Mitali Patel
India
Research Article
A Quality by Design Concept on Lipid Based Nanoformulation Containing
Antipsychotic Drug: Screening Design and Optimization using Response
Surface Methodology
Author(s): Mitali Patel and Krutika SawantMitali Patel and Krutika Sawant
The purpose of this study was to implement Quality by Design (QbD) concept to Solid Lipid Nanoparticles (SLN) containing Asenapine maleate (AM) in order to identify critical process and formulation variables which can affect product quality such as particle size (PS) and entrapment efficiency (EE). Initially, risk assessment using ishikawa diagram and preliminary investigation of critical variables was carried out. Two statistical designs were used to optimize critical variables which can affect product quality attributes i.e. PS and EE. Plackett Burman Design (PBD) was used to screen 8 variables and results showed that lipid concentration, surfactant concentration and sonication time had significant effect on PS and EE. These critical factors were further optimized using Central Composite Design (CCD), a type of response surface methodology, to assess its effect on PS and EE. Design .. View More»
DOI:
10.4172/2157-7439.1000442