Development of Paroxetine Hydrochloride Single Layer Controlled-Release Tablets Based on 3² Factorial Design.

ABSTRACT: Major depressive disorder (MDD) is one of the main contributors to disability and suicide mortality globally. Paroxetine hydrochloride (PHH) is the most potent antidepressant used for MDD treatment. Due to its reduced side effects PAXIL® CR is a widely-used controlled-release formulation of PHH. However, the complicated double-layer production of PAXIL® CR faces the risk of layer separation. In this study, PHH enteric coating single layer controlled-release tablets (PHH-EC-SLTs) were designed as a simplified substitution of PAXIL® CR through a rational formulation screening. The optimized PHH-EC-SLTs showed similar release behaviors in vitro to PAXIL® CR and the release profiles corresponded to a zero-order release model (R² = 0.9958). Polymer matrix erosion was the main release mechanism,

SUBMITTER: Yang Y 

PROVIDER: S-EPMC6321141 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature