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Delayed release tablet dissolution related to coating thickness by terahertz pulsed image mapping.

John A Spencer1, Zongming Gao, Terry Moore

  • 1U.S. Food & Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St. Louis, Missouri 63101, USA. John.Spencer@fda.hhs.gov

Journal of Pharmaceutical Sciences
|August 28, 2007
PubMed
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Coating thickness of Asacol tablets, measured using Terahertz pulsed imaging (TPI), correlated with drug dissolution rates. This non-destructive method may enhance quality control for delayed-release dosage forms.

Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Delayed-release dosage forms utilize specialized coatings for targeted drug delivery in the lower intestinal tract.
  • Asacol tablets exhibit unpredictable dissolution in pH conditions below 7, which can occur naturally.
  • Accurate assessment of coating integrity is crucial for ensuring consistent drug release.

Purpose of the Study:

  • To investigate the relationship between Asacol tablet coating thickness and dissolution behavior.
  • To evaluate the utility of Terahertz pulsed imaging (TPI) as a method for measuring coating thickness.
  • To explore TPI as a potential replacement for traditional dissolution testing.

Main Methods:

  • Terahertz pulsed imaging (TPI) was employed to precisely map the coating thickness of Asacol tablets.

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  • Tablets were subsequently subjected to dissolution testing using the United States Pharmacopeia (USP) method at pH 6.8.
  • Correlation analysis was performed between coating thickness measurements and mean dissolution times.

    • Main Results:

    • A significant correlation was observed between the average coating thickness of Asacol tablets and their mean dissolution times.
    • Coating thickness measurements from a single surface did not show a strong correlation with dissolution results.
    • TPI provided accurate and comprehensive coating thickness data.

    Conclusions:

    • Average coating thickness, as determined by TPI, is a reliable predictor of Asacol tablet dissolution.
    • TPI offers a rapid and non-destructive alternative to conventional dissolution testing.
    • The findings suggest TPI's potential for application in pharmaceutical product development and process analysis.