Non-impactor-Based Methods for Sizing of Aerosols Emitted from Orally Inhaled and Nasal Drug Products (OINDPs)

Mitchell, Jolyon; Bauer, Richard; Lyapustina, Svetlana; Tougas, Terrence P.; Glaab, Volker

doi:10.1208/s12249-011-9662-6

Cited by 25 publications

(11 citation statements)

References 52 publications

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“…Among various cascade impactors, the next-generation impactor (NGI) is the apparatus recommended by the USP for the assessment of aerodynamic droplet sizes from nebulizer systems, because it is a direct measurement of drug mass deposited based on aerodynamic droplet sizes. [211][212][213][214][215][216] Alternatively, laser diffractometry is accepted for droplet size measurement specifically for homogeneous solutions, but not for dispersed systems or when significant droplet evaporation occurs. [217,218] The test should be performed at airflow rate of 15 L/min and with a cooled impactor to avoid droplet evaporation.…”

Section: Characterization Of Nebulizer Formulationsmentioning

confidence: 99%

The function and performance of aqueous aerosol devices for inhalation therapy

Carvalho

McConville

2016

Journal of Pharmacy and Pharmacology

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Objectives In this review paper, we explore the interaction between the functioning mechanism of different nebulizers and the physicochemical properties of the formulations for several types of devices, namely jet, ultrasonic and vibrating-mesh nebulizers; colliding and extruded jets; electrohydrodynamic mechanism; surface acoustic wave microfluidic atomization; and capillary aerosol generation. Key findings Nebulization is the transformation of bulk liquids into droplets. For inhalation therapy, nebulizers are widely used to aerosolize aqueous systems, such as solutions and suspensions. The interaction between the functioning mechanism of different nebulizers and the physicochemical properties of the formulations plays a significant role in the performance of aerosol generation appropriate for pulmonary delivery. Certain types of nebulizers have consistently presented temperature increase during the nebulization event. Therefore, careful consideration should be given when evaluating thermo-labile drugs, such as protein therapeutics. We also present the general approaches for characterization of nebulizer formulations. Summary In conclusion, the interplay between the dosage form (i.e. aqueous systems) and the specific type of device for aerosol generation determines the effectiveness of drug delivery in nebulization therapies, thus requiring extensive understanding and characterization.

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Section: Characterization Of Nebulizer Formulationsmentioning

confidence: 99%

The function and performance of aqueous aerosol devices for inhalation therapy

Carvalho

McConville

2016

Journal of Pharmacy and Pharmacology

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“…Possible interactions between crystal faces of theophylline and mannitol were probed applying a computational lattice matching approach, using the Geometric Real-space Analysis of Crystal Epitaxy (GRACE) software (Mitchell et al, 2011). Cut-off distances of dc = 0.5 Å and d0 = 0.3 Å were selected.…”

Section: Computational Lattice Matching Calculationsmentioning

confidence: 99%

Preparation of theophylline inhalable microcomposite particles by wet milling and spray drying: The influence of mannitol as a co-milling agent

Malamatari¹,

Somavarapu²,

Kachrimanis

et al. 2016

International Journal of Pharmaceutics

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Inhalable theophylline particles with various amounts of mannitol were prepared by combining wet milling in isopropanol followed by spray drying. The effect of mannitol as a co-milling agent on the micromeritic properties, solid state and aerosol performance of the engineered particles was investigated. Crystal morphology modelling and geometric lattice matching calculations were employed to gain insight into the intermolecular interactions that may influence the mechanical properties of theophylline and mannitol. The addition of mannitol facilitated the size reduction of the needle-like crystals of theophylline and also their assembly in microcomposites by forming a porous structure of mannitol nanocrystals wherein theophylline particles are embedded. The microcomposites were found to be in the same crystalline state as the starting material(s) ensuring their long-term physical stability upon storage. Incorporation of mannitol resulted in microcomposite particles with smaller size, more spherical shape and increased porosity. The aerosol performance of the microcomposites was markedly enhanced compared to the spray-dried suspension of theophylline wet milled without mannitol. Overall, wet co-milling with mannitol in an organic solvent followed by spray drying may be used as a formulation approach for producing respirable particles of water-soluble drugs or drugs that are prone to crystal transformation in an aqueous environment (i.e. formation of hydrates).

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“…However, inhalation characteristic tests by pharmacopeial methods (e.g., cascade impactor and multi-stage liquid impinger (MSLI)) require much time even for only a few samples [ 21 ]. From this point, pharmacopeial methods are not preferable for optimization by statistical techniques [ 22 ]. Time-of-flight (TOF) measurement is one method that can measure the aerodynamic particle size distribution of many samples in a short time [ 21 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

Simple Method to Measure the Aerodynamic Size Distribution of Porous Particles Generated on Lyophilizate for Dry Powder Inhalation

et al. 2020

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Recently, statistical techniques such as design of experiments are being applied for efficient optimization of oral formulations. To use these statistical techniques for inhalation formulations, efficient methods for rapid determination of the aerodynamic particle size distribution of many samples are needed. Therefore, we aimed to develop a simple method to measure aerodynamic particle size distribution that closely agrees with the results of inhalation characteristic tests. We added attachments for dispersion to the aerodynamic particle sizer (APS) so that formulations could be dispersed under the same condition as for multi-stage liquid impinger (MSLI) measurement. Then, we examined the correlation between MSLI and APS using lyophilizate for dry powder inhalation formulations that generate porous particles just on inhalation. It is difficult to obtain the accurate aerodynamic particle size distribution of porous particles by APS because the particle density is difficult to estimate accurately. However, there was a significant correlation between MSLI and APS when the particle density settings for APS measurement was calculated by a conversion factor based on the result of MSLI. The APS with dispersion attachments and this conversion factor can measure a number of samples in a short time, thereby enabling more efficient optimization of dry powder inhalers.

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Non-impactor-Based Methods for Sizing of Aerosols Emitted from Orally Inhaled and Nasal Drug Products (OINDPs)

Cited by 25 publications

References 52 publications

The function and performance of aqueous aerosol devices for inhalation therapy

The function and performance of aqueous aerosol devices for inhalation therapy

Preparation of theophylline inhalable microcomposite particles by wet milling and spray drying: The influence of mannitol as a co-milling agent

Simple Method to Measure the Aerodynamic Size Distribution of Porous Particles Generated on Lyophilizate for Dry Powder Inhalation

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