Abstract
Mucoadhesive buccal film is developed as a promising dosage form, which has prominent advantages because of drug delivery through buccal mucosa. New formulation of buccal films containing rizatriptan benzoate (RB) was prepared by solvent casting method using various concentrations of hydroxypropyl methylcellulose (HPMC K4M), polyvinyl alcohol (PVA), polyethylene oxide (PEO), glycerol, stevia, and goat buccal mucosa used as a model membrane. In this work, the effect of polymers and plasticizer concentrations on drug release profile, disintegration and dissolution time, mechanical properties, and mucoadhesive characteristics of films was studied. Scanning electron microscopy analysis revealed uniform distribution of RB in film formulations. Chemical compounds and thermal analysis of the films were studied by Fourier transform infrared spectroscopy and differential scanning calorimetry, respectively. The buccal films produced were uniform in drug content and thickness. All formulations have in vitro release of 98–102% between 40 and 80 min. Also ex vivo mucoadhesion strength was in the range of 0.205 ± 0.035 to 0.790 ± 0.014 N for all formulations. A formulation consisting RB (50 mg), HPMC K4M, PVA, and PEO (63 mg), glycerol (1.5 ml), stevia (5 mg) was selected as our optimum composition. More satisfactory results were obtained in terms of disintegration and dissolution time, mechanical properties, and mucoadhesive characteristics. In addition, it showed about 99.89% RB released in 45 min. The results suggest that RB-loaded mucoadhesive buccal films could be a potential candidate to achieve optimum drug release for effective treatment of migraine.
Highlights
Novel drug delivery systems enhance bioactivity and bioavailability of drugs and reduce their side effects (Lopez et al 2015)
New formulation of buccal films containing rizatriptan benzoate (RB) was prepared by solvent casting method using various concentrations of hydroxypropyl methylcellulose (HPMC K4M), polyvinyl alcohol (PVA), polyethylene oxide (PEO), glycerol, stevia, and goat buccal mucosa used as a model membrane
RB release kinetic was evaluated based on four mathematical models: zero order, first order, Higuchi, and Korsmeyer– Peppas (Mathiowitz 1999; Siepmann et al 2011)
Summary
Novel drug delivery systems enhance bioactivity and bioavailability of drugs and reduce their side effects (Lopez et al 2015). Oral cavity mucosa is one of the most suitable drug administration routes This route has many advantages such as preventing drug degradation in gastrointestinal tract, by passing first pass hepatic metabolism, low enzymatic activity, and more patient acceptance compared to ocular, nasal, rectal, and vaginal. It can permeate low molecular weight drugs through mucosal epithelium quickly because of high surface area of oral mucosal layer when compared to ocular and nasal (Rana and Murthy 2013; Sattar et al 2014; Silva et al 2015). Minimum side effects, more accurate dosing than drops or syrup formulations, and larger surface area for drug absorption, mucoadhesive buccal films are more preferable than other forms (Khan et al 2016; Scarpa et al 2017)
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