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<p>Mesalamine (MES) and curcumin (CUR) are long known to have anti-inflammatory and antioxidant effects, which make them viable options in the control of inflammatory bowel disease. However, they have low water solubility and oral bioavailability. To address such limitations, a mesalamine and curcumin co-loaded self-nanoemulsifying drug delivery system (SNEDDS) was developed. The systematic optimisation of the formulation was performed, using a central composite design approach with Capmul MCM, Tween 80 and Transcutol P as oil, surfactant and co-surfactant, respectively. The optimised SNEDDS had an average size of 137.54 ± 1.58&#xa0;nm, polydispersity index (0.286 ± 1.41) and zeta potential (-17.25 ± 2.83 mV), which implies a homogenous and stable nanoemulsion. The loading efficiency of MES as well as CUR was found to be 86.38 ± 2.18% and 79.63 ± 1.93%, respectively. Also, results of the in-vitro release studies indicated that both drugs had a faster dissolution rate when SNEDDS was used as compared to the physical mixture. The results of cytotoxicity tests using MTT showed significant cell viability at all the concentrations, which confirms the biocompatibility of the formulation. Moreover, in vitro anti-inflammatory activity was estimated in Caco-2 and HT-29 cell lines, indicating a significant downregulation in the pro-inflammatory biomarkers such as TNF-alpha, IL-6, and nitric oxide, in a dose-dependent manner. Stability studies were also done as recommended by ICH Q1(R2) and showed stability in physical and chemical properties after three months. Overall, the outcomes demonstrated that the mesalamine and curcumin SNEDDS was a stable, safe, and effective delivery system, providing significant potential as a localised oral medication in IBD.</p> Graphical Abstract <p></p>

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QbD-Oriented Optimisation of Dual Drug-Loaded SNEDDS of Mesalamine and Curcumin for Enhanced Oral Delivery in Inflammatory Bowel Disease

  • 期刊论文

  • 发表日期：

    2026年3月20日

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  • Raj Kamal,
  • Abhishek Chauhan,
  • Sonia Dhiman,
  • Thakur Gurjeet Singh,
  • Mohit Kumar,
  • Ankit Awasthi

摘要

Mesalamine (MES) and curcumin (CUR) are long known to have anti-inflammatory and antioxidant effects, which make them viable options in the control of inflammatory bowel disease. However, they have low water solubility and oral bioavailability. To address such limitations, a mesalamine and curcumin co-loaded self-nanoemulsifying drug delivery system (SNEDDS) was developed. The systematic optimisation of the formulation was performed, using a central composite design approach with Capmul MCM, Tween 80 and Transcutol P as oil, surfactant and co-surfactant, respectively. The optimised SNEDDS had an average size of 137.54 ± 1.58 nm, polydispersity index (0.286 ± 1.41) and zeta potential (-17.25 ± 2.83 mV), which implies a homogenous and stable nanoemulsion. The loading efficiency of MES as well as CUR was found to be 86.38 ± 2.18% and 79.63 ± 1.93%, respectively. Also, results of the in-vitro release studies indicated that both drugs had a faster dissolution rate when SNEDDS was used as compared to the physical mixture. The results of cytotoxicity tests using MTT showed significant cell viability at all the concentrations, which confirms the biocompatibility of the formulation. Moreover, in vitro anti-inflammatory activity was estimated in Caco-2 and HT-29 cell lines, indicating a significant downregulation in the pro-inflammatory biomarkers such as TNF-alpha, IL-6, and nitric oxide, in a dose-dependent manner. Stability studies were also done as recommended by ICH Q1(R2) and showed stability in physical and chemical properties after three months. Overall, the outcomes demonstrated that the mesalamine and curcumin SNEDDS was a stable, safe, and effective delivery system, providing significant potential as a localised oral medication in IBD.

Graphical Abstract