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Start Over Author "Nakach, Mostafa" Publisher elsevier bv
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9. Engineering of nano-crystalline drug suspensions: Employing a physico-chemistry based stabilizer selection methodology or approach

Author

Authelin, Jean-Rene, Nakach, Mostafa, Authelin, Jean-René, Tadros, Tharwat, Galet, Laurence, Chamayou, Alain, Centre de recherche d'Albi en génie des procédés des solides divisés, de l'énergie et de l'environnement (RAPSODEE), Centre National de la Recherche Scientifique (CNRS)-IMT École nationale supérieure des Mines d'Albi-Carmaux (IMT Mines Albi), and Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)

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)
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.

Published
2014

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