Tablet Piroksikam ODT

8/19/2019 Tablet Piroksikam ODT

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2/21

DAFTAR II

TIN,AUAN T"NTAN' $AHAN AKTIF

T%%

-T%%

%"NILAIAN RIIKO

%RODUT D"I'N

%RO" D"I'N


3/21


4/21

N

H

N

NO

S

O O

CH3

OH

Gam#ar&.& /uu/ i2i %i/osi2 Cee2n= )00!>

N2 i2i : 4hi9/osi)2eilN)i/i9il>)H1=)enBoiBin3/os2i91=1

9iosi9

Ru2us i2i : 15H13 N3O4

$e/ 2oleul : 331=35

Tii leu/ : 1!8E)0)E Re7nol9 %/s9= 1!8)>.

%i/osi2 2e2ilii 9u enu /isl oli2o/? 7iu /isl /u2

7n6 2e2ilii ii leu/ 1!+ @ 1!8G= 9n enu uus 7n6 2e2ilii

ii leu/ 1!! @ )01G.

ilis : Dl2 enu 9 sil 9 suhu )0 @ 40G sel2 9u hun i

9isi2n 9l2 C9h e/C/n. e9n6n i 9isi2n 9l2 C9h

7n6 i9 e/C/n 9n e/en /9isi ;h7 300 @ 830 n2> 9

30G i/osi2 hn7 e/hn sel2 &) 2 Lun9= 1!!4>.


5/21

II. TARGET PRODU'T PROFILE.

Tar"() Pr*u+) Pr,i!($ -TPP

In9i;ions n9 us6e • Te/i n6 nn6 9 sien

/heu2oi9 /h/iis 9n oseo/h/iis

Me;hnis2 o? ;ion Menu/unn in?l2si= n7e/i 9n 9e22

9en6n 2en6h2 i


6/21

III. QUALITY TARGET PRODU'T PROFILE

TPQP E!(m(n)$ Tar"()

Dos6e Fo/2 Tle

Dos6e Desi6n ODT O/ll7 Disine6/in6 Tle>

Roue o? A92inis/ion O/l

Dos6e /en6h )0 26

%h/2;oinei;s • Diso/si i 9i 'I tract

• Konsen/si e ls2 2en;i 3

5 2 seelh e2in o/l.

• In 9en6n /oein ls2: !!.• Te/9eesi 9l2 AI.

• 1) nn6 7iu 50 2 sehin66

onsen/si 9/ un i9 e/;i

unu &1) h/i.

• %i/osi2 9i2eolis2e 9i hi

9en6n ;/ hi9/osilsi 9n

onu6si 9en6n s2 6luo/on

9n e/es/esi e/u2 leC u/in

9en6n u2lh 7n6 leih e;il

2ellui ?eses. Ku/n6 9/i 5 enu

e/uh 9ies/esin 2ellui u/in

u ?eses. Cee2n= )00!>.

D/u6 %/o9u; -uli7

A/iues

%h7si;l A/iues $ul= uih= e/lo6o 9n e/9 6/is

en6h

I9eni?i;ion Men66unn 2eo9e se/o?oo2e/i

9n FTIR FI *>

Ass7 H%L 9en6n ?se 6e/ ;2u/n

u??e/ 92 2ehnol 55:45> U% 3)>

onen Uni?o/2i7 !&@103 U% 3)>

Dissoluion h 4=5 i9 u/n6 9/i &5 9l2

45J

U% 3)>

Resi9ul onen Au sul? Msi2l 0=3

Lo62 e/ Msi2l 50 2 FI

I*>

(e/ onen Ti9 leih 9/i 0=5 U% 3+>

onine/ losu/e 7se2 Disi2n 9 suhu 40G 9l2

e2sn e/uu / 9n e9

;h7

A92inis/ion Ti9 e/en6/uh oleh 2nn$A$"


7/21


8/21

ini u6 2e2ilii e?e u/iosu/i se/ 9i6unn unu en6on 6ou u.

Dl2 en6on /eu2i isn7 9i6unn 9osis i/osi2 )0 26 seh/i

9l2 9osis un66l u 9osis e/6i 10 @ 30 26 seh/i. Unu en6on 6ou

u 9i6unn 9osis 40 26 e/h/i sel2 5 & h/i Re7nol9= 1!8)>.

,. A#$r5$i *an #ia7ai!a#i!i)a$.

%i/osi2 7n6 9ie/in e/ o/l 9iso/si 9en6n i 9i slu/n ;e/n=

onsen/si 9l2 ls2 e/;i 9 35 2 seelh e2e/in.

". P(r$6ara)an FI *>

I*(n)i,ika$i

• Ko;o seu2lh se/u le se/ 9en6n leih u/n6 40 26

i/osi2 9en6n 10 2l kloroform P = s/in6= un s2i e/in6.

e/u2 se/n in?/2e/h /esi9u 9i9ise/sin 9l2 minyak mineral

P, 2enunun 2si2u2 hn7 9 iln6n 6elo2n6 7n6 s2

see/i 9 Piroksikam BPFI.

