Identification of Critical Quality Attributes of Sodium Polyacrylate(Partially neutralized)for Gel Plaster Based on Statistical Analysis
Objective:This study aims to examine the physicochemical properties of sodium polyacrylate(partially neutralized)from various manufacturers.It analyzes critical quality attributes and investigates their relationship with gel plaster performance indicators.The goal is to provide a reference for selecting suitable excipients for gel plaster.Methods:We characterized six samples from three manufacturers and employed statistical analysis to identify critical quality attributes.Two types were selected to prepare gel plaster.The impact on adhesion and in vitro release was evaluated.A random forest model validated the influence of the identified critical quality attributes.Results:Significant differences were observed in the physicochemical properties of samples from different manufacturers.Six critical quality attributes were identified:viscosity,particle size D90,pH value,low polymer,acrylic residual monomer,and loss on drying.The random forest model confirmed these attributes'substantial impact on plaster performance.Conclusion:The six identified critical quality attributes are key factors affecting sample properties and gel plaster performance.Optimizing these attributes can enhance plaster adhesion and drug release characteristics.This study presents a statistical approach to identify critical quality attributes of sodium polyacrylate(partially neutralized).However,the small sample size limits the study.Future research should validate these findings on a larger scale.
万方数据
维普
