The effect of design and size of the fluid-bed equipment on the particle size-dependent trend of particle coating thickness and drug prolonged-release profile

Brezovar, Teja (author), Hudovornik, Grega (author), Perpar, Matjaž (author), Luštrik, Matevž (author), Dreu, Rok (author)

The focus of the current work is to study and demonstrate the impact of the design, the scale, and settings of fluid-bed coating equipment on the differences in pellet coating thickness, which in case of prolonged-release pellets dictates the drug release. In the first set of coating experiments, the pellet cores were coated with the Tartrazine dye with the aim of estimating the coating equipment performance in terms of coating thickness distribution, assessed through color hue. In the second set, drug-layered pellets were film-coated with prolonged-release coating and dissolution profile tests were performed to estimate the thickness and uniformity of the coating thickness among differently sized pellets. In both study parts, film coating was performed at the laboratory and the pilot scale and essentially two types of distribution plate and different height adjustments of the draft tube were compared. The dye coating study proved to be extremely useful, as the results enable process correction and the optimal use of the process equipment in combination with the appropriate process parameters. Preferential film coating of larger drug-containing pellets was confirmed on the laboratory scale, while on the pilot scale, it was possible to achieve preferential coating of smaller pellets using rational alternatives of settings, which is desirable in terms of particle size-independent drug release profile of such prolonged-release dosage forms.

• Language: English
• Keywords: pellet film coating, Wurster chamber, swirl generator, prolonged release, preferential coating
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy; FS - Faculty of Mechanical Engineering; MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2023
• Number of pages: 16 str.
• Numbering: Vol. 24, iss. 4, art. 93
• PID: 20.500.12556/RUL-145071
• UDC: 615.45:661.12
• ISSN on article: 1530-9932
• DOI: 10.1208/s12249-023-02540-9
• COBISS.SI-ID: 147500291
• Publication date in RUL: 03.04.2023

Record is a part of a journal

• Title: AAPS PharmSciTech
• Shortened title: AAPS PharmSciTech
• Publisher: American Association of Pharmaceutical Scientists, Springer Nature
• ISSN: 1530-9932
• COBISS.SI-ID: 1247345

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: peletna filmska prevleka, wursterjeva komora, vrtinčni generator, podaljšano sproščanje, prednostna prevleka, farmacevtska tehnologija, farmacevtske oblike

Projects

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

• Funder: ARRS - Slovenian Research Agency
• Project number: P2-0162
• Name: Večfazni sistemi