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Lubricant-Induced Crystallization of Itraconazole From Tablets Made of Electrospun Amorphous Solid Dispersion  Balázs Démuth, Attila Farkas, Attila Balogh,

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Presentation on theme: "Lubricant-Induced Crystallization of Itraconazole From Tablets Made of Electrospun Amorphous Solid Dispersion  Balázs Démuth, Attila Farkas, Attila Balogh,"— Presentation transcript:

1 Lubricant-Induced Crystallization of Itraconazole From Tablets Made of Electrospun Amorphous Solid Dispersion  Balázs Démuth, Attila Farkas, Attila Balogh, Karolina Bartosiewicz, Barnabás Kállai-Szabó, Johny Bertels, Tamás Vigh, Jurgen Mensch, Geert Verreck, Ivo Van Assche, György Marosi, Zsombor K. Nagy  Journal of Pharmaceutical Sciences  Volume 105, Issue 9, Pages (September 2016) DOI: /j.xphs Copyright © 2016 American Pharmacists Association® Terms and Conditions

2 Figure 1 Dissolution profiles of tablets containing ITR-PVPVA64 electrospun solid dispersion and 1% MgSt (n = 3). Parameters: USPII, 900 mL of 0.1 N HCl, 100 rpm, 37 ± 0.5°C, 50 mg dose. Journal of Pharmaceutical Sciences  , DOI: ( /j.xphs ) Copyright © 2016 American Pharmacists Association® Terms and Conditions

3 Figure 2 Polarized light microscopy image of filtered sample after dissolution of tablet with (a) MgSt and (b) Raman spectra of (1) MgSt, (2) crystalline ITR, and (3) crystal in the filtered powder. Journal of Pharmaceutical Sciences  , DOI: ( /j.xphs ) Copyright © 2016 American Pharmacists Association® Terms and Conditions

4 Figure 3 Temperature and lubricant content dependency of ITR dissolution profile (n = 3). Parameters: USPII, 900 mL of 0.1 N HCl, 100 rpm, 37 ± 0.5°C, 50 mg dose. Journal of Pharmaceutical Sciences  , DOI: ( /j.xphs ) Copyright © 2016 American Pharmacists Association® Terms and Conditions

5 Figure 4 Polarized light microscopy image of filtered sample after dissolution of tablet with (a) SSF and (b) Raman spectra of (1) SSF, (2) crystalline ITR, and (3) filtered powder. Journal of Pharmaceutical Sciences  , DOI: ( /j.xphs ) Copyright © 2016 American Pharmacists Association® Terms and Conditions

6 Figure 5 Dissolution from optimal tablets (with SSF) and with additional MgSt powder in the dissolution medium (n = 3). Parameters: USPII, 900 mL of 0.1 N HCl, 100 rpm, 37 ± 0.5°C, 50 mg dose. Journal of Pharmaceutical Sciences  , DOI: ( /j.xphs ) Copyright © 2016 American Pharmacists Association® Terms and Conditions

7 Figure 6 Dissolution of ITR from randomly chosen tablets produced on rotary press (a) and from tablets at starting point and kept at 25°C/60% RH for 1 and 3 months (b). Parameters: USPII, 900 mL of 0.1 N HCl, 100 rpm, 37 ± 0.5°C, 50 mg dose. Journal of Pharmaceutical Sciences  , DOI: ( /j.xphs ) Copyright © 2016 American Pharmacists Association® Terms and Conditions


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