Aerolizer

Manufactured by Novartis

Sourced in Switzerland, United Kingdom

The Aerolizer is a dry powder inhaler (DPI) device used for the administration of certain medications in the form of powdered formulations. It is designed to facilitate the delivery of the medication directly into the lungs. The Aerolizer operates by the patient's inspiratory flow, which disperses the powdered medication within the device and allows it to be inhaled.

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Lab products found in correlation

Handihaler, by Boehringer Ingelheim (3 mentions) Diskhaler, by GlaxoSmithKline (1 mentions) Elix essential, by Merck Group (1 mentions)

5 protocols using aerolizer

Formoterol Fumarate Lactose Blend: Aerosol Delivery Evaluation

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Formoterol fumarate lactose blend (Foradil ® Aerolizer r® ,, Novartis -inhalation powder in hard gelatine capsules combined with Aerolizer device -, Batch U0093)) was purchased from the local pharmacy. One capsule contains 12 µg of formoterol fumarate in 25 mg of lactose.
Human recombinant insulin (Batch WEP1223) was purchased by Wako Chemicals (Japan).
The respirable insulin powder was obtained from an acidic drug solution spray dried according to the method previously described (Balducci et al., 2014) (link). All chemicals used were of analytical grade and water was purified by Elix ® Essential (Merck Millipore, USA). Size 3 hypromellose capsules (Vcaps ® DPI), used for spray-dried insulin were provided by Capsugel (Colmar, France).
The devices used in the study were the following:
Aerolizer® (Novartis, Switzerland), coded AR;
• RS01 (Plastiape Spa, Italy);
• HandiHaler® (Boehringer Ingelheim, Germany), coded HH;
• Turbospin® (PH&T, Italy), coded, TS.
• Aerolizer ® (Novartis, Switzerland) -AR;
• RS01 (Plastiape Spa, Italy);
• HandiHaler ® (Boehringer Ingelheim, Germany) -HH;
• Turbospin ® (PH&T, Italy) -TS.

Martinelli F., Balducci A.G., Rossi A., Sonvico F., Colombo P, & Buttini F. (2015). "Pierce and inhale" design in capsule based dry powder inhalers: Effect of capsule piercing and motion on aerodynamic performance of drugs. International journal of pharmaceutics, 487(1-2).

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Pulmonary Deposition of 5FU Powders

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The in vitro profile of pulmonary deposition of the powders was determined using the Dry Powder Inhaler Andersen Cascade Impactor (ACI-DPI, Apparatus D European Pharmacopoeia, Copley Scientific Limited, Erweka, Germany), consisting of 8 stages (0–7) with rotary impactor plates connected to a flow controller and vacuum pump. Samples of 5FU-MS (30 mg), 5FU-NS (20 mg), and the drug 5FU pure (21 mg) were transferred to hard gelatin capsules (size 3), which were introduced into the single-dose inhaler (Aerolizer^®, Novartis, Basel, Switzerland) and perforated twice. This experiment was conducted under controlled inhalation rate of 28.3 L·min⁻¹ for 4 s and a pressure of 4 kPa. After inhalation, the particles retained in each stage were rinsed off with ultrapure water. The concentration of 5FU was quantified by HPLC-UV according to the extraction method described in Section 4.3.2. The Fine Particle Dose (FPD), Fine Particle Fraction (FPF), Respirable Fraction (RF), and Dose Issued (DI) of inhaled powders for pulmonary absorption were determined according to the equations described by Meenach et al. (2013) [46 (link)].

Zatta K.C., Frank L.A., Reolon L.A., Amaral-Machado L., Egito E.S., Gremião M.P., Pohlmann A.R, & Guterres S.S. (2018). An Inhalable Powder Formulation Based on Micro- and Nanoparticles Containing 5-Fluorouracil for the Treatment of Metastatic Melanoma. Nanomaterials, 8(2), 75.

