Mucoadhesive Buccal Film Infused with Berberine Hydrochloride for Management of Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) has become pandemic as an increasingly prevalent metabolic disorder that is characterized by insulin resistance, progressive β-cell failure and chronic hyperglycemia with serious microvascular and macrovascular complications. Although there are numerous traditional antidiabetic treatments, they are commonly associated with drawbacks of long-term use including poor patient compliance, systemic effects, requirement for multiple dosing and extensive first pass metabolism. Berberine hydrochloride, as an isoquinoline alkaloid extracted from various medicinal plants like Berberis species, has shown a potential in the treatment of diabetes mellitus by targeting on the activation of AMP-activated protein kinase (AMPK), improvement of insulin sensitivity and inhibition of gluconeogenesis and regulation lipid metabolism. And high oral bioavailability of hesperidin can hardly be achieved due to extremely low oral and intestinal absorption and a considerable first-pass effect in the liver.The limitation can be addressed by resorting to mucoadhesive buccal drug delivery systems, which offer the possibility of direct absorption through the buccal mucosa with avoidance of first-pass hepatic metabolism and enhancing systemic bioavailability. Buccal film have drawn interest due to their unique benefits of comfort in administration, fast onset of action, long duration of time at the application site, enhanced patient compliance and drug release control. This review is an attempt to summarize the epidemiology and pathophysiology of T2DM, conventional as well as novel antidiabetic drug delivery systems and pharmacological profile of berberine hydrochloride. Attention is given to the justification for delivering a product by the buccal route, anatomy and physiology of oral cavity, mucoadherent forces, ingredients of formulations and manufacturing methods and assessment parameters of mucoadhesive films.