FORMULASI “SEDIAAN KAPSUL”
OLEH : KELAS
:A
KELOMPOK
: I (SAT SATU)
ASISTEN
: LINDA PRIARTI
NO
NAMA
NIM
1
ADE CITRA NUR SAKTI
O1A114001
2
AHMAD WALIUDIN
O1A114003
3
ASTRID AMALIA AMANAT
O1A114006
4
DEVITA SUBA MAIRI
O1A114009
JURUSAN FARMASI FAKULTAS FARMASI UNIVERSITAS UNIVERSITAS HALU OLEO KENDARI 2016
TT
FORMULASI “SEDIAAN KAPSUL ” A. FORMULA ASLI R B!"#$%&'( B. RANCAN)AN FORMULA B!"#$%&'( * +, PVP M,. S-#/#1 T#( 2 A/%"!( L#-%"# #& 100 C. MASTER FORMULA 1. N#+# P/%& 2. +(#5 P/%& 3. T#8,,#( F%/+(#"! 4. T#8,,#( P/%&"! *. N%. /,!"-/#"! 6. N%. :#-$5 N%
N#+# B#5#8
#"( 7 +, 1* M! 2016 16 M! 201 DKL 1600100401A1 601001 F8,"!
K%8"8-/#" ! * +,
P/ &%"!"
P/ :#-$5
* +, +,
+, +,
1
+,
+,
P(!$!8
2
+,
+,
+,
+,
1. 2.
B!"#$%&'( PVP
;#- #-!< P8,!#A8-! #&5/8-= (!8$!/
3.
M, "-#/#-
4.
T#(
*.
A/%"!(
A&"%/:8
L#-%"#
;#- 8,!"!
A& 100
D. ALASAN PEMILIHAN ;AT AKTIF B!"#$%&'( #(#5 8$#5#/ &!<8!(+-#8# "-!+(#8 &!,8##8 8- 8,%:#-#8 "+:(!- 8- >##"! "" ":(+ /%"&/ &!-(!-! #-# %/#"!. #"!8'# -/-#+# &! "" :"#/ :!#"#8'# <-!< (#+ 6 "#+#! 12 ?#+ "-(#5 &%"!" %/#( @S-+#8= 2009
E. ALASAN PEMILIHAN BENTUK SEDIAAN D#(#+ <%/+(#"! !8! &!:#- (#+ :8- #"( #/8# ::/## 8-8,#8 '#8, &!+!(!! "&!##8 :8- #"(= #8-#/# (#!8 #"( +8-! /#"# :# %:#- -! +8'8#8,#8 #- &8,#8 + &!(%(# +8#/! (#+ 8#+!(#8 (!$!8 -!# :#"#5 #/8#8'#= + 8- +8(#8 &8,#8 &/#<- #!/ &!:#8&!8,#8 &8,#8 -#:(- /#8, -#+:#5#8 :/#/-! '#8, &!/(#8 $#8,#8, "$#/#
F. ALASAN PEMILIHAN ;AT TAMBAHAN 1. PVP P%>!&%8 ++!(!! :#8'# ,8##8 (#+ <%/+(#"! <#/+#"-!= :!#"#8'# &!,8##8 (#+ "&!##8 #-. D#(#+ +:#-#8 -#:(-= $#!/#8 %>!&%8 &!,8##8 (#+ 8,!#- (#+ ,/#8(#"! :#"#5. P%>!&%8 ?,# &!-#+:#5#8 (#+ +:#-#8 "/: /!8, ,/#8(#"! in situ %(5 8#+:#5#8 #!/= #(%5%(= #-# $#!/#8 5!&/%#(%5%( 2. A/%"!( A/%"!( &!,8##8 "$#/# (#" (#+ :!, <#/+#"!= %"+-! /%& +##8#8. U/#8 #/-!( '#8, $!( (#" /+##8 '#8, :"#/ ++:/!#8 "!<#- #(!/#8 '#8, &!!8,!8#8 '#8, #- &!-+#8 8- +8!8,#-#8 "!<#- #(!/#8 "/: /!8,. A/%"!( @"/: "!(!# &!,8##8 ":#,#! :#5#8 8'#(- '#8, +8,#8&8, #/-!( '#8, "#8,#- 5#(" :/"!<#- #&"%/:-!< '#8, +8-! +:## $#!/ +8#+##8 /+##8 '#8, /!8, &8,#8 $#/# +8'/# (:!5#8 $#!/#8 '#8, #. A/%"!( ++!(!! +#+#8 #:"%/"! '#8, :"#/ '#8, #- +8,/#8,! (+:#:#8 +!8'# # /+##8 ,/#8( +8,/#8,! "!<#- (8, # ,/#8(. A/%"!( #- +8!8,#-#8 "!<#- #(!/#8 /! ,/#8(. A/%"!( ?,# #- +8,#-#"! (8,-8'# #/-!( "#- "#+# (#!88'# "5!8,,# +8,/#8,! ,"#8 #8-#/ #/-!(. S(#!8 !- #/%"!( +#+ +8,!#- (+:#: +(#(! ,," "!#8%(8'# @+8'/# #!/ 40 /! +#""#8'#= ":#,#! "/: +#"!5 +#+ ++/-#5#8#8 '# #(!/8'# '#8, :#! @I"+#!(= 2014. 3. T#( M#,8"!+ "-#/#-
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
I8&!#"!
