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Powder Self-Emulsifying Drug Delivery System for Mitotane: In Vitro and In Vivo Evaluation.

Mohamed Skiba1, Valentin Lefébure1, Frederic Bounoure1

  • 1Normandie Univ., UNIROUEN, INSERM, NORDIC UMR 1239, F-76000 Rouen, France.

Pharmaceutics
|September 28, 2024
PubMed
Summary
This summary is machine-generated.

A novel powder self-emulsifying drug delivery system (P-SEDDS) significantly enhances mitotane bioavailability. This P-SEDDS formulation improves solubility and absorption for better therapeutic outcomes in treating adrenocortical cancer.

Keywords:
Cushing’s diseaseLysodren®adrenocortical carcinomabioavailabilitymitotanepowder self-emulsifying drug delivery systemα-cyclodextrin

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Nanotechnology

Background:

  • Mitotane (o,p'-DDD) treats adrenocortical cancer but has poor oral bioavailability due to low aqueous solubility.
  • Existing formulations limit mitotane's therapeutic efficacy and increase potential toxicity.

Purpose of the Study:

  • To develop and characterize a novel powder self-emulsifying drug delivery system (P-SEDDS) for mitotane.
  • To enhance mitotane's oral bioavailability, solubility, and therapeutic efficacy.
  • To overcome challenges associated with mitotane's high logP and poor water solubility.

Main Methods:

  • Formulation of mitotane-loaded P-SEDDS using alpha-cyclodextrin and oil.
  • Characterization of P-SEDDS pharmaceutical properties.
  • In vivo pharmacokinetic evaluation in rat models.

Main Results:

  • The optimized P-SEDDS formulation demonstrated significantly enhanced mitotane bioavailability in rats.
  • Improved dissolution velocity and absorption of mitotane were observed with the P-SEDDS.
  • P-SEDDS showed superior in vitro and in vivo performance compared to conventional mitotane formulations (Lysodren®).

Conclusions:

  • Mitotane-loaded P-SEDDS is a viable strategy to improve the dissolution rate and oral bioavailability of this poorly soluble drug.
  • The P-SEDDS approach offers potential for enhanced therapeutic efficacy and reduced toxicity for mitotane treatment.
  • This formulation strategy holds promise for improving the delivery of other poorly water-soluble drugs.