Agglomerate Strength and Dispersion of Salmeterol Xinafoate from Powder Mixtures for Inhalation

Adi, Handoko; Larson, Ian; Chiou, Herbert; Young, Paul M.; Traini, Daniela; Stewart, Peter

doi:10.1007/s11095-006-9082-6

Cited by 77 publications

(45 citation statements)

References 11 publications

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“…Nevertheless, the FPF of salmeterol xinafoate from this binary mixture significantly decreases and is less than half of that of the formulation employing the drug only. Thus, the fine-particle generation of the drug from the carrier particles into the air stream was significantly less than that from aerosolising salmeterol xinafoate alone [83]. Inadequate drug/carrier separation is one of the main explanations for the low deposition efficiency encountered with DPIs [10].…”

Section: Carrier-particle Surface Modificationmentioning

confidence: 99%

Lactose characteristics and the generation of the aerosol

Pilcer¹,

Wauthoz²,

Amighi³

2012

Advanced Drug Delivery Reviews

179

113

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Section: Carrier-particle Surface Modificationmentioning

confidence: 99%

Lactose characteristics and the generation of the aerosol

Pilcer¹,

Wauthoz²,

Amighi³

2012

Advanced Drug Delivery Reviews

179

113

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“…The first one supposes the occupation of the high-energy sites on the carrier by the lactose fine particles leaving low-energy sites available for the API, thus enabling greater API detachment (22,34). In the second theory also called redistribution theory, aggregates of API and lactose fine particles termed multiplets are formed enabling greater API detachment (22,(34)(35)(36). At the present time, there is no preferential theory to explain the influence of lactose fine particles.…”

Section: Influence Of Carrier Particle Sizementioning

confidence: 99%

Dry Powder Inhalers: Study of the Parameters Influencing Adhesion and Dispersion of Fluticasone Propionate

Thi

Robins³

et al. 2012

AAPS PharmSciTech

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Abstract. Interactions between particles are dependent on the physicochemical characteristics of the interacting particles but it is also important to consider the manufacturing process. Blending active pharmaceutical ingredient (API) with carrier is a critical stage that determines the blend homogeneity and is the first step towards obtaining the final quality of the powder blend. The aim of this work was to study parameters that influence the interactions between API and carrier in adhesive mixtures used in DPI and their effect on API dispersion. The study was done with fluticasone propionate blended with lactose 'Lactohale 200'. The study was based on the influence of the operating conditions (speed, mixing time, resting steps during mixing), the size of the carrier and the storage conditions on the blend properties and on the API dispersion. The quality of the blends was examined by analysing the API content uniformity. Adhesion characteristics were evaluated by submitting mixtures to a sieving action by air depression with the Alpine air-jet sieve. Aerodynamic evaluation of fine particle fraction (FPF) was obtained using a Twin Stage Impinger; the FPF being defined as the mass percentage of API below 6.4 μm. For good dispersion and therefore good homogeneity of the API in the carrier particles, speed and powder blending time have to be sufficient, but not too long to prevent the appearance of static electricity, which is not favourable to homogeneity and stability. The FPF increases with the decrease in the carrier size. The storage conditions have also to be taken into consideration. Higher humidity favours the adhesion of API on the carrier and decreases the FPF.

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“…However, these studies were based on relatively small datasets, and the carriers used have mainly been different coarse fractions of lactose. It has also been shown that the particle size distribution of the added fine lactose is an important factor in determining whether the DPI formulation performance increases as more lactose fines are added, with finer sub-cuts of the lactose known to be more effective in improving DPI performance (11,(23)(24)(25). Following on from the hypothesis of Shur et al that increased cohesion of the carrier results to an increased DPI formulation performance (12), the study reported here aimed to investigate the influence of the addition of extrinsic lactose fines with different process histories (micronized vs. milled), and thus size distributions, to the bulk flow and fluidization properties of a wide range of different carriers, and aimed to investigate whether the increased cohesion would universally account for the improved DPI performance for a wide selection of lactose carriers.…”

Section: Introductionmentioning

confidence: 99%

An Investigation into the Effect of Fine Lactose Particles on the Fluidization Behaviour and Aerosolization Performance of Carrier-Based Dry Powder Inhaler Formulations

Kinnunen

Hebbink²,

Peters³

et al. 2014

AAPS PharmSciTech

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Abstract. The effect of milled and micronized lactose fines on the fluidization and in vitro aerosolization properties of dry powder inhaler (DPI) formulations was investigated, and the suitability of static and dynamic methods for characterizing general powder flow properties of these blends was assessed. Lactose carrier pre-blends were prepared by adding different lactose fines (Lactohale® (LH) 300, 230 and 210) with coarse carrier lactose (Lactohale100) at 2.5, 5, 10 and 20 wt% concentrations. Powder flow properties of lactose pre-blends were characterized using the Freeman Technology FT4 and Schulze RST-XS ring shear tester. A strong correlation was found between the basic flow energy (BFE Norm ) measured using the Freeman FT4 Rheometer and the flowability number (ff c ) measured on Schulze RST-XS. These data indicate that both static and dynamic methods are suitable for characterizing general powder flow properties of lactose carriers. Increasing concentration of fines corresponded with an increase in the normalized fluidization energy (FE Norm ). The inclusion of fine particles of lactose resulted in a significant (p<0.05) increase in fine particle delivery of budesonide and correlated with FE Norm . This trend was strongest for lactose containing up to 10 wt% LH300. A similar trend was found for the milled lactose grades LH230 and LH210. However, the increase in FE Norm upon addition of milled fines only corresponded to a very slight improvement in the performance. These data suggest that whilst the fluidization energy correlated with fine particle delivery, this relationship is specific to lactose grades of similar particle size.

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Agglomerate Strength and Dispersion of Salmeterol Xinafoate from Powder Mixtures for Inhalation

Abstract: The outcomes of this research demonstrated how agglomerate structure influenced dispersion and the key role of fine lactose particle size in SX dispersion from mixtures for inhalation.

Cited by 77 publications

References 11 publications

Lactose characteristics and the generation of the aerosol

Lactose characteristics and the generation of the aerosol

Dry Powder Inhalers: Study of the Parameters Influencing Adhesion and Dispersion of Fluticasone Propionate

An Investigation into the Effect of Fine Lactose Particles on the Fluidization Behaviour and Aerosolization Performance of Carrier-Based Dry Powder Inhaler Formulations

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