Aerodynamic sizing of metered dose inhalers: An evaluation of the andersen and next generation pharmaceutical impactors and their USP methods

Kamiya, Akihiko; Sakagami, Masahiro; Hindle, Michael; Byron, Peter R.

doi:10.1002/jps.20091

Cited by 32 publications

(28 citation statements)

References 15 publications

(31 reference statements)

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“…Flat design of NGI is often considered more suitable for automated measurements. NGI also has steeper collection efficiency curves, offering the advantage of more accurate size fractionation (78,106). There are several other impactors included in Pharmacopoeias (Table I), such as Multistage Liquid Impinger (MSLI).…”

Section: Cascade Impactor (Ci)mentioning

confidence: 99%

Particle Size Analysis in Pharmaceutics: Principles, Methods and Applications

et al. 2006

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Physicochemical and biopharmaceutical properties of drug substances and dosage forms can be highly affected by the particle size, a critical process parameter in pharmaceutical production. The fundamental issue with particle size analysis is the variety of equivalent particle diameters generated by different methods, which is largely ascribable to the particle shape and particle dispersion mechanism involved. Thus, to enable selection of the most appropriate or optimal sizing technique, cross-correlation between different techniques may be required. This review offers an in-depth discussion on particle size analysis pertaining to specific pharmaceutical applications and regulatory aspects, fundamental principles and terminology, instrumentation types, data presentation and interpretation, in-line and process analytical technology. For illustration purposes, special consideration is given to the analysis of aerosols using time-of-flight and cascade impactor measurements, which is supported by a computational analysis conducted for this review.

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Section: Cascade Impactor (Ci)mentioning

confidence: 99%

Particle Size Analysis in Pharmaceutics: Principles, Methods and Applications

et al. 2006

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“…The pMDI was primed and then inserted into the ''throat'' of the cascade impactor. A total of 20 doses of HFA-BDP (100 mg?actuation -1 ) were drawn into the cascade impactor at a continuous flow of 28.3 L?min -1 in order to optimise analytical sensitivity and to minimise bounce effects [25].…”

Section: Ethical Considerationsmentioning

confidence: 99%

Spacer inhalation technique and deposition of extrafine aerosol in asthmatic children

Roller¹,

Zhang²,

Troedson³

et al. 2006

European Respiratory Journal

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The aim of the present study was to measure airway, oropharyngeal and gastrointestinal deposition of 99m Tc-labelled hydrofluoroalkane-beclomethasone dipropionate after inhalation via a pressurised metered-dose inhaler and spacer (Aerochamber Plus TM ) in asthmatic children.A group of 24 children (aged 5-17 yrs) with mild asthma inhaled the labelled drug. A total of 12 children took five tidal breaths after each actuation (tidal group). The other 12 children used a slow maximal inhalation followed by a 5-10-s breath-hold (breath-hold group). Simultaneous anterior and posterior planar c-scintigraphic scans (120-s acquisition) were recorded.For the tidal group, mean¡SD lung deposition (% ex-actuator, attenuation corrected) was 35.4¡18.3, 47.5¡13.0 and 54.9¡11.2 in patients aged 5-7 (n54), 8-10 (n54) and 11-17 yrs (n54), respectively. Oropharyngeal and gastrointestinal deposition was 24.0¡10.5, 10.3¡4.4 and 10.1¡6.2. With the breath-hold technique, lung deposition was 58.1¡6.7, 56.6¡5.2 and 58.4¡9.2. Oropharyngeal and gastrointestinal deposition was 12.9¡3.2, 20.1¡9.5 and 20.8¡8.8.Inhalation of the extrafine formulation with the breath-hold technique showed significantly improved lung deposition compared with tidal breathing across all ages. Oropharyngeal and gastrointestinal deposition was markedly decreased, regardless of which inhalation technique was applied, compared with a previous paediatric study using the same formulation delivered via a breath-actuated metered-dose inhaler.

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“…Eur., 2004). It has been suggested that the recovery from the ACI may be lower than that obtained from the MSLI or NGI due to greater ACI inter-stage wall losses (Kamiya et al, 2004;Marple et al, 2003a,b;. Recoveries from the ACI did appear to be marginally smaller although there was no significant difference in the recovery of SX (p > 0.05).…”

Section: Discussionmentioning

confidence: 87%

“…Few reported studies have compared the ACI or the MSLI with the recently introduced NGI. Kamiya et al (2004) employed a pressurised metered dose inhaler (pMDI) formulation in such a comparison and reported equivalence between the two impactors while , who also tested pMDI formulations, reported significant differences. The different conclusions reached by the aforementioned studies may have resulted from differences in the methods employed in the testing of inhalers and the analysis of results.…”

Section: Introductionmentioning

confidence: 95%