scholarly journals Study of pressurised metered dose inhalers for the purpose of standardization of quality attributes characterizing uniformity of dosing

2021 ◽  
pp. 11-23
Author(s):  
Elena Bezuglaya ◽  
Nikolay Lyapunov ◽  
Vladimir Bovtenko ◽  
Igor Zinchenko ◽  
Yurij Stolper
Keyword(s):  
Particle Size ◽  
Fine Particle ◽  
Fine Particles ◽  
Average Dose ◽  
Metered Dose Inhalers ◽  
Fine Particle Dose ◽  
Particle Dose ◽  
Metered Dose ◽  
Delivered Dose

Aim. The purpose was to provide the rationale of test in regard to uniformity of fine particles dose for pressurised metered dose inhalers (pMDIs). Materials and methods. The pMDIs containing suspensions of salbutamol sulfate (SS) or solutions of beclometasone dipropionate (BD) were studied by laser diffraction and high performance liquid chromatography (HPLC). The particle size distribution of SS, the average dose mass and uniformity of dose mass, the average delivered dose and the uniformity of delivered dose, the average fine particles dose and uniformity of fine particles dose were determined. Apparatus A was used for assessment of fine particles dose. Results. The two analytical procedures for the quantitative determination of SS and BD by HPLC were validated in the ranges with low concentrations of these substances. The 5 medicinal products in pMDI dosage form were studied: 3 preparations were with SS and 2 ones contained BD. It was shown that three products with SS were very similar in regard to particle size distribution in containers and the average values of delivered dose were almost the same, but these products were different in the average dose mass and fine particle dose. According to the research results, the expediency of determining the average dose mass and the tests concerning uniformity of dosing of preparations by dose mass and by fine particle dose was substantiated. It was shown that in the case of pMDI the dosing of solutions of BD was more uniform compared to suspensions of SS. The approaches of leading and other pharmacopoeias concerning uniformity of dosing for pMDIs were critically discussed. The expediency of determination of uniformity of fine particle dose at the stage of pharmaceutical development was substantiated, as the therapeutic effect depends on fine particle dose. Issues concerning standardization pMDIs in regard to uniformity of fine particle dose were discussed. Conclusions. The expediency of standardization and quality control of pMDIs in regard to such attributes as the average dose mass, which characterizes the volume of the metering chamber of the valve as well as the uniformity of the dose mass and the uniformity of fine particle dose, which assure the therapeutic effect of each dose of the product was substantiated

scholarly journals Inspiratory flows and the aerosol cloud from dry powder inhalers

Alergoprofil ◽  
2021 ◽  
Vol 17 (2) ◽  
pp. 25-33
Author(s):  
Andrzej Emeryk ◽  
Justyna Emeryk-Maksymiuk ◽  
Kamil Janeczek
Keyword(s):  
Fine Particle ◽  
Clinical Effect ◽  
Dry Powder Inhalers ◽  
Particle Fraction ◽  
Dry Powder ◽  
Pulmonary Deposition ◽  
Fine Particle Dose ◽  
Particle Dose ◽  
The Relationship ◽  
Delivered Dose

The relationship between the delivered dose, the fine particle fraction and the fine particle dose and the value of inspiratory flow generated by the patient is one of the most important features of dry powder inhalers (DPIs). It significantly affects the amount of pulmonary deposition of the inhaled drug and the clinical effect of the drug. The results of research evaluating these relationships for popular in Poland dry powder inhalers are presented. Flow-dependent, relatively flow-dependent and relatively flow-independent inhalers are demonstrated.

scholarly journals Comparative in vitro evaluation of four corticosteroid metered dose inhalers: Consistency of delivered dose and particle size distribution

2009 ◽  
Vol 103 (8) ◽  
pp. 1167-1173 ◽  
Author(s):  
Tjalling W. de Vries ◽  
Bart L. Rottier ◽  
Doetie Gjaltema ◽  
Paul Hagedoorn ◽  
Henderik W. Frijlink ◽  
...  
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution ◽  
Metered Dose Inhalers ◽  
In Vitro Evaluation ◽  
Metered Dose ◽  
Delivered Dose

scholarly journals Tuning Aerosol Particle Size Distribution of Metered Dose Inhalers Using Cosolvents and Surfactants

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Imran Y. Saleem ◽  
Hugh D. C. Smyth
Keyword(s):  
Particle Size ◽  
Fine Particle ◽  
Laser Diffraction ◽  
Particle Sizes ◽  
Size Distributions ◽  
Metered Dose Inhalers ◽  
Particle Size Distributions ◽  
Metered Dose ◽  
Aerosol Particle Size ◽  
Median Particle

Objectives.The purpose of these studies was to understand the influence of cosolvent and surfactant contributions to particle size distributions emitted from solution metered dose inhalers (pMDIs) based on the propellant HFA 227.Methods.Two sets of formulations were prepared: (a) pMDIs-HFA 227 containing cosolvent (5–15% w/w ethanol) with constant surfactant (pluronic) concentration and (b) pMDIs-HFA 227 containing surfactant (0–5.45% w/w pluronic) with constant cosolvent concentration. Particle size distributions emitted from these pMDIs were analyzed using aerodynamic characterization (inertial impaction) and laser diffraction methods.Results. Both cosolvent and surfactant concentrations were positively correlated with median particle sizes; that is, drug particle size increased with increasing ethanol and pluronic concentrations. However, evaluation of particle size distributions showed that cosolvent caused reduction in the fine particle mode magnitude while the surfactant caused a shift in the mode position. These findings highlight the different mechanisms by which these components influence droplet formation and demonstrate the ability to utilize the different effects in formulations of pMDI-HFA 227 for independently modulating particle sizes in the respirable region.Conclusion. Potentially, the formulation design window generated using these excipients in combination could be used to match the particle size output of reformulated products to preexisting pMDI products.

scholarly journals Numerical and Experimental Investigation on Key Parameters of the Respimat® Spray Inhaler

Processes ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 44
Author(s):  
Yi Ge ◽  
Zhenbo Tong ◽  
Renjie Li ◽  
Fen Huang ◽  
Jiaqi Yu
Keyword(s):  
High Speed ◽  
Fine Particles ◽  
Geometric Parameters ◽  
Metered Dose Inhalers ◽  
Geometric Pattern ◽  
Long Duration ◽  
Metered Dose ◽  
New Type ◽  
Computational Fluid Dynamics Cfd ◽  
Spray Velocity

Respimat®Soft MistTM is a newly developed spray inhaler. Different from traditional nebulizers, metered-dose inhalers, and dry powder inhalers, this new type of inhaler can produce aerosols with long duration, relatively slow speed, and a high content of fine particles. Investigating the effect of the key geometric parameters of the device on the atomization is of great significance for generic product development and inhaler optimization. In this paper, a laser high-speed camera experimental platform is built, and important parameters such as the geometric pattern and particle size distribution of the Respimat®Soft MistTM are measured. Computational fluid dynamics (CFD) and the volume of fluid method coupled with the Shear Stress Transport (SST) k-ω turbulence model are applied to simulate the key geometric parameters of the device. The effects of geometric parameters on the spray velocity distribution and geometric pattern are obtained. The angle of flow collision, the sphere size of the central divider and the length and width of the flow channel show significant impacts on the spray atomization.

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