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Purpose <p>Ambroxol hydrochloride possesses an intensely bitter taste that may reduce patient acceptability, particularly in pediatric and geriatric populations. The present study aimed to develop taste-masked Orodispersible tablets (ODTs) of Ambroxol hydrochloride using ion-exchange resins and comparatively evaluate Amberlite IRP64 and Amberlite IRP69.</p> Methods <p>Drug–resin complexes were prepared using batch processing at drug-to-resin ratios of 1:1, 1:2, 1:3, and 1:4 and evaluated for drug loading, pH influence, compatibility, particle size, and in vitro release behavior. Optimized resinates were formulated into ODTs by direct compression and evaluated for pre- and post-compression properties and dissolution characteristics.</p> Results <p>Amberlite IRP64 at a 1:4 ratio exhibited maximum drug loading efficiency (98.26%). Maximum loading occurred at pH 7.0 (99.40%). Formulation F2 demonstrated rapid disintegration (46&#xa0;s) and highest cumulative drug release (92.86% within 60&#xa0;min). Release kinetics followed the Higuchi model, indicating diffusion-mediated drug release.</p> Conclusion <p>Comparative evaluation indicated superior performance of Amberlite IRP64 for Ambroxol complexation. Resin-based taste masking produced ODTs with satisfactory physicochemical properties and promising in vitro performance.</p>

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Comparative in vitro Evaluation of Ion-Exchange Resin–Based Taste-Masked Orodispersible Tablets of Ambroxol Hydrochloride

  • 期刊论文

  • 发表日期：

    2026年6月23日

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  • Divya Avasthi,
  • Sharad Pawar,
  • Sudheer Kumar,
  • Shubham Sharma

摘要

Purpose

Ambroxol hydrochloride possesses an intensely bitter taste that may reduce patient acceptability, particularly in pediatric and geriatric populations. The present study aimed to develop taste-masked Orodispersible tablets (ODTs) of Ambroxol hydrochloride using ion-exchange resins and comparatively evaluate Amberlite IRP64 and Amberlite IRP69.

Methods

Drug–resin complexes were prepared using batch processing at drug-to-resin ratios of 1:1, 1:2, 1:3, and 1:4 and evaluated for drug loading, pH influence, compatibility, particle size, and in vitro release behavior. Optimized resinates were formulated into ODTs by direct compression and evaluated for pre- and post-compression properties and dissolution characteristics.

Results

Amberlite IRP64 at a 1:4 ratio exhibited maximum drug loading efficiency (98.26%). Maximum loading occurred at pH 7.0 (99.40%). Formulation F2 demonstrated rapid disintegration (46 s) and highest cumulative drug release (92.86% within 60 min). Release kinetics followed the Higuchi model, indicating diffusion-mediated drug release.

Conclusion

Comparative evaluation indicated superior performance of Amberlite IRP64 for Ambroxol complexation. Resin-based taste masking produced ODTs with satisfactory physicochemical properties and promising in vitro performance.