Sandeep K Ramineni1, Thomas D Dziubla2, Larry L Cunningham3, David A Puleo4. 1. Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA. 2. Department of Chemical and Materials Engineering, University of Kentucky, Lexington, KY, USA. 3. College of Dentistry, University of Kentucky, Lexington, KY, USA. 4. Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA. Electronic address: puleo@uky.edu.
Abstract
OBJECTIVE: To investigate the ability of mucoadhesive films to locally deliver an immune response modifier (imiquimod) to oral mucosa. STUDY DESIGN: 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. CONCLUSION: 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.
OBJECTIVE: To investigate the ability of mucoadhesive films to locally deliver an immune response modifier (imiquimod) to oral mucosa. STUDY DESIGN: 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. CONCLUSION: 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: Sandeep K Ramineni; Craig B Fowler; Paul D Fisher; Larry L Cunningham; David A Puleo Journal: Biomed Mater Date: 2015-03-02 Impact factor: 3.715
Authors: Tomasz Osmałek; Anna Froelich; Barbara Jadach; Adam Tatarek; Piotr Gadziński; Aleksandra Falana; Kinga Gralińska; Michał Ekert; Vinam Puri; Joanna Wrotyńska-Barczyńska; Bozena Michniak-Kohn Journal: Pharmaceutics Date: 2021-06-15 Impact factor: 6.321