Pellet Coating Thickness Determination by Near-Infrared
Reflectance Spectroscopy: Comparison of Two Reference Methods

J 2010

Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods

MUSELÍK, Jan; Kateřina DVOŘÁČKOVÁ; Kateřina KREJČOVÁ; Miloslava RABIŠKOVÁ; Jiří PAZOUREK et al.

Základní údaje

Originální název

Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods

Autoři

MUSELÍK, Jan; Kateřina DVOŘÁČKOVÁ; Kateřina KREJČOVÁ; Miloslava RABIŠKOVÁ; Jiří PAZOUREK; Sylvia MARTON; Michaela DRAČKOVÁ a Lenka VORLOVÁ

Vydání

Current Pharmaceutical Analysis, Sharjah, Bentham Science Publishers, 2010, 1573-4129

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Spojené arabské emiráty

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 1.710

Označené pro přenos do RIV

Ano

Organizační jednotka

Farmaceutická fakulta

DOI

https://doi.org/10.2174/157341210793292419

UT WoS

000284942100001

Klíčová slova anglicky

Near-infrared spectroscopy; Pharmaceutical applications; Pellet coating; Coating thickness

Příznaky

Recenzováno

Změněno: 15. 5. 2021 19:02, doc. RNDr. Bc. Jiří Pazourek, Ph.D.

Anotace

V originále

The application of classical methods for pellet coating thickness determination (weight gain, microscopic analysis, dissolution testing) is time-consuming or does not consider pellets loss during the coating procedure. Therefore, these methods are not optimal for process control during pellets coating. The aim of this study was to develop rapid and valid methods for the determination of pellets average coating thickness by near infrared spectroscopy (NIRS). NIRS is not the primary method; therefore reference data are required for calibration. Data obtained from two reference methods for coating thickness determination (microscopic analysis, a geometric model calculated from pellets weight and density) were mutually compared. A geometric model was chosen as the simpler, quicker and more robust reference method. The polymer films studied were ethylcellulose (EC) and Eudragit (R) RS (ERS) applied on pellets in a Wurster column. The calibration models were carried out by partial least squares (PLS) regression, with two factors for EC and ERS films, respectively. The PLS validation sets had r > 0.97, and a standard error of validation, 3.29 mu m (range tested 10 - 70 mu m), for the EC film and 1.10 mu m (range tested 2 - 20 mu m) for the ERS film. The obtained results clearly demonstrate the feasibility of NIRS as a part of quality control procedure in the pharmaceutical industry.

Citovat

MUSELÍK, Jan; Kateřina DVOŘÁČKOVÁ; Kateřina KREJČOVÁ; Miloslava RABIŠKOVÁ; Jiří PAZOUREK; Sylvia MARTON; Michaela DRAČKOVÁ a Lenka VORLOVÁ. Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods. Current Pharmaceutical Analysis. Sharjah: Bentham Science Publishers, 2010, roč. 6, č. 4, s. 225-233. ISSN 1573-4129. Dostupné z: https://doi.org/10.2174/157341210793292419.

@article{1768640,
   author = {Muselík, Jan and Dvořáčková, Kateřina and Krejčová, Kateřina and Rabišková, Miloslava and Pazourek, Jiří and Marton, Sylvia and Dračková, Michaela and Vorlová, Lenka},
   article_location = {Sharjah},
   article_number = {4},
   doi = {https://doi.org/10.2174/157341210793292419},
   keywords = {Near-infrared spectroscopy; Pharmaceutical applications; Pellet coating; Coating thickness},
   language = {eng},
   issn = {1573-4129},
   journal = {Current Pharmaceutical Analysis},
   title = {Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods},
   url = {https://www.eurekaselect.com/72656/article},
   volume = {6},
   year = {2010}
}

TY  - JOUR
ID  - 1768640
AU  - Muselík, Jan - Dvořáčková, Kateřina - Krejčová, Kateřina - Rabišková, Miloslava - Pazourek, Jiří - Marton, Sylvia - Dračková, Michaela - Vorlová, Lenka
PY  - 2010
TI  - Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods
JF  - Current Pharmaceutical Analysis
VL  - 6
IS  - 4
SP  - 225-233
EP  - 225-233
PB  - Bentham Science Publishers
SN  - 15734129
KW  - Near-infrared spectroscopy
KW  - Pharmaceutical applications
KW  - Pellet coating
KW  - Coating thickness
UR  - https://www.eurekaselect.com/72656/article
N2  - The application of classical methods for pellet coating thickness determination (weight gain, microscopic analysis, dissolution testing) is time-consuming or does not consider pellets loss during the coating procedure. Therefore, these methods are not optimal for process control during pellets coating. The aim of this study was to develop rapid and valid methods for the determination of pellets average coating thickness by near infrared spectroscopy (NIRS). NIRS is not the primary method; therefore reference data are required for calibration. Data obtained from two reference methods for coating thickness determination (microscopic analysis, a geometric model calculated from pellets weight and density) were mutually compared. A geometric model was chosen as the simpler, quicker and more robust reference method. The polymer films studied were ethylcellulose (EC) and Eudragit (R) RS (ERS) applied on pellets in a Wurster column. The calibration models were carried out by partial least squares (PLS) regression, with two factors for EC and ERS films, respectively. The PLS validation sets had r > 0.97, and a standard error of validation, 3.29 mu m (range tested 10 - 70 mu m), for the EC film and 1.10 mu m (range tested 2 - 20 mu m) for the ERS film. The obtained results clearly demonstrate the feasibility of NIRS as a part of quality control procedure in the pharmaceutical industry.
ER  -

MUSELÍK, Jan; Kateřina DVOŘÁČKOVÁ; Kateřina KREJČOVÁ; Miloslava RABIŠKOVÁ; Jiří PAZOUREK; Sylvia MARTON; Michaela DRAČKOVÁ a Lenka VORLOVÁ. Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods. \textit{Current Pharmaceutical Analysis}. Sharjah: Bentham Science Publishers, 2010, roč.~6, č.~4, s.~225-233. ISSN~1573-4129. Dostupné z: https://doi.org/10.2174/157341210793292419.

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