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Novel semisolid SNEDDS based on PEG-30-dipolyhydroxystearate: development and characterization.

Tamer H Hassan1, Hendrik Metz1, Karsten Mäder1

  • 1Department of Pharmaceutics and Biopharmaceutics, Institute of Pharmacy, Martin-Luther-University Halle-Wittenberg, Wolfgang-Langenbeck-Strasse 4, D-06120 Halle (Saale), Germany.

International Journal of Pharmaceutics
|December 3, 2014
PubMed
Summary

This study developed novel semisolid self-nanoemulsifying drug delivery systems (SNEDDS) using PEG-30-dipolyhydroxystearate (Cithrol® DPHS). The critical ratio of Cithrol® DPHS to Capmul® MCM determined nanoemulsion stability and dispersibility.

Keywords:
Capmul(®) MCMCithrol(®) DPHSESRKolliphor(®) HS 15PEG-30-dipolyhydroxystearateSNEDDSSelfemulsifyingSoluplus(®)Tempolbenzoate

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Self-nanoemulsifying drug delivery systems (SNEDDS) offer enhanced drug solubility and bioavailability.
  • Developing stable, semisolid SNEDDS formulations remains a challenge for various therapeutic applications.

Purpose of the Study:

  • To investigate PEG-30-dipolyhydroxystearate (Cithrol® DPHS) and Soluplus® as key components in novel semisolid SNEDDS.
  • To formulate and characterize semisolid SNEDDS for potential therapeutic use.

Main Methods:

  • Formulation of semisolid SNEDDS using Cithrol® DPHS, Capmul® MCM, and Kolliphor® HS 15.
  • Characterization via photon correlation spectroscopy (PCS), differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), electron spin resonance (ESR), and proton nuclear magnetic resonance ((1)H NMR).

Main Results:

  • Successful preparation of semisolid SNEDDS that melt at body temperature.
  • Nanoemulsion dispersions exhibited hydrodynamic diameters below 25 nm.
  • The Cithrol® DPHS:Capmul® MCM ratio was identified as crucial for dispersibility and nanoemulsion stability.

Conclusions:

  • Cithrol® DPHS and Capmul® MCM are viable excipients for creating stable semisolid SNEDDS.
  • The developed SNEDDS possess desirable characteristics for drug delivery, including small droplet size and body-temperature melting point.