Related Experiment Videos
Omeprazole absorption from a compounded transdermal formulation in healthy volunteers
Curtis E Haas1, Lydia Lin, Denise Cloen
1Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, NY 14260-1200, USA. haas@buffalo.edu
Journal of the American Pharmacists Association : Japha
|September 1, 2005
Summary
This study found poor transdermal absorption of omeprazole gel in healthy volunteers, with plasma concentrations significantly lower than oral dosing. The compounded transdermal formulation was not bioequivalent to the oral capsule.
Area of Science:
- Pharmacokinetics
- Drug Delivery Systems
- Gastroenterology
Background:
- Omeprazole is a proton pump inhibitor commonly administered orally.
- Transdermal drug delivery offers potential advantages but requires adequate absorption.
- Evaluating novel formulations like transdermal gels is crucial for alternative administration routes.
Purpose of the Study:
- To assess the pharmacokinetic profile of omeprazole delivered via a compounded transdermal gel.
- To compare the transdermal absorption of omeprazole to historical oral administration data.
Main Methods:
- A single-dose pharmacokinetic study was conducted in eight healthy volunteers.
- Omeprazole gel (40 mg) was applied to the forearm, and plasma concentrations were measured over 8 hours.
- Liquid chromatography-tandem mass spectrometry was used to quantify omeprazole levels.
Main Results:
- Five out of eight volunteers exhibited undetectable plasma omeprazole concentrations.
- Detectable concentrations were very low (0.204-0.552 ng/mL), approximately 1,000-fold lower than oral dosing.
- Mean Cmax was 0.153 ng/mL, with Tmax around 6 hours in those with detectable levels.
Conclusions:
- The compounded transdermal omeprazole gel demonstrated poor drug absorption.
- This formulation is not bioequivalent to the standard oral omeprazole capsule.
- Further research may be needed to optimize transdermal delivery of omeprazole.