformin! to /i!/e&t &tandard& of 'uality. -elation&/ip A It i& a re&ult of &trate!ic action&0 re&ultin! in !ro.t/ and &ucce&&0 en/ancin! our cu&tomer 2alue. Tru&t 9 E2erla&tin! Spirit A Tru&t i& a /i!/ly 2alued a&&et0 itB& a promi&e to meet our cu&tomer& e7pectation&. Our dedicated team& add pul&e to t/e perforrn 1etter. performance of t/e company and our capa1ility to Con&umer& A Our con&umer& are our main focu&. All our initiati2e& are ta$en .it/ t/e o1Cecti2e to under&tand t/eir need& and deli2er true 2alue a& de&ired 1y t/em. Employee& A Our people0 t/rou!/ pa&&ion0 creati2ity and a compellin! de&ire to .in in t/e mar$etplace0 are our 1i!!e&t a&&et. <CONTIN@O@S INNO?ATION0 -I?ES O@- ?ISION<

It i& all a1out tran&latin! idea& into product& t/at en/ance /ealt/ and ea&e of life. #E P-O:ISE0 #E PE-DO-:.

Products

ANTACI 1. Ta1let GASCI Eac/ c/e.a1le ta1let ried Aluminium >ydro7ide :a!ne&ium Tri&ilicate Simet/icone 2%m! 2. Sac/et io&mectite 3. Ta1let Damotidine Calcium Car1onate :a!ne&ium >ydro7ide Pa&te @SP 1;m! 5.P +;;m! 5.P 1(%m! 3; 7 2) AluFP2c Gel contain&AE 2%;m! 2%;m! 3 !m 1;G& AluFP2c

ANTI EPILEPTIC 1. 2. 3. Ta1let P/enytoin Sodium 1;;m! 1; 71;G& AluFP?C 1; 71;G& AluFP?C 1;G& AluFAlu Cap&ule P/enytoin Sodium 1;;m! Cap&ule Ga1apentin ";; m!

ANTI >I? 1. Ta1let Lami2udine 1%;m! H Iido2udine 3;;m! 2. Ta1let Lami2udine 1;;m! 3. Ta1let Iido2udine 3;;m! 1;G& AluFAlu 1;G& AluFAlu 1;G& AluFAlu

ANTI @LCE-ATI?E 1. Ta1let 2. Ta1let 3. Ta1let ". Cap&ule %. Cap&ule (. Ta1let ). Ta1let +. Ta1let Cimetidine 2;;m! F";;m! E&omepra8ole 2;m! F ";m! Damotidine 2;m! F ";m! Lan&opra8ole 1%m! F 3;m! Omepra8ole 2; m! F"; m! Pantopra8ole 2;m! F ";m! -a1epra8ole 2;m! F ";m! -anitidine 1%;m!F3;;m! 1;71; AluFP2c 1;G& AluFAlu 1;71; AluFP2c 1;G& AluFAlu 1;G& AluFAlu 1;G& AluFAlu 1;G& AluFAlu 1;71; AluFAlu

:@SCLOE S=ELETAL ISO- E-S 1. Ta1let Ti8anidine >ydroc/loride 2m! 2. Ta1let :elo7icam ).%F 1%m! 3. Ta1let Aceclofenac 1;;m! ". Cap&ule Piro7icam 2; m! %. Cap&ule Celeco7i1 1;;m!F2;; m! 261; AluFAlu %71;F 1;71;G& AluFAlu 1;G& AluFAlu 1; 7 1; AluFP2c 1;G& AluFAlu

ANTIP-OTOIOALF ANTIA:OE5IC 1. Ta1let 2. Ta1let 3. Ta1let ". Ta1let %. Ta1let COL AN CO@G> 1. TA5LET Am1ro7ol >ydroc/loride 3;m! 1;71;G& AluFP?C 2 !m 1;G& AluFAlu 1; 7 1;G& Alu F P?C 2. SAC>ET Acetylcy&teine 2;; m! 3. CAPS@LE Car1oci&teine 3;; m! Eac/ &oft !elatin cap&ule contain&AE e7tromet/orp/an >ydro 1romide 5.P. 1; m! CAPS@LE P/enylep/rine >ydroc/loride 5.P. % m! C/lorp/eniramine :aleate 5.P. 2 m! 2. SJ-@P Eac/ % ml contain&AE Am1ro7ol >ydroc/loride 5.P. 1% m! Car1oci&teine 5.P. 1;; m! In a fla2oured &yrupy 1a&e. Eac/ ta1let contain&AE Am1ro7ol >ydroc/loride 5.P. 3;m! Car1oci&teine 5.P. 2;;m! :etronida8ole 2;;m! Ornida8ole 2%;F %;;m! Oflo7acin H Ornida8ole Ciproflo7acin H Tinida8ole Oflo7acin H Tinida8ole 1;71; AluFP2c 1;G& AluFAlu 1;G& AluFAlu 1;G& AluFAlu 1;G& AluFAlu

(; ml

3. TA5LET

2 7 1;

". TA5LET

Eac/ uncoated ta1let contain&A e7tromet/orp/an >ydro1romide 5.P. 1; m! Guaifene&in 5.P 1;; m! 5rom/e7ine >ydroc/loride 5.P. + m! C/lorp/eniramine :aleate 5.P. 2 m! Eac/ % ml contain&AE Sal1utamol Sulp/ate 3e' to Sal1utamol 2 m!4 Am1ro7ol >ydroc/loride 5.P. 1% m! Guaifene&in 5.P. %; m! :ent/ol 5.P. ;.% m! Eac/ uncoated caplet contain&AE Paracetamol 5.P %;;m! P/enylep/rine >ydroc/loride 5.P %m! Caffeine 3An/ydrou&4 5.P 3;m! C/lorp/eniramine :aleate 5.P 2m! %;;m! 1;m! 2;m! %;m!

