Nanocrystals: industrially feasible multifunctional formulation technology for poorly soluble actives

Area of Science:

• Pharmaceutical Sciences
• Nanotechnology
• Drug Delivery

Background:

• Poor drug solubility and low oral bioavailability present significant challenges in pharmaceutical development.
• Nanocrystal technology emerges as a versatile formulation strategy to overcome these limitations.
• Second-generation nanocrystals (smartCrystals) represent advancements in particle engineering.

Purpose of the Study:

• To review the industrial feasibility of nanocrystal production processes (bottom-up and top-down).
• To discuss regulatory aspects and nanotoxicology associated with nanocrystal formulations.
• To explore the diverse applications and delivery strategies of nanocrystals across various administration routes and industries.

Main Methods:

• Review of industrially available production processes for nanocrystals.
• Analysis of regulatory considerations and safety profiles (nanotoxicology).
• Examination of current market status and clinical development of nanocrystal products.

Main Results:

• Nanocrystals demonstrate industrial feasibility through established production methods.
• Various nanocrystal formulations (tablets, capsules, nanosuspensions) are commercially available or in clinical trials.
• Successful application in oral and intravenous delivery, with potential for dermal, mucosal, ocular, and pulmonary routes.

Conclusions:

• Nanocrystal technology is a viable and adaptable approach for enhancing the delivery of poorly soluble compounds.
• The technology extends beyond pharmaceuticals to cosmetics and nutraceuticals.
• Future directions include targeted delivery strategies and expanded applications for novel actives.