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 (avtor), Hudovornik, Grega (avtor), Perpar, Matjaž (avtor), Luštrik, Matevž (avtor), Dreu, Rok (avtor)

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.

• Jezik: Angleški jezik
• Ključne besede: pellet film coating, Wurster chamber, swirl generator, prolonged release, preferential coating
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo ; FS - Fakulteta za strojništvo ; MF - Medicinska fakulteta
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2023
• Št. strani: 16 str.
• Številčenje: Vol. 24, iss. 4, art. 93
• PID: 20.500.12556/RUL-145071
• UDK: 615.45:661.12
• ISSN pri članku: 1530-9932
• DOI: 10.1208/s12249-023-02540-9
• COBISS.SI-ID: 147500291
• Datum objave v RUL: 03.04.2023

Gradivo je del revije

• Naslov: AAPS PharmSciTech
• Skrajšan naslov: AAPS PharmSciTech
• Založnik: American Association of Pharmaceutical Scientists, Springer Nature
• ISSN: 1530-9932
• COBISS.SI-ID: 1247345

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: peletna filmska prevleka, wursterjeva komora, vrtinčni generator, podaljšano sproščanje, prednostna prevleka, farmacevtska tehnologija, farmacevtske oblike

Projekti

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P1-0189
• Naslov: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P2-0162
• Naslov: Večfazni sistemi