title: Local delivery of imiquimod in hamsters using mucoadhesive films and their residence time in human patients.
abstract: OBJECTIVE
  To investigate the ability of mucoadhesive films to locally deliver an immune response modifier (imiquimod) to oral mucosa.
  
  
  METHODS
  After determining the residence time of films in hamster cheek pouches, drug-loaded films and commercially available imiquimod cream were tested for localization of drug in mucosal tissue. The residence time of drug-free films at different locations was also tested in humans.
  
  
  RESULTS
  Mucoadhesive films delivered imiquimod to the buccal mucosa with no measureable amounts in blood. In contrast, although the cream formulation resulted in higher tissue levels, it also led to significant systemic distribution of imiquimod. In humans, the films resided on tissue for up to 4 hours, increasing in the order of tongue < cheek < gingiva.
  
  
  CONCLUSIONS
  Preclinical findings of localized imiquimod delivery in animals and residence in humans support future investigations of the mucoadhesive system in controlled clinical trials for treating oral precancerous lesions.
authors.affiliation: Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA.
authors.forename: Sandeep K
authors.initials: SK
authors.lastname: Ramineni
authors.affiliation: Department of Chemical and Materials Engineering, University of Kentucky, Lexington, KY, USA.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Dziubla
authors.affiliation: College of Dentistry, University of Kentucky, Lexington, KY, USA.
authors.forename: Larry L
authors.initials: LL
authors.lastname: Cunningham
authors.affiliation: Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA. Electronic address: puleo@uky.edu.
authors.forename: David A
authors.initials: DA
authors.lastname: Puleo
mesh_terms: D000278:Administration, Buccal; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage*; D000818:Animals; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002266:Carboxymethylcellulose Sodium / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D006224:Cricetinae; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects*; D010865:Pilot Projects; D011205:Povidone / Q000737:chemistry
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D011205:Povidone; D002266:Carboxymethylcellulose Sodium; D000077271:Imiquimod