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[5-Methoxypsoralen: bioavailability and pharmacokinetics].

V Nitsche, H Mascher

Arzneimittel-Forschung

|January 1, 1982

Summary

A new soft gelatine capsule formulation of 5-methoxypsoralen (5-MOP) significantly improved bioavailability compared to a hard gelatine capsule formulation. This study details the enhanced absorption and pharmacokinetic profile of 5-MOP.

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Area of Science:

Pharmacology
Pharmaceutics
Drug Delivery Systems

Background:

5-methoxypsoralen (5-MOP) is a compound used in photochemotherapy.
Optimizing 5-MOP bioavailability is crucial for effective therapeutic outcomes.
Different galenic formulations can significantly impact drug absorption and efficacy.

Purpose of the Study:

To compare the bioavailability of two distinct galenic formulations of 5-methoxypsoralen (5-MOP).
To evaluate a suspension in soft gelatine capsules against a micronized powder in hard gelatine capsules.
To analyze the pharmacokinetic parameters of 5-MOP following administration of different formulations.

Main Methods:

A comparative bioavailability study involving six healthy volunteers.
Administration of 40 mg dosage of two 5-MOP formulations: suspension in soft gelatine capsules and micronized powder in hard gelatine capsules.
Analysis of plasma samples using a validated, rapid analytical method with a detection limit of 2 ng/ml.

Main Results:

The suspension formulation in soft gelatine capsules demonstrated significantly higher bioavailability (p ≤ 0.05) based on AUC comparison.
The elimination half-life of 5-MOP was determined to be 2.3 hours.
The elimination rate constant for 5-MOP was found to be 0.344 h⁻¹.

Conclusions:

Soft gelatine capsules containing a 5-MOP suspension offer superior bioavailability compared to hard gelatine capsules with micronized powder.
The developed analytical method is accurate, rapid, and suitable for routine pharmacokinetic analysis of 5-MOP.
These findings support the use of optimized galenic formulations for enhanced 5-MOP delivery and therapeutic efficacy.

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