Quality by design approach for optimizing preparation and characterization of buccal film formulation with different polymers

Aksu B., Coşkunmeriç N., Yeğen G., Özalp Y., Okur N. Ü.

International Journal of Pharmaceutical Research, vol.11, pp.1153-1160, 2019 (Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 11
  • Publication Date: 2019
  • Journal Name: International Journal of Pharmaceutical Research
  • Journal Indexes: Scopus
  • Page Numbers: pp.1153-1160
  • Keywords: Buccal drug delivery, Film, Quality by design
  • Istanbul Medipol University Affiliated: Yes


Bilayered oromucosal film preparations (buccal films) offer a promising way to enable drug administration via the oral cavity. Polymeric film formulations containing chitosan, sodium alginate or carbopol were evaluated to select a formulation for the development of buccal drug delivery systems. Quality by Design (QbD) is increasingly becoming an important and widely used approach in the pharmaceutical industry. QbD requires producing an understanding of the critical variables affecting the attribues of products. In this study, the principles of QbD have been uniquely applied to 54 different kinds of film formulation contain different excipients as Chitosan, Carbopol, Sodium Alginate, Glycerine, PEG 400, Propylene Glycol to obtain appropriate buccal formulations. Each of the prepared formulations contains different ingredients combination and ingredients’ ratio (% w/v), which appear changes. For this aim, to evaluate the effects of variables to the film formulations, they were characterized as thickness, weight uniformity, swelling and moisture loss.