2009
DOI: 10.1089/jamp.2008.0697
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In Vitro Drug Delivery Performance of a New Budesonide/Formoterol Pressurized Metered-Dose Inhaler

Abstract: Budesonide/formoterol pMDI provides a consistent delivered dose with an appropriate respirable fraction for therapeutic effectiveness. The product satisfies the performance requirements of current U.S. pharmacopeial and regulatory standards for pharmaceutical pMDI products.

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Cited by 12 publications
(7 citation statements)
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“…GFF MDI demonstrated delivery of a consistent FPF for flow rates of 30-90 L/min, which may help to provide reliable dosing to patients with COPD with variable peak inhalation flow rates and volumes. These results are higher than, or comparable with, other MDIs, including an ultrafine solution-based formulation (23)(24)(25)(26)(27). The flow rate independence of other MDIs has previously been shown, but across a narrower range of flow rates (24,27,32).…”
Section: Discussionsupporting
confidence: 55%
“…GFF MDI demonstrated delivery of a consistent FPF for flow rates of 30-90 L/min, which may help to provide reliable dosing to patients with COPD with variable peak inhalation flow rates and volumes. These results are higher than, or comparable with, other MDIs, including an ultrafine solution-based formulation (23)(24)(25)(26)(27). The flow rate independence of other MDIs has previously been shown, but across a narrower range of flow rates (24,27,32).…”
Section: Discussionsupporting
confidence: 55%
“…The mean in vitro lung doses per actuation as measured on the filters at each altitude are listed in Table . The in vitro lung doses were close to reported fine particle doses for inhalers with high performance, that is, 90–100 μg for the budesonide component of Symbicort ® , or slightly larger than the reported fine particle doses for Ventolin ® and Airomir™, as expected. The in vitro lung dose for QVar ® agreed with previously reported mouth–throat deposition using the Alberta Idealized Throat …”
Section: Resultssupporting
confidence: 81%
“…1.4 (ICS) 1.5(LABA) 73 3.5 (ICS) 3.3 (LABA 74 2.9 (ICS) 3.4 (LABA) 75 4.2 (LAMA) 76 3.5 (ICS) 3.5 (LABA) 77 Not available Spiromax®. 31 Compared with the results obtained at a simulated inhalation volume of 4 l, DD was unaffected by inhalation volume down to 1 l with Turbuhaler®, with significant differences only for the higher strength at 0.5 l, and both strengths at 0.25 l (all p < 0.0125).…”
Section: Inhalation Volumementioning
confidence: 99%