Tablet Coating Thickness Affecting Dissolution Testing

During a research and development project supported by RSSL on a new tablet coating, a pharmaceutical manufacturer encountered unexpected problems with dissolution testing.

Background

During a research and development project supported by RSSL on a new tablet coating, a pharmaceutical manufacturer encountered unexpected problems with dissolution testing.


Approach

Initial investigation into the problem using light microscopy and scanning electron microscopy (SEM) examination did not reveal any inconsistencies in the tablet coating.

Difficulty in accurately measuring the thickness of cross-sections of the convex surfaces, led to non-destructively scanning a tablet by X-ray microtomography (XRT). Advanced image analysis was then used to measure the coating thickness of the entire tablet to determine any defects, which could explain the unexpected dissolution results.

Results

The 3-D thickness measurements of the tablet demonstrated an uneven and thinner than expected tablet coating, which was then identified to be the cause for the failing dissolution results.

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