Title:Nano-crystalline Suspensions by Top Down Processes: Review of Manufacturing Considerations
Volume: 8
Issue: 3
Author(s): Mostafa Nakach*, Ranjita Shegokar*, Jean-René Authelin and Tharwat Tadros
Affiliation:
- Sanofi R&D, 1, Impasse des ateliers 94403, Vitry sur Seine,France
- Freie Universitat Berlin, Institute of Pharmacy, Department of Pharmaceutics, Biopharmaceutics & NutriCosmetics, Kelchstr. 31, 12169 Berlin,Germany
Keywords:
Formulation, High Pressure Homogenization (HPH), industrial production, milling, modeling, nano-crystalline,
nano-suspension, stabilization, surfactant.
Abstract: Background: Nano-crystalline suspensions obtained by top down process are used to overcome
the poor water solubility of Active Pharmaceutical Ingredient (API).
Discussion: Nano-crystalline suspensions are a versatile technology and can be used for administering
drug via different application routes. They are manufactured mainly by using technologies like stirred
bead milling and high pressure homogenization. To make nano-crystalline suspensions successful as
drug delivery system, several aspects needs to be considered in terms of formulation composition, manufacturing
process and the technology to be used for particles size reduction.
Conclusion: This paper reviews all above aspects though eyes of engineer and industrial production
feasibility. In addition to that, this review outlines importance of technology selection to obtain the desired
particle size and product in compliance to pharmaceutical regulation. Finally, the important parameters
and factors are outlined for the industrial manufacturing process.
