title: A novel tri-layered buccal mucoadhesive patch for drug delivery: assessment of nicotine delivery.
abstract: OBJECTIVE
  The aim of this study was to assess the potential of a novel delivery device for administering drugs that suffer from a high degree of first-pass metabolism.
  
  
  METHODS
  A tri-layered buccal mucoadhesive patch, comprising a medicated dry tablet adhered to a mucoadhesive film, was prepared and characterized by its physicochemical properties and mucoadhesive strength. Nicotine was used as a model drug for the characterization of drug release and drug permeation. The influence of different adsorbents on the release of nicotine base from the patches was evaluated in vitro. Different molecular forms of nicotine (base and complex salt) were evaluated for their effect on release performance and permeation in vitro.
  
  
  RESULTS
  Results demonstrated acceptable physicochemical and mucoadhesive properties for the tri-layered patch. Rapid release of nicotine was observed when nicotine base was incorporated with calcium sulfate dihydrate as the adsorbent. Patches incorporating nicotine base showed distinct advantages over those containing nicotine polacrilex, in terms of drug release (complete drug release achieved at 30 vs 60 min) and transmucosal permeation (37.28 ± 4.25 vs 2.87 ± 0.26% of the dose permeating through mucosa within 120 min).
  
  
  CONCLUSIONS
  The novel tri-layered patch can effectively adhere to, and deliver an active ingredient through the buccal mucosa, confirming its potential for buccal mucoadhesive drug delivery.
authors.affiliation: Sansom Institute for Health Research, Division of Health Sciences, University of South Australia, Adelaide, SA, Australia.
authors.forename: Shasha
authors.initials: S
authors.lastname: Rao
authors.forename: Yunmei
authors.initials: Y
authors.lastname: Song
authors.forename: Frank
authors.initials: F
authors.lastname: Peddie
authors.forename: Allan M
authors.initials: AM
authors.lastname: Evans
mesh_terms: D000269:Adhesives; D000278:Administration, Buccal; D058956:Administration, Mucosal; D000327:Adsorption; D000818:Animals; D002133:Calcium Sulfate / Q000737:chemistry; D016503:Drug Delivery Systems / Q000379:methods*; D006801:Humans; D009055:Mouth; D009061:Mouth Mucosa; D009538:Nicotine / Q000008:administration & dosage*; D013552:Swine; D013607:Tablets; D013678:Technology, Pharmaceutical
chemical_list: D000269:Adhesives; D013607:Tablets; D009538:Nicotine; D002133:Calcium Sulfate