Formulation and evaluation of fast dissolving sublingual films of rizatriptan benzoate

Authors

  • Afaf Ramadan Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy (Girls), Al- Azhar University, Cairo, Egypt
  • Shereen El-Adawy Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt
  • Heba Hamdi Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), Cairo, Egypt

Keywords:

Rizatriptan benzoate, fast dissolving sublingual film, solvent casting technique, stability studies, pharmacokinetics

Abstract

Rizatriptan benzoate is anti-migraine drug which has oral bioavailability of 47% due to hepatic first pass metabolism. The present study investigated the possibility of developing fast dissolving sublingual films to provide rapid drug onset. Nine formulae were prepared with different concentrations 1%, 2%, and 3% of carboxymethyl cellulose, hydroxypropyl methylcellulose E6 and E15 as water soluble polymers, by solvent casting technique. The prepared films were subjected to characterization for thickness, weight variations, folding endurance, surface pH, disintegration time, drug content and in-vitro drug release. Compatibility between drug and polymers were studied.  Film with 1% CMC was disintegrated in time of 30 seconds with rapid drug release 100% in 120 seconds. Stability study was carried out within 90 days for formulae chosen F1, F2, F4 and F7. They were stored at 40 oC/45% RH and 50 oC/45% RH. Highest percent drug remained was detected in formula F1 which was evaluated for in vivo release studies using human volunteers. The peak serum concentration (Cmax), half time (T½), time for maximum plasma concentration (Tmax) and area under curve (AUC) were calculated. Tmax for the sublingual film was faster than conventional oral route.

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Published

2015-03-05

How to Cite

Afaf Ramadan, Shereen El-Adawy, & Heba Hamdi. (2015). Formulation and evaluation of fast dissolving sublingual films of rizatriptan benzoate. World Journal of Pharmaceutical Sciences, 3(3), 609–621. Retrieved from https://wjpsonline.com/index.php/wjps/article/view/fast-dissolving-sublingual-films-rizatriptan-benzoate

Issue

Section

Research Article