Idealhalers Versus Realhalers: Is It Possible to Bypass Deposition in the Upper Respiratory Tract?

Weers, Jeffry G.; Son, Yoen-Ju; Glusker, Mark; Haynes, Alfred; Huang, Di; Kadrichu, Nani; Le, John; Li, Xue; Malcolmson, Richard; Miller, Danforth P.; Tarara, Thomas E.; Ung, Keith; Clark, Andrew R.

doi:10.1089/jamp.2018.1497

Cited by 30 publications

(31 citation statements)

References 53 publications

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“…The mass balance for salmeterol and fluticasone was 98%. The impaction parameter ( 20 , 21 ) da 2 Q was 440 μm 2 L/min for fluticasone and 360 μm 2 L/min for salmeterol. In the impaction parameter calculation, the flow value of 55 L/min was used.…”

Section: Resultsmentioning

confidence: 99%

“…(21) In addition to benefits of higher air flow resistance for reducing air flow and optimized mouthpiece that enables bypassing teeth and tongue, (15,21) Weers et al bring up possibilities reducing aerodynamic diameter of the particles for optimizing MIPP further. (21) The large porous particles (low aerodynamic particle size) combined with high resistance inhaler could potentially reduce the URT <2% with MIPP level <150 lm 2 $L/min and reduce the product's airflow dependency neglible. (21) A second entry product such as S-F Easyhaler in the first place needs to be adapted to the originator product's pharmacokinetic performance and, therefore, not all of the de-velopment options can be used.…”

Section: Discussionmentioning

confidence: 99%

“…(21) The large porous particles (low aerodynamic particle size) combined with high resistance inhaler could potentially reduce the URT <2% with MIPP level <150 lm 2 $L/min and reduce the product's airflow dependency neglible. (21) A second entry product such as S-F Easyhaler in the first place needs to be adapted to the originator product's pharmacokinetic performance and, therefore, not all of the de-velopment options can be used. (13) Easyhaler has design differences compared with Diskus, for example, higher air flow resistance and the elongated mouthpiece.…”

Section: Discussionmentioning

confidence: 99%

“…A recent article by Weers et al discussed how to bypass deposition in upper respiratory track (URT) deposition. ( 21 ) In addition to benefits of higher air flow resistance for reducing air flow and optimized mouthpiece that enables bypassing teeth and tongue, ( 15 , 21 ) Weers et al bring up possibilities reducing aerodynamic diameter of the particles for optimizing MIPP further. ( 21 ) The large porous particles (low aerodynamic particle size) combined with high resistance inhaler could potentially reduce the URT <2% with MIPP level <150 μm 2 ·L/min and reduce the product's airflow dependency neglible.…”

Section: Discussionmentioning

confidence: 99%

“…( 21 ) The large porous particles (low aerodynamic particle size) combined with high resistance inhaler could potentially reduce the URT <2% with MIPP level <150 μm 2 ·L/min and reduce the product's airflow dependency neglible. ( 21 )…”

Section: Discussionmentioning

confidence: 99%

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Consistent Dosing Through the Salmeterol–Fluticasone Propionate Easyhaler for the Management of Asthma and Chronic Obstructive Pulmonary Disease: Robustness Analysis Across the Easyhaler Lifetime

Turpeinen

Eriksson

Happonen

et al. 2021

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: Easyhaler (registered trademark by Orion Corporation) is a multidose dry powder inhaler (DPI) for the treatment of asthma and chronic obstructive pulmonary disease (COPD), designed to be simple and easy to use. Salmeterol-fluticasone propionate (S-F) Easyhaler (50/250 and 50/500 lg per dose), available in several European countries, provides combined inhaled corticosteroid and long-acting beta agonist therapy for the management of asthma and COPD. A requirement of the European Committee for Medical Products for Human Use guidelines is to demonstrate product performance under conditions that mimic real-life patient use. Therefore, our aims were to assess the robustness of the S-F Easyhaler by assessing the delivered dose (DD) and fine particle dose (FPD) throughout the inhaler lifespan and under simulated environmental stress conditions. Methods: This was a noncomparative exploratory in vitro study. Two batches and six to nine inhalers per batch from both dose strengths were used to assess drug delivery performance over the inhaler lifespan (doses 1-60). For determining the impact of simulated environmental stress (tests for exposure of dropping, vibration, moisture, and freeze-thawing) on DD and FPD, one batch and three inhalers per batch from both dose strengths were used per test, respectively. Aerodynamic particle size distribution was evaluated during the simulated dropping and vibration tests. Results: DD and FPD from both dose strengths of S-F Easyhaler performance remained consistent through the inhaler lifespan and simulated environmental stress did not affect its performance. Similar DD and FPD values were observed with or without dropping, vibration, exposure to moisture, and freeze-thawing, and no inhaler breakages occurred during the simulated tests. Conclusions: The in vitro performance of S-F Easyhaler at both dose strengths suggests that reliable dosing and robustness can be achieved under real-life stress conditions; S-F Easyhaler is a durable DPI for the management of asthma and COPD.

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Section: Resultsmentioning

confidence: 99%