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Updated: Sep 16, 2025

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Optimization and Evaluation of Colchicine Patch Formulation Based on Box-Behnken Design.

Wenliang Dong1,2,3, Jiahao Feng1,2, Xiang Liu1,2

  • 1College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China.

AAPS Pharmscitech
|July 8, 2025
PubMed
Summary
This summary is machine-generated.

Researchers optimized colchicine (COL) transdermal patches using BOX-Behnken Design (BBD) for improved adhesion and drug delivery. The optimized patches offer a promising alternative to oral COL, potentially reducing side effects.

Keywords:
in vitro permeation testingin vitro release testingbox-behnken experimental designcolchicinetransdermal patch

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Oral colchicine (COL) administration is associated with gastrointestinal side effects.
  • Transdermal drug delivery systems offer a potential route to bypass first-pass metabolism and reduce systemic toxicity.
  • Optimization of transdermal patch quality attributes is crucial for effective drug delivery.

Purpose of the Study:

  • To optimize colchicine (COL) transdermal patches to enhance adhesion, drug release, and transdermal penetration.
  • To develop a high-performance COL transdermal formulation using BOX-Behnken Design (BBD).
  • To evaluate the quality attributes and stability of the optimized COL transdermal patches.

Main Methods:

  • BOX-Behnken Design (BBD) was employed to optimize COL content, penetration enhancer (azone, propylene glycol) concentration, and solvent evaporation time.
  • Seventeen experimental runs were conducted to assess the impact of these variables.
  • Quality attributes including adhesion, in vitro release (IVRT), and transdermal permeation (IVPT) were evaluated. Fourier-Transform Infrared Spectroscopy (FT-IR) and accelerated stability studies were also performed.

Main Results:

  • The optimized formulation contained 9.8% COL, 5% azone, and 5% propylene glycol, with 23 minutes of evaporation at 80°C.
  • The optimized patch exhibited favorable adhesion properties and followed the Weibull equation for drug release and permeation over 48 hours.
  • Achieved cumulative release was 27.62 mg, and cumulative penetration was 256.34 µg/cm², with no significant component interactions and good stability.

Conclusions:

  • BOX-Behnken Design effectively optimized COL transdermal patches, yielding a formulation with enhanced quality attributes.
  • The developed transdermal system demonstrates potential for improved COL delivery, offering an alternative to oral administration.
  • The optimized COL transdermal patches show promise for reducing side effects associated with conventional oral colchicine therapy.