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8-Methoxypsoralen (8-MOP) in neuer galenischer Zubereitung und seine Beziehung zum 8-MOP-Serumspiegel

8-Methoxypsoralen (8-MOP) — A new galenic form and its relation to 8-MOP serum levels

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Summary

A bioequivalence study was performed with two different 8-MOP preparations. Thirty-eight patients participated in the investigation. We compared a product already marketed containing a micronized powder in hard gelatine capsules with a new product in soft gelatine capsules containing the 8-MOP in a solution. With the new galenic preparation the serum level obtained was 3.2 (P≤0.01) times higher than with the old product. Thus, the improved resorption out of the solution was mainly responsible for these results.

Zusammenfassung

Es wurde eine Studie zur Bioverfügbarkeit von 8-MOP an 38-Psoriasispatienten durchgeführt. Zur Anwendung kamen ein handelsübliches 8-MOP-Präparat, das den Wirkstoff in Form eines mikronisierten Pulvers in Hartgelatinekapseln enthielt und ein 8-MOP-Präparat mit neuer Galenik in gelöster Form, abgefüllt in Weichgelatinekapseln. Mit der neuen galenischen Zubereitung konnten bereits nach einer halben Stunde um den Faktor 3,2 (P≤0.01, Wilcoxon Test) höhere und stabilere 8-MOP-Serumspiegel erzielt werden, wofür in erster Linie die verbesserten Resorptionsbedingungen verantwortlich sind.

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Authors and Affiliations

  1. Pharmakologische Untersuchungsges. m. b. H., Arnethgasse 5-7, A-1171, Wien

    V. Nitsche

  2. II. Univ. Hautklinik (Vorstand: Prof. Dr. G. Niebauer), Spitalgasse 2, A-1090, Wien, Austria

    M. Raff & H. Bardach

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  1. V. Nitsche
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  2. M. Raff
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  3. H. Bardach
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Nitsche, V., Raff, M. & Bardach, H. 8-Methoxypsoralen (8-MOP) in neuer galenischer Zubereitung und seine Beziehung zum 8-MOP-Serumspiegel. Arch Dermatol Res 271, 11–17 (1981). https://doi.org/10.1007/BF00417383

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  • DOI: https://doi.org/10.1007/BF00417383

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