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Chemical and Microbiological Stability Supporting Extended BUDs in Pentravan® Based Transdermal Preparations
Hudson Polonini1, Carolina Schettino Kegele1, Bruna Marianni1
1Fagron BV, Rotterdam, The Netherlands.
International Journal of Pharmaceutical Compounding
|May 17, 2026
Summary
Compounded transdermal drug formulations in Pentravan® showed excellent chemical and antimicrobial stability. This supports extended beyond-use dates (BUDs) up to 180 days for key APIs, ensuring medication quality and patient safety.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Compounding Pharmacy
Background:
- Transdermal drug delivery is crucial for personalized medicine, offering improved patient adherence and avoiding first-pass metabolism.
- Establishing scientifically justified beyond-use dates (BUDs) for compounded transdermal formulations requires rigorous stability data.
- Pentravan® is a common vehicle for transdermal compounding, necessitating stability assessments for various active pharmaceutical ingredients (APIs).
Purpose of the Study:
- To evaluate the chemical and antimicrobial stability of compounded transdermal formulations containing dehydroepiandrosterone (DHEA), estradiol, progesterone, and propranolol hydrochloride in Pentravan®.
- To determine appropriate beyond-use dates (BUDs) for these transdermal preparations based on stability data.
- To assess the compatibility of multiple APIs within a single transdermal vehicle and their impact on formulation stability.
Main Methods:
- Development and validation of stability-indicating UHPLC methods for DHEA, estradiol, progesterone, and propranolol hydrochloride.
- Forced-degradation studies to confirm method specificity.
- Storage of formulations at room temperature and analysis over 180 days, with antimicrobial effectiveness testing (AET) per USP <51>.
Main Results:
- All analytical methods met validation criteria (specificity, linearity, precision, accuracy).
- Formulations with estradiol, progesterone, propranolol hydrochloride, and high-concentration DHEA (10.0%) remained stable for 180 days.
- Low-concentration DHEA (0.1%) showed potency loss at 180 days, suggesting a 150-day BUD. All formulations met AET requirements.
Conclusions:
- Pentravan® supports extended BUDs up to 180 days for multiple transdermal APIs, maintaining chemical stability and preservative efficacy.
- Concentration-dependent stability was observed for DHEA, highlighting the need for formulation-specific BUD assignment.
- These findings provide evidence for reliable compounding of transdermal medications with extended shelf-life.
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