Formulation and in vitro Evaluation of pH Dependent Colon Targeted Controlled Release Tablet of Mesalamine Containing Cyamopsis tetragonoloba Gum and Sodium Alginate

Objectives: The goal of the study was to treat ulcerative colitis by targeting drug delivery to the colon via the novel ingredient’s guar gum and pH-dependent polymer sodium alginate. The drug was released at a high pH in the colon due to the sodium alginates. Guar gum was a novel ingredient that was used as a release retarder, binder, and swelling agent. The galactomannan enzyme naturally degrades the guar gum. Because this enzyme is only found in the human body’s GIT colon, the tablet colon is naturally target-specific. Materials and Methods: The tablet was prepared through wet granulation using an IPA solution. The formed granules subjected to the pre-formulation studies had free flow ability and a uniform size or shape. After the pre-formulations, the tablets were formed using the ZP-17 machine, and post-compression studies such as the hardness test, friability test, weight variation test, and thickness or diameter test were performed. Results: The precompression and post-compression studies, including the hardness test, friability test, weight variation test, and thickness or diameter test, were in the specification. The disintegration test was performed on the tablets, but due to the swelling nature of guar gum, they did not disintegrate. The dissolution studies were performed for 24 hr using acidic and basic buffers. The drug releases at a basic pH of 7.4 in the presence of the galactomannose enzyme, which shows its pH dependence and colon targeting. The various kinetic models were used to release kinetic models. According to the kinetic release studies, the R2 explained that formulations were controlled releases and followed the zero order, which is independent of drug concentration.