FORMULATION AND EVALUATION OF NOVEL CHROMENE DERIVATIVE AS AN ANTI INFLAMMATORY AGENT USED FOR IBD
Objective: To formulate and evaluate an extended-release (ER) tablet of a new molecule, 2-amino-4-(4-bromophenyl)-7-hydroxy-4H-chromene-3- carbonitrile using a combination of two polymers (hydroxypropyl methyl cellulose [HPMC] K100 and HPMC phthalate) which control the rate and degree of the drug release through 12 hrs period and protect the drug release from acidic pH.
Methods: Five batches of tablets (4HC1, 4HC2, 4HC3, 4HC4, 4HC5) were produced by direct compression method. Morphological evaluation of the powder blend was carried out by differential scanning calorimetry and Powered X-ray diffractometry. The evaluation studies such as flow properties, hardness, friability, drug content, and release study were conducted according to pharmacopoeial standards.
Results: The physicochemical characteristics of all the granules and tablets were generally satisfactory. The drug release followed zero order, Higuchi model kinetics with diffusion and dissolution mediated mechanism. Tablets were evaluated for physicochemical parameters and promising. Stability studies indicated the dosage form is stable for 3 months at accelerated conditions.
Conclusion: From the results received from all test, it was concluded that formulation 4HC4 are the most suitable choice for developing 12 hrs ER
tablets. This finding reveals that a particular concentration of HPMC K100 was capable of producing ER.
Keywords: Chromene derivative, Extended-release, Hydroxypropyl methylcellulose phthalate, Hydroxypropyl methylcellulose K100.
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