Table 3.

Stability of ODSF

Storage Conditions	Month	Drug Content (%)	Cumulative Drug Release at 1 h (%)	Particle Size (nm)	PDI	Zeta Potential (mV)
25±2°C with 65±5% RH	0	100±1.25	97.2±2.35	133±1.47	0.147±0.020	50.3±3.02
	1	99.8±2.35	95.6±95.6	140±1.12	0.149±0.003	51.7±1.37
	3	98.7±2.58	96.0±3.48	143±2.57	0.149±0.006	50.8±0.379
	6	98.5±3.03	91.2±1.95	147±3.44	0.157±0.004	49.7±0.737
40±2°C with 75±5% RH	0	101±2.02	93.9±3.33	135±1.66	0.133±0.009	50.2±0.666
	1	97.2±1.25	95.8±4.25	140±1.02	0.137±0.001	51.0±0.416
	3	98.3±1.87	96.5±2.48	149±3.37	0.151±0.007	50.9±0.529
	6	97.6±2.21	91.4±3.75	153±2.28	0.162±0.004	50.6±0.404

Notes: Cumulative release of OP from ODSF was measured in 900 mL of 0.1 N HCl (pH 1.2) using the United States Pharmacopeia dissolution test apparatus I with a rotating speed of 100 rpm at 37±0.2°C. Each value is shown as mean±standard deviation (n=6).

Abbreviations: OP, oxaliplatin; DLM, N^α-deoxycholyl-l-lysyl-methylester; OP/DLM, ion-pairing complex between OP and DLM; P188, poloxamer 188; OP-SF, solid oral formulation of OP with P188 and Labrasol; ODSF, solid oral formulation of OP/DLM with P188 and Labrasol; PDI, polydispersity index; RH, relative humidity.