Development and evaluation of sustained release matrix tablets of pregabalin: A case study based on quality by design to analyze the impact of variables.

The current research work describes systematic development of sustained release matrix tablets of a hydrophilic drug, pregabalin, using employing rational blend of hydrophilic polymers such as polyoxyethylene and carbomer as the release controlling polymers. As per the QbD-based approach, the patient-centric quality target product profile was defined and critical quality attributes were earmarked. Preliminary studies were conducted for screening the formulation and process variables. Systematic optimization of the highly critical and influential formulation variables were optimized with the help of an orthogonal experimental design. The impact of independent factors such as the amount of polyvinyl pyrrolidone, polyethylene oxide and carbomer 971P was optimized on in vitro drug release parameters at different time points as the dependent factors. The optimized tablet formulation was subjected to film coating with opadry color concentrate with the help of standard pan coating process. Further, the process optimization was performed for evaluating the impact of key process parameters on the quality attributes of the drug product. Overall, the study indicated successful development of the sustained release tablet formulation of pregabalin using hydrophilic polymers, where experimental design use provides significantly benefit in the product and process understanding.