纳米医学与纳米技术杂志

抽象的

A Quality by Design Concept on Lipid Based Nanoformulation Containing Antipsychotic Drug: Screening Design and Optimization using Response Surface Methodology

Mitali 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 space was identified and implementation of control strategy for responses generated quality of the desired product. Design space was generated for SLN for reducing intra-batch and inter-batch variability in formulation development process. Analysis of robustness of design space predicted that the formulation must be prepared in established design space to reduce batch variations. The results conclusively demonstrated the potential of QbD concept to build quality in SLN formulation.