Preparation and Evaluation of a Bio-Erodible Bio-Adhesive Drug Delivery System Designed for Intraoral Extended Release of Flurbiprofen: In Vitro and In Vivo Assessments
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Site-specific drug delivery for the local treatment of the diseases in the oral cavity is far superior to the systemic administration, for both safety and efficacy reasons. This study presents the design and development of an innovative bio-adhesive delivery system (BDS) based on a bio-erodible semi-interpenetrating polymeric network (semi-IPN) for intraoral extended release of flurbiprofen (FBP).
A unique combination of hydrolyzed gelatin (HG) cross-linked by tannic acid (TA) and Eudragit S, as the linear polymer, was used to compose the structure of the semi-IPN. The effect of structural factors, associated with the composition of the semi-IPN, on the release profile of FBP from the system was assessed using an in vitro dissolution method. The release rate of the drug in the oral cavity of healthy volunteers was also studied.
The degree of cross-linking of HG and the weight ratio between the cross-linked polymer and the linear polymer were found to be crucial factors affecting the release profile of FBP from the system. Likewise, the presence of a high concentration of plasticizer was essential for achieving a proper flexibility of the system as proved by a DSC method. The in vivo tests demonstrated a disparity between the volunteers in the FBP concentration found in the saliva, especially after 120 min post-administration of BDS. Both f1 and f2 tests indicated that the packaged BDS can be absolutely stable for at least 6 months at 30 °C.
KeywordsSite-specific drug delivery Semi-interpenetrating polymeric network (semi-IPN) Topical treatment Dissolution test Hydrolyzed gelatin Tannic acid Eudragit S
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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