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Amisulpride-CD-Loaded Liposomes: Optimization and In Vivo Evaluation.

Marwa H Shukr1, Omar A Ahmed Farid2

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Summary

This study developed novel double-loaded liposomes for Amisulpride (AMS), enhancing its bioavailability and drug release for schizophrenia treatment. Optimized AMS-hydroxyl propyl-β-cyclodextrin liposomes significantly improved Cmax and relative bioavailability compared to commercial tablets.

Keywords:
amisulprideatypical antipsychoticcyclodextrinsdouble loadingliposomes

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Area of Science:

  • Pharmaceutics and Drug Delivery
  • Nanotechnology in Medicine
  • Pharmacology

Background:

  • Amisulpride (AMS) is an atypical antipsychotic essential for schizophrenia management.
  • Conventional drug formulations may have limitations in efficacy and delivery.
  • Liposomal drug delivery systems offer potential for improved therapeutic outcomes.

Purpose of the Study:

  • To optimize Amisulpride-cyclodextrin (AMS-CD) liposomes using a 2^3 full factorial design.
  • To investigate the impact of cyclodextrin type, drug/CD ratio, and loading strategy (single vs. double) on liposome characteristics.
  • To evaluate the in vitro and in vivo performance of optimized double-loaded Amisulpride liposomes.

Main Methods:

  • A 2^3 full factorial design was employed to study Amisulpride-hydroxyl propyl-β-cyclodextrin (AMS-HP-β-CD) liposomes.
  • Variables included cyclodextrin type, drug/CD ratio, and single/double loading configurations.
  • Key dependent variables analyzed were entrapment efficiency, particle size, polydispersibility, and zeta potential.

Main Results:

  • An optimized formulation achieved high entrapment efficiency (64.55%), small particle size (40.1 nm), and a negative zeta potential (-48.8 mV).
  • Double-loaded liposomes (AMS-HP-β-CD in aqueous phase, free drug in bilayer) demonstrated superior in vitro drug release compared to single-loaded and conventional liposomes.
  • The optimized double-loaded liposomal formulation showed a 1.55-fold increase in Cmax and a 1.94-fold increase in relative bioavailability versus commercial tablets.

Conclusions:

  • Double-loaded Amisulpride-hydroxyl propyl-β-cyclodextrin liposomes represent a promising advanced drug delivery system.
  • This formulation significantly enhances Amisulpride's pharmacokinetic profile, offering improved therapeutic potential for schizophrenia.
  • The study highlights the effectiveness of factorial design in optimizing complex liposomal formulations for enhanced drug delivery.