Comparison of the robustness of pellet film coating with and without in-process coating thickness evaluation

Brezovar, Teja (author), Svetič, Sandi (author), Dreu, Rok (author)

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
• UDC: 661.12:615.454
• ISSN on article: 1999-4923
• DOI: 10.3390/pharmaceutics14112274
• COBISS.SI-ID: 127052291
• Publication date in RUL: 25.10.2022

Record is a part of a journal

• Title: Pharmaceutics
• Shortened title: Pharmaceutics
• Publisher: MDPI
• ISSN: 1999-4923
• COBISS.SI-ID: 517949977

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