Foster®: A High-Efficiency Combination Metered Dose Inhaler with Consistent Particle Size Distribution at Alternative Flow Rates

Maria, Roberta De; Zagnoni, Ingrid; Bodria, Alessandro; Bonelli, S; Alberi, Massimiliano Dagli; Lewis, David; Johnson, R.R.; O’Shea, Helen

doi:10.1007/s13556-013-0006-6

Cited by 11 publications

(12 citation statements)

References 7 publications

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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%

“…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). One commonly recognized user error with suspension-based MDIs is insufficient shaking prior to taking a dose (3) and, although not typically stated in patient instructions, imparting a delay between shaking and dose administration may also introduce dosing variability (14).…”

Section: Discussionmentioning

confidence: 60%

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Drug Delivery from an Innovative LAMA/LABA Co-suspension Delivery Technology Fixed-Dose Combination MDI: Evidence of Consistency, Robustness, and Reliability

et al. 2017

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Abstract.To ensure consistency of clinical outcomes, orally inhaled therapies must exhibit consistent delivered dose and aerosol properties at the time of manufacturing, throughout storage, and during various patient-use conditions. Achieving consistency across these scenarios has presented a significant challenge, especially for combination products that contain more than one drug. This study characterized the delivered dose and aerosol properties of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI; Bevespi Aerosphere™). GFF MDI, a fixed-dose combination (FDC) of a long-acting muscarinic antagonist, glycopyrrolate (18 μg, equivalent to glycopyrronium 14.4 μg), and a long-acting β 2 -agonist, formoterol fumarate (9.6 μg; equivalent to formoterol fumarate dihydrate 10 μg), is formulated using innovative co-suspension delivery technology, which suspends micronized drug crystals with spray-dried phospholipid porous particles in hydrofluoroalkane propellant. In this study, delivered dose uniformity was assessed through the labeled number of doses, and aerosol properties, such as percent fine particle fraction (FPF) and mass median aerodynamic diameter, were determined by cascade impaction. GFF MDI achieved reproducible dose delivery and an FPF greater than 55%, whether formulated and delivered as a monocomponent or dual FDC. The performance of GFF MDI was maintained across various manufacturing batches, under extended storage, and with variations in flow rate. Furthermore, unlike a GFF drug crystal-only suspension, drug delivery remained consistent for GFF MDI when simulated patient-handling errors were applied, such as reduced shake energy and delays between shaking and actuation. These results demonstrate that cosuspension delivery technology overcomes well-known sources of variability in MDI drug delivery.KEY WORDS: dose consistency; co-suspension delivery technology; respiratory drug delivery; metered dose inhaler (MDI); chronic obstructive pulmonary disease (COPD).

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Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 60%

Drug Delivery from an Innovative LAMA/LABA Co-suspension Delivery Technology Fixed-Dose Combination MDI: Evidence of Consistency, Robustness, and Reliability

et al. 2017

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“…(3) Subsequent studies have confirmed the consistency between FRI and scintigraphy ( Table 1). (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16) An extrafine formulation of a fixed-dose dual combination of the inhaled corticosteroid (ICS) beclomethasone dipropionate (BDP) and the long-acting b 2 -agonist formoterol fumarate (FF) has been available since 2006 for regular treatment of asthma, and since 2014 for symptomatic treatment of severe chronic obstructive pulmonary disease (COPD) as a pressurized metered-dose inhalation (pMDI; Foster Ò ; Chiesi Farmaceutici SpA, Parma, Italy). In 2017, a fixed-dose triple combination of BDP, FF, and the long-acting muscarinic antagonist glycopyrronium bromide (GB; Trimbow Ò ; Chiesi Farmaceutici SpA), in a similar extrafine pMDI formulation was approved for the maintenance treatment of COPD and is in development for severe asthma.…”

Section: Introductionmentioning

confidence: 99%

Predicting Lung Deposition of Extrafine Inhaled Corticosteroid-Containing Fixed Combinations in Patients with Chronic Obstructive Pulmonary Disease Using Functional Respiratory Imaging: An In Silico Study

Usmani

Mignot

Kendall

et al. 2021

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: Functional respiratory imaging (FRI) is a computational fluid dynamics-based technique using three-dimensional models of human lungs and formulation profiles to simulate aerosol deposition. Methods: FRI was used to evaluate lung deposition of extrafine beclomethasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) and extrafine BDP/FF delivered through pressurized metered dose inhalers and to compare results with reference gamma scintigraphy data. FRI combined high-resolution computed tomography scans of 20 patients with moderate-to-severe chronic obstructive pulmonary disease (mean forced expiratory volume in 1 second 42% predicted) with in silico computational flow simulations, and incorporated drug delivery parameters to calculate aerosol airway deposition. Inhalation was simulated using profiles obtained from real-life measurements. Results: Total lung deposition (proportion deposited in intrathoracic region) was similarly high for both products, with meanstandard deviation (SD) values of 31.0%-5.7% and 28.1%-5.2% (relative to nominal dose) for BDP/FF/GB and BDP/FF, respectively. Pairwise comparison of the deposition of BDP and FF gave a mean intrathoracic BDP/FF/GB:BDP/FF deposition ratio of 1.10 (p ¼ 0.0405). Mean intrathoracic, central and peripheral deposition ratios for BDP were 1.09 (95% confidence interval [

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“…In their review, the authors question our findings and note that in-house studies show BDP/FORM has a consistent particle size distribution (i.e. MMAD) at flow rates of 28-30 and 60 L/min [2]. However, their own data clearly demonstrate that the FPD, and therefore FPF, of BDP/FORM is flow ratedependent.…”

mentioning

confidence: 61%

Letter in Response to the Review by De Maria et al. 2014

Johal

Howald²,

Fischer³

et al. 2014

Comb Prod Ther

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We would like to clarify some points about the DIFFUSE (Defining fluticasone propionate/ formoterol particulate size) study (December 2013, p 39) [1] in light of the recent review by De Maria and colleagues [2]. Our in vitro study assessed the effects of inhalation flow rate on the aerodynamic particle size distribution Hence, the flow rate dependency of inhalers is of interest to physicians as well as regulators. Including a faster flow rate of 60 L/min in our study was therefore appropriate, and is relevant to the real-life use of these inhalers.All inhalers were tested across pre-defined parameters, using the same apparatus and the same ambient conditions, to ensure a fair and appropriate comparison. The review questions the use of an Andersen Cascade Impactor (ACI):an ACI is arguably the most widely used tool for testing inhalers, and is routinely used at flow rates of 30, 60 L/min, and above [9][10][11][12][13][14]. Indeed, the authors of the review have themselves used

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Foster®: A High-Efficiency Combination Metered Dose Inhaler with Consistent Particle Size Distribution at Alternative Flow Rates

Cited by 11 publications

References 7 publications

Drug Delivery from an Innovative LAMA/LABA Co-suspension Delivery Technology Fixed-Dose Combination MDI: Evidence of Consistency, Robustness, and Reliability

Drug Delivery from an Innovative LAMA/LABA Co-suspension Delivery Technology Fixed-Dose Combination MDI: Evidence of Consistency, Robustness, and Reliability

Predicting Lung Deposition of Extrafine Inhaled Corticosteroid-Containing Fixed Combinations in Patients with Chronic Obstructive Pulmonary Disease Using Functional Respiratory Imaging: An In Silico Study

Letter in Response to the Review by De Maria et al. 2014

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