1;G&K

%. SJ-@P

1;; ml

(. TA5LET

2% 7 "G&

Eac/ 23!m &ac/et contain&AE Paracetamol 5.P ). SAC>ET P/enylep/rine >ydroc/loride 5.P P/eniramine :aleate 5.P ?itamin C 5.P

23 !m &ac/et

INTRODUCTION:A ta1let i& a p/armaceutical do&a!e form. It compri&e& a mi7ture of acti2e &u1&tance& ande7cipient&0 u&ually in po.der form0 pre&&ed or compacted from a po.der into a &olid do&e. T/e e7cipient& can include diluent&0 1inder& or !ranulatin! a!ent&0 !lidant& 3flo. aid&4 and lu1ricant& to en&ure efficient ta1lettin!L di&inte!rant& to promote ta1let 1rea$Eup in t/e di!e&ti2e tractL &.eetener& or fla2our& to en/ance ta&teL and pi!ment& to ma$e t/e ta1let& 2i&ually attracti2e. A polymer coatin! i& often applied to ma$e t/e ta1let &moot/er and ea&ier to &.allo.0 to control t/e relea&e rate of t/e acti2e in!redient0 to ma$e it more re&i&tant to t/e en2ironment 3e7tendin! it& &/elf life40 or to en/ance t/e ta1letB& appearance. Adva ta!es o" ta#lets : Ta1let& are &imple and con2enient to u&e. T/ey pro2ide an accurately mea&ured do&a!e of t/e acti2e in!redient in a con2enient porta1le pac$a!e. T/ey can 1e de&i!ned to protect un&ta1le medication& or di&!ui&e unpalata1le in!redient&. Colored coatin!&0 em1o&&ed mar$in!& and printin! can 1e u&ed to aid ta1let reco!nition.

:anufacturin! proce&&e& and tec/ni'ue& can pro2ide ta1let& &pecial propertie&0 for e7ample0 &u&tained relea&e or fa&t di&&ol2in! formulation&.

D$sadva ta!es o" ta#lets :

Some dru!& may 1e un&uita1le for admini&tration 1y t/e oral route. Dor e7ample0 protein dru!& &uc/ a& in&ulin may 1e denatured 1y &tomac/ acid&. Some dru!& may 1e deacti2ated 1y t/e li2er ./en t/ey are carried t/ere from t/e !a&trointe&tinal tract 1y t/e /epatic portal 2ein. T/e oral 1ioa2aila1ility of &ome dru!& may 1e lo. due to poor a1&orption from t/e !a&trointe&tinal tract. Suc/ dru!& may need to 1e !i2en in 2ery /i!/ do&e& or 1y inCection.

%e eral &rocess o" ta#lets : 14 -a. material 24 :i7in! 34 5lendin! "4 Granulation (4 Sie2in! )4 Compre&&ion +4 Coatin! ,4 Pac$in! #et !ranulation ry !ranulation Acti2e p/armaceutical in!redient& E7cipient&

%4 Granule lu1rication

DRU% PROFILE:
Paraceta'ol Structure :

Cate!or( : Anal!e&ic IUPAC a'e : N E3"E/ydro7yp/enyl4acetamide Molecular )e$!*t : 1%1.1(2 !Fmol Molecular "or'ula + C+>,NO2 ,$oava$la#$l$t( : M1;;N Descr$&t$o - Paracetamol i& cla&&ified a& a mild anal!e&ic. It i& commonly u&ed for t/e relief of /eadac/e& and ot/er minor ac/e& and pain& and i& a maCor in!redient in numerou& cold and flu remedie&. In com1ination .it/ opioid anal!e&ic&0 paracetamol can al&o 1e u&ed in t/e mana!ement of more &e2ere pain &uc/ a& po&tE&ur!ical pain and pro2idin! palliati2e care in ad2anced cancer patient&.T/ou!/ paracetamol i& u&ed to treat inflammatory pain0 it i& not !enerally cla&&ified a& an NSAI 1ecau&e it e7/i1it& only .ea$ antiEinflammatory acti2ity.

PLAN OF -OR.:
i&pen&in! 3 .ei!/in! of eac/ in!redient in t/e mi7ture i& determined accordin! to do&e.4

Si8in! 3Si8e reduction0 millin!0 cru&/in!.4

5lendin!

