Fabrication and Characterization of Buccal Film Loaded Self-emulsifying Drug Delivery SystemcontainingLysiphyllum strychnifolium Stem Extracts.

Abstract

Lysiphyllum strychnifolium has long been used as a popular herbal medicinal plant for treating fever and alcohol intoxication. This study aimed to prepare buccal film for L. strychnifolium stem extracts. These extracts were less soluble in water and were therefore loaded in self-emulsifying systems before being mixed into the film. Astilbin was selected as a chemical marker in L. strychnifolium stem extracts. Firstly, the L. strychnifolium stem extracts were entrapped in the self-emulsifying systems which were designed and optimized based on 32 factorial design. The optimal formulation was 0.60 g of surfactant-co-surfactant mixture (Tween® 80 and polyethylene glycol 400 in the ratio of 7.5:1) and 0.40 g of caprylic/capric triglyceride. Secondly, the optimal self-emulsifying system was loaded in the polymeric film which consisted of polyvinyl alcohol blended with poloxamer 407 using glycerin as a plasticizer. The properties of the prepared buccal film were unchanged, and the film showed an amorphous state, indicating all ingredients might be completely dissolved in the film. The buccal film could be placed in direct contact with the mouth without oral mucosal irritation, and showed a smooth and homogeneous surface with a rough and compact cross-sectional morphology. Astilbin content in the buccal film was 61.39 ± 11.45 µg/cm2. Astilbin was released from the buccal film while the permeation rate was low. The release mechanism was both swelling and diffusion, and followed anomalous or non-Fickian transfer. The permeability coefficient of the cumulative amount of astilbin permeated from buccal film was 1.0192 ± 0.1395 ×10-3 cm/h. Thus, the buccal film can be prepared by using a self-emulsifying system for herbal applications and shows potential as a safe and convenient form of oral drug administration.