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Formulation, Characterization and In Vitro Evaluation of Mesalamine and Bifidobacterium bifidum Loaded Hydrogel Beads in Capsule System for Colon Targeted Delivery

  • Research Article
  • Advancements in Modified-release Oral Drug Delivery - Delivery throughout the Gastro-intestinal Tract
  • Published:
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Abstract

Mesalamine is a first-line drug for the treatment of inflammatory bowel diseases. However, its premature release associated with marketed formulations leads to adverse effects like gastric trouble, vomiting, and diarrhoea. To minimize these side effects, colon-targeted drug delivery is essential. Besides conventional pharmacotherapy, bifidogenic probiotics with anti-inflammatory activity has been reported to elicit a significant impact on the remission of ulcerative colitis. Bifidogenic probiotics being acid-labile necessitate developing a gastro-resistant formulation for enhancing the delivery of viable cells to the colon. The present study was aimed at developing a fixed-dose unit dosage form of mucoadhesive hydrogel beads loaded with mesalamine and Bifidobacterium bifidum further encapsulated in Eudragit® capsules for the targeted drug delivery at colonic pH. The hydrogel beads were prepared by ionotropic gelation, with the effect of single and dual-crosslinking approaches on various formulation characteristics studied. Standard size 00 Eudragit® gastro-resistant capsules were prepared and the dried beads were filled inside the capsule shells. The formulation was then evaluated for various parameters, including physicochemical characterization, in vitro biocompatibility and anti-inflammatory activity. No interaction was observed between the drug and the polymers, as confirmed through FTIR, XRD, and DSC analysis. The mean particle size of the beads was ~ 457–485 µm. The optimized formulation showed a drug entrapment efficiency of 95.4 ± 2.58%. The Eudragit® capsule shells disintegrated in approximately 13 min at pH 7.4. The mucoadhesive hydrogel beads sustained the drug release above 18 h, with 50% of the drug released by the end of 12 h. The optimized formulation demonstrated significant (p < 0.05) gastro-resistance, biocompatibility, sustained drug release, cell viability, and anti-inflammatory activity.

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Acknowledgements

The authors would like to thank the Faculty of Pharmaceutical Sciences, PCTE Group of Institutes, Ludhiana, Punjab, India for their continuous support. The authors are thankful to BEC Chemicals Ltd., Mumbai, and Evonik Industries, Mumbai for providing the gift samples of mesalamine and Eudragit® S100 respectively. The authors are thankful to Consern Pharmaceuticals, Ludhiana, Punjab, India, for providing the laboratory and instrumental support.

Funding

This study was funded and supported by the Faculty of Pharmaceutical Sciences, PCTE Group of Institutes, Ludhiana, Punjab, India.

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Authors and Affiliations

  1. Faculty of Pharmaceutical Sciences, PCTE Group of Institutes, Near Baddowal Cantt, Ferozepur Rd, Ludhiana, Punjab, 142021, India

    Jagtar Singh, Mohit Sharma, Harmeet Singh & Puneet Utreja

  2. Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, SAS Nagar, Mohali, Punjab, 160062, India

    Jagtar Singh

  3. School of Bioengineering and Biosciences, Lovely Professional University, Jalandhar - Delhi, Grand Trunk Rd, Phagwara, Punjab, 144411, India

    Pinky Arora

  4. School of Pharmaceutical Sciences, Lovely Professional University, Jalandhar - Delhi, Grand Trunk Rd, Phagwara, Punjab, 144411, India

    Shubham Kumar

  5. Faculty of Medical Lab Sciences, PCTE Group of Institutes, Near Baddowal Cantt, Ferozepur Rd, Ludhiana, Punjab, 142021, India

    Pinky Arora

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  4. Pinky Arora
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Contributions

Jagtar Singh: Designed the study, conceptualization and methodology; Performed the experiments; Analysed and interpreted the data; and prepared the original draft.

Mohit Sharma: Performed the experiments, Analysed and interpreted the data.

Harmeet Singh: Supervised the study; Performed the experiments; and Analysed and interpreted the data.

Pinky Arora: Statistical analysis and interpreted the data.

Puneet Utreja: Contributed reagents; materials, tools, analytical support; and lab infrastructure.

Shubham Kumar: Supervised the study; Analysed and interpreted the data; and prepared the paper.

Corresponding author

Correspondence to Shubham Kumar.

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Singh, J., Sharma, M., Singh, H. et al. Formulation, Characterization and In Vitro Evaluation of Mesalamine and Bifidobacterium bifidum Loaded Hydrogel Beads in Capsule System for Colon Targeted Delivery. AAPS PharmSciTech 25, 61 (2024). https://doi.org/10.1208/s12249-024-02764-3

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