#et !ranulation 3in2ol2e& .et ma&&in! of po.der 1lend .it/ !ranulatin! a!ent4

ryin! 3$eepin! t/e re&idual moi&ture lo. enou!/ to pre2ent product deterioration and en&ure free flo.in! propertie&4

Compre&&ion of !ranule&

E2aluation& Dollo.in!& are t/e te&t& to 1e performed .it/ final product. 1. 2. 3. ". %. (. ). +. ,. 1;. e&cription i&inte!ration time :oi&ture content 3#ater 1y =D4 A2era!e .ei!/t Dria1ility >ardne&& etermination of t/ic$ne&& A&&ay Content uniformity i&&olution

LIST OF E/UIPMENTS USED:

Sr. No. 1 2 3 " % ( ) +

E'uipment ?i1ro &ifter Dluid 5ed E'uipment *uadro coEmill 5in 1lender ?i1ro &ifter 5ilayer Compre&&ion :ac/ine :etal etecter edu&ter

Dunction Siftin! Granulation :illin! 5lendin! Siftin! Compre&&ion etection of metal edu&tin! of ta1let&

, 1; 11 12 13 1" 1%

i&&olution Apparatu& @SPEII Analytical 1alance i&inte!ration apparatu& Dria1ility te&t apparatu& >ardne&& te&ter =arl O Di&c/er ?ernier caliper&

i&&olution &tudie& #ei!/in! of material& Dor di&inte!ration time Dor fria1ility of ta1let Dor /ardne&& of ta1let :oi&ture content etermination of t/ic$ne&&

MANUFACTURIN% PROCESS TA,LETIN% MET0ODS:

Co'&ress$o c(cle Granule& from /opper empty in t/e feed frame 3A4 containin! &e2eral interconnected compartment&. T/e&e compartment& &pread t/e !ranulation o2er a .ide area to pro2ide time for t/e die& 354 to fill. T/e pull do.n cam 3C4 !uide& t/e lo.er punc/e& to t/e 1ottom0 allo.in! t/e die& to o2erfill T/e punc/e& t/en pa&& o2er a .ei!/tEcontrol cam 3E40 ./ic/ reduce& t/e fill in t/e die& to t/e de&ired amount A &.ipe off 1lade 3 4 at t/e end of t/e feed frame remo2e& t/e e7ce&& !ranulation and direct& it around t/e turret and 1ac$ into t/e front of t/e feed frame T/e lo.er punc/e& tra2el o2er t/e lo.er compre&&ion roll 3D4 ./ile &imultaneou&ly t/e upper punc/e& ride 1eneat/ t/e upper compre&&ion roll 3G4 T/e upper punc/e& enter a fi7ed di&tance into t/e die&0 ./ile t/e lo.er punc/e& are rai&ed to &'uee8e and compact t/e !ranulation .it/in t/e die&

After t/e moment of compre&&ion0 t/e upper punc/e& are .it/dra.n a& t/ey follo. t/e upper punc/ rai&in! cam 3>4 T/e lo.er punc/e& ride up t/e cam 3I4 ./ic/ 1rin!& t/e ta1let& flu&/ .it/ or &li!/tly a1o2e t/e &urface of t/e die&

T/e ta1let& &tri$e a &.eep off 1lade affi7ed to t/e front of t/e feed frame 3A4 and &lide do.n a c/ute into a receptacle

At t/e &ame time0 t/e lo.er punc/e& reEenter t/e pull do.n cam 3C4 and t/e cycle i& repeated

T/e principle modification from earlier e'uipment /a& 1een an increa&e in production rate ./ic/ i& re!ulated 1y Num1er of toolin! &et& Num1er of compre&&ion &tation& -otational &peed of t/e pre&&

Process$ ! &ro#le's Ca&&$ ! i& t/e partial or complete &eparation of t/e top or 1ottom cro.n& of a ta1let from t/e main 1ody of t/e ta1let. La'$ at$o i& &eparation of a ta1let into t.o or more di&tinct layer&. 5ot/ of t/e&e pro1lem& u&ually re&ult from air entrapment durin! proce&&in!. P$c1$ ! i& remo2al of a ta1letG& &urface material 1y a punc/. St$c1$ ! i& ad/e&ion of ta1let material to a die .all. T/e&e t.o pro1lem& re&ult from e7ce&&i2e moi&ture or &u1&tance& .it/ lo. meltin! temperature& in t/e formulation Mottl$ ! i& an une'ual color di&tri1ution on a ta1let0 .it/ li!/t or dar$ area& &tandin! on ot/er.i&e uniform &urface. T/i& re&ult& from u&e of a dru! .it/ a color different from t/at of t/e ta1let e7cipient& or from a dru! .it/ colored de!radation product&.

#ei!/t 2ariationE!ranule &i8e di&tri1ution0 poor fio.0 punc/ 2ariation >ardne&& 2ariation ou1le impre&&ionEmono!ram& or en!ra2in! on punc/

