Comparison
of various Disssolution specification as per IP/ BP/ USP/ EP
OFFICIAL
DISSOLUTION APPARTUS:
A) Indian
Pharmacopoeia: Apparatus: 1 & 22
1 – Paddle Type
2
– Basket Type
B) United
States Pharmacopoeia:
i) For
Uncoated, Plain coated Tablets & Capsules: Apparatus: 1 – 2
1 – Basket Type
2
– Paddle Type
ii) For
Extended release & Enteric coated: Apparatus 3 & 4
3 – Reciprocating cylinder
4 – Flow through cell Type.
iii) For
Transdermal Patches:
5 – Paddle over disk
6 – Cylinder
7 – Reciprocating Holder
C) British
Pharmacopoeia: Apparatus 1, 2 & 3
1
– Basket Type
2 – Paddle Type
3 – Flow through cell Type
i) For Transdermal
Patches: Disk assembly method
Paddle over extraction cell
Rotating cylinder
D)
European Pharmacopoeia: i) For Solid dosage form:
Paddle Type
Basket Type
Flow
through cell Type
Ii) For
Transdermal Patches:
Disk assembly method
Cell method
Rotating cylinder
For special dosage form:
Chewing
Apparatus (medicated chewing gum
|
Dosage form
|
BP
|
IP
|
USP
|
EP
|
|
Uncoated
tablet
|
(A)Basket
Apparatus
(B)Paddle
Apparatus
For (A)
& (B) use 1000ml vessel, 36.5˚- 37.7˚C, pH ±0.05 unit, speed ±5%, 25±2mm
distance between lowest point of vessel and lowest point of rotating element.
(C)Flow
Through Cell Apparatus : 36.5˚-37.5 ˚C, sampling at 45 mins or as specified, flowrate ±5%
|
(A)Paddle
Apparatus
(B)Basket
Apparatus.
Conditions
same as BP
|
(A)Basket
Apparatus
(B)Paddle
Apparatus.
Conditions
used for (A) &(B) are same as in case for BP
|
(A)Basket
Apparatus
(B)Paddle
Apparatus
Same
conditions for (A) & (B) as in case of BP
(C)Flow
through Apparatus: specifically
intended for lipophilic solid dosage forms such as suppositories &
soft capsules.
|
|
Coated
Tablet
|
Basket
and Paddle Apparatus
|
Paddle
and Basket Apparatus
|
Basket
and Paddle Apparatus
|
Basket and
Paddle Apparatus
|
|
Extended
Release
|
--------
|
--------
|
(A)Basket
and Paddle Apparatus:Time - Test time points generally expressed in hours. Specimens
withdrawn with a tolerance of ± 2% of the stated time
(B)
Reciprocating Cylinder:
(C) Flow
through Cell: Same
condition as in Basket and Paddle Apparatus
|
--------
|
|
Rectal
& vaginal
|
-----
|
------
|
-----------
|
Same as
solid dosage form
|
As Per U.S.P. :-
APPARATUS SUITABILITY TEST :-
USP REFERENCE STANDARDS FOR APPARATUS –I ,II ,IV & V:
USP Prednisone Tablet RS
(Dissolution Calibrator ,Disintegrating)
USP Salicylic acid Tablet RS
(Dissolution Calibrator ,Non-disintegrating)
USP REFERENCE STANDARDS FOR APPARATUS –III:
USP Chlorpheniramine Extended-Release Tablets RS
(Drug
Release Calibrator, Single Unit)
USP
Theophylline Extended-Release Beads RS
(Drug
Release Calibrator, Multiple Unit)
FOR
BASKET & PADDLE APPARATUS:-
v AS
PER USP :-
|
FOR
NOMINAL CAPACITY
|
HEIGHT (mm)
|
INSIDE
DIAMETER
|
|
1 L
|
160 to
210
|
98 to
106 mm
|
|
2 L
|
280 to
300
|
98 to
106 mm
|
|
4 L
|
280 to
300
|
145
to155 mm
|
AS PER IP
, BP & EP :-
|
FOR
NOMINAL CAPACITY
|
HEIGHT
|
INSIDE
DIAMETER
|
|
1 L
|
168 ± 8
mm
|
98 to
106 mm
|
As Per
U.S.P. :-
Basket
apparatus is
generally used for capsules. Rotated at 100 rpm/min.
Paddle
apparatus is
generally used for tablets. Rotated at 50 or 75 rpm/min.
METHOD OF
DEAERATION (USP):
Heat the
medium,while stirring gently to 41˚ C.
Immediately
filter under vaccum using filter having porosity of
0.45 μ or
less, with vigrous stirring.
Continue
stirring under vaccum for about 5 min.
For
Conventional Dosage forms:
AS PER IP
, BP , EP ,USP (FOR UNIT SAMPLE):-
|
STAGE
|
NUMBER
TESTED
|
ACCEPTANCE
CRITERIA
|
|
S1
|
6
|
Each
Unit NLT Q+ 5%
|
|
S2
|
6
|
Avg. of
12 Units ( S1 + S2 ) is Equal to OR Greater than Q, & No Unit is less
than Q - 15%
|
|
S3
|
12
|
Avg. of
24 Units ( S1 + S2 + S3) is Equal to OR Greater than Q, & NMT 2 Units are
LESS than Q - 15%
&
No Unit is less than Q - 25%
|
AS PER
USP (FOR POOLED SAMPLE):-
|
STAGE
|
NUMBER
TESTED
|
ACCEPTANCE
CRITERIA
|
|
S1
|
6
|
Avg. AMOUNT
DISSOLVED IS NLT Q + 10%
|
|
S2
|
6
|
Avg.
AMOUNT DISSOLVED ( S1 + S2 ) IS EQUAL TO OR GREATER THAN Q + 5%
|
|
S3
|
12
|
Avg.
AMOUNT DISSOLVED ( S1 + S2 + S3) IS EQUAL TO OR GREATER THAN Q.
|
REFERENCES :
INDIAN PHARMACOPOEIA -2007, P.NO.:179 to182
UNITED STATES PHARMACOPOEIA (USP XXVI),
P.NO.:2155 to 2165
EUROPEAN PHARMACOPOEIA- 5.0, P.NO.:228 to 233
BRITISH PHARMACOPOEIA-1993, VOL-II,A160
