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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Laser diffraction as a powerful tool for amorphous solid dispersion screening and dissolution understanding.

Maria C Paisana1, Paulo R Lino2, Patricia D Nunes3

  • 1R&D Analytical Development, Hovione Farmaciencia SA, Lumiar, 1649-038 Lisboa, Portugal.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|April 18, 2021
PubMed
Summary
This summary is machine-generated.

Amorphous solid dispersions (ASDs) enhance drug bioavailability through colloidal species formation, a process monitored by laser diffraction. This method aids early-stage ASD development by tracking drug colloids and dissolution.

Keywords:
Amorphous solid dispersionsColloidsDissolutionLaser-diffractionLiquid-liquid phase separationSpray-drying

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Physical Chemistry

Background:

  • Biopharmaceutics Classification System (BCS) class II and IV drugs often require advanced formulations like amorphous solid dispersions (ASDs) to improve bioavailability.
  • Beyond amorphous solubility, the formation of colloidal species via liquid-liquid phase separation (LLPS) significantly enhances drug absorption.
  • LLPS occurs when dissolution rates are faster than crystallization kinetics, leading to supersaturation and colloid formation.

Purpose of the Study:

  • To develop and implement an analytical methodology for assessing a drug's propensity to form colloidal species in biorelevant media.
  • To investigate the colloidal formation and crystallization kinetics of itraconazole (ITZ) using hydroxypropyl methylcellulose (HPMC-AS) polymers.
  • To compare colloid formation from a solvent-shift approach with that from spray-dried ITZ ASDs.

Main Methods:

  • Utilized laser diffraction to monitor colloidal species formation and crystallization kinetics.
  • Employed a solvent-shift approach to induce colloid formation for itraconazole (ITZ).
  • Prepared and analyzed spray-dried ITZ amorphous solid dispersions (ASDs) for comparison.

Main Results:

  • Laser diffraction successfully detected and monitored the formation of ITZ colloidal species across different methodologies.
  • Colloid generation extent correlated with ASD disintegration and dissolution rates.
  • Polymers exhibiting faster wettability kinetics facilitated quicker ASD disintegration and subsequent colloidal formation.

Conclusions:

  • Laser diffraction provides valuable complementary data on colloidal formation and ASD dissolution profiles.
  • This technique serves as an excellent screening strategy for early-stage amorphous solid dispersion development.
  • Understanding colloidal species formation is crucial for optimizing drug delivery systems and enhancing bioavailability.