Wednesday, July 14, 2021

Procedure for dissolution test apparatus

Learn how to operate a dissolution test apparatus, which is used to measure the rate at which solid dosage forms dissolve.

The dissolution test is required in the pharmaceutical industries as well as research laboratories to determine the rate of dissolution of solid dosage forms such as tablets, capsules, and caplets, etc. It is one of the quality control tests that is used to evaluate oral dosage form according to different Pharmacopoeias such as USP/BP/IP. The rate and extent of dissolution of a drug are tested in vitro by an appropriate dissolution test. There are different types of dissolution tester are available, the USP apparatus 2 (paddle) is the most commonly used.


Standard operating procedure (SOP) for dissolution test apparatus:

  • Operate the instrument as per the standard operating procedure (SOP).
  • Enter the detail in the logbook kept with the instrument.
  • Ensure the proper connection of the power cord, heater controller cable & external probe to the socket provided on the rear panel.
  • Switch on the instrument.
  • Before performing practical work on the equipment, ensure that the equipment is properly calibrated as per the standards specified in the Pharmacopoeia.
  • Pressing the ‘Lift-up’ provided on the front panel and remove bath top plates & fill the bath with distilled water up to mark level then place the top plate.
  • Keep vessels filled with the required amount of dissolution media (E.g. Buffer solution, generally 900 ml).
  • Install the paddle or basket as per the requirement of the process.
  • Lower the stirrer unit by pressing the 'Down' key from the front panel.
To set the desired parameter:
 RPM setting: Press “RPM” key from front the panel using up (Ù), Down (Ú) and digit scroll (×) key and set desired “RPM” then press the F1 key for rotating the paddle, then press ‘ENTER’ key.
Temperature setting: Press the “TEMP” key from the front panel using the up (Ù), Down (Ú) and digit scroll (×) key. Set the required temperature then press ENTER key.
Sample interval setting: Press the TIME key and set the required value using up (Ù), Down and digit scroll (×) key.
  • For heater ON/OFF press TEMP. Key and F1 key simultaneously then press ENTER key.
  • When starting the heater, the circulating pump is automatically started by default.
  • Press heater on switch also which is provided on the front panel of the temp. The controller is located on the right side of the device.
  • If the Temp reaches the set temp. Then press the START key from the front panel to start the test. It shows the run time screen and the LED on the front panel will glow indicating the temperature run condition.
  • After completing the test, press “STOP” key to stop the test and a halt time will be displayed.
  • Press F1 or F2 key to start or stop the test.
  • Clean the instrument thoroughly and enter the detail in the logbook.

 

Sample withdrawal procedure for dissolution tester:

In the sampling interval, withdraw the sample at the appropriate time and maintain the sink condition by adding a dissolution medium (Buffer/HCl solution). If you are taking samples manually, using pipettes, need to be taken properly. The autosampler is already set up to take the sample from the proper position.

Samples are taken halfway between the top of the paddle or basket and the top of the medium and not less than 1 cm from the vessel wall. Generally, this is taken at an acceptance criteria of ±2%.

Power fail condition:

  • Throughout the process, if power fails, a power failure screen will be displayed when power is resumed.
  • Using the F1 or F2 keys, the user can restart or stop the test.
  • If the F1 key is pressed, the test will start from the point where it stopped and the device will display the run screen again.

Precautions for dissolution apparatus:

  • Before switching ON the heater, ensure that the tank is filled with distilled or purified water without a vessel to the mark of the device.
  • If necessary, change the water in the bath on a weekly or monthly basis.
  • Do not over-tighten the shaft of the paddle or basket, and do not hold or manually stop the paddle or basket while it is in operation.
  • Once the work is done, position the lift at the bottom, not the top of the middle.
  • The physical calibration of the dissolution apparatus should be done every three months, while chemical calibration with prednisolone tablets should be done every six months.

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