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Open AccessReview

Understanding Critical Quality Attributes for Nanocrystals from Preparation to Delivery

by Leena Peltonen *,† and Clare Strachan
Division of Pharmaceutical Chemistry and Technology, University of Helsinki, P. O. Box 56, Viikinkaari 5 E, 00014, Finland
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editors: Thomas Rades, Holger Grohganz and Korbinian Löbmann
Molecules 2015, 20(12), 22286-22300; https://doi.org/10.3390/molecules201219851
Received: 6 October 2015 / Revised: 8 December 2015 / Accepted: 8 December 2015 / Published: 12 December 2015
(This article belongs to the Collection Poorly Soluble Drugs)
Poor solubility of active pharmaceutical ingredients (APIs) is a great challenge for the pharmaceutical industry and, hence, drug nanocrystals are widely studied as one solution to overcome these solubility problems. Drug nanocrystals have comparatively simple structures which make them attractive for the formulation for poorly soluble drugs, and their capability to improve the dissolution in vitro is easily demonstrated, but turning the in vitro superior properties of nanocrystals to success in vivo, is often demanding: controlled (including enhanced) drug dissolution followed by successful permeation is not guaranteed, if for example, the dissolved drug precipitates before it is absorbed. In this review critical quality attributes related to nanocrystal formulations from production to final product performance in vivo are considered. Many important parameters exist, but here physical stability (aggregation tendency and solid state form), solubility properties influencing dissolution and supersaturation, excipient use to promote the maintenance of supersaturation, and finally the fate of nanocrystals in vivo are the main subjects of our focus. View Full-Text
Keywords: bioavailability; drug nanocrystals; permeation; precipitation; solubility; stability; supersaturation bioavailability; drug nanocrystals; permeation; precipitation; solubility; stability; supersaturation
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Peltonen, L.; Strachan, C. Understanding Critical Quality Attributes for Nanocrystals from Preparation to Delivery. Molecules 2015, 20, 22286-22300.

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