Article: In vitro-in vivo evaluation of a controlled release buccal bioadhesive device for oral drug delivery

Purpose: To investigate the use of buccal bioadhesive device in targeting controlled drug delivery to the gastrointestinal tract.

Methods: A three-leg crossover study was designed to evaluate the application of buccal bioadhesive device for providing controlled drug delivery to the gastrointestinal tract of a model drug cyanocobalamin in four healthy adult male beagle dogs.

Results: In vitro dissolution studies using deionized water as the medium indicated that 100% of the drug was released within 15 min from a immediate release oral capsule formulation, whereas 90% of the drug was released within a period of 18 hrs from a buccal bioadhesive device formulation. Drug release from the buccal bioadhesive devices appeared to follow Higuchi's square root of time dependent model. The terminal half-life of the drug following I.V. administration in four dogs was found to be 16.4+/-2.4 hrs. Following immediate release oral capsule administration of the drug Cmax, tmax and bioavailability were 2333+/-1469 ng/L, 2.5+/-1.0 hrs and 14.1+/-7.9%, respectively. Following buccal bioadhesive device administration of the drug Cmax, t(max) and bioavailability were 4154+/-1096 ng/L, 11+/-1.2 hrs and 35.8+/-4.1%, respectively. Significantly higher bioavailability of the drug was observed with the buccal bioadhesive device administration when compared to the immediate release oral capsule.

Conclusions: The buccal bioadhesive device appears to improve the oral bioavailability of cyanocobalamin by providing controlled delivery of the drug to the gastrointestinal tract.

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In Vitro-in Vivo Evaluation of a Controlled Release Buccal Bioadhesive Device for Oral Drug Delivery