Pharmacokinetic Profiling of Gallic Acid Oral Dissolving Film Prepared from Pimenta dioica Extract in Rabbit Plasma

Abstract

Introduction:

Gallic acid, a key bioactive polyphenol found in Pimenta dioica extract, exhibits diverse pharmacological properties, yet its pharmacokinetic behavior in novel oral delivery systems remains insufficiently explored. Enhancing its bioavailability is essential for maximizing therapeutic potential.

Objective

This study aimed to assess the pharmacokinetic characteristics of gallic acid in rabbit plasma following oral administration and to compare the performance of the pure compound with orally dissolving film (ODF) formulations at two dose levels.

Method

An HPLC method using a Hypersil ODS C18 column and UV detection at 264 nm was developed and validated to quantify gallic acid in plasma samples. Rabbits received either pure gallic acid or ODF formulations at 400 mg/kg and 800 mg/kg. Pharmacokinetic parameters were analyzed using PKSolver 2.0 under a non-compartmental model.

Results

Gallic acid exhibited rapid absorption and distribution in all treatment groups. The elimination half-life values were 6.79 h for the pure drug, 3.65 h for the 400 mg/kg ODF, and 3.44 h for the 800 mg/kg ODF. Both ODF formulations produced higher AUC and C max values compared with the pure compound, indicating improved systemic exposure and bio-availability.

Conclusion

The orally dissolving film formulations of Gallic acid demonstrated superior pharmacokinetic performance relative to the pure drug, suggesting that Pimenta dioica–based ODFs may serve as effective delivery systems for enhancing the oral bioavailability of gallic acid.