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Nanomaterial Drug Products: Manufacturing and Analytical Perspectives

The AAPS Journal volume 19, pages 18–25 (2017)Cite this article

ABSTRACT

The increasing use of nanotechnology, including nanoparticles, in the preparation of drug products requires both manufacturing and analytical considerations in order to establish the quality metrics suitable for performance and risk assessment. A range of different nanoparticle systems exists including (but not limited to) nano-drugs, nano-additives, and nano-carriers. These systems generally require more complex production and characterization strategies than conventional pharmaceutical dosage forms. The advantage of using nanoparticle systems in pharmaceutical science is that the effective and desired function of the material can be designed through modern manufacturing processes. This paper offers a systematic nomenclature which allows for greater understanding of the drug product under evaluation based on available data from other nanoparticle reports. Analytical considerations of nano-drugs, nano-additives, and nano-carriers and the way in which they are measured are directly connected to quality control. Ultimately, the objective is to consider the entire nano-drug, nano-additive, and nano-carrier product life cycle with respect to its manufacture, use, and eventual fate. The tools and approaches to address the needs of these products exist; it should be the task of the pharmaceutical scientists and those in related disciplines to increase their understanding of nanomedicine and its novel products.

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Affiliations

  1. Department of Environmental Science, Baylor University, Waco, Texas, USA

    Christie M. Sayes & Grace V. Aquino

  2. RTI International, Research Triangle Park, North Carolina, USA

    Anthony J. Hickey

Authors
  1. Christie M. Sayes
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  2. Grace V. Aquino
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  3. Anthony J. Hickey
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Corresponding author

Correspondence to Christie M. Sayes.

Additional information

Guest Editors: Katherine Tyner, Sau (Larry) Lee, and Marc Wolfgang

Glossary

Nano-additive (abbrev. NA)

An inactive ingredient or excipient; excipients on the nanoscale that are added to dosage forms; used as a transport module for a drug

Nano-carrier (abbrev. NC)

Non-drug components (additives) prepared as nanoparticles in which the drug is either dispersed (in a single particle) or to which drug is added (particles of drug and carrier); used as a transport module for a drug

Nanocrystal

An example of a nanoparticle and used as an active pharmaceutical ingredient (API) in nanomedicine; a nanoparticle of near-pure drug form; usually composed of atoms, molecules, or other ingredients in a crystalline arrangement

Nano-drug (abbrev. ND)

An example of a therapeutic agent that is the drug alone on the nanoscale; can be a hard solid (e.g., tablets, capsules), soft solid (ointments, suppositories), liquid (solutions, suspensions), or gas (aerosol); a.k.a. nano-pharmaceutical

Nano-enabled

An adjective that describes something as functionally enhanced as compared to its non-nano form; objects may only have one or two dimensions on a nanoscale

Nanomedicine

The medical application of nanoscience; inclusive of drugs (or pharmaceuticals), therapeutic agents, devices, sensors, and machines

Nanoparticle

A particle, either naturally occurring or anthropogenic, that exists with mass and density on the nanoscale; equivalent to nanoparticulate and includes examples such as nanocrystal and nanopowder

Nanoparticle system

Population references for individual nanoparticle groups

Nanopowder

An example of a nanoparticle that exists in the solid state and not suspended in a liquid or gas

Nanoscale

Refers to the size of an agent on or within the nanometer size domain; usually reserved for materials between 1 and 1000 but sometimes defined as 1–100 for purposes outside pharmaceutical applications

Nanoscience

The foundational discipline of nano-related discoveries; the study of materials on the scale of nanometers

Nanotechnology

The application of nanoscience through engineering principles utilizing a material with dimensions of less than 100 nm or with a material engineered to exhibit properties unique from its bulk counterpart up to 1000 nm

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Sayes, C.M., Aquino, G.V. & Hickey, A.J. Nanomaterial Drug Products: Manufacturing and Analytical Perspectives. AAPS J 19, 18–25 (2017). https://doi.org/10.1208/s12248-016-0008-x

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  • DOI: https://doi.org/10.1208/s12248-016-0008-x

KEY WORDS

  • analytical characterizations
  • manufacturing considerations
  • nanomedicine
  • product life cycle