Investigating dissolution performance critical areas on coated tablets: a case study using terahertz pulsed imaging
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Investigating dissolution performance critical areas on coated tablets : a case study using terahertz pulsed imaging. / Ho, Louise; Müller, Ronny; Krüger, Cornelia; Gordon, Keith C; Kleinebudde, Peter; Pepper, Michael; Rades, Thomas; Shen, Yaochun; Taday, Philip F; Zeitler, J Axel.
In: Al Azhar Journal of Pharmaceutical Sciences, Vol. 99, No. 1, 2010, p. 392-402.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Investigating dissolution performance critical areas on coated tablets
T2 - a case study using terahertz pulsed imaging
AU - Ho, Louise
AU - Müller, Ronny
AU - Krüger, Cornelia
AU - Gordon, Keith C
AU - Kleinebudde, Peter
AU - Pepper, Michael
AU - Rades, Thomas
AU - Shen, Yaochun
AU - Taday, Philip F
AU - Zeitler, J Axel
PY - 2010
Y1 - 2010
N2 - During the process development of coated tablets, knowledge on the formation and the location of film coating 'weak spots' is a key factor to the success of the process and the resulting product batch. It is understood that the performance of the product batch may be greatly limited, and often compromised, by weak spots on the tablet film coat. This study uses circular, biconvex tablets to investigate the ability of terahertz pulsed imaging (TPI) to identify the affected areas on the tablet film coat that are critical for dissolution performance. From the TPI analysis we determined that the tablet central band exhibited the thinnest film coating, lowest coating density and highest surface roughness and thus was the performance limiting area of the film coating. Dissolution tests confirmed that the film coating on the tablet central band was indeed dissolution rate determining, with a faster mean dissolution time (MDT) of 7.4 h in comparison to 10.4 h for the convex top/bottom surface. TPI, as a nondestructive analytical technique, showed potential to be employed as a process analytical tool to probe film coating weak spots during film coating development and to assess the effect on the subsequent dissolution performance.
AB - During the process development of coated tablets, knowledge on the formation and the location of film coating 'weak spots' is a key factor to the success of the process and the resulting product batch. It is understood that the performance of the product batch may be greatly limited, and often compromised, by weak spots on the tablet film coat. This study uses circular, biconvex tablets to investigate the ability of terahertz pulsed imaging (TPI) to identify the affected areas on the tablet film coat that are critical for dissolution performance. From the TPI analysis we determined that the tablet central band exhibited the thinnest film coating, lowest coating density and highest surface roughness and thus was the performance limiting area of the film coating. Dissolution tests confirmed that the film coating on the tablet central band was indeed dissolution rate determining, with a faster mean dissolution time (MDT) of 7.4 h in comparison to 10.4 h for the convex top/bottom surface. TPI, as a nondestructive analytical technique, showed potential to be employed as a process analytical tool to probe film coating weak spots during film coating development and to assess the effect on the subsequent dissolution performance.
U2 - 10.1002/jps.21845
DO - 10.1002/jps.21845
M3 - Journal article
C2 - 19569058
VL - 99
SP - 392
EP - 402
JO - Al Azhar Journal of Pharmaceutical Sciences
JF - Al Azhar Journal of Pharmaceutical Sciences
SN - 1110-1644
IS - 1
ER -
ID: 40348790