Application of imaging based tools for the characterisation of hollow spray dried amorphous dispersion particles

Gamble, John F.; Ferreira, Ana P.; Tobyn, Mike; DiMemmo, Lynn M.; Martin, Kyle; Mathias, Neil; Schild, Richard L.; Vig, Balvinder S.; Baumann, John M.; Parks, Stacy L.; Ashton, Mike

doi:10.1016/j.ijpharm.2014.02.002

Cited by 32 publications

(12 citation statements)

References 33 publications

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“…Hollow central void particles were reported for BMS-817399 with 90.9% drug loading prepared by spray drying. 31,32 In our 40/60 ASD system, central void particles, as well as spherical particles with a relatively wide distribution of particle size were observed for freshly-made ASD. After 95% RH exposure, there were less spherical particles with fine and smooth surface; instead, more particles with irregular shape, porous and rough surface were observed (Fig.…”

Section: Surface Morphology and Chemical Composition Of Asds After Ammentioning

confidence: 73%

Moisture-Induced Amorphous Phase Separation of Amorphous Solid Dispersions: Molecular Mechanism, Microstructure, and Its Impact on Dissolution Performance

Chen

Pui

Liu

et al. 2018

Journal of Pharmaceutical Sciences

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Amorphous phase separation (APS) is commonly observed in amorphous solid dispersions (ASD) when exposed to moisture. The objective of this study was to investigate: (1) the phase behavior of amorphous solid dispersions composed of a poorly water-soluble drug with extremely low crystallization propensity, BMS-817399, and PVP, following exposure to different relative humidity (RH), and (2) the impact of phase separation on the intrinsic dissolution rate of amorphous solid dispersion. Drug-polymer interaction was confirmed in ASDs at different drug loading using infrared (IR) spectroscopy and water vapor sorption analysis. It was found that the drug-polymer interaction could persist at low RH (≤75% RH) but was disrupted after exposure to high RH, with the advent of phase separation. Surface morphology and composition of 40/60 ASD at micro-/nano-scale before and after exposure to 95% RH were also compared. It was found that hydrophobic drug enriched on the surface of ASD after APS. However, for the 40/60 ASD system, the intrinsic dissolution rate of amorphous drug was hardly affected by the phase behavior of ASD, which may be partially attributed to the low crystallization tendency of amorphous BMS-817399 and enriched drug amount on the surface of ASD. Intrinsic dissolution rate of PVP decreased resulting from APS, leading to a lower concentration in the dissolution medium, but supersaturation maintenance was not anticipated to be altered after phase separation due to the limited ability of PVP to inhibit drug precipitation and prolong the supersaturation of drug in solution. This study indicated that for compounds with low crystallization propensity and high hydrophobicity, the risk of moisture-induced APS is high but such phase separation may not have profound impact on the drug dissolution performance of ASDs. Therefore, application of ASD technology on slow crystallizers could incur low risks not only in physical stability but also in dissolution performance.

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Section: Surface Morphology and Chemical Composition Of Asds After Ammentioning

confidence: 73%

Moisture-Induced Amorphous Phase Separation of Amorphous Solid Dispersions: Molecular Mechanism, Microstructure, and Its Impact on Dissolution Performance

Chen

Pui

Liu

et al. 2018

Journal of Pharmaceutical Sciences

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“…Granulometric data and Raman spectra were obtained from automatic static image analysis of Malvern Morphologi G3-ID (Malvern Instruments Ltd., UK), which is an advanced particle characterization apparatus. This device allows thousands of particle shapes to be quantified in a few hours and it has recently been used for quality control in the pharmaceutical and mining industry (Kwan et al, 1999;Ulusoy and Kursun, 2011;Schneider and Marcini, 2013;Gamble et al, 2014). Nevertheless, only a few studies have exploited image-based methods in sedimentology so far, apart from preliminary studies designed to demonstrate its potential (Altuhafi et al, 2012;Polakowski et al, 2014;Duval et al, 2015;Sochan et al, 2015;Campaña et al, 2016;Nielsen et al, 2016;Polo-Díaz et al, 2016;Becker et al, in press).…”

Section: Automated Static Image Analysis Proceduresmentioning

confidence: 99%

Granulometric characterization of paleosols in loess series by automated static image analysis

Varga

Kovács

Szalai

et al. 2018

Sedimentary Geology

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An automated image analysis method is proposed here to study the size and shape of siliciclastic sedimentary particles of paleosols of Central European loess sequences. Several direct and indirect measurement techniques are available for grain size measurements of sedimentary mineral particles. Indirect techniques involve the use of some kind of physical laws, however, all requirements for calculations are in many cases not known. Even so, the direct manual microscopic observation and measurement of large, representative number of grains is timeconsuming and sometimes rather subjective. Therefore, automated image analyses techniques provide a new and perspective way to analyse grain size and shape sedimentary particles. Here we test these indirect and direct techniques and provide new granulometric data of paleosols. Our results demonstrate that grain size data of the mineral dust samples are strongly dependent on shape parameters of particles, and shape heterogeneity was different of the different size classes. Due to the irregular grain shape parameters, uncertainties have arisen also for the sizes. In this paper we present a possible correction procedure to reduce the differences among the results of the laser diffraction and image analysis methods. By applying new correction factors, results of the two approaches could be get closer but the most definite factor, the unknown thickness of particles remained a problem to solve. The other presented method to assess the uncertain 3 rd dimension of particles by their intensity-size relationships makes us able to reduce further the deviations of the two sizing methods.

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“…However, some analytical techniques offer nowadays the possibility of rapid particle characterizations, such as instruments based on static image analysis that are widely used for quality control purposes in pharmaceutical manufacturing (e.g. Das et al, 2013;Gamble et al, 2014;Krupa et al, 2014;Ulusoy and Kursun, 2011). In the present study, a large diversity of sediment samples were analyzed using a Malvern Instruments Morphologi G3, in order to obtain further information about the morphology of the grains.…”

Section: Introductionmentioning

confidence: 99%

Assessing the uncertainty on particle size and shape: Implications for ESR and OSL dating of quartz and feldspar grains

Duval

Lozano

Guilarte

et al. 2015

Radiation Measurements

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h i g h l i g h t s Grain size and shape are two important parameters in ESR and OSL dating of sediment. We measure grain size and shape of 19 sediment samples by static image analysis. Grains should be in general approximated to smooth slightly elongated ellipsoids. We identify the sources of uncertainty influencing grain size and shape. The Impact of these results on the dose rate evaluation is quantified.

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Application of imaging based tools for the characterisation of hollow spray dried amorphous dispersion particles

Cited by 32 publications

References 33 publications

Moisture-Induced Amorphous Phase Separation of Amorphous Solid Dispersions: Molecular Mechanism, Microstructure, and Its Impact on Dissolution Performance

Moisture-Induced Amorphous Phase Separation of Amorphous Solid Dispersions: Molecular Mechanism, Microstructure, and Its Impact on Dissolution Performance

Granulometric characterization of paleosols in loess series by automated static image analysis

Assessing the uncertainty on particle size and shape: Implications for ESR and OSL dating of quartz and feldspar grains

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