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Spiromax, a New Dry Powder Inhaler: Dose Consistency under Simulated Real-World Conditions.

Abstract：

BACKGROUND:Spiromax(®) is a novel dry powder inhaler for patients with asthma or chronic obstructive pulmonary disease (COPD). The studies presented here provide further data on attributes (in vitro dosing consistency with budesonide-formoterol (DuoResp) Spiromax; flow rates through empty versions of the Spiromax and Turbuhaler inhaler) of importance to patients with asthma or COPD. METHODS:Dose-delivery studies were performed using low-, middle-, and high-strength DuoResp Spiromax. Dose consistency was assessed over inhaler life. Total emitted doses (TEDs) were measured at various flow rates, after exposure to high and low temperature or humidity, at different inhaler orientations, and after dropping the inhaler. The criterion for evaluating dose uniformity was whether mean TEDs were within the product specification limits. In separate studies, flow rates were measured after training, using the patient information leaflets, and again after enhanced training as part of a randomized, open-label, cross-over study. RESULTS:Mean values for both budesonide and formoterol were within 85%-115% of the label claim for each strength of DuoResp Spiromax for initial dose uniformity and for the other investigated conditions (temperature, humidity, orientation, dropping, knocking), with the exception of approximately an 80% increase in first dose after dropping the inhaler (subsequent doses not affected). In the flow rate patient study, two patients' inhalations with Spiromax and six with Turbuhaler were <30 L/min. The majority of asthma patients [91% (Spiromax) versus 82% (Turbuhaler)] achieved the preferred flow rate of >60 L/min. CONCLUSIONS:DuoResp Spiromax consistently meets dose uniformity criteria, under controlled laboratory conditions and with variations intended to mimic real-world use. Following enhanced training, all patients in the flow study were able to achieve the minimal inspiratory flow rate of >30 L/min, which is required for effective treatment.

journal_name

J Aerosol Med Pulm Drug Deliv

journal_title

Journal of aerosol medicine and pulmonary drug delivery

authors

Canonica GW,Arp J,Keegstra JR,Chrystyn H

doi

10.1089/jamp.2015.1216

subject

Has Abstract

pub_date

2015-10-01 00:00:00

pages

309-19

issue

eissn

1941-2711

issn

1941-2703

journal_volume

pub_type

杂志文章

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Spiromax, a New Dry Powder Inhaler: Dose Consistency under Simulated Real-World Conditions.