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Void forming index: A new parameter for detecting microstructural transformation caused by powder agglomeration.

Sunao Maruyama1, Etsuo Yonemochi2, Susumu Hasegawa3

  • 1Formulation Technology Research Laboratories, Pharmaceutical Technology Division, Daiichi Sankyo Co., Ltd., 1-12-1, Shinomiya, Hiratsuka, Kanagawa 254-0014, Japan; Department of Physical Chemistry, School of Pharmacy and Pharmaceutical Sciences, Hoshi University, 2-4-41, Ebara, Shinagawa-ku, Tokyo 142-8501, Japan.

International Journal of Pharmaceutics
|August 27, 2017
PubMed
Summary
This summary is machine-generated.

Powder agglomeration in dry powder inhalers (DPIs) impacts performance. Inverse gas chromatography (iGC) detects agglomeration via pressure drop changes, leading to a new Void Forming Index (VFI) for DPI development.

Keywords:
AgglomerationDry powder inhaler (DPI)Inverse gas chromatography (iGC)Pressure dropα-Lactose monohydrate

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Powder agglomeration during storage reduces dry powder inhaler (DPI) performance.
  • Capillary forces and crystalline transformations under humidity typically cause agglomeration.
  • Correlating limited crystalline transformation with agglomeration is challenging.

Purpose of the Study:

  • To investigate inverse gas chromatography (iGC) for direct detection of powder agglomeration.
  • To establish a novel index for evaluating powder agglomeration in DPI development.

Main Methods:

  • Utilized inverse gas chromatography (iGC) to measure lactose powder.
  • Employed powder X-ray diffraction (PXRD) and dynamic vapor sorption (DVS) for comparison.
  • Monitored pressure drop changes during iGC measurements.

Main Results:

  • iGC detected significant pressure drop changes in lactose, unlike PXRD and DVS.
  • Lactose powder agglomerated after iGC measurement, correlating with pressure drop.
  • A novel Void Forming Index (VFI) was developed based on iGC pressure drop.

Conclusions:

  • Pressure drop changes during iGC measurement indicate powder agglomeration onset.
  • The Void Forming Index (VFI) offers a valuable tool for assessing powder agglomeration.
  • VFI can aid in the development and optimization of dry powder inhalers.