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://dx.doi.org/10.2174/157341210793292419.
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Základní údaje
Originální název Pellet Coating Thickness Determination by Near-Infrared Reflectance Spectroscopy: Comparison of Two Reference Methods
Autoři MUSELÍK, Jan (203 Česká republika, garant, domácí), Kateřina DVOŘÁČKOVÁ (203 Česká republika), Kateřina KREJČOVÁ (372 Irsko), Miloslava RABIŠKOVÁ (203 Česká republika), Jiří PAZOUREK (203 Česká republika), Sylvia MARTON (348 Maďarsko), Michaela DRAČKOVÁ (203 Česká republika) a Lenka VORLOVÁ (203 Česká republika).
Vydání Current Pharmaceutical Analysis, Sharjah, Bentham Science Publishers, 2010, 1573-4129.
Další údaje
Originální 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
WWW URL
Impakt faktor Impact factor: 1.710
Organizační jednotka Farmaceutická fakulta
Doi http://dx.doi.org/10.2174/157341210793292419
UT WoS 000284942100001
Klíčová slova anglicky Near-infrared spectroscopy; Pharmaceutical applications; Pellet coating; Coating thickness
Příznaky Recenzováno
Změnil Změnil: doc. RNDr. Bc. Jiří Pazourek, Ph.D., učo 2356. Změněno: 15. 5. 2021 19:02.
Anotace
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.
VytisknoutZobrazeno: 24. 5. 2024 09:47