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

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

Povzetek

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.

Ključne besede

pelete;oblaganje pelet;premaz s podaljšanim sproščanjem;PAT;analiza slike;preostala voda;pellets;coating of pellets;prolonged release coating;image analysis;residual water;

Podatki

Jezik:	Angleški jezik
Leto izida:	2022
Tipologija:	1.01 - Izvirni znanstveni članek
Organizacija:	UL FFA - Fakulteta za farmacijo
UDK:	661.12:615.454
COBISS:	127052291
ISSN:	1999-4923
Št. ogledov:	19
Št. prenosov:	4
Ocena:	0 (0 glasov)
Metapodatki:

Ostali podatki

Sekundarni jezik:	Slovenski jezik
Sekundarne ključne besede:	Farmacevtska industrija;Farmacevtske oblike;
Vrsta dela (COBISS):	Članek v reviji
Strani:	16 str.
Letnik:	ǂVol. ǂ14
Zvezek:	ǂiss. ǂ11, art. 2274
Čas izdaje:	2022
DOI:	10.3390/pharmaceutics14112274
ID:	16877668