Scalable Design and Development of Modified Release Hydrochlorothiazide Formulation Employing Quality by Design Approach

Myocardial infarction, generally known as ‘heart attack’ occurs predominantly during the early morning hours and a cause of millions death worldwide. Hydrochlorothiazide is recommended drug for prevention heart disease, but commercial market lacks its long action (>4 h) formulation. The endeavor present research was to develop quality product profile hydrochlorothiazide modified release tablets (~14 h release) by applying computational design approach. Three independent factors were identified qualitative quantitative risk assessment. Selected dependent variables cumulative percent dissolved in 2, 5, 8 12 h. Graphical tools like half normal, normal Pareto charts used manage model selection. graphical relationship among critical, represented using contour plot three-dimensional surface plot. Design space plotting overlay three factors, two-level full factorial design. Outstanding correlation observed between predicted actual values. Similarity factor (F2) reproducible trials 78 79, content uniformity 100.9 % 100.4 %. Average weight, hardness, thickness, diameter friability within acceptable limits. Quality approach, along with management tool furnished an efficient effective paradigm structure hydrochlorothiazide.