DT50 –
How to deal with non-disintegrating capsule shells?
Where tablets typically disintegrate completely, recording the disintegration time of dosage forms such as hard-gelatine capsules can be challenging. Remaining residue (e.g. the empty capsule shell) makes it difficult for operators and automated detection systems alike to reliably determine the end-point for disintegration.
The DT50 disintegration tester reliably detects disintegration times of tablets and capsules alike. Residual heights of capsules and other dosage forms can simply be programmed individually for different capsule types & sizes. Other than conventional mechanical detection systems, the DT50 uses the same discs for both tablets and capsules.
How does it work? The DT50 automatically determines the remaining dosage height with each upward stroke of the basket using innovative electromagnetic detection technology. In simple terms, the disc causes a frequency shift as it moves closer to the bottom of the basket. The DT50 reliably detects this frequency shift. Whereas tablets leave no distance between disc and the bottom of the basket at the point of complete disintegration, the remaining residue of a capsule shell is often retained in the sample tube. Therefore, it's critical to define a height in which the capsule is considered to be completely disintegrated. As differently sized capsules may have different residual heights, the DT50 allows to program the acceptance level per product all while using the same automated discs.
*) Disc reaches programmed residual height. Capsule disintegrated.
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DT50Â Disintegration Tester Modular and bathless disintegration apparatus for fast and user-friendly testing. 100% automatic end-point detection and protocoling. |
Method development and validation Need help by defining and programming the residual height for your dosage form? Get in touch with our Pharma Services experts. |
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