SEKOLAH TINGGI FARMASI INDONESIA LABORATORIUM TEKNOLOGI FARMASI JURNAL PRAKTIKUM TEKNOLOGI FORMULASI SEDIAAN SOLIDA SEMESTER IV – 2016 Nama : Riri Ri!aa NMP : A 1"1 12# $a% A&%i'
: A(()*+ri)(
J+m(a, %a-(.%
: /0000 Ta-(.%
D)i )i a a a(a a(aa a *.m *.mi( i(i, i,a a )i )i
: 300 300 m4 : Kar.a .4a )i 300 m4 *+ a*a% m.m-.ri m.m-.ri&a &a .'.& m.+r+ m.+r+&a &a &aar &aar aam +ra% a(am ara,
M.%). *.m-+a%a I
PREFORMULASI I1 I1 Nama Nama $a% A&%i' &%i' S%r+&%+r
: Gra+(ai -aa,
: A(() (()*+ri *+ri) )((
B.ra% m)(.&+( P.m.ria P.m.ria
: 136511 : S.r-+& S.r-+& ,a(+5 *+%i, ,i44a ,i44a ,am*ir ,am*ir *+%i, *+%i, -.r-a+
K.(ar+ K.(ar+%a %a
(.ma, : Sa4a% Sa4a% +&ar +&ar (ar+% (ar+% a(am a(am air a .%a)( .%a)( (ar+% (ar+% a(am a(am
Ti%i& (.(., *H
(ar+%a (ar+%a &a(i+ &a(i+m m a a%ri a%ri+m +m ,ir)& ,ir)&i ia a
*ra&%i %ia& (ar+% a(am &()r)')rm a .%.r :3/078 :65/ – #5/
1
P.44+aaa %.ra*i: Pr)'i(a&i 4)+% a -a%+ aam +ra% a &a(i+m )&a(a% i 4i9a( OTT : %.r,aa* -a,a *.4)&iai (Farmakope Indonesia ed V. 2014) I2 ASPEK FARMAKOLOGI A-)r-i Ora( : A()*+ri)( ,am*ir 0; ia-)r*i
.%.(a,
*.m-.ria *.r)ra( Bi)%ra')rmai : M.&aim. < = %ia&a %ia& i&.%a,+i .4a *a%i m+>+( -r)&)i(a%ai !a4 im.iai )(., *.4,am-a%a
&)m*.%i%i'
ari
2
i)?im
ari
*,)*,)i.%.ra. < PDE III a 5 *aa %i4&a% (.-i, r.a, 5 PDE IV = 5 .a4&a ) @ -r)&)i(a%)r %ia&a *r)'i(a&i m+4&i im.iai m.(a(+i m.&aim.
m)(.&+(.r
!a4
%ia&
m.(i-a%&a
*.4,am-a%a PDE III a%a+ a%a4)im. r..*%)r a&%+ Par+, Di%ri-+i M.%a-)(im.
a.)i : 1 – 3 9am : V)(+m. i%ri-+i!a 156 LK4 :A(+*+ri)( im.%a-)(im. .iri )(., Ca%i
E(imiai
)&ia. m.9ai m.%a-)(i% a&%i' )C!*+ri)( < #/;= : E&&r.i a()*+ri)( a(am +ri .-.ar #6; a(am
D)i
-.%+& )C!*+ri)( a 12; a(am -.%+& +%+, : 100 m4
M.&aim. &.r9a : A()*+ri)( aa(a, )-a% *.!a&i% *irai <4)+%= !a4 a*a% m.+r+&a &aar aam +ra% a(am ara, A()*+ri)( -.&.r9a .4a m.4,am-a% Ca%i )&ia.
