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Mannitol in direct compression: Production, functionality, critical material attributes and co-processed excipients.

Lijun Lin1, Xiao Lin2, Lan Shen3

  • 1Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine of Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, PR China.

International Journal of Pharmaceutics
|April 21, 2025
PubMed
Summary
This summary is machine-generated.

Mannitol is a key pharmaceutical excipient for direct compression (DC) tableting due to its beneficial properties. Understanding its Critical Material Attributes (CMAs) and co-processed forms is crucial for improving tablet quality.

Keywords:
Co-processed excipientsCritical material attributesCritical quality attributesDirect compressionMannitolQuality by designTablet

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Mannitol is increasingly used as a lactose substitute in pharmaceutical formulations, particularly for tablets.
  • Its properties like water solubility, low hygroscopicity, and chemical inertness make it suitable for various dosage forms.
  • Direct compression (DC) tableting offers an efficient manufacturing process, and mannitol is a key excipient in this area.

Purpose of the Study:

  • To review recent advancements in mannitol for direct compression (DC) tableting.
  • To explore the functions of mannitol in tablet formulations and identify potential Critical Material Attributes (CMAs).
  • To discuss mannitol-based co-processed excipients and their impact on particle properties.

Main Methods:

  • Literature review focusing on recent research and development of mannitol in DC tableting.
  • Analysis of mannitol's physicochemical properties relevant to tableting performance.
  • Examination of co-processing techniques applied to mannitol and their outcomes.

Main Results:

  • Mannitol's properties are well-suited for DC tableting, offering advantages over other excipients.
  • Identification of key Critical Material Attributes (CMAs) for mannitol is essential for consistent tablet quality.
  • Co-processing mannitol can enhance its properties, leading to improved tablet characteristics.

Conclusions:

  • Mannitol is a valuable excipient for direct compression (DC) tableting, with its properties being critical for formulation success.
  • Further research into Critical Material Attributes (CMAs) and co-processed mannitol derivatives will drive innovation in tablet manufacturing.
  • This review provides a reference for optimizing mannitol utilization in pharmaceutical development.