. Author manuscript; available in PMC: 2022 Nov 1.

Published in final edited form as: Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2021 Jun 15;13(6):e1732. doi: 10.1002/wnan.1732

Table 2.

Discriminatory USP 4 for in vitro testing of NDDS

NDDS	In Vitro Release Methods	Study Findings	Reference
Cefuroxime Axetil NPs	•USP 4(flow rate 16 ml/min; 0.2-μm disc filter) •USP 1(100 rpm) •USP 2(100 rpm) •Dialysis bag (12-14 kDa MWCO)	USP apparatus 4 was testified to be unequivocally the most robust dissolution method to differentiate dissolution rate ratios of Cefuroxime Axetil NPs and unprocessed drug.	(Heng et al., 2008)
Dexamethasone Liposomes	•USP 4(flow rate 16 ml/min; 50 kDa MWCO) •Dialysis sac (50 rpm; 50 kDa MWCO) Reverse dialysis sac (50 rpm; 50 kDa MWCO)	USP apparatus 4 was able to discriminate between solution, suspension and also the extruded and non-extruded liposomes.	(Bhardwaj & Burgess, 2010)
Griseofulvin NP-laden strip-films	•USP 4(flow rate 16 ml/min; 0.2-μm disc filter) •USP 1 (50, 100, and 150 rpm)	Particle-size discriminatory nature of USP 4 suggested its potential to provide similar results for other BCS Class II drugs.	(Sievens-Figueroa et al., 2012)
Vitamin E acetate oil/ water nanoemulsions	•USP 4(flow rate 16 ml/min; 50 and 100 kDa MWCO) •Reverse dialysis sac (50 and 100 kDa MWCO)	A faster in vitro release was obtained from USP apparatus 4 as compared with dialysis sac and reverse dialysis methods.	(Morais & Burgess, 2014)
Atorvastatin NPs	•USP 4 (glass-bead mixing; flow rate 8,16 ml/min) •Dialysis bag in USP 1(75, 100, and 125 rpm; MWCO NA) •Dialysis bag in USP 4 (8, 16 mL/min; MWCO NA; not available)	USP 4 dissolution method established for Atorvastatin NPs using modified sample loading (glass-bead mixing with NPs) was found to be discriminatory.	(Gite et al., 2016)
Doxorubicin liposome	•USP 4(flow rate 16 ml/min; 10–300 kDa MWCO)	USP 4 assay adequatly distinguished between innovator Doxorubicin liposome product Doxil® and generic formulations of different compositions, release rates, and prepared by different manufacturing techniques.	(Yuan et al., 2017)
Bevacizumab liposome	•USP 4(flow rate 1ml/min; MWCO NA)	USP 4 was used to test in vitro release from different composition Bevacizumab liposomes.	(Karumanchi et al., 2018)
Amphotericin B liposome	•USP 4(flow rate 16 ml/min; 300 kDa MWCO)	USP 4 assay was able to elicit the distinction between marketed liposome formulation of Amphotericin B AmBisome® and other in-house formulations, prepared by extrusion or homogenization processes.	(Tang et al., 2019)