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Engineering of nano-crystalline drug suspensions: Employing a physico-chemistry based stabilizer selection methodology or approach
- Source :
- International Journal of Pharmaceutics, International Journal of Pharmaceutics, Elsevier, 2014, 476 (1-2), p. 277-288. ⟨10.1016/j.ijpharm.2014.09.048⟩
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- International audience; 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.
- Subjects :
- Time Factors
Chemistry, Pharmaceutical
Drug Storage
Pharmaceutical Science
Nanotechnology
Dispersant
Top down process
Excipients
[SPI]Engineering Sciences [physics]
chemistry.chemical_compound
Adsorption
Drug Stability
Suspensions
[SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering
Beads milling
Surface charge
Sodium dodecyl sulfate
Active ingredient
Chemistry
Temperature
Povidone
Sodium Dodecyl Sulfate
Dispersant agent
Wetting agent
Chemical engineering
Wettability
Nano-crystalline suspension
Nanoparticles
Wetting
Stabilizer
Nano crystalline
Stabilizer (chemistry)
Subjects
Details
- ISSN :
- 03785173
- Volume :
- 476
- Database :
- OpenAIRE
- Journal :
- International Journal of Pharmaceutics
- Accession number :
- edsair.doi.dedup.....ba92526a29ef1d270bf197b050c83702