DT A&&aratus:- :e&/ AppertureAE 2mm 3P1;40 Cycle&AE 2+ O 32 cycle&Fmin0 %; O (; mm di&tance from 1ottom 9 top0 Temp of .ater 3);C Q 2;C. If 1 or 2 ta1& fail0 repeat for 12 ta1&. PARAMETER VARIA,LES Limit& on ta1let .ei!/t are !enerally &et a& 3 to %N of a formulation Ta#let -e$!*t &pecific tar!et .ei!/t Some i&&ue& t/at may cau&e .ei!/t 2ariation are po.der flo. pro1lem&0 improper die fill0 and po.der &i8e di&tri1ution E7pre&&e& a& load re'uired to cru&/ a ta1let on end. :ea&ured u&in! a ta1let /ardne&& te&ter. Generally0 t/e lar!er t/e ta1let0 t/e /i!/er t/e /ardne&&. Smaller ta1let& Ta#let 0ard ess 31F"< round4 u&ually /a2e a /ardne&& R% $p. Lar!er ta1let& u&ually /a2e a /ardne&& R2; $p. Some i&&ue& t/at may cau&e 2ariation& in ta1let /ardne&& are incon&i&tent ta1let .ei!/t0 particle &i8e 2ariation&0 poor po.der compre&&i1ility0 in&ufficient 1inder le2el Ta#let T*$c1 ess @niform compre&&ion force and 2olume of die fill0 lead& to uniform t/ic$ne&& T/e time it ta$e& for t/e ta1let to 1rea$ up into indi2idual !ranule& or D$s$ te!rat$o T$'e particle&. Poor di&inte!ration can come from ta1let& ./ic/ are compre&&ed too /ard0 in&ufficient di&inte!rant le2el&0 or too muc/ 1inder. Fr$a#$l$t( Dria1ility i& t/e tendency of a ta1let to crum1le0 c/ip or 1rea$. It i& mea&ured 1y ta1let .ei!/t lo&& after rotation on a fria1ilator 3i.e. 1;; re2olution& or " minute& at 2% -P:4. Typically N lo&& i& R;.%N0 1ut can 1e up to 2N for 2ery lar!e ta1let&.

Dria1le ta1let& can 1e cau&ed 1y lo. moi&ture content0 in&ufficient 1inder0 ta1let confi!uration 3e.!. &/arp 2er&u& 1e2eled ed!e&4.

-EI%0T VARIATION:
23 Co te t o" Act$ve I !red$e t: - 14 A&&ay of Acti2e 24 2; ta1&A E Limit& ,;N to 11;N 43 U $"or'$t( o" -e$!*t5-t Var$at$o :2; ta1&0 calculate a2!. .t N:T 2 de2iate0 none t.ice t/e limit&. -e$!*t Var$at$o L$'$ts:23 For Ta#lets IP5,P +; m! or le&& L$'$t 1;N USP 13;m! or le&& 13;m! to 32"m! 43 For Ca&sule:-

:ore t/an +;m! or ).%N Le&& t/an 2%;m!

2%;m! or more

%N

:ore t/an 32"m!

Fr$a#$l$t( Test:- T/i& te&t i& additional to c/ec$ cru&/in! &tren!t/ of ta1let 1y t/i& te&t one can c/ec$ Cappin! 9For Lamination. @SP limit i& ;.% to 1N. -otationA E 2% rpm or 1;; rotation& in " IP Le&& t/an 3;;m! 3;;m! or :ore min. L$'$t 1;N ).%N

U $"or'$t( o" Co te t or Co te t U $"or'$t(:IP: - Acti2e le&& t/an 1;m! or 1;N0 ,P:- Acti2e le&& t/an 2 m! or 2N0 USP:- Acti2e le&& t/an 2%m! or 2%N. E1; ta1& limit N:T 1 ta1 de2iate +% O 11%N 9 none out&ide )% O 12%N of t/e A2! 2alueFIPF5PF@SP 3-elati2e Standard e2iation le&& t/an or e'ual to (N40 E If 2 or 3 indi2idual 2alue& are out&ide t/e limit& +% O 11%N of t/e A2! 2alue0 9 none out&ide )% O 12%N repeat for 2; ta1&. E Complie& ./en 3; ta1& N:T 3 of t/e indi2idual 2alue& are out&ide t/e limit +% O 11%N of t/e A2! 2alue0 and none out&ide )% O 12%N. D$s$ te!rat$o T$'e:U coated Ta#let Coated Ta#let N:T 1% min0 in .ater .it/ i&c 3);C Q 2;C N:T 3; min0 In .ater .it/ i&c for F$l' Coated Ta#0 and N:T (; min Ot/er t/an Dilm coated ta1let E ter$c Coated Ta# Intact for 1 /r in ;.1 N >Cl 9 di&inte!rate .it/in 2 /r in :i7ed (.+ P/o&p/ate 1uffer. Accordin! to @SP 1 /r in Simulated !a&tric fluid0 t/en in Simulated Inte&tinal Dluid. D$s&ers$#le5Solu#le Orod$s&ers$#le E""ervesce t Ta# #it/in 3 min in .ater at 2%;C Q 1;C 3IP4 9 1% O 2%;C 3,P4 #it/in 1 min % min in 2%; ml .ater at 2; O 3;;C 3IP4 9 % min in 2;; ml .ater at 1%E2%;C 3,P4 ,uccal 6 Su#l$ !ual Not Applica1le 1ut di&&ol2e .it/in 1% O 3; min.

/UALITY CONTROL DISINTE%RATORS:

S T/e 1rea$up of t/e ta1let& to &maller particle& i& important for di&&olution of t/e dru! and &u1&e'uent 1ioa2aila1ility. i&inte!rator& promote &uc/ 1rea$up. To rupture or 1rea$up of ta1let&0 di&inte!ratin! a!ent& mu&t &.ell or e7pand on e7po&ure to a'ueou& &olution. T/u&0 t/e mo&t effecti2e di&inte!ratin! a!ent& in mo&t ta1let &y&tem& are t/o&e .it/ t/e /i!/e&t .ater upta$e property. In !eneral0 t/e more /ydrop/ilic0 t/e 1etter di&interE!ratin! a!ent& are t/erefore /i!/ly /ydrop/ilic. A li&t of typical di&interE!rant& i& ta1ulated in Ta1le

S&ectro&*oto'eter:-

S&ectro&*oto'eters $ t*e P*ar'aceut$cal I dustr(

Color i& a main component in t/e production of p/armaceutical and per&onal care product&. Color can 1e u&ed for many rea&on& &uc/ a& to en&ure t/at a product ad/ere& to 'uality &tandard&0 or en/ance a productG& appearance. If a color i& not e7act0 it can alter t/e outcome of t/e final product and cau&e .a&te on t/e production line.