T/#! %8"-!#"! #- /%8!. P8,%"%8,#8 /":(+ +/!"##8 /#&!%(%,! 8- #:&%+8 #-# 8&%"%! ":(+"" %/#"!. K%8-/#!8&!#"! K%8&!"! %/#"! #:&%+8 #-= %:"-/"! !("= #8&!"!-!". P/5#-!#8 A8#= !: 5#+!(. E< "#+!8, R#"# -! 8'#+#8 # /-. D%"!" Dws 23 -#:. Anak 12 -#:. F#/+#%!8-! P# +:/!#8 %/#( #-# &:/ 8,,8##8 :!"#$%&'( &!%8>/"! :!" #-!< &"#$-'( +-#:%(!- @ 5!&/%"!<8!( '/!&'(2+-#8# %(5 8!+ "" :#-/!. P8'/##8 /! "#(/#8 8$/8##8 +!8!+#( &8,#8 -#:(- 8-/! :/(#!" #-# "%"!-%/!# ?+(#5 $!( &!"/# &!"/"!#8 (#+ /!8 ":#,#! ,(/%8! -/":-. B!"#$%&'( -/-#+# &! "/"!#8 (#+ -!8?#. H. URAIAN BAHAN 1. B!"#$%&'( @D!-?8 POM= 199 11* N#+# /"+! B!"#$%&'(+ @ N#+# (#!8 B!"#%&!( RMBM C22H19 NO4 361=4 R+" "-/-/
P+/!#8 K(#/-#8
P8'!+#8#8 K,8##8
S/: 5#:(/ -!5 #-# 5#+!/ -!5 -! :/:# -! :/#"#. P/#-!" -! (#/- (#+ #!/ (#/- (#+ 100 :#,!#8 etanol (95) P = (#+ 3* :#,!#8 kloroform P (#+ 10 :#,!#8 eter P . D#(#+ # -/-- :#!= -/(!8&8, /! $#5#'#. L#"#-!>+
2. A/%"!( @R%= 2009 1*16 N#+# R"+! C%((%!( "!(!$%8 &!%G!&
N#+# (#!8
A/%"!( C#:OS!( C#:OS!( M*P $%((%!( "!(!$# <+& "!(!$# (!,5- #85'&/%" "!(!$!$ #$!& "!(!$!$ #85'&/!& "!(!$%8 &!%G!& <+& RMBM S!O2 60=0 P+/!#8 B/#/8# -!5 :!/#8= -! :/:#= -! :/#"# 8%8 :: #+%/<= :/#"!/. K(#/-#8 P/#-!" -! (#/- (#+ (#/- %/,#8!= #!/= #"#+= $#(! #"#+ <(%/! (#/- (#+ (#/-#8 #8#" #(#(! 5!&/%"!. M+:8- &!"/"! %(%!& &8,#8 #!/. U8- A/%"!(= (#/-#8 (#+ #!/ #(#5 1*0 +, L # 2*C @H . I8%+#-!:!(!-#" K%+#-!:( &8,#8 /#/#"! &!-!("-!(:"-/%( P8'!+#8#8 D#(#+ # -/-- :#!.
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
K,8##8
B#5#8 (+#"
*. L#-%"# @D!-?8 POM= 199 33 R%= &.= 2009 36* N#+# /"+! L#$-%"+ N#+# (#!8 L#-%"# S#$$5#/+ L#$-!" RM BM C12H22O11.H2O 360=30 R+" "-/-/
P+/!#8 K(#/-#8
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
I8%+#-!:!(!-#"
P8'!+#8#8 K,8##8
I.
