title: Formulation, optimization and characterization of cationic polymeric nanoparticles of mast cell stabilizing agent using the Box-Behnken experimental design.
abstract: OBJECTIVE
  The present research work was intended to develop and optimize sustained release of biodegradable chitosan nanoparticles (CSNPs) as delivery vehicle for sodium cromoglicate (SCG) using the circumscribed Box-Behnken experimental design (BBD) and evaluate its potential for oral permeability enhancement.
  
  
  METHODS
  The 3-factor, 3-level BBD was employed to investigate the combined influence of formulation variables on particle size and entrapment efficiency (%EE) of SCG-CSNPs prepared by ionic gelation method. The generated polynomial equation was validated and desirability function was utilized for optimization. Optimized SCG-CSNPs were evaluated for physicochemical, morphological, in-vitro characterizations and permeability enhancement potential by ex-vivo and uptake study using CLSM.
  
  
  RESULTS
  SCG-CSNPs exhibited particle size of 200.4 ± 4.06 nm and %EE of 62.68 ± 2.4% with unimodal size distribution having cationic, spherical, smooth surface. Physicochemical and in-vitro characterization revealed existence of SCG in amorphous form inside CSNPs without interaction and showed sustained release profile. Ex-vivo and uptake study showed the permeability enhancement potential of CSNPs.
  
  
  CONCLUSIONS
  The developed SCG-CSNPs can be considered as promising delivery strategy with respect to improved permeability and sustained drug release, proving importance of CSNPs as potential oral delivery system for treatment of allergic rhinitis. Hence, further studies should be performed for establishing the pharmacokinetic potential of the CSNPs.
authors.affiliation: a Department of Pharmaceutics and Pharmaceutical Technology , Ramanbhai Patel College of Pharmacy (RPCP), Charotar University of Science and Technology (CHARUSAT) , Changa , Gujarat , India .
authors.forename: Balaram
authors.initials: B
authors.lastname: Gajra
authors.affiliation: a Department of Pharmaceutics and Pharmaceutical Technology , Ramanbhai Patel College of Pharmacy (RPCP), Charotar University of Science and Technology (CHARUSAT) , Changa , Gujarat , India .|b Department of Pharmaceutics , Indian Institute of Technology (Banaras Hindu University) , Varanasi , Uttar Pradesh , India.
authors.forename: Ravi R
authors.initials: RR
authors.lastname: Patel
authors.affiliation: a Department of Pharmaceutics and Pharmaceutical Technology , Ramanbhai Patel College of Pharmacy (RPCP), Charotar University of Science and Technology (CHARUSAT) , Changa , Gujarat , India .
authors.forename: Chintan
authors.initials: C
authors.lastname: Dalwadi
mesh_terms: D000818:Animals; D002412:Cations / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D048271:Chitosan / Q000737:chemistry*; D003692:Delayed-Action Preparations / Q000737:chemistry; D004337:Drug Carriers / Q000737:chemistry; D016503:Drug Delivery Systems / Q000379:methods; D005079:Excipients / Q000737:chemistry; D008407:Mast Cells / Q000737:chemistry*; D053758:Nanoparticles / Q000737:chemistry*; D010316:Particle Size; D011108:Polymers / Q000737:chemistry*; D017208:Rats, Wistar; D012107:Research Design
chemical_list: D002412:Cations; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D005079:Excipients; D011108:Polymers; D048271:Chitosan
keywords: Allergic rhinitis; Box–Behnken experimental design; chitosan nanoparticles; permeability enhancement; sodium cromoglicate