LIDYA AMELIANA
5/13/2015
EVALUASI???:
Monitoring kualitas produk
Untuk evaluasi kuantitatif & penilaian
sifat tablet.
Untuk mengecek kerusakan kimiawi
Mengecek adanya interaksi antar
komponen tablet
5/13/2015
a. Organoleptic properties
Color identitas dan acceptability must be
uniform within a single tablet, from tablet to
tablet and from lot to lot.spektrofotometer,
kolorimeter
Odor acceptability could indicate a
stability problem, such as the characteristic odor
of acetic acid in degrading aspirin tablets.
Taste acceptability, misal pd chewable tablet
3
5/13/2015
c. KESERAGAMAN BOBOT
Di FI IIISebanyak 20 tablet ditimbang, lalu dihitung
bobot rata-ratanya .
Syarat :
2 tablet menyimpang kolom A & 1
tablet kolom B
5/13/2015
5/13/2015
5/13/2015
322 PHT
10
e. Friability
Why??
1. menurunkan acceptability
2. menyebabkan terlihat kotor pada saat pembuatan coating
dan kemasan
3. Dapat menambah bobot tablet atau content uniformity
% friability = (W0 Wf / W0) x 100 %.
W0 = initial weight,
Wf = final weight.
5/13/2015
322 PHT
11
Friability
5/13/2015
322 PHT
13
322 PHT
14
5/13/2015
15
g. Dissolution
Dissolution is
substance that
unit time
conditions of
temperature
composition.
16
determine
bioequivalence.
Dissolution behavior of drugs has a
significant
effect
on
their
pharmacological activity. In fact, a direct
relationship between in vitro dissolution
rate of many drugs and their
bioavailability has been demonstrated
and is generally referred to as in vitro-in
vivo correlation, IVIVC
5/13/2015
17
5/13/2015
322 PHT
18
5/13/2015
19
h. CONTENT UNIFORMITY:
Faktor yg mempengaruhi:
- non-uniform distribution of drug
substance throughout the powder
mixture or granulation.
- segregasi.
- Variasi berat tablet
5/13/2015
20
PROCESSING PROBLEMS IN
TABLETS:
Tableting process (Capping, Lamination
& cracking).
Excipients (Picking, Sticking, Mottling &
Binding).
Machine related (Double impression).
5/13/2015
21
CAPPING:
Capping : pemisahan sebagian atau
keseluruhan bagian atas/bawah tablet
dari badan tablet
CAUSES
REMEDIES
1.
2.
3.
4.
Insufficient amount of
binder or improper binder.
5.
Insufficient or improper
lubricant.
6.
CAUSES
REMEDIES
1.
2.
3.
Lower punch remains below the Make proper setting of lower punch
face of die during ejection.
during ejection.
4.
5.
Lamination / Laminating
Laminasi : pemisahan tablet menjadi dua
bagian atau lebih
Reason: Airentrapment during
compression and subsequent release
on ejection.
CAUSES
REMEDIES
1.
2.
CAUSES
REMEDIES
1.
2.
Rapid decompression
Chipping
CAUSES
REMEDIES
1.
2.
3.
CAUSES
REMEDIES
1.
2.
3.
4.
Cracking
Cracking : keadaan dimana tablet pecah, lebih
sering di bagian atas-tengah
Reason: It is observed as a result of rapid
expansion of tablets, especially when deep
concave punches are used.
CAUSES
1.
3.
Tablets expand.
4.
2.
REMEDIES
CAUSES
REMEDIES
1.
2.
Sticking
Sticking : keadaan dimana granul
menempel pada dinding die (ada adhesi)
Reason: Improperly dried or improperly
lubricated granules.
CAUSES
REMEDIES
1.
2.
3.
4.
Hygroscopic
granular material.
5.
6.
Sr. No.
CAUSES
REMEDIES
1.
2.
Increase pressure.
3.
Reduce speed.
Picking
Picking : perpidahan bahan dari permukaan
tablet dan menempel pada permukaanpunch
Reason: Picking is of particular concern when
punch tips have engraving or embossing
letters, as well as the granular material is
improperly dried.
CAUSES
REMEDIES
1.
2.
3.
4.
5.
6.
CAUSES
REMEDIES
1.
2.
3.
4.
Mottling
Mottling : keadaan dimana distribusi zat
warna pada permukaan tablet tidak
merata
Reason: One cause of mottling may be a
coloured drug, whose colour differs from
the colour of excipients used for
granulation of a tablet.
CAUSES
REMEDIES
1.
2.
3.
4.
Improper mixing of a
coloured binder
solution.