• e/u2 se/n l/un ul/ 2enunun 2si2u2

hn7 9 nn6 6elo2n6 )43 n2 9n 334 n2.

P(n()a5an Ka*ar

Tle i/osi2 2en6n9un6 i9 u/n6 9/i !0=0 9n i9 leih

9/i 110=0 15H13 N3O4 9/i u2lh 7n6 e/e/ 9 lel.

L/un u Ti2n6 ss2 seu2lh %i/osi2 e 9l2 lu

enuu/ 7n6 sesui= l/un 9n en;e/n 9en6n s2 lo/i92enol 0=1 N

hin66 9ie/oleh l/un 9en6n 9/ 2en9ei L/un ui. L/un ui Ti2n6

9n se/u hlusn )0 le. Ti2n6 ss2 seu2lh se/u le se/

9en6n leih u/n6 10 26 i/osi2= 2sun e 9l2 lu enuu/ 1002l.

"n;e/n 9en6n s2 lo/i92enol 0=1 N s2i n9= s/in6. $un6 ?il/

e/2= ie 5 2l ?il/ e 9l2 lu enuu/ 1002l= en;e/n 9en6n s2

lo/i92enol 0=1 N s2i n9. %/ose9u/ Uu/ se/n L/un u 9n

L/un ui 9 nn6 6elo2n6 leih u/n6 334 n2 2en66unn s2


9/21

lo/i92enol 0=1 N se6i ln6o. Hiun6 u2lh 9l2 26 i/osi2=

15H13 N3O4= 9l2 B 7n6 9i6unn 9en6n /u2us:

9lh 9/ 9l2 26 e/ 2l %i/osi2 $%FI 9l2 L/un u AU 9n

A e/u/uu/u 9lh se/n L/un ui 9n L/un u.

Di$!u$i

• Me9i 9isolusi: !00 2l s2 lo/i9 0=01 N.

• Al ie ) : &5 /2.

• (u: 40 2eni.

• %/ose9u/ Lun enen u2lh i/osi2= 15H13 N3O4= 7n6 e/l/u

9en6n 2en6uu/ se/n liuo 7n6 9ien;e/n 9en6n Me9i 9isolusi

hin66 9/ i/osi2 leih u/n6 + µ6 e/ 2l 9n se/n

l/un u %i/osi2 $%FI 9 nn6 6elo2n6 se/n 2si2u2

leih u/n6 334 n2 2en66unn 2e9i 9isolusi se6i ln6o. Tole/nsi

Dl2 Cu 40 2eni h/us l/u i9 u/n6 9/i &0 -> 15H13 N3O4 9/i

u2lh 7n6 e/e/ 9 eie.

3. Inkm5a)i#i!i)a$ 1 %

2. Frmu!a$i

a. Frmu!a )(r5i!i3

Ba3an Fun"$iR(n)an"

P(makaian

F& F2 F0 F4

8 m" 8 m" 8 m" 8 m"

%i/oi;2 $hn Ai? 10 )0 10 )0 10 )0 10 )0

%*% %en6i 0=55 ) 4 4 8 ) 4 4 8

/oso


10/21

M6nesiun

e/Lu/in 0=)55 ) 4 ) 4 ) 4 ) 4

As/2 e2nis 110 4 8 4 8 4 8 4 8

TOTAL $"RAT TA$L"T )00 26

#. M()*( P(m#ua)an

%i/osi2 9iu se;/ ;e ln6sun6. %i/osi2= 2nniol= 9n M

9i;2u/ ho2o6en. Ke2u9in 9i2hn ;/oso


11/21

Konsen/si lu/in )i*ak #(r5(n"aru3 e/h9 ese/62n 9/ le.

Konsen/si lu/in #(r5(n"aru3 e/h9 9isolusi= /en se6in es/ lu/in

e/si? hi9/o?oi sehin66 9 2enu/unn 9issolusi 9/i hn o.

%/o9u; -A*/iel ?o/2ulsi

Uu/n /iel hn o Konsen/si lu/in

Kese/62n 9/ le LoC loC

Dissolusi Hi6h hi6h

2. O5)ima$i ,rmu!a 6an" *i3a$i!kan *ari R:D *i*a5a)kan *a)a $## 1

P(n"ika)Di$in)("ra

nHar*n($$ Fr(akn($) Di$in)("ra)(* Tim( Di$$!u)in

) 3 4 1.5 10 85

4 + 8 0.8 15 !0

) + & 0.! 1) 8&4 3 ! 0.+ )0 80

a. Dia"ram Par()

T e r m

Efect

B

AB

A

403020100

38,12Factor

A

Pareto Chart o the Efects(response is Kekerasan, Alpa ! ,0"#

T e r m

Efect

B

AB

A

8)"43210

,)24Factor

A

Pareto Chart o the Efects

(response is Kerap*an, Alpa ! ,0"#


12/21

T e r m

Efect

A

AB

B

800)0"0403020100

),24Factor

A

Pareto Chart o the Efects(response is Disol*si+, Alpa ! ,0"#

M e a n o f K e k e r a s a n

8,"

8,0

,"

,0

),"

),0

","

Pengikat Disintegran

Main Efects Plot (data means) or Kekerasan

T e r m

Efect

B

AB

A

0)0"0403020100

)),1Factor

A

Pareto Chart o the Efects(response is akt* -anc*r, Alpa ! ,0"#


13/21

M e a n o f K e r a p u h a n

1,2

1,1

1,0

0,.

