Purpose :
Tablet Dissolution is a standardized method for measuring the rate of drug release from a dosage form
Scope :
Drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms.
Procedure :
• Ensure, that the instrument is calibrated.
• Fix the paddle or basket as per the test requirement. Do not over tighten.
• Start the stirrer by pressing the RUN switch.
• Set the RPM by turning RPM knob clockwise to increase the RPM and anti-clockwise to decrease the RPM. After setting the RPM, lock the knob and stop the stirrer by pressing the reset switch. Do not turn the knob when it is in LOCK position always unlock the knob and turn.
• Set the time as specified in individual specification/monograph by using thumb wheel switch.
• Select the manual mode using the auto manual switch. This switch illuminates in auto mode. In auto mode the instrument will give an alarm after every set interval and the stirrer will keep on running.
• Add the required volume of the deaerated dissolution medium in the jars as specified in the individual specification / monograph.
• Bring the stirrer unit down by using up – stop – down switch. Run the apparatus to equibrate dissolution medium in the jars and check the temperature with a calibrated thermometer.
• If baskets are used, lift the stirrer unit, down by using up – stop – down switch. If paddle is used, place one tablet / capsule in the jar.
• Care to be taken: The inside distance between paddle or basket to the jars should be maintained at 25mm +2mm, during the test.
• Cover the jars containing dissolution medium with the lids provided.
• Start the stirrer by pressing the start switch. Run the apparatus for the set time.
• Collect the sample within +2% of specified time. [For eg If time is 30 mts., sample to be taken within 36 seconds.]
• Withdraw sample from a zone midway between the surface of the dissolution medium and the top of the rotating basket or blade, not less than 1cm. From the vessel wall and filter the solution.
• Lift the stirrer by using the up – stop – down switch at the end of the set time.
• Switch off the Instrument.
CALIBRATION PROCEDURE :
• At start set the Revolutions per minute to 50 and Start the instrument and check the initial RPM. At the end of 1 hour stop the instrument and check for number of revolutions per minute. Continue for another 1 hour and check for the number of revolutions per minute. Likewise the procedure is to be repeated for 100 RPM. The limit for the revolutions is ± 2% of the set value.
• At start set the temperature to 37° C and start instrument and check the initial temperature. At the end of 1 hour stop the instrument and note the temperature of the medium. Continue for another 1 hour and check the temperature of the medium. The limit of the temperature should be between 36.5°C to 37.5°C. Check the temperature of the dissolution medium by a calibrated thermometer.
• The wobbling of each shaft is measured by placing the Wobblometer at the center of the shaft of the paddle/Basket and note the value observed in the gauge of the wobblometer keeping the instrument on 50 RPM
