Influence of Enzymes and Surfactants on the Disintegration Behavior of Cross-Linked Hard Gelatin Capsules During Dissolution

ABSTRACTGelatin exhibits cross-linking upon storage at stress conditions. Capsules stored at these conditions fail to show appropriate in vitro dissolution. The aim of this study is to show the effect of surfactants in the medium on the disintegration of the gelatin capsule. This is demonstrated in...

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Bibliographic Details
Published in:Drug development and industrial pharmacy Vol. 32; no. 1; pp. 33 - 37
Main Authors: Pennings, F. H., Kwee, B. L. S., Vromans, H.
Format: Journal Article
Language:English
Published: Colchester Informa UK Ltd 01-01-2006
Taylor & Francis
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Summary:ABSTRACTGelatin exhibits cross-linking upon storage at stress conditions. Capsules stored at these conditions fail to show appropriate in vitro dissolution. The aim of this study is to show the effect of surfactants in the medium on the disintegration of the gelatin capsule. This is demonstrated in the presence and absence of the enzymes pancreatin and pepsin, the function of which is to improve the dissolution. Sodium lauryl sulfate (SLS) and Tween 80 are tested as surfactants. When SLS is used in the medium, dissolution is significantly hampered due to the formation of a less soluble precipitate of gelatin. Compared to SLS, Tween 80 shows far better disintegration and solubility results in dissolution media with neutral or low pH. Therefore, it is concluded in this study that Tween 80 is preferred when a surfactant is necessary to comply with sink condition requirements.
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ISSN:0363-9045
1520-5762
DOI:10.1080/03639040500387955