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Comparative Evaluation of Gelatin and HPMC Inhalation Capsule Shells Exposed to Simulated Humidity Conditions.

Sabrina Magramane1, Nikolett Kállai-Szabó1,2, Dóra Farkas1

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Summary

Hydroxypropyl methylcellulose (HPMC) capsules show better humidity resistance than gelatin capsules for dry powder inhalers (DPIs). HPMC capsules maintain integrity in high humidity, protecting sensitive active pharmaceutical ingredients (APIs).

Keywords:
HPMCcapsulesdry powder inhalers (DPIs)gelatinpositron annihilation lifetime spectroscopy (PALS)stability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • High humidity impacts dry powder inhaler (DPI) capsule performance.
  • Understanding capsule responses to moisture is crucial for drug delivery.

Purpose of the Study:

  • Investigate the effects of high humidity on gelatin and hydroxypropyl methylcellulose (HPMC) capsules.
  • Compare moisture dynamics, structural integrity, and mechanical properties.

Main Methods:

  • Exposure to controlled high humidity (25 °C, 75% RH).
  • Moisture uptake measurement (thermal analysis), visual assessment, wettability tests.
  • Mechanical testing (hardness, deformation, puncture), positron annihilation lifetime spectroscopy (PALS) for free volume analysis.

Main Results:

  • HPMC capsules showed rapid moisture uptake but retained integrity; gelatin capsules softened and lost puncture resistance.
  • Gelatin capsules reached higher equilibrium moisture content, leading to plasticization.
  • HPMC's amorphous structure allowed greater free volume expansion compared to gelatin's semi-crystalline matrix.

Conclusions:

  • HPMC capsules offer superior humidity resilience for DPI formulations.
  • HPMC is more suitable for protecting moisture-sensitive active pharmaceutical ingredients (APIs).
  • Adherence to recommended storage conditions is vital for capsule performance.