!ai%+
.?im
!a4
a*a%
m.4+-a,
,i*)Ca%i m.9ai Ca%i5 .(a9+%!a m.4+-a, Ca%i m.9ai aam +ra% Da(am %+-+, A()*+ri)( m.4a(ami
m.%a-)(im.
m.9ai
)&i*+ri)(
2
E'.& am*i4
:R+am <,.%i&a %.ra*i 9i&a r+am ri4a5 4+a&a &.m-a(i .4a ,a%i@,a%i am+ ,.%i&a .4.ra a*a-i(a m+>+( &.m-a(i r.a&i &+(i% i&ai%&a .4a *.4.(+*aa &+(i%5 .mam5 (im'a.)*a%i5 ar%ra(4ia5 a .)i)'i(ia5 ir)m miri* ir)m S%..@J),)
a%a+
L!.((5
9ara4
%.r9ai=
4a44+a a(+ra >.ra 9ara4 ma(ai. a&i% &.*a(a5 .r%i4)5 m.4a%+&5 4a44+a *.4.>a*a5 ,i*.r%.i5 .*)i% Ca%i i )%)% %a*a 4.9a(a5 a()*.ia5
,.*a%)%)&ii%a5
*ara@.%aia5
a
.+r)*a%i (Iso Farmakoterapi 1) I3 $a% Tam-a,a Sorbitol R+m+ &imia : 86H1"O6 P.m.ria :.r-+& 4ra+( a%a+ (.m*.4a ,i4r)&)*i *+%i, mai K.4+aa a(am ')rm+(a : Ba,a *.4ii A(aa *.am-a,a ?a% %am-a,a a(am ')rm+(a K.(ar+%a : a4a% m+a, (ar+% a(am air +&ar (ar+% a(am .%a)(5 a(am m.%,a)( a a(am aam a.%a% *H : 35/ @ # D.i%a : 1" 4>m3 A(ira : Kara&%.ri%i& a(ira -.rariai %.r4a%+4 *aa *ar%i&.( +&+ra a &.(a )r-i%)( i4+a&a Ni(ai -+-+& ,a(+ >..r+4 -+r+& m.4a(ir 5 .m.%ara K.(.m-a-a S%a-i(i%a
i(ai 4ra+(ar m.mi(i&i a(ira -ai& %.*a%@i&a%a :@ : S)r-i%)( aa(a, &imia r.(a%i' i.r% a &)m*a%i-.( .4a .-a4ia -.ar .&i*i. Ha( ii %a-i( i +ara .4a %ia& aa!a &a%a(i a i4i5 .>.r aam a -aa S)r-i%)( %ia& 4.(a* a%a+ %.r+rai i +,+ !a4 %i44i a%a+ i ,aa*a amia ii )'(amma-(. 5 )>)rr)i. 5 a ))(a%i(. M.&i*+ )r-i%)( %a,a %.r,aa* '.rm.%ai )(., -a!a&
mi&r))r4aim.
i%am-a,&a
5
*.4a.%
&. )(+i )r-i%)( S)(+i
,ar+ a*a%
3
iim*a a(am &a>a 5 *(a%i& 5 a(+mii+m 5 a %ai(. &)%ai.r -a9a S)(+i +%+& i9.&i a*a% i%.ri(&a .4a a+%)&(a' Ba,a maa( aa(a, ,i4r)&)*i a ,ar+ iim*a a(am aa, &.a* +ara i %.m*a% !a4 .9+& a &.ri4 (Farmakope Indonesia ed V.2014, Handbook Of Pharmacetica!
