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<p>Poor aqueous solubility remains a major obstacle in the development of many orally administered drugs, often limiting their bioavailability. Amorphous solid dispersions (ASDs) have therefore emerged as a highly effective formulation strategy to overcome this challenge and enhance drug absorption. Polymer selection plays a pivotal role in determining ASD performance, governing not only dissolution enhancement and supersaturation behavior but also physical stability, drug loading capacity, and manufacturability. This review critically examines the role of polymeric carriers of natural, semi-synthetic, and synthetic origin in ASD formulations, with emphasis on drug–polymer interactions, crystallization inhibition, and dissolution behavior. Key solution-state phenomena such as liquid–liquid phase separation (LLPS), amorphous–amorphous phase separation (AAPS), and nanodroplet stabilization are discussed in the context of polymer chemistry and drug properties. Regulatory considerations, including trends in FDA-approved ASD products and characterization expectations, are also addressed. Finally, emerging polymer technologies, high–drug-loading strategies, and unresolved challenges in predicting long-term stability and in vivo performance are discussed, providing a rational framework to guide future ASD design and polymer selection.</p>

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Role of polymeric carriers in amorphous solid dispersions: comprehensive review of stabilization mechanisms, dissolution behavior, and FDA-approved formulations

  • 期刊论文

  • 发表日期：

    2026年3月5日

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  • Mori Dhavalkumar,
  • Kiran Dudhat,
  • Sunny Shah,
  • Trupesh Pethani,
  • Jainabparvin Ansari,
  • Trinay Vora,
  • Jasmin Hingora,
  • Kaniz Sherasiya,
  • Rutvi Jiyani,
  • Chetan Borkhataria

摘要

Poor aqueous solubility remains a major obstacle in the development of many orally administered drugs, often limiting their bioavailability. Amorphous solid dispersions (ASDs) have therefore emerged as a highly effective formulation strategy to overcome this challenge and enhance drug absorption. Polymer selection plays a pivotal role in determining ASD performance, governing not only dissolution enhancement and supersaturation behavior but also physical stability, drug loading capacity, and manufacturability. This review critically examines the role of polymeric carriers of natural, semi-synthetic, and synthetic origin in ASD formulations, with emphasis on drug–polymer interactions, crystallization inhibition, and dissolution behavior. Key solution-state phenomena such as liquid–liquid phase separation (LLPS), amorphous–amorphous phase separation (AAPS), and nanodroplet stabilization are discussed in the context of polymer chemistry and drug properties. Regulatory considerations, including trends in FDA-approved ASD products and characterization expectations, are also addressed. Finally, emerging polymer technologies, high–drug-loading strategies, and unresolved challenges in predicting long-term stability and in vivo performance are discussed, providing a rational framework to guide future ASD design and polymer selection.