Dissolution apparatus: apparatus 5 (paddle overdisk) & apparatus 6

Apparatus:-5 (Peddle Over Disk):


Apparatus: - 

  • Use apparatus – 2, with addition of a stainless steel assembly designed for holding transdermal system at the bottom of the vessel.
  • Temperature: 37 ± 0.05°.
  • Distance between Peddle & Disk: 25 ± 2 mm.
  • Dead volume is kept in mind.
  • Disk assembly holds the system flat & is positional such that the release surface is parallel with bottom of the paddle blade.
  • Apparatus suitability test & Dissolution medium :- 
  • Proceed as directed for apparatus : 2.

Procedure:-
Place dissolution medium & apply the transdermal system to the disk assembly in such a way so that releasing surface facing up.
Time: - The test time points, generally three, are expressed in hrs.
Sample withdrawn within a tolerance of ± 15 mins. & ±2 %.
Interpretation: - Quantities of the active ingredient released from the system confirm to Acceptance table.
Level
No. Tested
Criteria
L1
6
No individual value lies out side the stated range.
L2
6
The average value of the 12 units (L1+L2) lies within the stated range. No individual value is outside the stated range by more than 10% of the average of the stated range.
L3
12
The average value of the 24 units (L1+L2+L3) lies within the stated range. No more than 2 of the 24 units are out side the stated range more than 10% of the stated range; none of the unit is outside the stated range by more than 20% of the average of the stated range.  

Apparatus: - 6 (Cylinder)

Apparatus:-

  • Use Apparatus -1, except to replace the basket & shaft with a SS cylinder stirring element.
  • The dosage unit is placed on the cylinder at the beginning.
  • The distance between bottom of the vessel & cylinder is maintained at 25 ± 2 mm.


Dissolution medium: - Use the medium specified in individual monograph.

Procedure: - 
Place the stated volume f the medium. Remove the protective layer from the system, and place the adhesive on a piece of cuprophan that is not les than 1 cm larger than the system. Apply adhesive on the back side of the system & than to the cylinder.

Time & Interpretation: - Proceed as directed under apparatus 5.

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