Comparison of Chitosan-Poloxamer Nanoparticles and Poloxamer-based In-Situ Forming Gel for Nose-to-Brain Delivery of Cetrorelix: In Vitro and Pharmacokinetic Studies in Rats

AAPS PharmSciTech. 2026 Jun 4;27(5):226. doi: 10.1208/s12249-026-03430-6.

Abstract

Intranasal drug delivery provides rapid absorption and high bioavailability while reducing systemic exposure, making it a hopeful route for nose-to-brain (N2B) transport. However, no effective N2B system has yet been systematically studied for cetrorelix, which is a GnRH antagonist used in reproductive medicine. In this study, a cetrorelix-loaded chitosan-Pluronic F-127 (Chi-Plx) nanoparticle system with a complementary Plx in-situ gel to extend nasal residence time was developed. The formulations were characterized for physicochemical properties, release behavior, cytotoxicity, and pharmacokinetics in rats. Chi-Plx nanoparticles exhibited a mean diameter of 18.7 ± 2.1 nm, PDI of 0.35 ± 0.03, and near-neutral zeta potential. They demonstrated a biphasic release profile with an initial burst (52%) followed by sustained release, achieving 70-80% cumulative release at 1440 min, while the in-situ gel released 65-70% over the same period. Cytotoxicity assays confirmed acceptable biocompatibility, with lower toxicity than the gel formulation. Pharmacokinetic analysis revealed that Chi-Plx nanoparticles achieved markedly higher brain Cmax (223.6 ± 3.6 ng/ml) and drug targeting efficiency (81.8 ± 0.7) compared to the in-situ gel (Cmax 81.6 ng/ml; Drug targeting efficiency (DTE) 34.7) and subcutaneous injection (Cmax 218.2 ng/ml; Drug targeting efficiency (DTE) 1.0). Serum exposure was substantially reduced after intranasal administration, minimizing systemic distribution. This study demonstrates, for the first time, that cetrorelix-loaded Chi-Plx nanoparticles can efficiently deliver peptide drugs to the brain via the intranasal route, offering a promising, needle-free strategy to enhance patient compliance and reduce adverse effects in GnRH-related therapies.

Keywords: Cetrorelix; Chitosan-poloxamer; In-situ gel; Nanoparticles; Nose to brain drug delivery.

Publication types

  • Comparative Study

MeSH terms

  • Administration, Intranasal / methods
  • Animals
  • Biological Availability
  • Brain* / metabolism
  • Chitosan* / chemistry
  • Drug Carriers / chemistry
  • Drug Delivery Systems / methods
  • Drug Liberation
  • Gels / chemistry
  • Gonadotropin-Releasing Hormone* / administration & dosage
  • Gonadotropin-Releasing Hormone* / analogs & derivatives
  • Gonadotropin-Releasing Hormone* / chemistry
  • Gonadotropin-Releasing Hormone* / pharmacokinetics
  • Male
  • Nanoparticles* / administration & dosage
  • Nanoparticles* / chemistry
  • Nasal Mucosa / metabolism
  • Poloxamer* / chemistry
  • Rats
  • Rats, Sprague-Dawley

Substances

  • Chitosan
  • Poloxamer
  • Gels
  • Gonadotropin-Releasing Hormone
  • cetrorelix
  • Drug Carriers