R+m+ &imia P.m.ria
"#cipients ed $.200%) Gelatin : 8#6H12"O2 N2" : L.m-ara5 &.*i4a a%a+ *)%)4a5 a%a+ .r-+& &aar am*ai ,a(+ &+i4 (.ma, a%a+ >)&(a% %.ra4 ara -.rariai %.r4a%+4 +&+ra *ar%i&.( Lar+%a!a -.r-a+ (.ma, .*.r%i &a(+ Ji&a &.ri4 a%-i( i +ara5 %.%a*i m+a, %.r+rai )(., mi&r)-a 9i&a (.m-a- a%a+ a(am -.%+& (ar+%a G.(a%i %i*. A m.+9+&&a %i%i& i).(.&%ri& a%ara *H # a *H 5 4.(a%i %i*. B m.+9+&&a %i%i& i).(.&%ri&
a%ara *H "5# a *H /52 K.4+aa a(am ')rm+(a : P.4i&a% A(aa *.am-a,a ?a% %am-a,a a(am ')rm+(a: %ia& m.mi(i&i i'a% .-a4ai -a,a *.4)&iai K.(ar+%a : %ia& (ar+% a(am air i4i m.4.m-a4 a (+a& -i(a i>.(+* a(am air m.!.ra* air .>ara -.r%a,a* .-a!a& / – 10 &a(i -.ra%!a (ar+% a(am air *aa5 a(am aam a.%a% 6 N a a(am >am*+ra *aa 4(i.ri a a(am air %ia& (ar+% a(am .%a)(5 a(am &()r)')rm5 a(am .%.r5 a(am *H D.i%a A(ira K.(.m-a-a S%a-i(i%a
mi!a& (.ma& a a(am mi!a& m.4+a* : #@ : 132 4>m3 :@ :@ : G.(a%i &.ri4 %a-i( i +ara S)(+i 4.(a%i -.rair 9+4a %a-i( +%+& a&%+ !a4 (ama 9i&a iim*a a(am &)ii i4i %a*i m.r.&a %++& .4raai -a&%.ri Paa +,+ i a%a /078 5 )(+i 4.(a%i -.rair a*a% m.4a(ami .*)(im.riai (am-a% a
4
*.+r+a &.&+a%a 4.( a*a% %.r9ai *aa +(a4 D.*)(!m.ri?a@%i) m.9ai (.-i, >.*a% *aa +,+ i a%a 6/78 5 a 4.( K.&+a%a a*a% i&+ra4i .%.4a,!a &.%i&a )(+i i*aa&a *aa 078 .(ama 1 9am Ti4&a% a (+a!a .*)(im.riai %.r4a%+4 *aa -.ra% m)(.&+( 4.(a%i 5 .4a r.a, -.ra% m)(.&+( -a,a m.m-++& (.-i, >.*a% (Farmakope Indonesia ed V.2014, Handbook Of Pharmacetica!
P.m.ria
"#cipients ed $.200%) Metil Selulosa : .r-+& -.r.ra% a%a+ 4ra+(5 -.rara *+%i, S+*.. a(am air -.r.a&i .%ra( %.r,aa* (a&m+ P m.4.m-a4 a(am air a m.m-.%+& +*..
!a4 9.ri, ,i44a )*a(..5 &.%a(5 &)()ia( K.4+aa a(am ')rm+(a : D.i%.4ra A(aa *.am-a,a ?a% %am-a,a a(am ')rm+(a: &ar.a %ia& m.mi(i&i i'a% .-a4ai -a,a *.4)&iai K.(ar+%a : %ia& (ar+% a(am .%a)(5 a(am .%.r a a(am &()r)')rm (ar+% a(am aam a.%a% 4(a>ia( a a(am >am*+ra )(+m. ama .%a)( a a(am &()r)')rm *H : /@ D.i%a :13"1 4>m3 (Farmakope Indonesia ed V.2014, Handbook Of Pharmacetica!
R+m+ &imia P.m.ria
"#cipients ed $.200%) Kalsium Stearat : 836H#08aO" : P+%i, &.&+i4a @ *+%i, 5 -+-+& -.ar m.mi(i&i
-a+ !a4 &,a .i&i% B.-a ari -+%ira K.4+aa a(am ')rm+(a : L+-ri&a A(aa *.am-a,a ?a% %am-a,a a(am ')rm+(a: &ar.a %ia& m.mi(i&i i'a% .-a4ai -a,a *.4)&ia K.(ar+%a : Pra&%i %ia& (ar+% a%a+ %ia& (ar+% a(am .%a)( </; = 5.%.r 5 &()r)')rm 5 a.%) 5 a air S.i&i% (ar+% a(am air *aa a(&),)( 5 a a!+ra *aa *H D.i%a A(ira
a mi.ra( mi!a& Lar+% a(am air *aa *irii :@ :106" – 106 4>m 3 : 212–226;
5
K.(.m-a-a S%a-i(i%a
:@ : Ka(i+m %.ara% %a-i( a ,ar+ iim*a i .-+a, aa, %.r%+%+* i %.m*a% !a4 .9+& a
&.ri4 (Farmakope Indonesia ed V.2014, Handbook Of Pharmacetica!
