1.

Identify the following terms .

Give its importance and acceptance criteria
dissolved respect 'Ve medium 2
Disintegration test →
mainly to identify the % drug in
mainly to whether tablets capsule,
.

→ measure
pigoyufion test
or

, hot
disintegrate within the time
or

o for quality -
control and quality assurance

formulation / Capsules
→
aids and
design drug delivery optimization 0 about 6 tablets are analysed

be
→
assess
product stability o
temperature must
37.0+1 - zoc

formulation over time

→ monitor changes o disk is used to avoid Hating of capsules

vitro correlations
establish 29
/
→
in-vivo in 0
Cycle frequency : to
32 cycles distance of
mints
through
-

55 +1-2 mm
o
very important in decision -

making process

→ from regulatory perspective as it helps in

°
Disintegration time for tablets
the Uncoted tab 15
development
→
and of =
mins
approval generic
→ Soluble tab = 3 mins
dosage forms least

→ Dispersible tab = 3 mins

has seven types :

Effervescent tab 5 mins
=
→
o
Aa
should not disintegrate in Rome, in

→ basket →
EC fay buffer within 60mm""
Usp disintegrate in

As per
→ paddle coated tablet
apparatus
→

type 1
is
60 minutes
Sugarcoated =

reciprocating cylinder
→ 1-

basket + film coated

= 30mi" "
"

→ flow through cell

paddle disc
→

apparatus
over
type 2 is

→
rotating cylinder Disintegration time for
capsule
paddle
o

hard capsule
reciprocating disc
→ → = 30 mins

60 minuets
→ soft capsule =

Ha
Should not disintegrate in Rome, in

dissolved capsule
=

0
applicable to liquid samples ① =
Amt of → enteric
disintegrate in buffer within 60mm"

active ingredients
0 has 3 stages
factors affecting disintegration ?
6 units unit should be
51 Qtsyo
-
→ =
each

{
0 Lubricants
each unit should be equal to or

units 't
→
52 6 -
more than Q value and no un
Binders
diff o
=

formulations a -15%
less than
ohardness
than A
eah out should be more
,
→
83 = 12 units -

less than 0--15%0

not more than 2 units are
o has 2 stages
and units less than 0--2590
no
6 units
LI
] all units shodddismtego.ie
=
→

within time
/ £ → L2
=
12 units
the

V It

acceptance V
criteria acceptance
criteria

a. Hardness test
test to check durability at
Friability mainly performed
→ the
3 .

form
tablet and mass lost in powder through
between 2 jars tht 00h
chipping while transportation gfeblef is poland
Acceptance ortevia
used
the tablets
0
types of tablets

uncoated tablets due to mechanical

% loss
→
weight
→ compressed tablets
not more than
action should be

0 calculation formula for friability lest

I
1%
% weight loss =
W.tw# ✗ too

W ,
= initial wt .

Wz e final wt .
 dissolution
Differentiate the different apparatus vsel for testy thot may alter final result
prevents unwanted chemical
2.
rxn

↳
basket attache the end of the rotating shaft
fixed to firmly to

basket
a

→ -
the
rotatory shaft is

stirrer
facts
a
as

attached vertically end

paddle
fixed to blade at the
.

the rotating shaft is

-
a

for controlled
release preparations
development
product tablets

reciprocating cylinder
used
extended release , chewable
in
→ → He

d. "" " ed
→
is
" te a reservoir
,
commonly used in
impairs
→ flow through all
tht hold the picket ma way
astutely
can
disk
shaft and a

has
a

leveled of the paddle

surface be

paddle
→
disc
all
- that Fae
over

iusled of a basket one

reset
stainless cylinder
rotating cylinder
uses a
→ -

flat bottom adnder shaped vessel volume

reciprocating disc
→ utn a
has
-

capacity of 3-0 -20091

3-
Materials in a
disintegration apparatus B
A test
test
rack 0
rigid basket rack assembly soppwhy cylindrical transport tubes

assembly
o Basket 3

0 1000mL low form beater 0 Woven gauze

-

0 immersion fluid ovuetal rod

thermostatic 01h beaker
a
arrangement
o
Discs

4- ont
] equal than
tablets ath mass
/1 tablet weight fees Gsoag
or
the ,
than
of whole fvblets ayfh out more areas
sample
mass is
fate ,

take a sayle ot 10 tablets

8- Constant force -
give vayy results

Constant speed -
more accurate results