Measur$ ! Color )$t* Accurac( Spectrop/otometer& en&ure t/at a productG& color matc/e& &pecification& 1y e2aluatin! and e7pre&&in! it in numerical term&. :anufacturer& can control pi!ment& and /ue& in pill&0 po.der&0 li'uid&0 and ot/er p/armaceutical product& more ea&ily .it/ t/e color information pro2ided 1y t/e &pectrop/otometer. T/i& e7treme accuracy reduce& .a&te and output& /i!/er 'uality item& .it/ !reater efficiency0 ./ic/ .ill increa&e profit&. S&ectro&*oto'eter Solut$o s "or t*e P*ar'aceut$cal I dustr(: CM-7 ,e c*-to& S&ectro&*oto'eter T/i& 'uic$ and &imple 1enc/ top &pectrop/otometer can en&ure t/at color &tay& uniform t/rou!/out

de2elopment of co&metic& or in t/e production of a 1atc/. .e( Features:

:ea&ure& in 3 &imple &tep& Inte!rated &oft.are and LC &creen eliminate& need for a &eparate computer PASSFDAIL !radin! for 'uic$ readin!& ?er&atility to mea&ure a different &ample &i8e& and form&

CM 89::A T/i& &pectrop/otometer pro2ide& a le2el of accuracy t/at e7ceed& mo&t re'uirement& in t/e color indu&try. It& 2er&atility ma$e& it &uita1le for 2irtually any color mea&urement need. .e( Features:

Ea&ily mea&ure& reflecti2e and fluore&cent color& ?er&atile mea&urement area for 2ariou& &ample &i8e& and .ide ran!e of material& #indo.& compati1le for ea&y control and editin! 6enon fla&/ for accurate mea&urement of 2ery dar$ &/ade&

0$!*-&er"or'a ce l$;u$d c*ro'ato!ra&*( <0PLC3:-

>i!/Eperformance

li'uid

c/romato!rap/y 3formerly

referred

to

a& /i!/Epre&&ure

li'uid

c/romato!rap/y40 >PLC0 i& a c/romato!rap/ic tec/ni'ue u&ed to &eparate t/e component& in a mi7ture0 to identify eac/ component0 and to 'uantify eac/ component. C/romato!rap/y can 1e de&cri1ed a& a ma&& tran&fer proce&& in2ol2in! ad&orption. >PLC relie& on pump& to pa&& a pre&&uri8ed li'uid and a &ample mi7ture t/rou!/ a column filled .it/ a &or1ent0 leadin! to t/e &eparation of t/e &ample component&. T/e acti2e component of t/e column0 t/e &or1ent0 i& typically a !ranular material made of &olid particle& 3e.!. &ilica0 polymer&0 etc.40 2O%; micrometer& in &i8e. >PLC i& di&tin!ui&/ed from traditional 3<lo. pre&&ure<4 li'uid c/romato!rap/y 1ecau&e operational pre&&ure& are &i!nificantly /i!/er 3%;O3%; 1ar40 ./ile ordinary li'uid c/romato!rap/y typically relie& on t/e force of !ra2ity to pa&& t/e mo1ile p/a&e t/rou!/ t/e column. ue to t/e &mall &ample amount &eparated in analytical >PLC typical column dimen&ion& are 2.1O".( mm diameter0 and 3;O 2%; mm len!t/. Al&o >PLC column& are made .it/ &maller &or1ent particle& 32O%; micrometer in a2era!e particle &i8e4. T/i& !i2e& >PLC &uperior re&ol2in! po.er ./en &eparatin! mi7ture&0 ./ic/ i& ./y it i& a popular c/romato!rap/ic tec/ni'ue. A di!ital microproce&&or and u&er &oft.are control t/e >PLC in&trument and pro2ide data analy&i&. Some model& of mec/anical pump& in a >PLC in&trument can mi7 multiple &ol2ent& to!et/er in ratio& c/an!in! in time0 !eneratin! a compo&ition !radient in t/e mo1ile p/a&e. ?ariou& detector& are in common u&e0 &uc/ a& @?F?i&0 p/otodiode array 3P A4 or 1a&ed on ma&& &pectrometry. :o&t >PLC in&trument& al&o /a2e a column o2en t/at allo.& for adCu&tin! t/e temperature t/e &eparation i& performed at.

