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Design, Characterization, and Aerosol Dispersion Performance Modeling of Advanced Co-Spray Dried Antibiotics with Mannitol as Respirable Microparticles/Nanoparticles.

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Presentation on theme: "Design, Characterization, and Aerosol Dispersion Performance Modeling of Advanced Co-Spray Dried Antibiotics with Mannitol as Respirable Microparticles/Nanoparticles."— Presentation transcript:

1 Design, Characterization, and Aerosol Dispersion Performance Modeling of Advanced Co-Spray Dried Antibiotics with Mannitol as Respirable Microparticles/Nanoparticles for Targeted Pulmonary Delivery as Dry Powder Inhalers  Xiaojian Li, Frederick G. Vogt, Don Hayes, Heidi M. Mansour  Journal of Pharmaceutical Sciences  Volume 103, Issue 9, Pages (September 2014) DOI: /jps.23955 Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

2 Figure 1 The chemical structures of antibiotic drugs (tobramycin and azithromycin) and d-mannitol. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

3 Figure 2 SEM micrographs of Co-SD tobramycin:mannitol (TOB:MAN) and Co-SD azithromycin:mannitol (AZI:MAN) particles (magnification 10,000×) for: (a) TOB:MAN = 1:0.1; (b) TOB:MAN = 1:0.25; (c) TOB:MAN = 1:0.5; (d) TOB:MAN = 1:0.75; (e) TOB:MAN = 1:1; (f) AZI:MAN = 1:0.1; (g) AZI:MAN = 1:0.25; (h) AZI:MAN = 1:0.5; (i) AZI:MAN = 1:0.75; and (j) AZI:MAN = 1:1. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

4 Figure 3 X-ray powder diffraction patterns for: (a) Co-SD tobramycin:mannitol formulations; and (b) Co-SD azithromycin:mannitol formulations. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

5 Figure 4 Representative DSC thermograms for Co-SD TOB:MAN and Co-SD AZI powders: (a) Co-SD TOB:MAN 1:0.1 (hermetic); (b) AZI:MAN = 1:0.1 (hermetic); and (c) AZI:MAN = 1:0.5 (pin-holed). Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

6 Figure 5 Representative HSM micrographs of Co-SD powders for: (a) TOB:MAN 1:0.5; and (b) AZI:MAN 1:0.5. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

7 Figure 6 Water vapor sorption isotherms at 25°C and 37°C of Co-SD powders [weight change (%) vs. relative humidity (RH)] for: (a) TOB:MAN =1:0.5; and (b) AZI:MAN =1:0.5. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

8 Figure 7 (a) Brightfield micrograph of Co-SD TOB:MAN = 1:0.5 particles obtained using a ×10 objective. CRM mapping was performed in the region marked with the red box; increasing blue color corresponds to increasing intensity of Raman signal in the 1425–1480 cm−1 region. (b) Fluorescence micrograph of the same region. (c) Raman spectra from three points obtained using CRM, shown in comparison with SD tobramycin and alpha mannitol prepared as pure materials. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

9 Figure 8 (a) Brightfield micrograph of Co-SD AZI:MAN = 1:0.5 particles obtained using a ×50 objective. CRM mapping was performed in the region marked with the red box; increasing blue color corresponds to increasing intensity of Raman signal in the 845–900 cm−1 region. (b) CRM mapping results with increasing red color corresponding to increasing intensity of Raman signal in the 1670–1750 cm−1 region. (c) Raman spectra from three points obtained using CRM, shown in comparison with SD azithromycin and alpha mannitol prepared as pure materials. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

10 Figure 9 ATR–FTIR spectra for Co-SD antibiotic drug:mannitol powders of: (a) TOB:MAN; and (b) AZI:MAN. Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

11 Figure 10 Aerosol dispersion performance using the NGI® under an airflow rate (Q) of 60 L/min with the HandiHaler® DPI device for Co-SD antibiotic drug:mannitol powders of: (a) TOB:MAN; and (b) AZI:MAN (mean ± standard deviation, n = 3). Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

12 Figure 11 Linear correlation plots of aerosol dispersion performance parameters versus Tg for: (a) Co-SD TOB:MAN powders; and (b) Co-SD AZI:MAN powders (mean ± standard deviation, n = 3). Journal of Pharmaceutical Sciences  , DOI: ( /jps.23955) Copyright © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association Terms and Conditions

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