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Multiphase Drug Distribution and Exchange in Oil-in-Water Nanoemulsion Revealed by High-Resolution 19 F qNMR

Journal Article · · Molecular Pharmaceutics
 [1];  [2];  [3];  [4];  [5];  [6]
  1. Northeast Medical Products Laboratory, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food and Drug Administration, Jamaica, New York 11433, United States
  2. Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States
  3. Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States
  4. Division of Liquid Based Products I, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States
  5. Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, Missouri 63110, United States
  6. Division of Complex Drug Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, United States
Not provided.
Research Organization:
Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
Sponsoring Organization:
USDOE Office of Science (SC)
DOE Contract Number:
SC0014664
OSTI ID:
1981953
Journal Information:
Molecular Pharmaceutics, Journal Name: Molecular Pharmaceutics Journal Issue: 7 Vol. 19; ISSN 1543-8384
Publisher:
American Chemical Society (ACS)
Country of Publication:
United States
Language:
English

References (28)

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The evolving landscape of drug products containing nanomaterials in the United States journal April 2017
Quantitative NMR spectroscopy in pharmaceutical applications journal August 2010
Evidence of coexisting microemulsion droplets in oil-in-water emulsions revealed by 2D DOSY 1H NMR journal March 2018
Universal referencing in multinuclear magnetic resonance spectroscopy journal February 1980
Mechanism of Formation and Structure of Micro Emulsions by Electron Microscopy journal October 1959
Reverse-dialysis can be misleading for drug release studies in emulsions as demonstrated by NMR dilution experiments journal October 2021
Nanoemulsions: formation, properties and applications journal January 2016
Stability of forskolin in lipid emulsions and oil/water partition coefficients. journal January 1991
Application of Ultra-Centrifugation and Bench-Top 19F NMR for Measuring Drug Phase Partitioning for the Ophthalmic Oil-in-Water Emulsion Products journal March 2018
Microemulsions: a qualitative thermodynamic approach journal May 1990
Lemon oil solubilization in mixed surfactant solutions: Rationalizing microemulsion & nanoemulsion formation journal January 2012
A Simple and Noninvasive DOSY NMR Method for Droplet Size Measurement of Intact Oil-In-Water Emulsion Drug Products journal February 2019
Therapeutic nanoemulsions in ophthalmic drug administration: Concept in formulations and characterization techniques for ocular drug delivery journal December 2020
Nanoemulsions versus microemulsions: terminology, differences, and similarities journal January 2012
Improving the Performance of High-Precision qNMR Measurements by a Double Integration Procedure in Practical Cases journal March 2016
Difluprednate: More than meets the eye journal January 2015
New Tools Provide New Insights in NMR Studies of Protein Dynamics journal April 2006
Difluprednate for inflammatory eye disorders journal January 2011
Ophthalmic Nanoemulsions: From Composition to Technological Processes and Quality Control journal September 2021
Interphase transfer rates in emulsions studied by NMR spectroscopy journal May 1994
Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease journal March 2017
NMR Nomenclature: Nuclear Spin Properties and Conventions for Chemical Shifts journal December 2002
Formulation of an ophthalmic lipid emulsion containing an anti-inflammatory steroidal drug, difluprednate journal September 2005
Factors that affect the rate of oil exchange between oil-in-water emulsion droplets stabilized by a nonionic surfactant: droplet size, surfactant concentration, and ionic strength journal July 1993
Kinetics of Swelling of Oil-in-Water Emulsions Stabilized by Different Surfactants journal May 1999
The Static Magnetic Field Dependence of Chemical Exchange Linebroadening Defines the NMR Chemical Shift Time Scale journal March 2000
2D NMR peak profiling to compare chemical differences between batches of pentosan polysulfate sodium journal March 2022

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