Dissolution Apparatus:- Reciprocating holder & Cell Method
Apparatus:
- 7 (Reciprocating holder)
Specified for use with a variety of dosage forms.
Apparatus:-
Consists of a
set of volumetrically calibrated or tarred solution containers made of glass or
suitable material, a motor and driven assembly to reciprocate the system
vertically or horizontally, and a set of suitable sample holder.
Dissolution
medium:-
As specified
in the individual monograph.
Sample preparation A (Coated
tablet drug delivery system):-
Attach each system to be tested to a
suitable sample holder. (By gluing, placing into small nylon bag or metal
coil.)
Sample
preparation B (Trans dermal drug delivery system):-
Attach the
system to a suitable sized sample holder with a suitable O- ring.
Sample
preparation C (Other drug delivery system):-
Attach each system to be tested to a
suitable sample holder as described in individual monograph.
Procedure:-
Suspend sample holder from a vertically
reciprocating shaker that each system is continuously immersed in an accurately
measured volume of dissolution medium.
Reciprocate at a frequency of about 30 cycles per
min. with amplitude of about 2 cm.
Interpretation:
- Proceed as directed under apparatus 5.
Reciprocating disk holder.
HEAD
|
ROD
|
O-RING
|
|||||
System
|
A (Dia.)
|
B
|
C
|
Material
|
D
|
Material
|
(not shown)
|
1.6 cm2
|
1.428
|
0.9525
|
0.4750
|
SS/TV
|
30.48
|
SS/P
|
Parker 2-113-V884-75
|
2.5 cm2
|
1.778
|
0.9525
|
0.4750
|
SS/TV
|
30.48
|
SS/P
|
Parker 2-016-V884-75
|
5 cm2
|
2.692
|
0.7620
|
0.3810
|
SS/TV
|
8.890
|
SS/P
|
Parker 2-022-V884-75
|
7 cm2
|
3.1750
|
0.7620
|
0.3810
|
SS/TV
|
30.48
|
SS/P
|
Parker 2-124-V884-75
|
10 cm2
|
5.0292
|
0.6350
|
0.3505
|
SS/TV
|
31.01
|
SS/P
|
Parker 2-225-V884-75
|
SS/TV=
Either stainless steel or virgin Teflon,
P= Plexiglas.
Transdermal system holder -- cylinder.
Oral extended release tablet holder – rod, pointed for gluing.
Transdermal system holder- angled disk.
Oral extended – release tablet holder - spring holder.
Cell Method (European Pharmacopoeia).
Equipment:-
Use the peddle & vessel from peddle apparatus
with Extraction cell.
The extraction cell consists of a support, a cover, and
if necessary a membrane placed on the patch.
Support: Central part of the support forms a cavity
intended to hold the patch. The following diameters can be used 27 mm, 38 mm,
45 mm, 52 mm corresponding to volume of 1.48 ml, 2.94 ml, 4.13 ml and 5.52 ml
respectively.
Hold the patch flat with the release surface
uppermost and parallel to the bottom of the paddle.
Temperature: 32 ± 0.5° maintained.
Procedure:-
Precisely
centre the patch in the cell with the releasing surface uppermost. Introduce
the cell flat into the bottom of the vessel with the cover facing upward.
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