Quality by Design Approach in the Formulation of Glibenclamide Mucoadhesive Buccal Films

Abstract

Glibenclamide, an oral hypoglycemic BCS class II drug that gets completely metabolized in the liver, serves as a suitable candidate for buccal drug delivery. The study aims to formulate and evaluate mucoadhesive buccal films (MBF) of Glibenclamide by Quality by Design approach to ensure the quality of a developed product. Initially, Plackett Burman Design was used as a screening method to determine the factors affecting the characteristics of the MBF. The selected factors were further evaluated using 3² full factorial design for confirming the effect of these variables. Responses like Drug release, mucoadhesion time, permeability were considered the main Critical Quality Attributes. The film was evaluated for swelling, mucoadhesion, folding endurance, permeability, drug release. Contour and surface response plots were used to determine the design space (DS). The formulated film gave a robust design within 1.3-1.7 % for HPMC K 15M and 0.5-1.5 % for glycerin. The optimized formulation prepared within the DS showed in-vitro drug release (80.11%), mucoadhesive strength (60.3 g), and ex-vivo permeation (82.85 %), which lies within pre-determined full ranges of Quality Target Product Profile (QTTP). The optimized formulation within the DS was in good agreement with QTPP, which ensures the accuracy and robustness of the formulation.

GRAPHICAL ABSTRACT

Keywords:

• Mucoadhesive buccal films
• Glibenclamide
• Quality by Design
• Plackett Burman design