Next Article in Journal
New Ways to Treat Tuberculosis Using Dendrimers as Nanocarriers
Next Article in Special Issue
Engineering Cocrystals of Poorly Water-Soluble Drugs to Enhance Dissolution in Aqueous Medium
Previous Article in Journal
The Effect of Molecular Properties on Active Ingredient Release from Electrospun Eudragit Fibers
Previous Article in Special Issue
Relative Contributions of Solubility and Mobility to the Stability of Amorphous Solid Dispersions of Poorly Soluble Drugs: A Molecular Dynamics Simulation Study
Article Menu
Issue 3 (September) cover image

Export Article

Open AccessFeature PaperReview
Pharmaceutics 2018, 10(3), 104; https://doi.org/10.3390/pharmaceutics10030104

Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques

Division of Pharmaceutical Chemistry and Technology, Drug Research Program, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, 00014 Helsinki, Finland
Received: 29 May 2018 / Revised: 4 July 2018 / Accepted: 19 July 2018 / Published: 25 July 2018
(This article belongs to the Special Issue Dissolution Enhancement of Poorly Soluble Drugs)
Full-Text   |   PDF [1294 KB, uploaded 25 July 2018]   |  

Abstract

Drug nanocrystals are nanosized solid drug particles, the most important application of which is the improvement of solubility properties of poorly soluble drug materials. Drug nanocrystals can be produced by many different techniques, but the mostly used are different kinds of media milling techniques; in milling, particle size of bulk sized drug material is decreased, with the aid of milling beads, to nanometer scale. Utilization of Quality by Design, QbD, approach in nanomilling improves the process-understanding of the system, and recently, the number of studies using the QbD approach in nanomilling has increased. In the QbD approach, the quality is built into the products and processes throughout the whole production chain. Definition of Critical Quality Attributes, CQAs, determines the targeted final product properties. CQAs are confirmed by setting Critical Process Parameters, CPPs, which include both process parameters but also input variables, like stabilizer amount or the solid state form of the drug. Finally, Design Space determines the limits in which CPPs should be in order to reach CQAs. This review discusses the milling process and process variables, CPPs, their impact on product properties, CQAs and challenges of the QbD approach in nanomilling studies. View Full-Text
Keywords: drug nanocrystals; wet media milling; Quality by Design (QbD); Critical Quality Attributes (CQA); process variables drug nanocrystals; wet media milling; Quality by Design (QbD); Critical Quality Attributes (CQA); process variables
Figures

Figure 1

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
SciFeed

Share & Cite This Article

MDPI and ACS Style

Peltonen, L. Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques. Pharmaceutics 2018, 10, 104.

Show more citation formats Show less citations formats

Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Related Articles

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Pharmaceutics EISSN 1999-4923 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top