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Engineering of nano-crystalline drug suspensions: employing a physico-chemistry based stabilizer selection methodology or approach.

Abstract：

:This paper describes a systematic approach to select optimum stabilizer for the preparation of nano-crystalline suspensions of an active pharmaceutical ingredient (API). The stabilizer can be either a dispersant or a combination of dispersant and wetting agent. The proposed screening method is a quick and efficient way to investigate a large number of stabilizers based on the principles of physical-chemistry and employs a stepwise approach. The methodology has been divided in two main parts; the first part being focused on the qualitative screening with the objective of selecting the best candidate(s) for further investigation, the second part has been focused on quantitative screening with the objective to optimize the ratio and amount of wetting and dispersing agents, based on wettability, surface charges measurement, adsorption evaluation, process-ability evaluation and storage stability. The results showed clearly that SDS/PVP 40/60% (w/w) (sodium dodecyl sulfate/poly(vinyl pyrrolidone)) at a total concentration of 1.2% was the optimum stabilizer composition, at which the resulting nanosuspensions were stable for more than 50 days at room temperature.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Nakach M,Authelin JR,Tadros T,Galet L,Chamayou A

doi

10.1016/j.ijpharm.2014.09.048

subject

Has Abstract

pub_date

2014-12-10 00:00:00

pages

277-88

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(14)00703-0

journal_volume

476

pub_type

杂志文章

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