O&erat$o :

Sc*e'at$c re&rese tat$o o" a 0PLC u $t 314 Sol2ent re&er2oir&0 324 Sol2ent de!a&&er0 334 Gradient 2al2e0 3"4 :i7in! 2e&&el for deli2ery of t/e mo1ile p/a&e0 3%4 >i!/Epre&&ure pump0 3(4 S.itc/in! 2al2e in <inCect po&ition<0 3(B4 S.itc/in! 2al2e in <load po&ition<0 3)4 Sample inCection loop0 3+4 PreEcolumn 3!uard column40 3,4 Analytical column0 31;4 etector 3i.e. I-0 @?40 3114 ata ac'ui&ition0 3124 #a&te or fraction collector. A typical !radient profile in re2er&ed p/a&e c/romato!rap/y mi!/t &tart at %N acetonitrile 3in .ater or a'ueou& 1uffer4 and pro!re&& linearly to ,%N acetonitrile o2er %O2% minute&. Period& of con&tant mo1ile p/a&e compo&ition may 1e part of any !radient profile. Dor e7ample0 t/e mo1ile p/a&e compo&ition may 1e $ept con&tant at %N acetonitrile for 1O3 min0 follo.ed 1y a linear c/an!e up to ,%N acetonitrile. T/e c/o&en compo&ition of t/e mo1ile p/a&e 3al&o called eluent4 depend& on t/e inten&ity of interaction& 1et.een 2ariou& &ample component& 3<analyte&<4 and &tationary p/a&e 3e.!. /ydrop/o1ic interaction& in re2er&edEp/a&e >PLC4. ependin! on t/eir affinity for t/e &tationary and mo1ile p/a&e& analy&e& partition 1et.een t/e t.o durin! t/e &eparation proce&& ta$in! place in t/e column. T/i& partitionin! proce&& i& &imilar to t/at ./ic/ occur& durin! a li'uidOli'uid e7traction 1ut i& continuou&0 not &tepE.i&e. In t/i& e7ample0 u&in! a .aterFacetonitrile !radient0 more /ydrop/o1ic component& .ill elute 3come off t/e column4 late0 once t/e mo1ile p/a&e !et& more concentrated in acetonitrile 3i.e. in a mo1ile p/a&e of /i!/er elutin! &tren!t/4.

Ta#let Fr$a#$l$t(

Sal$e t Features :

:icroproce&&or control Pro!ramma1le counter Side l&oadin! drum& irect readin! in N Slee$ Ca1inet

T/i& mac/ine i& &pecially to determine t/e dura1ility of ta1let& from t/e time of production to t/e time u&e0 a& it& i& important to te&t a1ra&ion and impact /ardne&& of t/e ta1let&. T/e apparatu& con&i&t of tran&parent acrylic drum&. T/e drum& are e'uipped .it/ a pla&tic 1lade ./ic/ carrie& t/e ta1let& alon! .it/ it upto predetermined /ei!/t ./ile t/e drum& are rotatin! and ta1let& are allo.ed to &lide and let t/em &lide do.n. T/e ta1let& are .ei!/t 1efore and after t/e ru11in! in t/e drum /a& ta$en place. T/e difference in .ei!/t indicate& t/e rate of a1ra&ion. T/e microproce&&or fa1ricator i& e'uipped .it/ :icroEComputer 1a&ed i!ital di&play &y&tem. T/e touc/ &.itc/e& are pro2ided on t/e front panel of t/e apparatu& for &ettin! t/e re'uired total num1er of re2olution of t/e drum ./ic/ rotate& at 2% re2olution& per minute. Eac/ re2olution of t/e from &tartin! from minimum num1er 1 to re'uired &et num1er to ,,,, i& di&played on t/e .indo. a& per preE&ettin!. An audi1le alarm &ound& alarmin! t/e operator t/at t/e te&t o2er. In t/i& ne. &op/i&ticated model calculator i& not re'uired0 a& t/e percenta!e of t/e a1ra&ion of t/e ta1let& i& directly di&played on t/e front panel 1y feedin! t/e correct data .it/ t/e /elp of pro!ramma1le touc/ S.itc/e&.

Ca&sule F$ll$ ! Mac*$ e

Deature& T/e mac/ine &tand& &uperior to ot/er mac/ine& in t/e mar$et 1y it& /i!/ &peed cam di2idin! 3inde7in! 4 de2ice mec/ani&m. T/e .or$in! of t/e mac/ine i& a& follo.& cap&ule loadin! and &eparation0 reCect cap&ule di&po&al0 po.der 35ul$4 fillin!0 cap&ule clo&in! 3loc$in!4 and it& eCection completely automatically. 5y PLC control0 operation i& made ea&y to adCu&t t/e Speed0 countin! and failure& etc. .it/ ea&e. T/e fillin! i& &upported .it/ a porou& ramE &'uee8in! po.der 31ul$4 fillin! de2ice pro2ided0 do&in! i& 2eraciou&. E'uipped .it/ complete &afety and protection de2ice&0 operation i& &teady and credi1le. #e manufacture and &upply &emi automatic cap&ule fillin! mac/ine& .it/ &in!le or dou1le loader a& per t/e re'uirement&. Our mac/ine& /a2e /i!/ output in term& of cap&ule& per /our and are &uita1le for a ran!e of cap&ule& &i8e& includin! po.der and !ranule&.

