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Non-salt based co-amorphous formulation produced by freeze-drying.

Mohammed Suleiman Alsalhi1, Paul G Royall2, Hisham Al-Obaidi3

  • 1Institute of Pharmaceutical Science, King's College London, SE1 9NH, UK; College of pharmacy, King Saud University, Riyadh, Saudi Arabia.

International Journal of Pharmaceutics
|September 15, 2023
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Summary

This study developed a novel non-salt co-amorphous system (CAM) using tryptophan and indomethacin via freeze-drying. Optimized ratios significantly improved drug dissolution and physical stability, offering a scalable manufacturing approach for poorly soluble drugs.

Keywords:
Co-amorphous systemDissolutionFreeze dryingNon-ionic interactionOptimal ratioPhysical stability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Co-amorphous systems (CAMs) offer a promising strategy to enhance the dissolution of Biopharmaceutics Classification System (BCS) Class II drugs.
  • Current CAM formulations often rely on salt formation and mechanical activation, limiting their application due to a lack of understanding of non-ionic interactions and scalable processes.
  • Investigating non-salt-based CAMs and exploring alternative manufacturing methods like freeze-drying is crucial for broader medicinal product development.

Purpose of the Study:

  • To investigate the effect of tryptophan (non-ionic amino acid) to indomethacin (model drug) ratios on a non-salt-based CAM.
  • To develop and characterize CAMs using a scalable freeze-drying process with a tert-butyl alcohol-water cosolvent system.
  • To evaluate the dissolution performance and physical stability of the developed CAMs.

Main Methods:

  • Preparation of tryptophan-indomethacin co-amorphous systems (CAMs) using freeze-drying with a tert-butyl alcohol-water cosolvent system.
  • Systematic characterization of CAMs using Differential Scanning Calorimetry (DSC), UV-Vis spectroscopy, Fourier Transform Infrared (FT-IR) spectroscopy, Nuclear Magnetic Resonance (NMR) spectroscopy, Thermogravimetric Analysis (TGA), and X-ray Powder Diffraction (XRPD).
  • Assessment of dissolution performance and physical stability under defined storage conditions.

Main Results:

  • Freeze-drying with the cosolvent system successfully produced tryptophan-indomethacin CAMs.
  • Molecular interactions, including hydrogen bonding (H-bonding), H/π, and π-π interactions, were confirmed via FT-IR and NMR.
  • Drug release rates significantly improved for formulations with drug:amino acid molar ratios of 1.5:1 (1:0.42 wt ratio) or lower compared to pure indomethacin.
  • Formulations with drug:amino acid molar ratios of 2.3:1 (1:0.25 wt ratio) or lower exhibited physical stability for at least 9 months under dry conditions (5% RH, 25°C), unlike pure amorphous indomethacin.

Conclusions:

  • Freeze-drying using a tert-butyl alcohol-water cosolvent system is a viable method for producing non-salt-based drug-amino acid co-amorphous systems (CAMs).
  • Optimized drug-to-co-former ratios are critical for achieving enhanced dissolution and long-term physical stability of BCS Class II drugs.
  • This approach demonstrates the potential for developing scalable and effective formulations for poorly soluble drugs.