QUALITY BY DESIGN APPROACH FOR THE FORMULATION OF DUAL RELEASE DRUG DELIVERY SYSTEM: A CHRONOMODULATED APPROACH

The focus of the current article is to prepare the chrono-modulated dual release formulation using various optimization techniques. The conventional formulations as the Controlled Release Drug Delivery System (CRDDS) are not effective in the chronomodulated formulation. The advancement in research and development in CRDDS leads to the formulation of chronomodulated formulations. Dual release tablets are those in which two drugs are given in a single tablet in different layer as to avoid the incompatibility problem or single drug is given in two different layers as maintenance dose and loading dose. The formulation is fruitful in various diseases such as diabetes, arthritis, asthma, etc., and provides compliance to the patient as a patient has no need to wake up during night hours to take the mediation. The Quality by Design (QbD) techniques is used to make the formulation as much as safe and efficacious. By applying the QbD, product variability is reduced and leads to quality improvement, risk reduction, and production enhancement. In conclusion, chronomodulated drug delivery system using QbD tools can be effective for dual-release formulation.