In vivo evaluation of an Ultra-fast Disintegrating Wafer matrix : a molecular simulation approach to the ora-mucoadhesivity
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Date
Authors
Reddy, Deshika
Choonara, Yahya E.
Kumar, Pradeep
Govender, Mershen
Indermun, Sunaina
Du Toit, Lisa C.
Meyer, Leith Carl Rodney
Pillay, Viness
Journal Title
Journal ISSN
Volume Title
Publisher
Elsevier
Abstract
The purpose of this study was to design and evaluate the performance of an Ultra-fast Disintegrating Wafer (U-D-WAF) loaded with highly water soluble diphenhydramine hydrochloride (DPH) through the oramucosa of the Large White Pig model. For the first time this work explored the oramucosivity of the U-D-WAF by detailed molecular modeling of the matrix on buccal tissue in order to mechanistically deduce the mucodhesivity. The U-D-WAF was formulated using a blend of hydroxypropylcellulose, poly(acrylic) acid, sodium starch glycolate and β –cyclodextrin in accordance with a Box-Benkhen experimental design for optimization prior to ex vivo permeation and in vivo release studies in the Large White Pig. Molecular simulation studies assess the mucoadhesivity of the U-D-WAF to the oramucosa. A mean Drug Entrapment Efficiency of 72.96 ± 4.32%, disintegration time of 29.33 ± 15.91 s and drug release after 60 s of 86.32 ± 20.37% was recorded. Ex vivo permeation studies revealed cumulative drug permeation of 86.32 ± 20.34% 60 s after onset. In vivo evaluation of the optimized U-D-WAF had a Cmax = 59 μgL−1 approximately 300 s after administration. The ultrafast disintegration of the U-D-WAF matrix with desirable mucoadhesivity in in vitro and in vivo studies makes it suitable for effective and rapid oramucosal drug delivery.
Description
Keywords
Ultra-fast disintegrating wafer (U-D-WAF), Diphenhydramine hydrochloride (DPH), Mucoadhesivity, Molecular modeling, In vivo permeabilty, Rapid disintegration, Wafer matrix, Oramucosal drug delivery
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Citation
Reddy, D., Choonara, Y.E., Kumar, P. et al. 2017, 'In vivo evaluation of an Ultra-fast Disintegrating Wafer matrix : a molecular simulation approach to the ora-mucoadhesivity', Journal of Drug Delivery Science and Technology, vol. 37, pp. 123-133.