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"Aging" in co-amorphous systems: Dissolution decrease and non-negligible dissolution increase during storage without

Luyan Shen1, Xianzhi Liu1, Wencheng Wu1

  • 1Chemical Biology Research Center, School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou 325035, Zhejiang, China; Wenzhou Institute, University of Chinese Academy of Science, Wenzhou 325024, Zhejiang, China.

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Co-amorphous systems enhance drug solubility but their dissolution rates can change during storage. This study shows dissolution rates may decrease or increase even when the amorphous form is maintained, highlighting storage stability concerns.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science

Background:

  • Co-amorphous systems are a key strategy for improving the solubility of poorly water-soluble drugs.
  • Previous research primarily focused on the initial dissolution rates and physical stability of co-amorphous systems after storage.

Purpose of the Study:

  • To investigate the impact of storage on the dissolution rate of co-amorphous systems, beyond just physical form stability.
  • To understand the factors influencing changes in dissolution rates during storage.

Main Methods:

  • Preparation of indomethacin co-amorphous systems with arginine, tryptophan, and phenylalanine.
  • Storage of systems under dry and high humidity (60% RH) conditions for 40 and 80 days.
  • Assessment of physical stability (recrystallization) and intrinsic dissolution rate (IDR).

Main Results:

  • No recrystallization was observed in co-amorphous systems after storage.
  • Significant decreases and unexpected increases in intrinsic dissolution rate (IDR) were observed after storage.
  • Molecular mixing and moisture uptake during storage were identified as potential factors influencing IDR changes.

Conclusions:

  • Maintaining the amorphous form of co-amorphous systems does not guarantee the preservation of their enhanced dissolution rates.
  • Dissolution rate changes, both decreases and increases, must be carefully evaluated during the storage of co-amorphous systems.
  • Further research into the aging mechanisms of co-amorphous systems is warranted.