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Related Experiment Videos

Amorphous solid dispersions: Utilization and challenges in preclinical drug development within AstraZeneca.

Akosua B Anane-Adjei1, Esther Jacobs1, Samuel C Nash1

  • 1Advanced Drug Delivery, Pharmaceutical Sciences, R&D AstraZeneca, Granta Park, Cambridge CB21 6GH, UK.

International Journal of Pharmaceutics
|December 21, 2021
PubMed
Summary

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Poor aqueous solubility of active pharmaceutical ingredients (APIs) is a major challenge. Polymer-based amorphous solid dispersions (ASDs) offer a promising formulation strategy to improve solubility and oral absorption during drug development.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Materials Science

Background:

  • Poor aqueous solubility of active pharmaceutical ingredients (APIs) presents a significant hurdle in early-stage drug development.
  • This limitation impacts the oral absorption and overall efficacy of numerous drug candidates.
  • Developing effective formulation strategies is crucial for overcoming bioavailability challenges.

Purpose of the Study:

  • To review the design, manufacture, and utilization of polymer-based amorphous solid dispersions (ASDs).
  • To highlight the importance of ASDs in addressing solubility and oral absorption issues of APIs.
  • To focus on pre-formulation assessments and workflows used in preclinical drug development.

Main Methods:

  • Review of existing literature on amorphous solid dispersions.

Related Experiment Videos

  • Analysis of formulation strategies for poorly soluble APIs.
  • Examination of preclinical development workflows and pre-formulation assessments.

    • Main Results:

    • Polymer-based ASDs are an increasingly common and effective formulation strategy.
    • ASDs significantly enhance the solubility and oral absorption of challenging APIs.
    • Pre-formulation assessments are critical for successful ASD development.

    Conclusions:

    • Amorphous solid dispersions are a vital tool in modern pharmaceutical development for poorly soluble drugs.
    • Effective design and manufacturing of ASDs, supported by robust pre-formulation studies, are key to successful preclinical development.
    • This approach facilitates the progression of drug candidates with poor solubility through the development pipeline.