. Author manuscript; available in PMC: 2021 Mar 20.

Published in final edited form as: J Pharm Biomed Anal. 2019 Dec 27;181:113073. doi: 10.1016/j.jpba.2019.113073

Table 4.

Bench-top plasma stability of NLG207 nanoparticles at room temperature

Nominal	Immediately After Preparation	One Hour Post Preparation		Two Hours Post Preparation
-Total CPT -[Free CPT]^*	GM (ng/mL)	GM (ng/mL)	MC (%)	GM (ng/mL)	MC (%)
30 ng/mL [1.0 ng/mL]	32.07	35.03	9.2	34.05	6.2
30 ng/mL [1.0 ng/mL]	1.01	1.18	17.6	1.35	33.8
300 ng/mL [9 ng/mL]	342.7	330.29	−3.6	337.0	−1.7
300 ng/mL [9 ng/mL]	9.34	10.91	16.8	13.19	41.2
3000 ng/mL [90 ng/mL]	3282	3449	5.1	3496	6.5
3000 ng/mL [90 ng/mL]	90.28	110.1	22	130.7	44.8
9000 ng/mL [270 ng/mL]	9207	9237	0.3	9395	2.0
9000 ng/mL [270 ng/mL]	300.7	345.0	14.7	422.1	40.4

Abbreviations: GM, grand mean; MC, mean change from fresh.

- Based on the totality of data, approximately 3% [2.5 to 3.5%] of total CPT from NLG207 NDCs is present as free CPT under standard conditions. The nominal concentrations of free CPT listed are 3% of the nominal total CPT concentrations. For the 30 ng/mL total CPT concentration range, the nominal free CPT concentration is rounded up to 1.0 ng/mL (3.33% of total CPT) to reflect the lower limit of quantitation.