Correlation of Drug Substance Particle Size Distribution with Other Bulk Properties to Predict Critical Quality Attributes

2014 ◽  
Vol 19 (9) ◽  
pp. 1076-1081 ◽  
Author(s):  
Henry G. Morrison ◽  
Wenle Tao ◽  
William Trieu ◽  
Shawn D. Walker ◽  
Sheng Cui ◽  
...  
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution ◽  
Quality Attributes ◽  
Drug Substance ◽  
Bulk Properties ◽  
Critical Quality Attributes

scholarly journals Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Erika Bojnanska ◽  
Michal Kalina ◽  
Ladislav Parizek ◽  
Eva Bartonickova ◽  
Tomas Opravil ◽  
...  
Keyword(s):  
Particle Size ◽  
Zeta Potential ◽  
Particle Size Distribution ◽  
Dissolution Rate ◽  
Size Distribution ◽  
Drug Product ◽  
Drug Formulation ◽  
Drug Substance ◽  
Critical Parameters ◽  
Dissolution Profile

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.

Effects of Particle Size Distribution on Corrosion Rate of Carbon Steel in Soil

2020 ◽  
Vol 69 (4) ◽  
pp. 102-106
Author(s):  
Shota Ohki ◽  
Shingo Mineta ◽  
Mamoru Mizunuma ◽  
Soichi Oka ◽  
Masayuki Tsuda
Keyword(s):  
Particle Size ◽  
Carbon Steel ◽  
Corrosion Rate ◽  
Particle Size Distribution ◽  
Size Distribution

DENSE SPRAY CORRECTIONS FOR DIFFRACTION-BASED PARTICLE SIZE DISTRIBUTION MEASUREMENTS

1995 ◽  
Vol 5 (1) ◽  
pp. 75-87 ◽  
Author(s):  
Christine M. Woodall ◽  
James E. Peters ◽  
Richard O. Buckius
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution

Influence of Cementite Particle Size Distribution on Machinability and Tool Life of High Carbon Cr-bearing Steels

1998 ◽  
Vol 84 (5) ◽  
pp. 387-392 ◽  
Author(s):  
Takashi INOUE ◽  
Yuzo HOSOI ◽  
Koe NAKAJIMA ◽  
Hiroyuki TAKENAKA ◽  
Tomonori HANYUDA
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution ◽  
Tool Life ◽  
Cementite Particle ◽  
High Carbon ◽  
Bearing Steels

Study of the microstructure and particles of vanadium (III) oxide, vanadium (V) oxide and lithium aluminate powders

2020 ◽  
Vol 86 (1) ◽  
pp. 32-37
Author(s):  
Valeria A. Brodskaya ◽  
Oksana A. Molkova ◽  
Kira B. Zhogova ◽  
Inga V. Astakhova
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Vanadium Oxide ◽  
Size Distribution ◽  
Microstructural Analysis ◽  
Coherent Scattering ◽  
Powder Materials ◽  
Lithium Aluminate ◽  
Range Limit ◽  
Oxide Particles

Powder materials are widely used in the manufacture of electrochemical elements of thermal chemical sources of current. Electrochemical behavior of the powders depends on the shape and size of their particles. The results of the study of the microstructure and particles of the powders of vanadium (III), (V) oxides and lithium aluminate obtained by transmission electron and atomic force microscopy, X-ray diffraction and gas adsorption analyses are presented. It is found that the sizes of vanadium (III) and vanadium (V) oxide particles range within 70 – 600 and 40 – 350 nm, respectively. The size of the coherent-scattering regions of the vanadium oxide particles lies in the lower range limit which can be attributed to small size of the structural elements (crystallites). An average volumetric-surface diameter calculated on the basis of the surface specific area is close to the upper range limit which can be explained by the partial agglomeration of the powder particles. Unlike the vanadium oxide particles, the range of the particle size distribution of the lithium aluminate powder is narrower — 50 – 110 nm. The values of crystallite sizes are close to the maximum of the particle size distribution. Microstructural analysis showed that the particles in the samples of vanadium oxides have a rounded (V2O3) or elongated (V2O5) shape; whereas the particles of lithium aluminate powder exhibit lamellar structure. At the same time, for different batches of the same material, the particle size distribution is similar, which indicates the reproducibility of the technologies for their manufacture. The data obtained can be used to control the constancy of the particle size distribution of powder materials.

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