Optimization of Risperidone and Quercetin Solid Lipid Nanoparticles Loaded Nasal Insitu Gel by Design Expert and Quality by Design Approach

Abstract

Purpose

The objective of the current study is synthesis and optimization of Nasal Insitu Gel loaded with Risperidone (RIS) and Quercetin (QUE) Solid Lipid Nanoparticles (SLN) by Design Expert and Quality by Design (QbD)Approach.

Method

QTTP (Quality target product profile), critical process parameters (CPP), critical quality attributes (CQAs) were identified. Preliminary screening of factors which affect CPP and CQAs was carried out using Placket Burman design. SLN were prepared by solvent diffusion method. Optimization of SLN was carried by 2² (RIS) and 2³ (QUE) factorial designs. Temperature, Type of co-surfactant, Concentration of surfactant (%) were identified as independent factors and responses were recorded against Particle size, % Entrapment Efficiency. Characterization of prepared SLN were done by analysis of particle size, PDI, Zeta Potential, FTIR, Entrapment Efficiency, TEM etc., synthesized SLN were incorporated into Insitu gel which was evaluated for gelation temperature, viscosity, in-vitro drug diffusion etc.

Results

RIS SLN and QUE SLN were successfully synthesized. Particle size was found 157.4 ± 2 nm 153 ± 3 nm. Respectively. PDI was observed 0.261 for RIS SLN and 0.240 and QUE SLN. % EE were obtained 91.73 ± 2.6%, 91.73 ± 2.6% respectively indicated successful drug encapsulation. TEM study supported spherical nature. DSC and FTIR study showed successful incorporation of drugs into SLN. SLN were successfully incorporated into 18% concentration of poloxamer for formation of nasal insitu gel. In-vitro diffusion study revealed sustained and controlled drug release.

Conclusion

The study successfully developed and optimized SLNs loaded with RIS and QUE SLN for nasal administration using the QbD approach. The combination of SLNs and insitu gel provided a stable and effective nasal delivery system. The developed SLNs and insitu gel formulation are promising for nasal administration, offering a viable alternative to oral delivery by effectively bypassing first-pass metabolism and improving drug availability.