Particle Size Distribution

Randall, C.W.

doi:10.1201/b14204-7

Cited by 6 publications

(6 citation statements)

References 55 publications

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“…This was proven with microscopy studies which showed the presence of agglomerates in the tablet when using smallest particle size of Theophylline. In general, agglomerated particles are undesirable because they reduce the surface area leading to slower dissolution rate (Randall, 1995). SEM images (Fig.…”

Section: Dissolution Ratementioning

confidence: 99%

Roller compaction of different pseudopolymorphic forms of Theophylline: Effect on compressibility and tablet properties

Hadžović

Betz

Hadzidedic

et al. 2010

International Journal of Pharmaceutics

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Section: Dissolution Ratementioning

confidence: 99%

Roller compaction of different pseudopolymorphic forms of Theophylline: Effect on compressibility and tablet properties

Hadžović

Betz

Hadzidedic

et al. 2010

International Journal of Pharmaceutics

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“…Further, the shaking and vibration conditions must be optimized so as to ensure adequate separation of particles and to minimize particle fracturing. Due to significant cohesive forces of smaller particles, sieve analysis is only applicable for particles in excess of 38 μm (Randall 1995), although small-mesh sieves and electrodeposited screens are under development to measure particles below this size. In general, sieving is preferentially limited to particles >75 μm, because microscopic characterization becomes increasingly difficult above this.…”

Section: Sieve Analysismentioning

confidence: 99%

“…With both types of instruments, inaccuracy can be created by particle aggregation and multiple scattering -the scattered light of one particle is further scattered by other particles. In addition, light scattering measurements tend to be biased in favour of larger particles and the results are also affected by particle shape (Randall 1995). Despite the limitations of laser diffraction, it has the following advantages compared with other particle sizing techniques:…”

Section: Laser Diffractionmentioning

confidence: 99%

Particulate Analysis – Particle Size

Zeng

2011

Solid State Characterization of Pharmaceuticals

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“…Particle size, shape, and solid-state form of the API and its spatial distribution in the excipient matrix control the dissolution rate, bioavailability, and stability of the final product (1–5). …”

Section: Introductionmentioning

confidence: 99%

“…The efficacy of pharmaceutical tablets depends on both the physical and chemical properties of the active pharmaceutical ingredient (API). Particle size, shape, and solid-state form of the API and its spatial distribution in the excipient matrix control the dissolution rate, bioavailability, and stability of the final product ( 1 – 5 ).…”

Section: Introductionmentioning

confidence: 99%

Assessment of Active Pharmaceutical Ingredient Particle Size in Tablets by Raman Chemical Imaging Validated using Polystyrene Microsphere Size Standards

Kuriyama

Ozaki

2014

AAPS PharmSciTech

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Particle size is a critical parameter for controlling pharmaceutical quality. The aim of this study was to assess the size of the micrometer-scale active pharmaceutical ingredients (API) in tablets using Raman chemical imaging and to understand the effects of formulation on particle size. Model tablets containing National Institute of Standards and Technology traceable polystyrene microsphere size standards were developed to determine the binarization threshold value of Raman chemical images for API particle sizing in specific formulations and processes. Three sets of model tablets containing 5, 10, and 15 μm polystyrene microspheres, used to mimic API, were prepared using a commercial tablet formulation (Ebastel tablets, mean API particle size was about 5 μm). Raman mapping with a 50× objective (NA, 0.75) was applied to tablet cross-sections, and particle size of polystyrene microspheres was estimated from binary images using several binarization thresholds. Mean particle size for three sets of polystyrene microspheres showed good agreement between pre- and postformulation (the slope = 1.024, R = 1.000) at the specific threshold value ((mean + 0.5σ) of the polystyrene-specific peak intensity histogram), regardless of particle agglomeration, tablet surface roughness, and laser penetration depth. The binarization threshold value showed good applicability to Ebastel tablets, where the API-specific peak intensity histogram showed a pattern similar to that of polystyrene microspheres in model tablets. The model tablets enabled determination of an appropriate binarization threshold for assessing the mean particle size of micrometer-scale API in tablets by utilizing the unique physicochemical properties of polystyrene microspheres.

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Particle Size Distribution

Cited by 6 publications

References 55 publications

Roller compaction of different pseudopolymorphic forms of Theophylline: Effect on compressibility and tablet properties

Roller compaction of different pseudopolymorphic forms of Theophylline: Effect on compressibility and tablet properties

Particulate Analysis – Particle Size

Assessment of Active Pharmaceutical Ingredient Particle Size in Tablets by Raman Chemical Imaging Validated using Polystyrene Microsphere Size Standards

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