R+m+ &imia P.m.ria
"#cipients ed $.200%) Zinc Stearate : 836H#0O"$ :*+%i,5 r+a,5 -+-+& ,ir)')-i&5 -.-a ari -+%ira
a .4a -a+ !a4 &,a K.4+aa a(am ')rm+(a : G(ia A(aa *.am-a,a ?a% %am-a,a a(am ')rm+(a: &ar.a %ia& m.mi(i&i i'a% .-a4ai -a,a *.4)&iai K.(ar+%a : *ra&%i %ia& (ar+% a(am .%a)(5 .%.r5 air5 a *.(ar+% )&i4.5 (ar+% a(am aam5 -.?..5 a D.i%a A(ira S%a-i(i%a
*.(ar+% ar)ma%i> (ai!a : 10 4>m3 :@ : ?i> %.ara%. %a-i( a ,ar+ iim*a a(am aa, %.r%+%+* -ai& i %.m*a% !a4 .9+& a
II
&.ri4 (Handbook Of Pharmacetica! "#cipients ed $.200%) FORMULASI TEKNIK PEMBUATAN a F)rm+(a !a4 a&a i-+a% R A(()*+ri)( 100 m4 S)r-i%)( 156; G.(a%i "; Air M.%i( .(+()a 3; Ka(i+m %.ara% 1; $i> %.ara% 2; A(()*+ri)( : $a% a&%i' S)r-i%)( : Ba,a *.4ii G.(a%i : P.4i&a% M.%i( .(+()a : D.i%.4ra Ka(i+m %.ara% : L+-ri&a $i> %.ara% : G(ia - M.%)a !a4 i4+a&a : Gra+(ai -aa, > A(aa *.mi(i,a m.%). : Kar.a ?a% a&%i' m.mi(i&i %i%i& (.(., !a4 >+&+* %i44i .,i44a a*a% i(a&+&a *.maaa A(aa *.r%im-a4a &).%rai !a4 i%im-a4
6
A(()*+ri)( 100m4
: Kar.a .4a )i 100 m4 *+ a*a% m.m-.ri&a .'.& m.+r+&a &aar aam
S)r-i%)( 156 ;
+ra% a(am ara, : S.+ai .4a r.%a4 &aar !a4
G.(a%i ";
i%.%+&a 10 ;@0 ; : S.+ai .4a r.%a4 &aar !a4 i%.%+&a 2 – 10;
M.%i( .(+()a 3;
: S.+ai .4a r.%a4 &aar !a i%.%+&a 05/ – /;
Ka(i+m %.ara% 1;
III
: S.+ai .4a r.%a4 &aar !a4
i%.%+&a 052/ – 2; $i> %.ara% 2; : S.+ai .4a r.%a4 &aar !a4 i%.%+&a 1 @ 3; (Handbook Of Pharmacetica! "#cipients ed $.200%) PERHITUNGAN a S.%ia* %a-(.% m.4a+4 : 300 m4 A(()*+ri)( - B)-)% %a-(.% : 3/0 m4 > J+m(a, %a-(.% : /0000 %a-(.% 10 ; //000 %a-(.% III1 U%+& Tia* Ta-(.% 1 Faa a(am A(()*+ri)( 053 4 C //000 4 16/00 4 S)r-i%)( 156; C 053/0 4 0506/1 4 C //000 3/0 4 G.(a%i "; C 053/0 4 001" 4 C //000 ##0 4 Air 2 Faa (+ar M.%i( .(+()a Ka(i+m %.ara% $i> %.ara%
3; C -)-)% 4ra+( 1; C -)-)% 4ra+( 2; C -)-)% 4ra+(
32B)-)% 4ra+( %.)ri%i: 16/00 4 3/0 4 ##0 4 #050 4 III2
IV
