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Solubility parameter-based screening methods for early-stage formulation development of itraconazole amorphous solid

Piero Piccinni1,2, Yiwei Tian1, Alyn McNaughton2

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|February 12, 2016
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Solubility parameter methods can predict amorphous solid dispersion formation with itraconazole (itz). However, physical stability testing at relevant temperatures is crucial for developing commercially viable amorphous drug products.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) enhance the solubility and bioavailability of poorly soluble drugs.
  • Itraconazole (itz) is a challenging drug for formulation due to its poor aqueous solubility.

Purpose of the Study:

  • To identify suitable polymeric excipients for forming amorphous solid dispersions with itraconazole (itz) using solubility parameter (δ) methods.
  • To evaluate the physical stability of these ASDs under various storage conditions.

Main Methods:

  • Preparation of ASDs using quench cooling and hot melt extrusion with polymers like Soluplus, Eudragit E PO (EPO), Kollidon 17PF (17PF), and Kollidon VA64 (VA64).
  • Assessment of drug-polymer miscibility using conventional and extended δ-based approaches, including the Flory-Huggins lattice model.
  • Solid-state characterization using differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD).

Main Results:

  • The predicted rank order of itraconazole miscibility with polymers was 17PF > VA64 > Soluplus > EPO, consistent with the Flory-Huggins model.
  • Melt extrusion formulation characterization correlated well with pre-formulation screening.
  • Long-term stability studies revealed poor physical stability for 17PF/vitamin E TPGS-itz compared to Soluplus and VA64 formulations.

Conclusions:

  • Solubility parameter (δ) methods are valuable for predicting the initial state of ASDs.
  • Assessing the physical behavior of ASD formulations at relevant temperatures is critical for successful commercial development.
  • Polymer selection and preparation methods significantly influence the physical stability of itraconazole amorphous solid dispersions.