TY - JOUR
T1 - The development of a single-use, capsule-free multi-breath tobramycin dry powder inhaler for the treatment of cystic fibrosis
AU - Zhu, Bing
AU - Padroni, Matteo
AU - Colombo, Gaia
AU - Phillips, Gary
AU - Crapper, John
AU - Young, Paul M.
AU - Traini, Daniela
PY - 2016/12/5
Y1 - 2016/12/5
N2 - The aerosol performance and delivery characteristics of tobramycin for the treatment of respiratory infection were evaluated using the Orbital™, a multi-breath, high dose, dry powder inhaler (DPI). Micronised tobramycin was prepared and tested in the Orbital and in the commercially available TOBI Podhaler (Novartis AG). Furthermore, the TOBI Podhaler formulation containing tobramycin as Pulmospheres was tested in both the commercial Podhaler device (T-326) and Orbital for comparison. By varying the puck geometry of the Orbital, it was possible to deliver equivalent doses of micronised tobramycin (114.09 ± 5.86 mg) to that of the Podhaler Pulmosphere product (116.01 ± 2.59 mg) over 4 sequential simulated breaths (60 L min−1 for 4 s) without the need for multiple capsules. In general, the aerosol performance of the micronised tobramycin from the Orbital was higher than the T-326 Podhaler device, with fine particle fraction (FPF) of 44.99% ± 1.09% and 37.03% ± 0.86%, respectively. When testing the Pulmosphere powder in the two devices, the T-326 had marginally better performance with a FPF of 68.77% ± 2.10% compared to 61.30% ± 3.45%. This is to be expected since the TOBI Podhaler and Pulmosphere are an optimised powder and device combination. The Orbital was shown to be capable of delivering high efficiency, high dose antibiotic therapy for inhalation without the need for the use of multiple capsules as used in current devices. This approach may pave the way for a number of antibiotic therapies and medicaments where high dose respiratory deposition is required.
AB - The aerosol performance and delivery characteristics of tobramycin for the treatment of respiratory infection were evaluated using the Orbital™, a multi-breath, high dose, dry powder inhaler (DPI). Micronised tobramycin was prepared and tested in the Orbital and in the commercially available TOBI Podhaler (Novartis AG). Furthermore, the TOBI Podhaler formulation containing tobramycin as Pulmospheres was tested in both the commercial Podhaler device (T-326) and Orbital for comparison. By varying the puck geometry of the Orbital, it was possible to deliver equivalent doses of micronised tobramycin (114.09 ± 5.86 mg) to that of the Podhaler Pulmosphere product (116.01 ± 2.59 mg) over 4 sequential simulated breaths (60 L min−1 for 4 s) without the need for multiple capsules. In general, the aerosol performance of the micronised tobramycin from the Orbital was higher than the T-326 Podhaler device, with fine particle fraction (FPF) of 44.99% ± 1.09% and 37.03% ± 0.86%, respectively. When testing the Pulmosphere powder in the two devices, the T-326 had marginally better performance with a FPF of 68.77% ± 2.10% compared to 61.30% ± 3.45%. This is to be expected since the TOBI Podhaler and Pulmosphere are an optimised powder and device combination. The Orbital was shown to be capable of delivering high efficiency, high dose antibiotic therapy for inhalation without the need for the use of multiple capsules as used in current devices. This approach may pave the way for a number of antibiotic therapies and medicaments where high dose respiratory deposition is required.
KW - Crystalline
KW - High dose dry powder inhaler
KW - Orbital
KW - Tobramycin
UR - http://www.scopus.com/inward/record.url?scp=84963655920&partnerID=8YFLogxK
UR - https://purl.org/au-research/grants/arc/LP130101123
U2 - 10.1016/j.ijpharm.2016.04.009
DO - 10.1016/j.ijpharm.2016.04.009
M3 - Article
C2 - 27063852
AN - SCOPUS:84963655920
VL - 514
SP - 392
EP - 398
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
IS - 2
ER -