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Evidence-Based Beyond-Use Dates for Pentravan® Compounded Formulations in Hormone Therapy and Pain Management
Hudson Polonini1, Carolina Schettino Kegele1, Bruna Marianni1
1Fagron BV, Rotterdam, The Netherlands.
International Journal of Pharmaceutical Compounding
|December 16, 2025
Summary
This study assessed the stability of compounded transdermal drug formulations in Pentravan®. Most formulations were stable, supporting reliable drug delivery and microbiological safety for extended beyond-use dates.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Compounding Pharmacy
Background:
- Transdermal drug delivery offers a non-invasive route for systemic medication administration.
- Compounded transdermal formulations require rigorous stability and safety evaluations.
- Pentravan® is a vehicle used for compounding various transdermal medications.
Purpose of the Study:
- To evaluate the physicochemical stability and microbiological safety of compounded transdermal formulations containing multiple active pharmaceutical ingredients (APIs).
- To establish appropriate beyond-use dates (BUDs) for these compounded formulations.
- To assess the suitability of Pentravan® as a transdermal vehicle for diverse APIs.
Main Methods:
- Twelve compounded transdermal formulations with varying concentrations of clonazepam, diclofenac sodium, estriol, lidocaine, melatonin, and testosterone in Pentravan® were prepared.
- Formulations were stored at room temperature for up to 180 days.
- Stability testing included analysis of API content, pH, visual characteristics, and antimicrobial effectiveness testing (AET).
Main Results:
- Most formulations maintained API content within 90-110% and exhibited stable pH and visual characteristics throughout the study.
- The diclofenac sodium 100.0 mg/mL formulation showed phase separation after 30 days.
- All formulations demonstrated adequate preservative efficacy against tested microorganisms, supporting established BUDs (e.g., 180 days for most APIs, 120 days for lidocaine, 60 days for melatonin).
Conclusions:
- Pentravan® is a reliable vehicle for compounding stable and microbiologically safe transdermal formulations across a range of APIs.
- Physicochemical and microbiological stability data support specific beyond-use dates for compounded transdermal products.
- Further investigation may be warranted for specific high-concentration formulations, such as diclofenac sodium 100.0 mg/mL.
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