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

Abstract

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.

Efficacy of Fluticasone and Salmeterol Dry Powder in Treating Patients with Bronchial Asthma and Its Effect on Inflammatory Factors and Pulmonary Function

“…It has been demonstrated that salmeterol ( β 2 receptor agonist) has a significant dilating effect on the bronchi of patients [ 19 ]. The release of pulmonary mast cell mediators such as triene and histamine is the basis for improvement and remission of the patient's disease condition, while fluticasone propionate is one of the glucocorticoids with strong water- and fat-soluble properties [ 20 ]. It can have an anti-inflammatory effect on the patient's body and clinical studies have confirmed that it does not cause any adverse effects [ 21 ].…”

Switching to the Dry-Powder Inhaler Easyhaler®: A Narrative Review of the Evidence

“…In a very recently reported non-comparative in vitro assessment of the salmeterol–fluticasone propionate Easyhaler (50/250 or 50/500 μg per dose) [ 25 ], performance, as quantified by the delivered drug dose (DD) and fine-particle dose, remained consistent throughout the lifespan of the inhaler (60 doses) and was unaffected by simulated environmental stress. Drug delivery remained unchanged with or without dropping (DD ranging from 99 to 104% for salmeterol and from 95 to 103% for fluticasone, when setting the initial dose values to 100%), vibration (DD after test: 100–102% and 97–100% for salmeterol and fluticasone, respectively), exposure to moisture (DD after test: 98–102% and 98–107% for salmeterol and fluticasone, respectively) and freeze–thawing (DD after test: 100–101% and 99–101% for salmeterol and fluticasone, respectively).…”

Inhalatory suchego proszku w dobie pandemii COVID-19 – co jest ważne dla pacjenta?

“…W tabelach 1 i 2 przedstawiono wybrane parametry charakteryzujące DPI zawierające połącze-Tabela 1. Najważniejsze parametry charakteryzujące DPI zawierające połączenie wGKS z LABA oraz produkowane przez nie chmury aerozolowe leków (na podstawie [11][12][13][14][15][16][17][18][19][20][21][22][23][24]). Tabela 2.…”