Formulation Development and Release Profile of Levomilnacipran Extended Release Capsules using Principles of Quality by Design

Abstract

The study’s goal was to use Quality By Design (QbD) principles to design an Extended Release dosage form of levomilnacipran and evaluate its in vitro release profile. Doses of levomilnacipran extended release capsules (LERC) ranging from 20 mg to 120 mg. QbD was employed in this work to design LERC capsule formulation and production, which ensures LERC safety and efficacy. To create the LERC, wurster coating was applied to non-pariel seeds, which were then filled with capsules. To provide prolonged absorption, a polymer derived from ethylcellulose was chosen. Extensive release capsules are made up of four main components: (1) Drug layering, (2) extended release coating, (3) lubricant application, and finally (4) capsule filling. Results revealed that there was no significant difference in release profile LERC in different doses; however, the highest release of drug was seen at 120 mg, that is, 93%. The present formulation may be used as an effective treatment therapy against major depressive disorder.