title: Formulation development and evaluation of zolmitriptan oral soluble films using 22factorial designs.
abstract: OBJECTIVE
  The present investigation involves the development of zolmitriptan oral soluble film (OSF) formulations and optimization with quality by design (QBD) using natural polymers and evaluation.
  
  
  METHODS
  Initially, various natural polymers such as sodium alginate, pectin, and gelatin were screened by casting films using solvent casting technique and the prepared films were evaluated. Based on the physical and mechanical properties, sodium alginate was selected as best film former and zolmitriptan-loaded films were casted. The formulation was optimized with the help of 22factorial experimental designs (QBD) in which sodium alginate concentration and plasticizer concentrations were used as factors and at two levels. The drug-loaded films were evaluated for various mechanical, physicochemical properties, andin vitrodrug release properties. Factor effects were interpreted by calculating the main factor effects and by plotting the interaction plots.
  
  
  RESULTS
  Thickness of the films, disintegration time, and percent drug loading efficiency were in the range of 0.698 ± 0.13-1.318 ± 0.22 mm, 175 ± 3.1-280 ± 1.7 s, and 68.34 ± 0.5-94.70 ± 0.7% w/v, respectively. Cumulative percent drug released was 61.8 ± 2.6-94.7 ± 4.1% after 30 min. Polymer concentration at two levels of plasticizer had statistically significant effect on drug loading efficiency andin vitrodrug release rate.X2formulation was found to be excellent in drug loading efficiency andin vitrodrug release profiles; hence, drug excipient compatibility studies using Fourier transform infrared spectroscopy and stability studies for 60 days were carried out forX2formulation and found to be stable.
  
  
  CONCLUSIONS
  Sodium alginate OSFs containing zolmitriptan was successfully prepared, optimized, and evaluated.
authors.affiliation: Department of Pharmaceutics, Hindu College of Pharmacy, Guntur, Andhra Pradesh, India.
authors.forename: Poluri
authors.initials: P
authors.lastname: Koteswari
authors.affiliation: Department of Pharmaceutics, Vignan Pharmacy College, Guntur, Andhra Pradesh, India.
authors.forename: G Puja
authors.initials: GP
authors.lastname: Sravanthi
authors.affiliation: Department of Pharmaceutics, Vignan Pharmacy College, Guntur, Andhra Pradesh, India.
authors.forename: M
authors.initials: M
authors.lastname: Mounika
authors.affiliation: Department of Pharmaceutics, Vignan Pharmacy College, Guntur, Andhra Pradesh, India.
authors.forename: S K
authors.initials: SK
authors.lastname: Mohammed Rafi
authors.affiliation: Department of Pharmaceutics, Vignan Pharmacy College, Guntur, Andhra Pradesh, India.
authors.forename: K
authors.initials: K
authors.lastname: Nirosha
keywords: Interaction plots; oral soluble film; quality by design; sodium alginate; zolmitriptan