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<p>The present research was focused on the formulation development and evaluations of a novel dual ionically engineered microbead system for colon-targeted delivery of capecitabine (CAP) drug. The formulations were prepared using 2<sup>3</sup> factorial design to systematically optimize formulation factors and their impact on microbead properties. The prepared formulations were then evaluated for particle size, drug entrapment efficiency (EE), drug content (DC), swelling behaviour, SEM, FTIR, XRD, DSC and in vitro drug release characteristics. The formulations exhibited particle sizes ranging from 790.7 to 876.7&#xa0;µm, with EE between 72.07% and 85.68% and DC ranging from 71.92% to 82.55%, respectively. Swelling studies demonstrated minimal expansion in simulated gastric fluid (SGF, pH 1.2) and maximum swelling in simulated intestinal and colonic environments (SIF, pH 6.8 and SCF, pH 7.4), indicated for its pH-responsive behaviour. The drug release kinetics confirmed for anomalous (non-Fickian) transport mechanism that was aligning closely with the Higuchi and Korsmeyer–Peppas models. The stability studies indicated for good physicochemical stability under both long-term and accelerated temperature conditions. Furthermore, in vitro cytotoxicity studies on HT-29 cell lines demonstrated enhanced anticancer activity of the optimized microbead compared to pure drug and standard drug, while in vivo roentgenographic evaluation confirmed for successful colonic targeting of CAP respectively. These findings suggested that dual-crosslinked microbeads offer a promising platform for efficient specific delivery of CAP into the bioenvironment of colon region.</p>

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Ionically engineered dual crosslinked microbeads of capecitabine for colon targeting: in vitro kinetic modelling and in vivo evaluations

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月8日

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  • Nidhi Agrawal,
  • Mohammad Akbar Siddiqui,
  • Sakshi Gupta,
  • Meenakshi Jaiswal,
  • S. K. Lanjhiyana

摘要

The present research was focused on the formulation development and evaluations of a novel dual ionically engineered microbead system for colon-targeted delivery of capecitabine (CAP) drug. The formulations were prepared using 23 factorial design to systematically optimize formulation factors and their impact on microbead properties. The prepared formulations were then evaluated for particle size, drug entrapment efficiency (EE), drug content (DC), swelling behaviour, SEM, FTIR, XRD, DSC and in vitro drug release characteristics. The formulations exhibited particle sizes ranging from 790.7 to 876.7 µm, with EE between 72.07% and 85.68% and DC ranging from 71.92% to 82.55%, respectively. Swelling studies demonstrated minimal expansion in simulated gastric fluid (SGF, pH 1.2) and maximum swelling in simulated intestinal and colonic environments (SIF, pH 6.8 and SCF, pH 7.4), indicated for its pH-responsive behaviour. The drug release kinetics confirmed for anomalous (non-Fickian) transport mechanism that was aligning closely with the Higuchi and Korsmeyer–Peppas models. The stability studies indicated for good physicochemical stability under both long-term and accelerated temperature conditions. Furthermore, in vitro cytotoxicity studies on HT-29 cell lines demonstrated enhanced anticancer activity of the optimized microbead compared to pure drug and standard drug, while in vivo roentgenographic evaluation confirmed for successful colonic targeting of CAP respectively. These findings suggested that dual-crosslinked microbeads offer a promising platform for efficient specific delivery of CAP into the bioenvironment of colon region.