Development and evaluation of extended release bioadhesive sodium fluoride tablets

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Effective caries prevention relies on localized fluoride delivery to the oral cavity.
• Current fluoride dosage forms lack extended release capabilities, limiting their efficacy.
• Developing novel delivery systems for sustained fluoride release is crucial.

Purpose of the Study:

• To investigate the impact of specific polymers on the in vitro dissolution and ex vivo bioadhesion of sodium fluoride matrix tablets.
• To evaluate poly (methyl vinyl ether-co-maleic anhydride) mixed calcium/sodium salt (Gantrez MS) and sodium carboxymethylcellulose (NaCMC) for extended fluoride release.
• To assess the potential of these formulations for enhanced bioadhesion and prolonged drug delivery.

Main Methods:

• Sodium fluoride matrix tablets were formulated using Gantrez MS, NaCMC, PEG8000, and Carbopol 934.
• In vitro dissolution studies were conducted using USP Apparatus 2 and a specialized low-volume, low-flow dissolution apparatus.
• Ex vivo bioadhesion was assessed using excised bovine gingiva and a TA.XT2i Texture Analyzer.

Main Results:

• Dissolution profiles at 2, 4, and 8 hours were significantly influenced by the proportions of Gantrez MS and NaCMC.
• A significant interaction between Gantrez MS and NaCMC fractions affected drug release at 2 and 4 hours.
• Peak bioadhesive force and work of bioadhesion were significantly dependent on Gantrez MS and NaCMC fractions.

Conclusions:

• Bioadhesive matrix fluoride tablets incorporating Gantrez MS and NaCMC can be designed for extended release properties.
• These novel formulations hold potential for improved caries prevention through sustained oral fluoride delivery.
• The study demonstrates the feasibility of creating effective, long-lasting fluoride delivery systems.