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Solubility Enhancement of Ebastine by Formulating Microemulsion Using D-Optimal Mixture Design: Optimization and

Apoorva Ratnakar Barve1, Gauri Ramchandra Kapileshwari1, Cleona Elizabeth Mary DCruz1

  • 1Department of Pharmaceutics, Goa College of Pharmacy, Panaji, India.

Assay and Drug Development Technologies
|September 7, 2022
PubMed
Summary

This study enhanced ebastine solubility and dissolution using a microemulsion system. The optimized formulation significantly improved drug release, demonstrating microemulsions as an effective delivery strategy for poorly soluble drugs.

Keywords:
allergic rhinitisebastinehistamine H1 antagonistssolubility enhancementurticaria

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Ebastine, a BCS class II drug, exhibits poor aqueous solubility, limiting its therapeutic efficacy.
  • Allergic rhinitis and chronic idiopathic urticaria are common conditions treated with ebastine.

Purpose of the Study:

  • To enhance the aqueous solubility and dissolution rate of ebastine.
  • To formulate and optimize a microemulsion system for ebastine delivery.

Main Methods:

  • A microemulsion system was formulated using oleic acid, Transcutol® HP, and Tween®80.
  • Phase titration and custom mixture design with D-optimality were employed for formulation development and optimization.
  • The optimized formulation was characterized for physical properties and in vitro drug release.

Main Results:

  • The optimized microemulsion formulation showed high cumulative drug release (82.9%–90.6% dissolution, 83.3%–100% diffusion).
  • In vitro release kinetics indicated mixed-order release (dissolution) and anomalous diffusion (dissolution studies) or zero-order release (diffusion studies).

Conclusions:

  • Microemulsion formulation is a promising strategy for improving the solubility and dissolution rate of ebastine.
  • This approach can enhance the bioavailability of BCS class II drugs.