D$ssolut$o
T/e p/armaceutical &cienti&t .ould li$e to find a relation&/ip 1et.een an in 2itro c/aracteri&tic of a do&a!e form0 and it& in 2i2o performance. i&inte!ration .a& ori!inally t/ou!/t to 1e t/i& c/aracteri&tic. T/e @SP introduced it& di&inte!ration te&t in 1,%;. #it/ ad2ance& in met/odolo!y0 t/e di&inte!ration te&t .a& found to 1e too in&en&iti2e0 and di&&olution te&t met/od& .ere introduced in t/e @SP in 1,(+. i&&olution i& principally u&eful a& a *C te&t. It ca #e predicti2e of in 2i2o 1e/a2ior0 1ut t/i& mu&t 1e demon&trated 1y an inE2i2o inE2itro correlation &tudy 3I?I?C4. USP =2:>>?: TNo product0 includin! &u&pen&ion& and c/e.a1le ta1let&0 &/ould 1e de2eloped .it/out di&&olution or dru! relea&e c*aracter$@at$o ./ere a &olid p/a&e e7i&t&. Tand T i&&olution test$ ! i& re'uired for all &olid oral P/armacopeia do&a!e form& in ./ic/ a1&orption of t/e dru! i& nece&&ary for t/e product to e7ert t/e de&ired t/erapeutic effect. E7ception& are for ta1let& meetin! a re'uirement for

completene&& of &olution or for rapid 31; to 1% minute&4 di&inte!ration for &olu1le or radio la1eled dru!&.U D$ssolut$o Re;u$re'e ts Artemet/er cap&ule& E &olid oral do&a!e form&. Artemet/er ta1let& O a& a1o2e Arte&unate ta1let& O a& a1o2e Artemet/erFlumefantrine ta1let& O no reference to di&&olution Artemet/erFlumefantrine oral &u&pen&ion O no reference to di&&olution0 includin! in t/e referenced !eneral mono!rap/A TLi'uid preparation& for oral u&eU under t/e &ection0 TPo.der& for oral i&&olution. Carry out t/e te&t a& de&cri1ed under %.% i&&olution te&t for

&olution&F&u&pen&ion&Fdrop&U A2aila1ility in Ot/er P/armacopeia 5P 2;;+A no mono!rap/&. @SP 2;;,A

APIAs: a'od$a;u$ eB a'od$a;u$ e 0ClB 'e"lo;u$ e Dosa!e For's: Amodia'uine >Cl Ta1let& Sulfado7ineFPyrimet/amine Ta1let&

Dor 1ot/ of t/e a1o2e0 di&&olution limit& are included. USP Mo o!ra&* D$ssolut$o Met*ods5L$'$ts A'od$a;u$ e 0Cl Ta#lets :ediumA .aterL ,;; mL. Apparatu& 2A %; rpm. NLT )%N 3*4 in 3; minute&

Sul"adoC$ e5P(r$'et*a'$ e Ta#lets :ediumA p> (.+ p/o&p/ate 1uffer0 prepared a& directed under 5uffer Solution& in t/e &ection -ea!ent&0 Indicator&0 and Solution&L 1;;; mL.

Apparatu& 2A )% rpm. NLT (;N 3*4 eac/ API in 3; minute&.

D$s$ te!rat$o <DT3 Test$ ! Note t/at di&inte!ration i& !enerally an inEproce&& te&t ./en t/e API i& not /i!/ly &olu1le. i&inte!ration i& indicated in t/e P/Int General C/apter on ta1let& for 2ariou& ta1let type& 3uncoated0 &olu1le ta1let&0 effer2e&cent ta1let&0 coated ta1let&4. >o.e2erA a &tatement i& included re!ardin! all ta1let&A T#/ere a re'uirement for t/e T i&&olution te&tU i& &pecified in t/e indi2idual mono!rap/0 t/e %.3 re'uiredU. D$s$ te!rat$o vs D$ssolut$o IC> *(A i&inte!ration may 1e &u1&tituted for di&&olution ./enA Erapidly di&&ol2in! DPPG& 3di&&olution V+;N in 1% minute& at p> 1.20 ".; and (.+4 and DPPG& containin! APIG& ./ic/ are /i!/ly &olu1le t/rou!/out t/e p/y&iolo!ical ran!e 3do&eF&olu1ility 2olume R 2%; mL from p> 1.2 to (.+4 Most a&&ro&r$ate )*e : relation&/ip 1et.een T and di&&olution i& e&ta1li&/ed0 or T &/o.n to 1e more di&criminatin! t/an di&&olution. i&inte!ration te&t for ta1let& and cap&ule& i& not

In t/e&e ca&e& de2elopment information &/ould 1e pro2ided to &upport t/e ro1u&tne&& of t/e formulation and manufacturin! proce&& .it/ re&pect to t/e &election of di&&olution 2&. di&inte!ration te&tin! 3&ee eci&ion Tree P)3144. Met*od Descr$&t$o T/e .ritten procedure &/ould includeA Apparatu& Standard and &ample preparation :et/od of analy&i& 3e! @?0 >PLC4 Samplin! procedure 3inter2al&0 filtrationK0 /andlin! of &ample&0 dilution&4 Calculation& Acceptance Criteria

/ua t$tat$ve Est$'at$o o" Tel'$sarta I ,ul1 Dru! A d Ta#lets ,( UV S&ectrosco&(:Result a d D$scuss$o T/e mean percent la1el claim& e&timated 1y propo&ed met/od for ta1let formulation& I0 II and III .ere ,,.;10 1;;."," and 1;;.121 re&pecti2ely ./ic/ are 2ery clo&e to 1;;0 indicatin! t/e accuracy of t/e met/od. T/i& al&o indicate& t/at t/ere .a& no interference of urea and t/e commonly u&ed additi2e& pre&ent in t/e ta1let formulation in t/e e&timation 1y t/e propo&ed met/od. ?alidation of t/e propo&ed met/od i& furt/er confirmed 1y t/e lo. 2alue& of &tandard de2iation0 percent coefficient of 2ariation and &tandard error 3Ta1le4. T/e mean percent reco2ery 2alue& ran!ed from ,,.13 to 1;;.;( and .ere 2ery clo&e to 1;;. Al&o t/e 2alue& of &tati&tical parameter& 2i8. &tandard de2iation0 percent coefficient of 2ariation and &tandard error .ere &i!nificantly lo. 3Ta1le 4. T/u&0 t/e propo&ed met/od of analy&i& .a& 2ery .ell 2alidated. Ta#le : Stat$st$cal Data 6 Re!ress$o E;uat$o "or Tel'$sarta

