Quality control and physico-chemical properties of vitamin K1 self-nanoemulsifying drug delivery systems / 国际药学研究杂志
Journal of International Pharmaceutical Research
; (6): 604-608, 2017.
Article
em Zh
| WPRIM
| ID: wpr-617563
Biblioteca responsável:
WPRO
ABSTRACT
Objective To establish assay methods for the determination of dissolution,content and related substances of vita-min K1 self-nanoemulsifying drug delivery system(VK1-SNEDDS),and investigate the physico-chemical properties of the preparation. Methods The UV method was established to determine the dissolution of VK1-SNEDDS. The content and related substances were de-termined by HPLC. The appearance,self-emulsification time,micro-morphology,droplet size and zeta potential were also investigat-ed. Results The linearity range of established UV and HPLC methods was 0.85-20.4 and 2.16-216μg/ml,respectively,and all the recovery,precision,specificity and sensitivity met requirements. VK1-SNEDDS could disperse quickly after dilution. The transmission electron microscope(TEM)image of the optimized liquid SNEDDS showed that most of the emulsion droplets were of uniform size with no signs of coalescence. Droplet size of optimal formulation was revealed as 47.74 nm with polydispersibility index(PDI)of 0.248,and zeta potential was found to be-20.53 mV. Conclusion VK1-SNEDDS could form homogeneous and stable nanoemulsion when dilut-ed with aqueous phase and increase the dissolution of lipophilic drug. The methods are reliable,accurate and suitable for quality con-trol of VK1-SNEDDS.
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Base de dados:
WPRIM
Idioma:
Zh
Revista:
Journal of International Pharmaceutical Research
Ano de publicação:
2017
Tipo de documento:
Article