In Vitro and In Vivo Correlation of Colon-Targeted Compression-Coated Tablets

Table 5

Summary of the short term and long term stability study data in three different levels of QC samples.

Nominal concentration; (µg/mL)	Mean observed concentration (µg/mL)	% CV	% RE
3 freeze/thaw cycles ()
0.150	0.144 ± 0.01	7.30	4.14
20.00	20.11 ± 0.81	4.02	−0.56
40.00	37.93 ± 2.03	5.36	5.17
Room temperature at 24 h ()
0.150	0.148 ± 0.0073	4.91	1.11
20.00	19.56 ± 1.33	6.80	2.19
40.00	40.80 ± 2.47	6.06	−1.99
1 month at −20°C ()
0.150	0.153 ± 0.0026	1.67	−2.05
20.00	19.23 ± 1.33	6.91	3.83
40.00	39.32 ± 1.73	4.41	1.69
3 months at −20°C ()
0.150	0.145 ± 0.0046	3.13	3.12
20.00	19.74 ± 0.93	4.71	1.31
40.00	38.59 ± 1.45	3.75	3.53