This study aims to optimize the concentrations of hydroxypropyl methyl cellulose (HPMC) K4M and Eudragit L100-55 (methacrylic acid) in formulation of extended-release tablets containing guanfacine hydrochloride by employing a 3 2 -factorial design approach.Extended-release tablets of guanfacine hydrochloride reduce the need for frequent dosing to achieve the desired therapeutic outcomes.Cumulative drug release after 1, 8, and 20 hours of dissolution were taken as target responses and concentrations for both polymers as the variables.3D response surface and polynomial equations were generated for choosing the optimized formulation with the most favorable response.Suitability of the drug and excipients was assessed during preliminary evaluation and compatibility studies using an accelerated thermal stress study.The release kinetics of the formulations followed Hixson Crowell and Higuchi models, indicating slow erosion of polymer to release the drug over an extended time period.Validated optimization techniques confirmed predictability of the model.The stability study verified superiority of the optimized formulation after 3 months of storage.
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Patel et al. (2023) studied this question.
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