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Inhaler Device Evaluation in Asthma

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A total of 568 adult subjects (276 male, 292 female) who were on inhaler therapy for at least one month were included in this cross-sectional, observational study conducted at a tertiary pneumology out-patient clinic between June 2017 and February 2018. pMDIs and several DPIs including Aerolizer (Novartis, Surrey, UK), Handihaler (Boehringer Ingelheim, Ingelheim, Germany), Turbuhaler (Astra, Lund, Sweden) and Diskhaler (GlaxoSmithKline, Ware, UK) were assessed in this study as the most commonly used devices of those available in Turkey. Subjects > 18 y old who were diagnosed with asthma according to the Asthma, COPD, and asthma-COPD overlap syndrome, GINA, and GOLD criteria were included in this study. 11 The use of inhaler therapy for less than one month, lack of attendance to regular control visits, confirmed or suspected pregnancy, breastfeeding, allergy, sensitivity or intolerance to asthma or COPD therapy, and being on nebulizer therapy were the exclusion criteria applied to this study.
Written informed consent was obtained from each subject following a detailed explanation of the study objectives and protocol. This study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and approved by the University of Health Sciences, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital Ethics Committee.

Ocakli B., Ozmen I., Tuncay E.A., Gungor S., Ozalp A., Yasin Y., Adiguzel N., Gungor G, & Karakurt Z. (2020). Influence of Gender on Inhaler Technique. Respiratory care, 65(10).

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Inhaled CHF6001 Safety and Pharmacokinetics

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Study CCD‐1006‐PR‐0048 (first in human (FIH)) and study CCD‐06001AA1‐08 (Extension) were randomized, double‐blind, placebo‐controlled studies in healthy participants to investigate the safety, tolerability, and pharmacokinetics of inhaled CHF6001. Both studies consisted of SAD and MAD parts, and the cohorts in the SAD and MAD parts were independent from each other. In the SAD parts of the two studies, single doses of CHF6001 ranging from 0.02 to 4.8 mg or placebo were administered via Aerolizer (Novartis AG. Kohlenstrasse 84, 4056 Basel, Switzerland) (FIH) or NEXThaler (Chiesi Farmaceutici S.p.A.. Via Palermo, 26 A, Parma, Italy) (Extension). Every participant received placebo as well as 2 to 3 different doses in multiple periods separated by at least 1 week of washout. In the MAD part of the FIH study, doses of 0.1, 0.3, 0.6, 1.2, or 1.6 mg or placebo were administered once daily in parallel cohorts, whereas in the Extension study 1.2, 2, or 2.4 mg or placebo were given twice daily.
Both studies were conducted in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice. Study protocols and amendments were approved by independent ethics committees. All participants provided written informed consent prior to study enrollment.

Jolling K., Äbelö A., Luyckx N., Nandeuil M., Govoni M., Cella M, & Lindauer A. (2019). Concentration–QT Modeling Following Inhalation of the Novel Inhaled Phosphodiesterase‐4 Inhibitor CHF6001 in Healthy Volunteers Shows an Absence of QT Prolongation. CPT: Pharmacometrics & Systems Pharmacology, 8(7), 460-468.

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Impact of Inhaler Devices and Airflow on Powder Aerosolization

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The influence of inhaler devices and airflow rates on the aerosolization performances of the powder formulations were examined using three different inhaler devices (Aerolizer, Rotahaler, and Handihaler) at three different flow rates (30, 45, and 60 L/min). Devices were selected based on their resistance (Aerolizer (pressure drop < 5 Mbar), Rotahaler (pressure drop 5–10 Mbar), and Handihaler (pressure drop > 10 Mbar) to airflow. Aerolizer (Novartis Pharmaceuticals UK Ltd., London, UK), Rotahaler (GlaxoSmithKline, London, UK), and Handihaler (Boehringer-Ingelheim, Ingelheim am Rhein, Germany) are low, medium, and high resistance devices, respectively [10 (link),21 (link)]. The in vitro aerosolization was performed following the same procedure mentioned above. Triplicate experiments were carried out for each device at each flow rate.

Momin M.A., Adhikari B.R., Sinha S., Larson I, & Das S.C. (2021). Roflumilast Powders for Chronic Obstructive Pulmonary Disease: Formulation Design and the Influence of Device, Inhalation Flow Rate, and Storage Relative Humidity on Aerosolization. Pharmaceutics, 13(8), 1254.

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