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Development and Evaluation of Extended Release Bioadhesive Sodium Fluoride Tablets

Owens, Tim Sadley
http://rave.ohiolink.edu/etdc/view?acc_num=ucin1100715863

Abstract Details

2004, PhD, University of Cincinnati, Pharmacy : Pharmaceutical Sciences.
Localized fluoride delivery to the oral cavity is important in caries prevention. Extended release local delivery of fluoride may allow the development of more effective caries preventatives. This work describes the effect of poly (methyl vinyl ether-co-maleic anhydride) mixed calcium/sodium salt (Gantrez MS), sodium carboxymethylcellulose (NaCMC), polyethylene glycol 8000 (PEG8000) and Carbopol 934 (C934) on the in vitro drug dissolution and ex vivo bioadhesion of sodium fluoride matrix tablets. The tablet is intended to adhere to the gingival tissue and release fluoride at a low level for an extended period of time. Excipients were chosen which may exhibit both extended release and bioadhesive properties when formulated into matrix tablets. Dissolution was studied using both USP Apparatus 2 and a low volume (3.1 ml), low flow (0.5 ml/min) dissolution apparatus designed to more closely mimic oral cavity conditions. In this preliminary investigation, it was found that in both apparatus, the percent drug dissolved at 2, 4 and 8 hours was statistically dependent on the fractions of Gantrez MS and NaCMC (probability > {t} of less than 0.05). The interaction term was significant at 2 and 4 hours in the USP apparatus and at 2, 4 and 8 hours in the low volume, low flow apparatus (probability > {t} of less than 0.05). Mixtures of at least 95 % NaCMC exhibited zero order drug dissolution (R2 = 0.94 to 1.0) in the low volume, low flow apparatus due to swelling controlled release in the constrained low flow apparatus. The fluoride concentration in the effluent of these high NaCMC formulas ranged from 0.2 ppm to 1.8 ppm. These levels have been shown previously by other researchers to provide significant in vitro and in vivo protection from caries. Ex vivo bioadhesion was studied using excised bovine gingiva and a TA.XT2i Texture Analyzer. Peak bioadhesive force and work of bioadhesion were found to be statistically dependent on the fractions of Gantrez MS and NaCMC with no interaction (probability > {t} of less than 0.01). Results indicate that bioadhesive matrix fluoride tablets of these mixtures can be designed to exhibit both bioadhesive and extended release properties.
Dr. Adel Sakr (Advisor)
145 p.
Health Sciences, Pharmacy
buccal; fluoride; extended release; bioadhesion; dissolution

Recommended Citations

Citations

  • Owens, T. S. (2004). Development and Evaluation of Extended Release Bioadhesive Sodium Fluoride Tablets [Doctoral dissertation, University of Cincinnati]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1100715863

    APA Style (7th edition)

  • Owens, Tim. Development and Evaluation of Extended Release Bioadhesive Sodium Fluoride Tablets. 2004. University of Cincinnati, Doctoral dissertation. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=ucin1100715863.

    MLA Style (8th edition)

  • Owens, Tim. "Development and Evaluation of Extended Release Bioadhesive Sodium Fluoride Tablets." Doctoral dissertation, University of Cincinnati, 2004. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1100715863

    Chicago Manual of Style (17th edition)

ucin1100715863
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© 2004, all rights reserved.
This open access ETD is published by University of Cincinnati and OhioLINK.