Self-Nanoemulsifying Lyophilized Tablets for Flash Oral Transmucosal Delivery of Vitamin K: Development and Clinical Evaluation Khalid M. El-Say, Tarek.

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Self-Nanoemulsifying Lyophilized Tablets for Flash Oral Transmucosal Delivery of Vitamin K: Development and Clinical Evaluation Khalid M. El-Say, Tarek A. Ahmed, Osama A.A. Ahmed, Khaled M. Hosny, Fathy I. Abd-Allah Journal of Pharmaceutical Sciences Volume 106, Issue 9, Pages 2447-2456 (September 2017) DOI: 10.1016/j.xphs.2017.01.001 Copyright © 2017 American Pharmacists Association® Terms and Conditions

Figure 1 Estimated response surface (3D) (a) and triangular dimensional contour plots (b) showing the effect of the mixture components on the globule size. Journal of Pharmaceutical Sciences 2017 106, 2447-2456DOI: (10.1016/j.xphs.2017.01.001) Copyright © 2017 American Pharmacists Association® Terms and Conditions

Figure 2 Release profiles of vitamin K from different SNELT formulations (F1-F6) and the commercial tablet. Each value represents the mean ± SD (n = 3). Journal of Pharmaceutical Sciences 2017 106, 2447-2456DOI: (10.1016/j.xphs.2017.01.001) Copyright © 2017 American Pharmacists Association® Terms and Conditions

Figure 3 Fourier transform infrared spectra of pure vitamin K and tablet ingredients as well as components of SNEDDS. Journal of Pharmaceutical Sciences 2017 106, 2447-2456DOI: (10.1016/j.xphs.2017.01.001) Copyright © 2017 American Pharmacists Association® Terms and Conditions

Figure 4 Photomicrographs of the SNELT surfaces by optical microscope images at 400× magnification power (a-f represent F1-F6, respectively). Journal of Pharmaceutical Sciences 2017 106, 2447-2456DOI: (10.1016/j.xphs.2017.01.001) Copyright © 2017 American Pharmacists Association® Terms and Conditions

Figure 5 Scanning electron microscopy photomicrographs of the SNELT formulations (a-f represent F1-F6, respectively). Journal of Pharmaceutical Sciences 2017 106, 2447-2456DOI: (10.1016/j.xphs.2017.01.001) Copyright © 2017 American Pharmacists Association® Terms and Conditions

Figure 6 Plasma concentration-time profiles of vitamin K after intramuscular and oral administration of commercial vitamin K products and oral administration of vitamin K SNELTs to human volunteers. Each value represents the mean ± SD (n = 6). *p < 0.05 compared to the commercial vitamin K tablet (oral); #p < 0.05 compared to the commercial vitamin K ampoule (IM). Journal of Pharmaceutical Sciences 2017 106, 2447-2456DOI: (10.1016/j.xphs.2017.01.001) Copyright © 2017 American Pharmacists Association® Terms and Conditions