Structure o" tel'$sarta

SUMMARY T/u&0 it may 1e concluded t/at t/e propo&ed met/od of analy&i&0 u&in! urea a& t/e /ydrotropic &olu1ili8in! a!ent i& ne.0 &imple0 co&tEeffecti2e0 en2ironmentally friendly0 &afe0 accurate and reproduci1le. @rea and t/e commonly u&ed ta1let e7cipient& did not interfere in Spectrop/otometric e&timation at 31% nm. ecided ad2anta!e i& t/at or!anic &ol2ent& are precluded 1ut not at t/e e7pen&e of accuracy. T/e propo&ed met/od i& .ort/ adoptin! in p/armacopoeia. 5y proper c/oice of /ydrotropic a!ent&0 t/e u&e of or!anic &ol2ent& in analy&i& may 1e di&coura!ed to a lar!e e7tent. T/e propo&ed met/od &/all pro2e e'ually effecti2e to analy8e Telmi&artan in t/e corre&pondin! dru! &ample and may pro2e to 1e of !reat importance in p/armaceutical analy&i&.

REFERENCES
1. T/e t/eory and practice of indu&trial p/armacy 1y Leon Lac/man0 A. lie1erman
2. Wo&ep/ Price -emin!ton 32;;(4. -emin!tonA T/e Science And Practice Of P/armacy.

Lippincott #illiam& 9 #il$in&. IS5N ;)+1)"()3(. 3. P/armaceutical do&a!e form& 2olE1 3unit operation& and mec/anical propertie&4 1y Au!&1ur!er and >oa!. ". <Ta1let /ardne&& te&tin!<. Sota7. -etrie2ed 1( De1ruary 2;13.
5. <Some Information on Ta1let >ardne&& Te&tin!<. En!ineerin! Sy&tem&. -etrie2ed 1(

De1ruary 2;13.
6. -o1ert Al1rec/t 3Wul 210 1,%34. <Ta1let >ardne&& Te&tin! :ac/ine<. @nited State& Patent

Office. -etrie2ed 1( De1ruary 2;13. @S 2("%,3(

7. <*uality control of &olid do&a!e form<. Scri1d. -etrie2ed 1( De1ruary 2;13. 8. :cCallum0 A.0 5uc/ter0 W. and Al1rec/t0 -. 31,%%4. <Compari&on and correlation of t/e

Stron! Co11 and t/e :on&anto ta1let /ardne&& te&ter&<. Wournal of t/e American P/armaceutical A&&ociation "" 324A +3O+%. doiA1;.1;;2FCp&.3;3;"";2;+. P:I 1"3%3)1,.
9. -u&& -o.lett 3Septem1er 10 2;;"4. <>o. :anyX A

ictionary of @nit& of :ea&urement<.

@ni2er&ity of Nort/ Carolina. -etrie2ed 1( De1ruary 2;13. 1;. T/e :erc$ Inde70 12t/ Edn.0 :er$ -e&earc/ La1. Pu1lication0 -a/.ay0 N.W.01,,(0 +"3;. 11. 5riti&/ P/armacopoeia0 Addendum0 Pu1li&/ed 1y >:SO Electronical pu1lication &ale&0 London0 1,,,0 %33.

12. European P/armacopoeia0 3rd Edn.0 Pu1li&/ed 1y Council of Europe0 Stra&1our!01,,)0 +;). 13. -a2i0 T.=. and Gand/imat/i0 :.0 Ea&tern P/armaci&t0 2;;;0 %;,0 "20 121. 1". S/a&tary0 C.S.P. and Pra&ad0 =.-.0 :i$roc/im Acta0 1,,(01220 )). 1%. S/a&tary0 C.P.S.0 -ao0 S.G. and -ama&rini2a&0 =.0 Indian ru!& 0 1,,20 3%0 %,". 1(. -eddy0 :.N.0 :urt/y0 T.=.0 -aCu0 G.?.0 :urali$ri&/na0 W.0 Se&/u$umar0 =. and San$ar0 .G.0 Indian W. P/arm. Sci.0 2;;20 ("0 )3. 1). Sane -.T.0 =ul$arani ?. .0 Patel :.=.and Tirod$ar ?.5.0 Indian ru!&0 1,,20 2,0 (%+. 1+. e Oli2eira0 ?.0 5er!old0 A.0 Sc/apo2al0 E.S.0 Anal. Lett.0 1,,(0 2,0 23)). 1,. Li *. C. and Li D. -.0 Jao.u Den7i Ia/i0 1,,,0 1,0 31). 2;. emote&0 :.0 ?incon0 G.A.0 Warry0 C.>.0 and Al1in0 >.C.0 W. C/romato!r. 5iomed. Appl.0 1,+,0 ",;0 11%. 21. ....medicamen.com