The Influence of Drug Morphology on Aerosolisation Efficiency of Dry Powder Inhaler Formulations

Adi, Handoko; Traini, Daniela; Chan, Hak‐Kim; Young, Paul M.

doi:10.1002/jps.21195

Cited by 84 publications

(53 citation statements)

References 32 publications

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“…The aerosol performance of dry powder aerosol formulations is influenced by several particle properties including size distribution, morphology, and particle surface properties, as described in detail. [28][29][30][31][32][33][34][35][36][37][38] Spray-drying is a high-throughput particle engineering design process that offers many advantages in designing and producing tailored particles for DPIs. 28,29 Organic solution advanced spray drying in closed-mode for DPIs has been reported in our previous studies.…”

Section: Introductionmentioning

confidence: 99%

Design, characterization, and aerosolization of organic solution advanced spray-dried moxifloxacin and ofloxacin dipalmitoylphosphatidylcholine (DPPC) microparticulate/nanoparticulate powders for pulmonary inhalation aerosol delivery

Duan¹,

Vogt²,

Li³

et al. 2013

IJN

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Section: Introductionmentioning

confidence: 99%

Design, characterization, and aerosolization of organic solution advanced spray-dried moxifloxacin and ofloxacin dipalmitoylphosphatidylcholine (DPPC) microparticulate/nanoparticulate powders for pulmonary inhalation aerosol delivery

Duan¹,

Vogt²,

Li³

et al. 2013

IJN

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“…It is well documented that the particle size, size distribution (4), morphology (33,34), surface roughness (23,35), surface area, flowability (6), density, and surface energy (7) of lactose carriers all have influence on the DPI formulations. The granulated lactose carrier particles produced in this study had similar solid-state, flowability, surface area, and true density, but different size, morphology, roughness, and bulk/tap density.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Granulated Lactose as a Carrier for DPI Formulations 1: Effect of Granule Size

2014

AAPS PharmSciTech

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ABSTRACT. The objective of this study was to investigate the effect of large granulated lactose carrier particle systems on aerosol performance of dry powder inhaler formulations. Granulated lactose carriers with average sizes ranging from 200 to 1,000 μm were prepared and subsequently fractionated into separate narrow size powders. The fractionated granulated lactose (GL) samples were characterized in terms of size, specific surface area, surface roughness, morphology, density, flowability, and solid-state. The in vitro aerosolization performance was performed on the different size fractions of GL samples from a commercial inhaler device (Aerolizer®) with a model formulation (2% w/w salbutamol sulfate). The cascade impaction parameters employed were 60 or 90 L/min with standard (aperture size, 0.6 mm) or modified piercing holes (aperture size, 1.2 mm) of the inhaler loaded capsules. It was shown that the largest size fraction formulation (850-1000 μm) had a slight improvement in the fine particle fraction (FPF) compared to immediately preceding size fractions, explained by a smaller adhesive force between drug and carrier. Compared to commercial piercing holes, enlarged piercing holes generated a slight decreasing trend of FPF as the lactose powder sizes increased from 200-250 μm to 600-850 μm, perhaps due to the reduced detachment force by flow forces. The size, surface roughness, density, and flowability of lactose carrier as well as device design all contributed to the aerosol dispersion performance of granulated lactose-based adhesive mixtures. It was concluded that poorer or enhanced redispersion performance is not an inherent property to the significantly large size of granulated lactose carriers as previously contended.

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“…Particle size, particle morphology, surface roughness and interfacial chemistry of the API and carrier particles have been shown to play a key role in determining these interfacial interactions (9)(10)(11)(12)(13)(14). Whilst the surface and interfacial properties of the API are known to be critical in controlling product performance of DPI products, the primary property characterized for the API component of DPI formulations remains to be the particle size.…”

Section: Electronic Supplementary Materialsmentioning

confidence: 99%

Effect of Device Design and Formulation on the In Vitro Comparability for Multi-Unit Dose Dry Powder Inhalers

Shur

Saluja

Lee

et al. 2015

AAPS J

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Abstract. The focus of this investigation was to understand the design space to achieve comparable in vitro performance of two multi-unit dose dry powder inhalers (DPIs)-Flixotide® Accuhaler® (reference product) and MultiHaler® (test product). Flow field, pressure drop and particle trajectories within the test and reference DPI devices were modelled via computational fluid dynamics (CFD). Micronized fluticasone propionate (FP) was characterized to determine particle size distribution (PSD), specific surface area (SSA) and surface interfacial properties using cohesive-adhesive balance (CAB). CFD simulations suggested that the pressure drop and airflow velocity in the MultiHaler® were greater than Accuhaler®. Two modified test devices (MOD MH 1 and MOD MH 2) were manufactured with the introduction of by-pass channels in the airflow path, which achieved comparable specific resistance and airflow path between the test and reference devices. Assessment of reference product formulation in modified test devices suggested that MOD MH 2 achieved comparable in vitro performance to the reference product. CAB analysis suggested that adhesion of all FP batches to lactose was different, with batch D showing greatest and batch A least adhesion to lactose. Test DPI formulations were manufactured using four different batches of FP with milled or sieved lactose, and showed that batch A FP formulated with sieved lactose in MOD MH 2 device demonstrated the highest degree of similarity to the Accuhaler® in vitro deposition. Application of CFD modelling and material characterization of formulation raw materials enabled the modification of device and formulation critical material attributes to create an in vitro comparable device/formulation system to the reference product.KEY WORDS: aerosolization; computational fluid dynamics; device design; dry powder inhaler; in vitro comparability; in vitro performance.

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The Influence of Drug Morphology on Aerosolisation Efficiency of Dry Powder Inhaler Formulations

Cited by 84 publications

References 32 publications

Design, characterization, and aerosolization of organic solution advanced spray-dried moxifloxacin and ofloxacin dipalmitoylphosphatidylcholine (DPPC) microparticulate/nanoparticulate powders for pulmonary inhalation aerosol delivery

Design, characterization, and aerosolization of organic solution advanced spray-dried moxifloxacin and ofloxacin dipalmitoylphosphatidylcholine (DPPC) microparticulate/nanoparticulate powders for pulmonary inhalation aerosol delivery

Evaluation of Granulated Lactose as a Carrier for DPI Formulations 1: Effect of Granule Size

Effect of Device Design and Formulation on the In Vitro Comparability for Multi-Unit Dose Dry Powder Inhalers

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