Archives of Pharmaceutical Science and Research

 
  E-ISSN 0975-2633, PRINT ISSN 0975-5284  
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  CONTENT  
 
VOLUME 16 ISSUE 2
JUNE 2026
    
     
  Review Article
   

 

DEVELOPMENT OF PLACKETT–BURMAN DESIGN OF
EXPERIMENTAL IN THE OPTIMIZATION OF ONDANSETRON MUCOADHESIVE NASAL SPRAY

Yadav Karthika, S Rajarajan, Beny Baby, K.Ramesh
 
ABSTRACT
 

The present investigation aimed to design and optimize a mucoadhesive nasal spray formulation of ondansetron hydrochloride to overcome the limitations of oral administration, particularly extensive first-pass metabolism and delayed onset of action. Intranasal delivery was selected as a promising route to achieve rapid absorption, improved bioavailability, and potential direct brain targeting.
A Plackett–Burman experimental design was employed to systematically screen the influence of critical formulation variables, including mucoadhesive polymers, viscosity modifiers, and co-solvents, on key performance attributes. Thirteen randomized trials were conducted to evaluate the effects of these factors on viscosity, pH, drug content uniformity, spray pattern, and mucoadhesive strength. In-vitro diffusion studies using Franz diffusion cells and ex-vivo permeation studies across goat nasal mucosa confirmed efficient drug release and permeation. Statistical analysis (ANOVA) validated the model, identifying significant variables that governed formulation performance.

The optimized nasal spray exhibited desirable physicochemical properties, consistent drug content, and uniform spray delivery. Ex-vivo studies demonstrated successful permeation through nasal mucosa, supporting the feasibility of intranasal administration. Stability testing under ICH accelerated conditions confirmed the robustness of the optimized formulation. Overall, the study establishes that ondansetron hydrochloride nasal spray, optimized using the Plackett–Burman design, offers a viable alternative to oral administration. The formulation provides enhanced bioavailability, rapid onset of therapeutic action, and improved patient compliance, highlighting its potential as an effective dosage form for clinical use.		  
 

Keywords –Plackett–Burman; Mucoadhesive nasal spray; optimization; statistical analysis.

  
     
     
     
     
     
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