A First-Principles model for Prediction of Product dose Uniformity based on Drug Substance Particle Size Distribution

2012 ◽  
Vol 101 (7) ◽  
pp. 2364-2371 ◽  
Author(s):  
Jon Hilden ◽  
Mark Schrad ◽  
Jennifer Kuehne-Willmore ◽  
Jessica Sloan
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution ◽  
First Principles ◽  
Drug Substance ◽  
Dose Uniformity

Metered dose inhalers III: metaproterenol sulphate; particle size distribution and dose uniformity

1997 ◽  
Vol 15 (11) ◽  
pp. 1709-1718 ◽  
Author(s):  
T.D Cyr ◽  
R.M Duhaime ◽  
S.J Graham ◽  
E.D Ormsby ◽  
R.C Lawrence ◽  
...  
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution ◽  
Metered Dose Inhalers ◽  
Dose Uniformity ◽  
Metered Dose

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.

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 Characterization and comparison of Re-Du-Ning aerosol particles generated by different jet nebulizers

RSC Advances ◽  
2019 ◽  
Vol 9 (52) ◽  
pp. 30292-30301 ◽  
Author(s):  
Yi Zhang ◽  
Brian Chi-Yan Cheng ◽  
Cui Li ◽  
Yonghua Tao ◽  
Chanjuan Yu ◽  
...  
Keyword(s):  
Particle Size ◽  
Particle Size Distribution ◽  
Size Distribution ◽  
Aerosol Particles ◽  
Dose Uniformity ◽  
Jet Nebulizers

Delivery dose uniformity determination by BRS 2000 breath simulator and realtime particle size distribution monitoring by Spraytec.

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
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