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The Effect of Cross-Linking on the In Vivo Disintegration of Hard Gelatin Capsules

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Abstract

Purpose. To evaluate if the cross-linking of gelatin affects in vivo capsule disintegration.

Methods. Scintigraphic investigation in nine healthy volunteers to provide for a real time visualisation of capsule disintegration.

Results. The moderately stressed capsules failed the USP dissolution specification for acetaminophen capsule when tested in water and conventional SGF but passed with the addition of pepsin. Moderately stressed capsules started to disintegrate at 10 ± 6 minutes (range 6 to 24 minutes) compared to 8 ± 2 minutes (range 5 to 11 minutes) for the unstressed capsule.

Conclusions. The results of the study clearly demonstrate that with the incisive technique of gamma scintigraphy there are no differences in the in vivodisintegration properties of moderately stressed and unstressed capsules.

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Authors and Affiliations

  1. Pharmaceutical Profiles Limited, 2 Faraday Building, Highfields Science Park, Nottingham, NG7 2QP, UK

    J. Brown & I. R. Wilding

  2. Capsugel Division of Warner-Lambert Company, 10 rue Timken, 68027, Colmar, France

    N. Madit & D. Cadé

  3. Capsugel Division of Warner-Lambert Company, 4144 Arlesheim/, Basel, Switzerland

    E. T. Cole

Authors
  1. J. Brown
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  2. N. Madit
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  3. E. T. Cole
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  4. I. R. Wilding
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  5. D. Cadé
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Brown, J., Madit, N., Cole, E.T. et al. The Effect of Cross-Linking on the In Vivo Disintegration of Hard Gelatin Capsules. Pharm Res 15, 1026–1030 (1998). https://doi.org/10.1023/A:1011973909815

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  • DOI: https://doi.org/10.1023/A:1011973909815

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