Complete Recipe for Mefenamic Acid Tablet Dissolution Rate Test (Indonesian Ministry of Health Compliance)
This article provides a comprehensive guide on conducting a dissolution rate test for mefenamic acid tablets, ensuring compliance with Indonesian Ministry of Health (Kemenkes RI) regulations. This is a crucial quality control procedure for pharmaceutical manufacturers. Note that this is for informational purposes only and should not be considered a substitute for official regulatory guidelines or professional laboratory procedures.
Understanding Dissolution Testing
Dissolution testing assesses the rate and extent to which an active pharmaceutical ingredient (API), in this case mefenamic acid, dissolves from a solid dosage form (tablet) under standardized conditions. This is critical because the dissolution rate directly impacts the bioavailability β how much of the drug is absorbed into the bloodstream and becomes available to exert its therapeutic effect. Kemenkes RI specifies strict requirements for acceptable dissolution profiles for various medications, including mefenamic acid tablets.
Materials and Equipment
Before commencing the dissolution test, gather the necessary materials and equipment:
- Mefenamic Acid Tablets: A sufficient number of tablets from the batch being tested.
- Dissolution Apparatus: A USP Apparatus I (basket method) or Apparatus II (paddle method) is typically used. Ensure its calibration and proper functionality.
- Dissolution Media: The specific media and its composition (pH, ionic strength) are defined in the relevant Kemenkes RI pharmacopoeia. This usually involves using a buffer solution at a specific pH.
- Sampling Syringes and Filters: Suitable for accurately withdrawing samples from the dissolution vessel and filtering to remove undissolved particles.
- UV-Vis Spectrophotometer: Used to measure the concentration of dissolved mefenamic acid in the samples. Youβll need to establish a calibration curve beforehand.
- Volumetric Flasks and Pipettes: For precise preparation of solutions and samples.
- Thermometer: To monitor the temperature of the dissolution media.
- Timer: To accurately record the dissolution time.
Procedure
The steps involved in conducting the dissolution test are:
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Preparation of Dissolution Media: Prepare the specified volume of dissolution media according to Kemenkes RI guidelines, ensuring accurate pH and temperature.
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Tablet Placement: Carefully place the tablet(s) into the dissolution vessel, ensuring proper positioning and immersion.
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Apparatus Setup and Operation: Set the dissolution apparatus to the specified rotation speed (rpm) and temperature, as defined in the Kemenkes RI regulations for mefenamic acid tablets. Begin the test and maintain these parameters throughout.
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Sampling: At predetermined time intervals (e.g., 15, 30, 45, and 60 minutes), withdraw a sample of the dissolution media using a syringe, ensuring that you don't disturb the tablet or the media. Filter the sample to remove undissolved particles.
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Analysis: Analyze the filtered sample using UV-Vis spectrophotometry to determine the concentration of dissolved mefenamic acid. Use the previously established calibration curve to quantify the results.
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Data Analysis: Calculate the percentage of mefenamic acid dissolved at each time point. Compare the results to the acceptance criteria defined in the relevant Kemenkes RI pharmacopoeia. Typically, this involves determining if the percentage of dissolved drug at a specified time point meets the minimum requirement.
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Documentation: Meticulously record all procedural steps, data, and observations. This is essential for compliance purposes and ensuring the integrity of the test results.
Interpreting Results
The results obtained should be carefully compared against the dissolution specification set by the Kemenkes RI. Failure to meet these specifications may indicate a problem with the formulation, manufacturing process, or quality of the raw materials. Proper interpretation requires a thorough understanding of pharmaceutical quality control principles.
This detailed outline provides a solid foundation for understanding the dissolution rate testing procedure for mefenamic acid tablets in accordance with Indonesian regulatory standards. Remember to always consult the official Kemenkes RI guidelines and pharmacopoeia for the most up-to-date and accurate information and procedures. This information is purely for educational purposes.
