Design, development, and evaluation of spray dried flurbiprofen loaded sustained release polymeric nanoparticles using QBD approach to manage inflammation
Shilpa R. Mandpe, Eknath Kole, Vishal R. Parate, Aniruddha Chatterjee, Arun S. Mujumdar, Jitendra Naik
Abstract
Spray-dried Flurbiprofen (FLB) loaded polymeric nanoformulation using Eudragit L 100 and Ethylcellulose. They were optimized and evaluated. This study determined drug release (%) and encapsulation efficiency (%) by developing a nanoparticulate system using the design of experiment (DoE) approach. FLB is slightly soluble in water; it dissolves slowly and has a low oral bioavailability. FLB-loaded polymeric nanoparticles were produced by solvent evaporation and Spray drying technology. In this research, nanoparticle formulation was prepared by screening and optimization by approaching two different statistical methods (Plackett-Burman and Central composite Designs). The polymeric nanoparticles were evaluated for various characteristics, including drug release, percentage of encapsulation efficiency, X-ray diffraction (X-RD), surface morphology, and Fourier transform infrared (FTIR) spectroscopy. Based on the X-RD analysis, it was found that the drug was successfully incorporated into the polymeric nanoparticles. As a result of nanoparticles containing FLB, % Drug release values were found to be nearly 85-90% increased while % EE was observed in the range of 79-89%. An excellent sustained release, i.e., 14 h, is possible by combining Ethylcellulose (EC) and Eudragit L 100 (ED-100) polymers. The results are beneficial in identifying the ideal formulation parameters for effective encapsulation.Abbreviations: FLB: Flurbiprofen; API: Active pharmaceutical ingredient; DR: Drug release; EE: Encapsulation efficiency; DoE: Design of experiment; X-RD: X-ray diffraction; FTIR: Fourier transform infrared spectroscopy.; PVA: Polyvinyl alcohol; EC: Ethylcellulose; EUGD: Eudragit L 100; NPs: Nanoparticles; PBD: Placket- Burman Design; CCD: Central Composite Design; CMV: Critical method variables; GIT: Gastrointestinal track; SLN: Solid lipid nanoparticles; NLC: Nanostructured lipid carriers; NSAID: Nonsteroidal anti-inflammatory drug; BCS: Biopharmaceutical classification system; PS: Particle size; PDI: Polydispersity Index; ZP: Zeta potential; FE-SEM: Field emission scanning electron microscopy; 2D: 2 Dimensional; 3D: 3 Dimensional