Volume : 13, Issue : 07, July – 2026
Title:
DESIGN, FORMULATION DEVELOPMENT, OPTIMIZATION, CHARACTERIZATION, AND EVALUATION OF A COLON-TARGETED DRUG DELIVERY SYSTEM OF MESALAMINE
Authors :
Prakash Ganesh Devake*, Dr. Mahesh Shrikant Patil, Dr. Ravi Uttamrao Kurhade,Mrs. Nishigandha Ganpatrao Shinde
Abstract :
Background: Colon-targeted drug delivery systems have attracted considerable attention for the effective management of inflammatory bowel diseases by delivering drugs specifically to the colon while minimizing premature drug release in the upper gastrointestinal tract. The present study aimed to develop and optimize a colon-targeted matrix tablet of Mesalamine using natural polysaccharide polymers.
Methods: Mesalamine matrix tablets were formulated using Xanthan gum and Guar gum as release-retarding polymers through the wet granulation technique. A 3² full factorial design was employed to optimize the formulation by evaluating the influence of polymer concentrations on swelling behavior and drug release characteristics. The prepared formulations were subjected to preformulation studies, FTIR compatibility analysis, pre- and post-compression evaluation, swelling index determination, in vitro dissolution studies under simulated gastrointestinal conditions, and accelerated stability testing.
Results: All formulations exhibited satisfactory flow properties and complied with pharmacopoeial specifications for hardness, friability, weight variation, thickness, and drug content. Swelling studies demonstrated progressive hydration with increasing polymer concentration, resulting in enhanced gel formation and sustained drug release. In vitro dissolution studies showed minimal drug release in simulated gastric (3.53–5.90%) and intestinal (29.82–37.13%) media, while maximum drug release (62.52–69.53%) occurred under simulated colonic conditions within 12 h, confirming effective colon targeting. Statistical optimization identified formulation F3 as the optimized formulation, exhibiting desirable swelling characteristics, controlled drug release, and excellent matrix integrity. Accelerated stability studies conducted at 40 ± 2°C/75 ± 5% RH for six months demonstrated no significant changes in the dissolution profile or physical characteristics of the optimized formulation.
Conclusion: The developed Mesalamine colon-targeted matrix tablets successfully achieved site-specific and sustained drug delivery using natural biodegradable polymers. The optimized formulation demonstrated excellent pharmaceutical performance, stability, and colon-specific drug release, suggesting its potential as an effective oral delivery system for the management of ulcerative colitis and other inflammatory bowel diseases.
Keywords: Mesalamine; Colon-targeted drug delivery; Matrix tablets; Xanthan gum; Guar gum; 3² Full Factorial Design; Controlled drug release; Swelling index; Ulcerative colitis; Inflammatory bowel disease.
Cite This Article:
Please cite this article in press Prakash Ganesh Devake et al., Design, Formulation Development, Optimization, Characterization, And Evaluation Of A Colon-Targeted Drug Delivery System Of Mesalamine, Indo Am. J. P. Sci, 2026; 13(07).
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