0,8

0,


Main Efects Plot (data means) or Kerapuhan

M e a n o f W a k t u H a n c u r

18

1

1)

1"

14

13

12

11


Main Efects Plot (data means) or Waktu Hancur

M e a n o f D i s o l u s i

8.

88

8

8)

8"

84

83

82


Main Efects Plot (data means) or Disolusi


14/21

M e a n

10"

.

8

)

"

4

nteraction Plot (data means) or Kekerasan

M e a n

10"

1,"0

1,2"

1,00

0,"

0,"0

nteraction Plot (data means) or Kerapuhan

/+

M e a n

10"

20

18

1)

14

12

10

nteraction Plot (data means) or Waktu Hancur


15/21

M e a n

10"

.0

88

8)

84

82

80

nteraction Plot (data means) or Disolusi

+. Dia"ram Kn)ur

D i s i n t e g r a n

4 03 "3 02 "2 0

),0

","

",0

4,"

4,0

3,"

3,0

Pengaruh Pengikat dan Disintegran terhadap Kekerasan

Gam#ar ;. %en6/uh en6i 9n Disine6/n e/h9 Kee/sn


16/21


4,03,"3,02,"2,0

),0

","

",0

4,"

4,0

3,"

3,0

0,1,

1,

0,

Pengaruh Pengikat dan Disintegran terhadap Kerapuhan

Gam#ar ;. %en6/uh en6i 9n Disine6/n e/h9 Ke/uhn


4 03 "3 02 "2 0

),0

","

",0

4,"

4,0

3,"

3,0

Pengaruh Pengikat dan Disintegran terhadap Waktu Hancur

Gam#ar ;. %en6/uh en6i 9n Disine6/n e/h9 (u Hn;u/


17/21


4,03,"3,02,"2,0

),0

","

",0

4,"

4,0

3,"

3,0

Pengaruh Pengikat dan Disintegran terhadap Disolusi

Gam#ar ;. %en6/uh en6i 9n Disine6/n e/h9 Disolusi

*. O7(r!ai* 'n)ur P!)


" 04 "4 03 "3 02 "

10

.

8

)

"

!"erla# Contour Plot


18/21

/I. PRO'ESS DESIGN

&. F!


19/21

30 15 !& !0

30 30 !0 80

40 15 !8 !5

40 30 !) 85

a. Dia"ram Par()

Term

$%

$

%

&''''*'+''

$ ,PM

-actor .ame

Eect

/012

Pareto Chart o the Eects(response is Disolusi3 4 5 '1'0)

Gam#ar ?.& %en6/uh R%M 2esin 9n Cu en;2u/n e/h9 9isolusi

Kee/n6n : (u en;2u/n 2e2e/in en6/uh 7n6 leih es/ e/h9 hsil

9isolusi le

Term

$%

$

%

+'&0&'0'

$ ,PM

-actor .ame

Eect

&/1'

Pareto Chart o the Eects(response is homogenitas3 4 5 '1'0)

Gam#ar ?.2 %en6/uh R%M 2esin 9n Cu en;2u/n e/h9 ho2o6enis

Kee/n6n : (u en;2u/n 2e2e/in en6/uh 7n6 leih es/ e/h9 hsil

ho2o6enis le 7n6 9ihsiln

#. Dia"ram Kn)ur


20/21

Gam#ar &2. %en6/uh R%M Mie/ 9n Cu en;2u/n e/h9 Ho2o6enis

, P M

2'1'+610+01'++10+'1'&610&01'

*'

2

2

2*

2+

2'

'1

+1

01

61

/'1

/+1

Pengaruh ,PM dan Waktu Pencampuran terhadap Disolusi

Gam#ar &0. %en6/uh R%M Mie/ 9n Cu en;2u/n e/h9 Disolusi

Da,)ar Pu$)aka

$NF +8.

$% )00!.


21/21

De/e2en Kesehn Reuli In9onesi.)014. Farmakope Indonesia, edisi V . De/e2en

Kesehn Reuli In9onesi. ,/.

M/in A. 1!!3. Physical Pharmacy. $li2o/e= UA. (illi2s n9 (ilins.

RoCe= R72on9 . )00!. andbook of Pharmaceutical !"cipients si"th edition. oesle7= No/h #o/shi/e= UK.

Ru9olh= ,. eel7 R., , )003. Pharmaceutical Process Validation #n International $hird

!dition, %evised and !"panded, &hapter ' Validation of (olid )osa*e Forms. M/;el

Dee/ In;. 1&4.

Cee2n= en . )00!. Martindale + $he &omplete )ru* %eference thirty-si"th edition.

Lon9on= UK.

U.. De/2en o? Helh n9 Hu2n e/.)00&. uidance for Industry and %evie (taff $ar*et Product Profile # (trate*ic

)evelopment Process $ool. ene/ ?o/ D/u6 "

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Tablet Piroksikam ODT