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Comparison of the robustness of pellet film coating with and without in-process coating thickness evaluation
ID Brezovar, Teja (Author), ID Svetič, Sandi (Author), ID Dreu, Rok (Author)

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Abstract
The robustness of the pellet coating process with and without the use of an in-process coating thickness analyzer (PATVIS APA) was investigated. Pellets containing model drug were coated with a prolonged release film coating, using different process conditions. In the first set of experiments film coating was performed as process repetitions with unintentional variation of process parameters, and in the second set, controlled changes (inlet air humidity, gap between distribution plate and Wurster partition, starting pellet load) were made. Within the first set of experiments, the coating process endpoint was determined either via gravimetric consumption of coating dispersion or by means of in-line coating thickness monitoring. The release profiles of the pellets were analyzed and the density of coating calculated. Both methods of the process endpoint determination can be relatively robust in batch processing, if key factors influencing drug release profile are under control. PATVIS APA was shown to be a useful tool to better understand the coating process and can be helpful if coating process interruptions are encountered. Water content was shown to be the key factor influencing the drug profile, presumably by influencing the structure and thickness of the coating applied.

Language:English
Keywords:pellets, coating of pellets, prolonged release coating, PAT, image analysis, residual water
Work type:Article
Typology:1.01 - Original Scientific Article
Organization:FFA - Faculty of Pharmacy
Publication status:Published
Publication version:Version of Record
Year:2022
Number of pages:16 str.
Numbering:Vol. 14, iss. 11, art. 2274
PID:20.500.12556/RUL-142209 This link opens in a new window
UDC:661.12:615.454
ISSN on article:1999-4923
DOI:10.3390/pharmaceutics14112274 This link opens in a new window
COBISS.SI-ID:127052291 This link opens in a new window
Publication date in RUL:25.10.2022
Views:886
Downloads:64
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Record is a part of a journal

Title:Pharmaceutics
Shortened title:Pharmaceutics
Publisher:MDPI
ISSN:1999-4923
COBISS.SI-ID:517949977 This link opens in a new window

Licences

License:CC BY 4.0, Creative Commons Attribution 4.0 International
Link:http://creativecommons.org/licenses/by/4.0/
Description:This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

Language:Slovenian
Keywords:pelete, oblaganje pelet, premaz s podaljšanim sproščanjem, PAT, analiza slike, preostala voda

Projects

Funder:ARRS - Slovenian Research Agency
Project number:P1-0189-2018
Name:Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

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