P%>!&%8 %+#-!:( (#+ (#/-#8 &8,#8 :/:#,#! ,#/#+ #8%/,#8!= /"!8 #(#+! "!8--!"= :#5#8 !+!# (#!88'#. M+:8- #&&$- +%(( (#+ (#/-#8 &8,#8 "(<#-5!#%(= 8#-/!+ "#(!"!(#-= #"#+ "#(!"!(#-= <8%:#/:!-#(= -#8!8= "8'## (#!88'#. K5#"!#- ::/## 8,#-= +!"#(8'# -5!+/%"#(= #- -/8,#/5 %(5 +:8-#8 %+(" &8,#8 %>!&%8. D#(#+ # -/-- :#! &! -+#- "? /!8, B#5#8 8,!#-
PERHITUN)AN BAHAN #. P/5!-8,#8 B#5#8 / D%"!" 1. B!"#$%&'( +, 2. PVP ❑
100
x mg= mg
3. M, "-#/#1
100
x mg= mg
4. T#( 2
100
x mg= mg
*. A/%"!( ❑
100
x mg= mg
6. L#-%"# +, @ +, J +, J +, J +, +, +, +, :. P/5!-8,#8 B#5#8 / B#-$5 1. B!"#$%&'( +, G +, 2. PVP +, G +,
3. M, "-#/# +, G +, 4. T#( *. A/%"!( +, G +, 6. L#-%"# +, G +, . METODE PEMBUATAN P+:#-#8 !( &!(##8 &8,#8 +-%& +!G!8, 8$-##8 !(= &8,#8 +8$#+/#8 :#5#8:#5#8 %:#- &8,#8 &!(8-= #- 8,!#-= ,(!= (:/!#8. C#+/#8 !8! +&!#8 &! ,!(!8, (#+ :8- :(#-#8 &8,#8 +-%& 8$-##8 !(. T#5# 8$-##8 !8! &!+#8# +#"# '#8, :/"!<#- (#"-!" ##8 +(#-! "#- -#:8, "!(!8&/ ++:8- !( '#8, :/:8- "!(!8&/. P!( !8! +&!#8 &!/&"! @&!%-%8, ""#! /#8 '#8, &!!8,!8#8. H#"!( /&"! -#&! +&!#8 &! :8- :(#-#8 $!(= :8- #5!/ !( '#!- &8,#8 +8,,8##8 #(#- 5"" '#!- !(( /%((/. K. RANCAN)AN KEMASAN PRIMER DAN SEKUNDER 1 R#8$#8,#8 K+#"#8 P/!+/ Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg Metoklopramida 10 mg
2 R#8$#8,#8 K+#"#8 S8&/
Komposisi: Tiap "0 mg mengandung: Metoklorpramid a....10strip Indikasi : #ntuk men$egah dan mengo%ati mual dan muntah.
Pil
Netto :100 mg
Diproduksi Oleh: PT. Daspin Farma Kendari Indonesia
pil
Netto :100 mg
Efek Samping : Gelisah, distonia dan geala parkinson. Penyimpanan : Dalam !adah tertutup kedap,
L. RANCAN)AN BROSUR D#"#&'(
K#"(
D#"#&'(
C#"(
N%. R, DKL 1600100401A1
N%. R, DKL 1600100401A1
K'+,'$"$" : T!# +, #"( +8,#8&8, B!"#$%&'( ................ +,
Ingr!"n#$ : E#$5 +, $#"(= $%8-#!8" B!"#$%&'( ............... +,
In!"-&$" : T/#! %8"-!#"! #- /%8!.
In!"%"'n$ : A$- #8& $5/%8!$ $%8"-!#-!%8
P8,%"%8,#8 /- ":(+
-5/#'. T5 +-'!8, %< -5 "-%+#$5
+/!"##8 /#&!%(%,! 8-
/!%/ -% /#&!%(%,!$#( G#+!8#-!%8 %<
#:&%+8 #-# 8&%"%!
-5 #:&%+8 %/ 8&%"$%' #8&
":(+"" %/#"!. D'$"$ : Dws 23 #". Anak 12 #". K'n#r&"n!"-&$" : K%8&!"! %/#"! #:&%+8 #-=
%:"-/"! !("= #8&!"!-!". E.- $&+,"ng : R#"# -! 8'#+#8 # /-. Pn/"+,&n&n : D#(#+ # -/-- /##-
N%. R,
DKL 1600100401A1
N%. B#-$5 601001 D!/%&"! %(5 PT. D#"!8 F#/+# K8/! I8&%8"!#
:<%/#<-/ "/,/'.
D'$&g : Adult 23 $#". Child 12 $#". 'n#r&"n!"%"'n$ : T5 %/#-!8, $%8&!-!%8" %< #$- #:&%+8= %:"-/$-!> !("= #8&!$!-!".
A!rg !r*g r&%#"'n : D!"$%+<%/- !8 -5 #:&%+8. S#'r&g : I8 # "#(& $%8-#!8/
N%. R,
DKL 1600100401A1
N%. B#-$5 601001 P/%&$& :' PT. D#"!8 F#/+# K8/! I8&%8"!#
M. DAFTAR PUSTAKA
A8%8!+= 2014= MIMS Petunjuk Konsultasi Indonesia E&!"! 14= MIMS P- L-&= S!8,#%/. D!-?8 POM= 199= Farmakope Indonesia E&!"! III= D#/-+8 K"5#-#8 RI= ##/-#. B5#--= B. S.S. A,/##(= 200= Pharmaceutical Technolog ! "apsules, D(5! I8"-!-- %< P5#/+#$-!$#( S$!8$ #8& R"#/$5= N D(5!. I"+#!(= S.A.= 2014= F%/+(#"! T#:(- K8'#5 M#& P#(!#"# D8,#8 M8,,8##8 A/%"!( S:#,#! A&"%/:8= Skripsi= U8!>/"!-#" H#"#8&&!8 M##""#/. R%= R#'+%8& C.= P#( . S5"'= M#/!#8 E. !88= 2009= #and$ook of Pharmaceutical %&cipients= S!G-5 E&!-!%8= P5#/+#$-!$#( P/""= USA. S-+#8= S.C.= 2009= Martindale ! The "omplete 'rug eference= 36-5 E&!-!%8= P5#/+#$-!$#( P/""= L%8&%8.