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Characterizing and Exploring the Differences in Dissolution and Stability Between Crystalline Solid Dispersion and

Xiaolin Wang1, Lu Zhang1, Danyang Ma1

  • 1Department of Pharmaceutics Science, Shenyang Pharmaceutical University, Shenyang, 110016, China.

AAPS Pharmscitech
|September 25, 2020
PubMed
Summary
This summary is machine-generated.

High drug-loading crystalline solid dispersion (CSD) and amorphous solid dispersion (ASD) were prepared to enhance drug dissolution. The 90% CSD showed 60% dissolution, while 10% ASD reached 90% dissolution, indicating ASD

Keywords:
amorphous solid dispersion (ASD)crystalline solid dispersion (CSD)dissolutionnimodipine (NMD)stability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Solid dispersions are crucial for improving the dissolution of poorly soluble drugs.
  • Amorphous solid dispersions (ASDs) often suffer from low drug loading and stability issues.
  • Crystalline solid dispersions (CSDs) offer a potential alternative for high drug loading and improved stability.

Purpose of the Study:

  • To investigate the dissolution and stability of high drug-loading CSD compared to low- and high-loading ASDs.
  • To evaluate the impact of drug loading on the physical state and performance of nimodipine solid dispersions.
  • To explore the potential of CSD for achieving high drug loading while maintaining good dissolution.

Main Methods:

  • Preparation of 90% nimodipine CSD using wet milling, spray drying with hydroxypropyl cellulose (HPC-SL) and sodium dodecyl sulfate.
  • Preparation of gradient drug-loaded ASDs via hot melt extrusion with HPC-SL.
  • Characterization using DSC, PXRD, FT-IR, SEM, and in vitro dissolution testing.

Main Results:

  • CSD samples contained nimodipine in a crystalline state.
  • Low-loading ASD (10%) exhibited uniform dispersion of amorphous nimodipine.
  • High-loading ASD showed aggregates of amorphous nimodipine.
  • 90% CSD achieved 60% cumulative dissolution.
  • 10% ASD reached 90% cumulative dissolution.

Conclusions:

  • CSD can achieve high drug loading (90%) with moderate dissolution (60%).
  • Low-loading ASD (10%) demonstrated superior dissolution (90%) due to uniform amorphous drug dispersion.
  • The physical state of the drug within the dispersion significantly impacts dissolution performance.
  • Further research is needed to optimize CSD stability and ASD drug loading for enhanced bioavailability.