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<p>Berberine hydrochloride (BER) and caffeic acid (CA)–loaded poly(D, L-lactide-co-glycolide) (PLGA) nanoparticles (PNPs) were synthesized using the nanoprecipitation technique. Box–Behnken design was used to optimize the formulation and process parameters. PNPs were characterized in terms of their particle size (PS), zeta potential, encapsulation efficiency, in vitro release, ex vivo skin permeation, and antioxidant activity. In ovo irritation study was done following Hen’s egg chorioallantoic membrane (HET-CAM) test. The PS of the optimized PNPs found to be 197.90 ± 2.81&#xa0;nm with a low polydispersity index (0.251 ± 0.08). Field emission scanning electron microscope (FE-SEM) images confirmed that the PNPs exhibited a spherical shape. The entrapment efficiencies were found to be 83.38 ± 3.34% for BER and 93.59 ± 1.31% for CA. After 24&#xa0;h of dissolution study, 96.85 ± 1.53% of BER and 91.69 ± 1.09% of CA was released, confirming extended-release drug release profile from the optimized PNPs. Ex vivo permeation study of the optimized PNPs on pig ear skin showed an improved permeation of CA and BER. The optimized PNPs showed an IC<sub>50</sub> of 9.74 ± 2.80&#xa0;μg/mL in comparison to the pure CA (11.74 ± 1.93&#xa0;μg/mL) and BER (62.92 ± 1.60&#xa0;μg/mL), indicating improved antioxidant activity of CA and BER. The results of in ovo HET-CAM assay showed that the optimized PNPs were non-irritant. In conclusion, the successfully developed and optimized PLGA-based nanoparticles co-loaded with berberine hydrochloride and caffeic acid demonstrated desirable physicochemical properties, high encapsulation efficiency, sustained drug release, enhanced skin permeation, and superior antioxidant activity, while exhibiting no irritation potential in the HET-CAM assay, highlighting their promise as a safe and effective topical delivery system for therapeutic applications.</p> Graphical Abstract <p></p>

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Berberine Hydrochloride and Caffeic Acid Loaded Dual Delivery PLGA Nanoparticles: Optimization, In Vitro, and In Ovo Studies

  • 期刊论文

  • 发表日期：

    2025年9月2日

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  • Pratibha Kaushal,
  • Rajendra Awasthi

摘要

Berberine hydrochloride (BER) and caffeic acid (CA)–loaded poly(D, L-lactide-co-glycolide) (PLGA) nanoparticles (PNPs) were synthesized using the nanoprecipitation technique. Box–Behnken design was used to optimize the formulation and process parameters. PNPs were characterized in terms of their particle size (PS), zeta potential, encapsulation efficiency, in vitro release, ex vivo skin permeation, and antioxidant activity. In ovo irritation study was done following Hen’s egg chorioallantoic membrane (HET-CAM) test. The PS of the optimized PNPs found to be 197.90 ± 2.81 nm with a low polydispersity index (0.251 ± 0.08). Field emission scanning electron microscope (FE-SEM) images confirmed that the PNPs exhibited a spherical shape. The entrapment efficiencies were found to be 83.38 ± 3.34% for BER and 93.59 ± 1.31% for CA. After 24 h of dissolution study, 96.85 ± 1.53% of BER and 91.69 ± 1.09% of CA was released, confirming extended-release drug release profile from the optimized PNPs. Ex vivo permeation study of the optimized PNPs on pig ear skin showed an improved permeation of CA and BER. The optimized PNPs showed an IC50 of 9.74 ± 2.80 μg/mL in comparison to the pure CA (11.74 ± 1.93 μg/mL) and BER (62.92 ± 1.60 μg/mL), indicating improved antioxidant activity of CA and BER. The results of in ovo HET-CAM assay showed that the optimized PNPs were non-irritant. In conclusion, the successfully developed and optimized PLGA-based nanoparticles co-loaded with berberine hydrochloride and caffeic acid demonstrated desirable physicochemical properties, high encapsulation efficiency, sustained drug release, enhanced skin permeation, and superior antioxidant activity, while exhibiting no irritation potential in the HET-CAM assay, highlighting their promise as a safe and effective topical delivery system for therapeutic applications.

Graphical Abstract