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Variability of serum levels for three oral 8-methoxypsoralen brands
T Walther1, B Quednow, U F Haustein
1Department of Dermatology, University of Leipzig, Germany.
Abstract:
We conducted a pilot study to investigate the serum level patterns of 3 commercial and internationally introduced 8-methoxypsoralen (8-MOP) preparations in 9 patients for their bioequivalence and registered the interindividual variability of serum levels over 8 h after intake of 30 mg 8-MOP equivalent doses. On average, the highest serum levels (Cmax 120.1, range 235-61 ng.ml-1) were reached as early as 0.5-1 h after ingestion of Geroxalen soft gelatin capsules, whereas lower serum levels were seen after intake of the Oxsoralen hard gelatin capsules (Cmax 82.3, range 154-47 ng.ml-1) and the Mopsoralen tablets (Cmax 81.3, range 172-26 ng.ml-1). The importance of 8-MOP serum level determination for better and efficient PUVA therapy is discussed.
Insights
This pilot study compared three 8-methoxypsoralen (8-MOP) preparations. Geroxalen soft gelatin capsules showed higher serum levels compared to Oxsoralen capsules and Mopsoralen tablets, suggesting formulation impacts bioavailability for PUVA therapy.
Area of Science:
- Pharmacology
- Dermatology
- Drug Formulation
Background:
- 8-methoxypsoralen (8-MOP) is crucial for PUVA therapy.
- Understanding 8-MOP serum levels is vital for treatment efficacy.
- Interindividual variability in drug absorption necessitates comparative studies.
Purpose of the Study:
- To investigate and compare serum level patterns of three commercial 8-methoxypsoralen (8-MOP) preparations.
- To assess the bioequivalence of different 8-MOP formulations.
- To analyze interindividual variability in serum 8-MOP concentrations over time.
Main Methods:
- Pilot study involving 9 patients.
- Administration of 30 mg 8-MOP equivalent doses of three preparations: Geroxalen soft gelatin capsules, Oxsoralen hard gelatin capsules, and Mopsoralen tablets.
- Serum level monitoring over 8 hours post-ingestion.
- Analysis of Cmax and serum level ranges.
Main Results:
- Geroxalen soft gelatin capsules yielded the highest average Cmax (120.1 ng.ml-1) at 0.5-1 hour.
- Oxsoralen hard gelatin capsules and Mopsoralen tablets showed lower average Cmax values (82.3 and 81.3 ng.ml-1, respectively).
- Significant interindividual variability in serum levels was observed across all preparations.
Conclusions:
- Formulation significantly impacts 8-methoxypsoralen (8-MOP) pharmacokinetics.
- Geroxalen soft gelatin capsules demonstrate potentially superior absorption compared to other tested formulations.
- Serum level monitoring of 8-MOP may enhance the efficiency and effectiveness of PUVA therapy.