Quality Control Tests for Tablets

Ensuring the quality and consistency of tablets and their coatings is critical. Quality control involves both in-process and finished product tests.

In-Process Tests

• These tests are conducted during manufacturing to monitor and control the process parameters.

1. Powder Flowability

   • Purpose: Ensure that the powder blends flow smoothly through the manufacturing equipment.

   • Methods:

     • Angle of Repose: Measures the slope formed by poured powder.
     • Flow Through an Orifice: Measures the rate at which powder flows through a standardized opening.
     • Hausner Ratio: Compares tapped and bulk densities.

2. Granule Size Distribution

   • Purpose: Ensure uniform granule size for consistent tablet compression.

   • Methods:

     • Sieving: Passing granules through a series of sieves.
     • Laser Diffraction: Analyzing particle size based on light scattering.

3. Moisture Content

   • Purpose: Prevent issues like stickiness, microbial growth, or degradation.

   • Methods:

     • Karl Fischer Titration: Quantitative determination of water content.
     • Loss on Drying (LOD): Heating the sample and measuring weight loss.

4. Tablet Hardness Testing

   • Purpose: Ensure mechanical strength for handling and packaging.

   • Methods:

     • Compression Testing: Using a hardness tester to apply force until the tablet breaks.

5. In-Process Uniformity

   • Purpose: Monitor uniform distribution of API and excipients.

   • Methods:

     • Sampling: Regularly taking samples from batches for testing.

Finished Product Tests

• These tests are conducted on the final tablet product to ensure it meets all quality specifications.

Weight Variation

• Purpose: Ensure each tablet contains a consistent amount of content.

• Methods:

• • Individual Weighing: Weighing a sample of tablets individually.
  • Statistical Analysis: Comparing mean and standard deviation against specifications.

Content Uniformity

• Purpose: Ensure each tablet contains the exact amount of API.

• Methods:

  • Spectroscopy: Using UV-Vis or IR spectroscopy to quantify API.
  • High-Performance Liquid Chromatography (HPLC): Precise measurement of API concentration.

Dissolution Testing

• Purpose: Ensure the tablet releases the API at the desired rate.

• Methods:

  • USP Apparatus: Using standardized dissolution apparatus (e.g., paddle, basket).
  • Spectrophotometric Analysis: Measuring API concentration in the dissolution medium over time.

Disintegration Testing

• Purpose: Assess the tablet’s ability to break down in the GI tract.

• Methods:

  • USP Disintegration Tester: Placing tablets in a controlled medium and observing disintegration time.

Hardness and Friability

• Hardness: Re-measured to confirm tablet strength.
• Friability: Assesses the tablet’s resistance to mechanical stress.

• Methods:

  • Using a friabilator to rotate tablets and measure weight loss.

Coating Integrity

• Purpose: Ensure the coating is uniform and defect-free.

• Methods:

  • Visual Inspection: Checking for visible defects.
  • Microscopy: Analyzing coating thickness and uniformity.
  • Solvent Extraction: Quantifying coating material.

Stability Testing

• Purpose: Assess the tablet’s shelf life under various environmental conditions.

• Methods:

  • Accelerated Stability Testing: Storing tablets at elevated temperature and humidity.
  • Real-Time Stability Testing: Monitoring tablets over extended periods under normal conditions.

Taste and Odor Assessment

• Purpose: Ensure palatability, especially for chewable or ODTs.

• Methods:

  • Sensory Evaluation: Trained panels assess taste and smell.

Uniformity of Coating

• Purpose: Verify consistent coating thickness and appearance across all tablets.

• Methods:

  • Thickness Measurement: Using micrometers or non-destructive techniques like near-infrared (NIR) spectroscopy.
  • Colorimetric Analysis: Ensuring consistent color intensity and hue.

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