P.im-a4a A(()*+ri)( S)r-i%)( G.(a%i Air M.%i( .(+()a Ka(i+m %.ara% $i> %.ara%
16/00 4ram 3/0 4ram ##0 4ram 4ram 4ram 4ram
ALUR PROSEDUR PEMBUATAN
7
Di%im-a4 ?a%@?a% !a4 a&a i*a&ai *aa 'a. a(am5 .+ai .4a -)-)% *.im-a4a mai4@mai4 ?a% K.m+ia i>am*+r&a a%+ *.r a%+ .>ara ,)m)4.5 &.>+a(i 4.(a%i5 i (ar+%&a %.r(.-i, a,+(+ .4a m.44+a&a air am*ai (ar+% K.m+ia i.m*r)%&a *aa am*+ra ?a%5 am-i( ..&a(i i a+& S.%.(a, maa .r-+& -aa, ,i44a a*a% i &.*a(5 &.m+ia ia!a& .4a m.44+a&a m., 12 K.m+ia i&.ri4&a S.%.(a, &.ri45 i >.& &aar air K.m+ia ia!a& &.m-a(i .4a m.44+a&a m., 2"325 (a(+ m.44+a&a m., "0 Gra+( !a4 i*a&ai aa(a, 4ra+( !a4 %.r%a,a *aa m., "0 Ji&a -a!a&!a !a4 ()() *aa aa% *.4a!a&a .4a m., "05 ma&a !a4 ()() %.r.-+% i-aa,i &.m-a(i5 i&.ri4&a a ia!a& am*ai ia*a%&a 4ra+( !a4 ama %.r%a,a *aa m., "0 &.m+ia 4ra+( i.a(+ai a i>am*+r&a .4a 'a. (+ar La(+ i>.%a& S.%.(a, 9ai %a-(.%5 i(a&+&a V
VI
.a(+ai %a-(.% EVALUASI ANG DILAKUKAN V1 Gra+( 1 P..%a*a &aar air 2 P..%a*a -)-)% 9.i !a%a5
-)-)%
9.i
mam*a%5
&.mam*a%a5 a *)r)i%a 3 K.>.*a%a a(ir " S++% i%ira,a% V2 Ta-(.% 1 P.am*i(a 2 K..ra4ama +&+ra 3 K..ra4ama -)-)% " K.&.raa %a-(.% / Fria-i(i%a 6 Fri&i-i(i%a # U9i a&%+ ,a>+r Tia* %a-(.% KEMASAN LABEL m.4a+4 Kemasan
A(()*+ri)( 300 m4
ALLUNOL Ta-(.%
D)i : Li,a% i-r)+.
PT : Araiaa Farma
Ii&ai : Li,a% i-r)+r
Ba+4 I).ia Ii : 300 %a-(.%
ALLUNOL Ta-(.% PT : Araiaa Farma Ba+4 I).ia Ii : 300 %a-(.%
&aar
P.!im*aa : iim*a i%.m*a% !a4 .9+& a &.ri4 .r%a %.r,iar ari iar ma%a,ari U%+& &.%.ra4a (.-i, (a9+% (i,a% i-r)+r N) R.4 : DKL//00011A1 NOBa%,: 0/1D101 8 T4*r)+&i : M.i 2016
S*a%. : M.i
Logo
Label Komposisi : Tiap tablet mengandung Allopurinoal......100mg Dosis : lihat di brosur. Indikasi : Lihat di brosur
K ALUNOL TABLET
Alunol 100mg
PT.ANIM PHARMA Bandung-Indonesa F#31:61F1321
Penyimpanan: #m $and!em $a!%angse&u'dan 'e(ng)!e(lndungda( *a+a%a. No.Reg,/1500100110A1 No.Ba!*+,05150101 Tgl.P(odu's,Me2015 $.da!e,Me2017 /$(odu'sole+,
Is100!a"le!
