Development of a PAT tool for monitoring the Wurster coater performance.
Int J Pharm
; 561: 171-186, 2019 Apr 20.
Article
en En
| MEDLINE
| ID: mdl-30802550
ABSTRACT
Real-time process analytical technology (PAT) is proposed as an effective approach for monitoring the performance of a Wurster coater. The coater was used for coating of 0.78â¯mm pharmaceutical pellets. The coating solution consisted of Hydroxypropyl methylcellulose/Poly ethylene glycol. During the coating process, small amounts of pellets (â¼2â¯g) were sampled at 10â¯min. intervals and the pressure fluctuations were recorded at the same time. The signals were analyzed using the wavelet transform (WT) and decomposed into different sub-signals. Principal component analysis (PCA) was employed to the energies of these sub-signals, whose outliers were eliminated using the Mahalanobis distance method. The reference coating thickness data were obtained via spectrophotometry during the coating process. The partial least squares (PLS) regression was incorporated with the PCA for the development of a model for prediction of the coating thickness. The PLS regression revealed that the pressure fluctuations can be used to evaluate the thickness with a good precision. This study demonstrated the applicability of pressure fluctuations for the prediction of the coating thickness. This method can be regarded as a new robust, fast and non-intrusive PAT approach for monitoring the coating process which can be easily used by engineers and practitioners.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Control de Calidad
/
Tecnología Farmacéutica
/
Composición de Medicamentos
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Int J Pharm
Año:
2019
Tipo del documento:
Article
País de afiliación:
Irán