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Spiriva handihaler

Manufactured by Boehringer Ingelheim
Sourced in Japan

Spiriva® Handihaler is a medical device used for the administration of the medication tiotropium bromide. It is a handheld inhalation device designed to deliver the medication directly to the lungs.

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Lab products found in correlation

2 protocols using spiriva handihaler

1

Evaluating Capsule-Based Dry Powder Inhalers

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As a model capsule-based DPIs, Spiriva® Handihaler® was purchased from Boehringer Ingelheim Japan Ltd. Spiriva® Handihaler® is a typical capsule-based DPIs, used for the treatment of COPD and for reducing COPD exacerbations. A dry powder in Spiriva® inhalation capsules containing tiotropium bromide (TIO) as the main component was used as a model drug. The capsule contained 5.5 mg of a powder formulation consisting of 18 µg micronized tiotropium (as bromide hydrate, 22.5 µg) with coarse lactose monohydrate (24 (link)). The Handihaler® (Boehringer Ingelheim Japan Ltd.) was used as a model high resistance device for capsule-based DPIs (device specific resistance 3.03 Pa* min2/l2) (25 (link)). Size 3 capsules with different compositions were supplied by Qualicaps, Co., Ltd. (G-Cap, gelatin capsule; PEG/G-Cap, gelatin capsule containing 5% PEG4000 as plasticizer; and HPMC-Cap, HPMC capsule). PEG/G-Cap is a gelatin capsule that is resistant to cracking due to the presence of PEG. HPMC-Cap is resistant to cracking under dry conditions and may be filled with highly hygroscopic drugs. Each capsule was stored at 15-25˚C and under 40-50% relative humidity (RH) in a glass desiccator. The characteristics of each capsule are presented in Table I. All other reagents and solvents were of analytical or HPLC grade.
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2

Randomized Crossover Study of Inhaled COPD Therapies

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We carried out a randomized, open-label, cross-over study (Fig. 1). Previously prescribed LAMA were stopped at the screening visit. After a 1- to 2-week period on ICS/LABA, patients were randomized to either ACL (Eklira Genuair, Astra Zeneca, Luton, UK) 322 µg bid or TIO (Spiriva HandiHaler, Boehringer, Bracknell, UK) 18 µg bid. Following the run-in period, at visit 1, baseline measurements were recorded. After 2–3 weeks on the study inhaler, participants returned to the department for visit 2. All measurements were taken at trough (i.e., 12 h post dose for ACL and ICS/LABA and 24 h post dose for TIO). Participants attended the department the same time during each study visit. After the first treatment period, participants entered a wash-out period of 1–2 weeks. The same process was repeated with the other study inhaler after cross-over.

After a 1- to 2-week run-in, patients received either tiotropium 18 µg od or aclidinium 322 µg bid for 2–3 weeks each with a 1- to 2-week wash-out in between. Baseline values were measured at Visit 1/3 and after chronic dosing at Visit 2/4

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