P.9.(aa !a4 %.ra*a% *aa &.maa a -r)+r *r)+& Nama a4a4 : ALUNOL N)R.4i%rai : DKL 1/00100110A1 N)-a%>, : 0/1D101 Ta44a( *r)+&i : M.i 201/ EC*: : M.i 201#
ALUNOL
Brosur Komposisi : Tia* %a-(.% m.4a+4 : A((+*+ri)( 300 m4 Mekanisme Kerja : A()*+ri)( aa(a, )-a% *.!a&i% *irai <4)+%= !a4 a*a% m.+r+&a &aar aam +ra% a(am ara, A()*+ri)( -.&.r9a .4a m.4,am-a% Ca%i )&ia. !ai%+ .?im !a4 a*a% m.4+-a, ,i*)Ca%i m.9ai Ca%i5 .(a9+%!a m.4+-a, Ca%i m.9ai aam +ra% Dosis : Dewasa: D)i aa( 300 m4 .,ari D)i ma&ima( !a4 ia9+r&a 00 m4 .,ari Pai. .4a 4a44+a 4i9a( 100 @ 200 m4 .,ari Anak 6 - ! ta"un: Bi(a i.r%ai *.!a&i% &a&.r5 )i ma&ima( 300 m4 .,ari Anak #i bawa" 6 ta"un: D)i ma&ima( 1/0 m4 .,ari $n#ikasi : G)+% a ,i*.r+ri.mia Kontra $n#ikasi : A(.r4i %.r,aa* A(+*+ri)( P..ri%a .4a *.!a&i% ,a%i a -). marr) +**r.i) %&ek Samping : R.a&i ,i*.r.i%ii%a5 r+am ma&+()*a*+(ar ia,+(+i *r+ri%+5 +r%i&aria5 .&')(ia%i' a (.i *+r*+ra5 .rma%i%i5 .'ri%i5 'a&+(i%i a ir)m. *)(iar%ri%i D.mam5 .)i)'i(ia5 &.4a4a(a ,a%i a 4i9a(5 m+a(5 m+%a,5 iar.5 raa m.4a%+&5 a&i% &.*a(a a raa ()4am $nteraksi 'bat : P.m-.ria A()*+ri)( -.rama .4a a?a%i)*ri5 m.r&a*%)*+ri a%a+ i&()%)'ami5 a*a% m.i4&a%&a .'.& %)&i& ari )-a% %.r.-+% Ja4a i-.ri&a -.rama@ama .4a 4aram -.i a )-a% i+r.%i& 4)()4a %ia?ia D.4a ar'ari a*a% m.4,am-a% m.%a-)(im. )-a% i ,a%i (er"atian : Ha%i@,a%i *aa *..ri%a ,i*.r.i%i' a ai%a ,ami( Hiari *aa *..ri%a 4a4a( 4i9a( a%a+ *..ri%a ,i*.r+ri.mia aim*%)ma%i& H.%i&a *.4)-a%a .4a A()*+ri)( -i(a %im-+( &.m.ra,a &+(i% a%a+ .mam A((+*+ri)( a*a% m.i4&a%&a 'r.&+.i .ra4a ar%ri%i 4)+% a&+%5 .-ai&!a )-a% a%i i'(amai a%a+ &)(&ii i-.ri&a -.rama *aa aa( %.ra*i Ha%i@,a%i -i(a i-.ri&a -.rama .4a iara-i
Simpan #i tempat sejuk #an kering)
*o) +eg) DKL,!!!!!A A+.S D%*GA* +%S%( D'K/%+ (/) Anim ("arma Ban#ung-$n#onesia
10
VII
DAFTAR PUSTAKA Dir.&%)ra% J.ra( Bia K.'armaia a A(a% &..,a%a201/ Farmakope Indonesia "disi V. K.m.%ria K..,a%a I).iaJa&ar%a S+&aar5 E &&<200= Iso Farmakoterapi. Ja&ar%a:
PTISFI
P..r-i%a Nia?i5 Sar'ara? K5 200 , Handbook of Pharmacetica! &anfactrin' Form!ations, econd "dition Vo!me One 8)m*r.. S)(i Pr)+>%5 I')rma ,.a(%,>ar.5 N. )r& R).5 R85 S,.>&.!5 PJ5 a +i5 ME5 200 , Handbook of Pharmacetica! "#cipients, i#th "dition, P,arma>.+%i>a( Pr. a Am.ri>a P,arma>i% A)>ia%i)5 L))
11
