Inhaled Corticosteroid Metered-Dose Inhalers: How Do Variations in Technique for Solutions Versus Suspensions Affect Drug Distribution?

Robinson, Christie; Tsourounis, Candy

doi:10.1345/aph.1r480

Cited by 5 publications

(3 citation statements)

References 11 publications

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“…With a small residual particle size, it is expected that a greater extent of the drug deposits in the peripheral airways (airway diameters, ≤2 mm), compared with a CFC BDP formulation with a residual size of approximately 3 μm (74), which primarily deposited in the central airways (78). The extrafine aerosol formulation approach permits QVAR ® to have a lower formulation drug concentration, increased inhalation technique tolerance and increased ratio of therapeutic efficacy to adverse effects because of the deposition of the drug in the peripheral airways compared to the CFC formulation (79,80). Treating the peripheral airways is important especially for a large proportion of asthmatic patients who experience persistent small airway dysfunction (77) and has been shown to improve the probability of patients achieving asthma control over a period of 1 year (81).…”

Section: Solution Formulation Strategiesmentioning

confidence: 99%

Advances in Metered Dose Inhaler Technology: Formulation Development

2014

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Pressurized metered dose inhalers (MDIs) are a long-standing method to treat diseases of the lung, such as asthma and chronic obstructive pulmonary disease. MDIs rely on the driving force of the propellant, which comprises the bulk of the MDI formulation, to atomize droplets containing drug and excipients, which ideally should deposit in the lungs. During the phase out of chlorofluorocarbon propellants and the introduction of more environmentally friendly hydrofluoroalkane propellants, many improvements were made to the methods of formulating for MDI drug delivery along with a greater understanding of formulation variables on product performance. This review presents a survey of challenges associated with formulating MDIs as solution or suspension products with one or more drugs, while considering the physicochemical properties of various excipients and how the addition of these excipients may impact overall product performance of the MDI. Propellants, volatile and nonvolatile cosolvents, surfactants, polymers, suspension stabilizers, and bulking agents are among the variety of excipients discussed in this review article. Furthermore, other formulation approaches, such as engineered excipient and drug-excipient particles, to deliver multiple drugs from a single MDI are also evaluated.

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Section: Solution Formulation Strategiesmentioning

confidence: 99%

Advances in Metered Dose Inhaler Technology: Formulation Development

2014

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“…Treatment for acute episodes is based on short-acting b2-agonists, usually administered, according to the international guidelines, with a metered dose inhaler (MDI) spacer (6)(7)(8). The same device must be used to daily deliver inhaled corticosteroids (ICS), i.e., to treat the underlying inflammatory chronic disorder (9,10). At variance, many parents and some doctors choose to administer the ICS or b2-agonists through nebulization (11)(12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

A Novel, Portable MESH Nebulizer—An Alternative to Metered Dose Inhaler: Efficacy and Usability in Preschool Wheezers

et al. 2020

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Introduction and Objectives: Wheezing episodes are the first causes of doctor's consultation in preschool age. Treatment is usually administered with a metered dose inhaler (MDI) spacer. At variance, many parents and doctors prefer to use a compressor nebulizer, which cannot be easily carried. The study is aimed at testing whether a pocket mesh nebulizer has similar efficacy and acceptability than a standard MDI device.Materials and Methods: The IPAC study was a randomized, controlled, non-inferiority trial (number: 1616/2018, Ospedale Pediatrico Bambino Gesu'—IRCCS). The study had two arms: cases, using MicroAIR U100, and controls, using MDI+spacer device. Both devices were adopted for long-term treatment and for exacerbations. Follow-up was organized with clinical visits and a daily e-diary connected to an application for mobile phone.Results: One hundred patients were enrolled. The frequency of asthmatic symptoms showed a non-inferiority for MicroAIR U100 group vs. MDI. Accordingly, no significant difference was found in the average % of days with cough, wheezing, breathlessness after exercise, days lost at school, and not-programmed visits. Considering only patients with >1 day with symptoms, no significant sdifferences were found in the number of exacerbations nor in the cumulative days with symptoms. The acceptance and usability of both devices have been favorable. However, the MDI+AeroChamber® device showed better acceptability.Conclusions: Our study shows that MicroAIR U-100, a mesh nebulizer, has similar clinical efficacy but lower acceptance and usability than an MDI plus Aerochamber® in delivering therapy in preschool wheezers. Therefore, MicroAIR U-100 might be a valuable second choice, when the delivery of medication with an MDI plus Aerochamber® is not accepted, or wrongly used by the parents.

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“…A common challenge in the use of inhaler devices that deliver asthma medications is improper inhalation technique, which is associated with low lung distribution, poor adherence and poorly controlled asthma [ 1–4 ]. Achieving the correct synchronization of inhalation following actuation has been shown to be the main step that patients fail during inhaler technique assessment [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

et al. 2015

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Objective: Evaluate the safety of albuterol multidose dry powder inhaler (MDPI), a novel, inhalation-driven device that does not require coordination of actuation with inhalation, in patients with persistent asthma. Methods: We report pooled safety data from two 12-week, multicenter, randomized, double-blind, repeat-dose, parallel-group studies and the 12-week double-blind phase of a 52-week multicenter safety study as well as safety data from the 40-week open-label phase of the 52-week safety study. In each study, eligible patients aged ≥12 years with persistent asthma received placebo MDPI or albuterol MDPI 180 µg (2 inhalations × 90 µg/inhalation) 4 times/day for 12 weeks. In the 40-week open-label phase of the 52-week safety study, patients received albuterol MDPI 180 μg (2 inhalations × 90 μg/inhalation) as needed (PRN). Results: During both 12-week studies and the 12-week double-blind phase of the 52-week study, adverse events were more common with placebo MDPI (50%; n = 333) than albuterol MDPI (40%; n = 321); most frequent were upper respiratory tract infection (placebo MDPI 11%, albuterol MDPI 10%), nasopharyngitis (6%, 5%), and headache (6%, 4%). Incidences of β2-agonist-related events (excluding headache) during the pooled 12-week dosing periods were low (≤1%) in both groups. The safety profile with albuterol MDPI PRN during the 40-week open-label phase [most frequent adverse events: nasopharyngitis (12%), sinusitis (11%), upper respiratory tract infection (9%)] was similar to that observed during the 12-week pooled analysis. Conclusions: The safety profile of albuterol MDPI 180 μg in these studies was comparable with placebo MDPI and consistent with the well-characterized profile of albuterol in patients with asthma.

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Inhaled Corticosteroid Metered-Dose Inhalers: How Do Variations in Technique for Solutions Versus Suspensions Affect Drug Distribution?

Cited by 5 publications

References 11 publications

Advances in Metered Dose Inhaler Technology: Formulation Development

Advances in Metered Dose Inhaler Technology: Formulation Development

A Novel, Portable MESH Nebulizer—An Alternative to Metered Dose Inhaler: Efficacy and Usability in Preschool Wheezers

Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

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