title: Determination of dependencies among in vitro and in vivo properties of prepared mucoadhesive buccal films using multivariate data analysis.
abstract: Mucoadhesive films represent the most developed medical form of buccal application. Despite the intense focus on buccal film-based systems, there are no standardized methods for their evaluation, which limits the possibility of comparison of obtained data and evaluation of the significance of influence of formulation and process variables on properties of resulting films. The used principal component analysis, together with a partial least squares regression provided a unique insight into the effects of in vitro parameters of mucoadhesive buccal films on their in vivo properties and into interdependencies among the studied variables. In the present study eight various mucoadhesive buccal films based on mucoadhesive polymers (carmellose, polyethylene oxide) were prepared using a solvent casting method or a method of impregnation, respectively. An ethylcellulose or hydrophobic blend of white beeswax and white petrolatum were used as a backing layer. The addition of polyethylene oxide prolonged the in vivo film residence time (from 53.24±5.38-74.18±5.13 min to 71.05±3.15-98.12±1.75 min), and even more when combined with an ethylcellulose backing layer (98.12±1.75 min) and also improved the film's appearance. Tested non-woven textile shortened the in vivo film residence time (from 74.18±5.13-98.12±1.75 min to 53.24±5.38-81.00±8.47 min) and generally worsened the film's appearance. Mucoadhesive buccal films with a hydrophobic backing layer were associated with increased frequency of adverse effects.
authors: Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic.
authors: David
authors: D
authors: Vetchý
authors: Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic.
authors: Hana
authors: H
authors: Landová
authors: Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic. Electronic address: gajdziokj@vfu.cz.
authors: Jan
authors: J
authors: Gajdziok
authors: Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic.
authors: Petr
authors: P
authors: Doležel
authors: Clinic of Oral and Maxillofacial Surgery, University Hospital Brno, Brno, Czech Republic.
authors: Zdeněk
authors: Z
authors: Daněk
authors: Department of Maxillo-Facial Surgery, University Hospital Ostrava, Ostrava, Czech Republic.
authors: Jan
authors: J
authors: Štembírek
mesh_terms: D000268:Adhesiveness / Q000187:drug effects; D000269:Adhesives / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism*; D000278:Administration, Buccal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism*; D002626:Chemistry, Pharmaceutical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000378:metabolism*; D015999:Multivariate Analysis; D055815:Young Adult
chemical_list: D000269:Adhesives; D002266:Carboxymethylcellulose Sodium
keywords: Backing layer; Carmellose; In vitro testing; In vivo evaluation; Method of impregnation; Mucoadhesive buccal films; Multivariate data analysis; Non-woven textile; Residence time; Solvent casting method