Research ArticleResearch
Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb and Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 68-87; DOI: https://doi.org/10.5731/pdajpst.2016.007229
Dennis Jenke
1Baxter Healthcare Corporation, Round Lake, IL, USA;
Thomas Egert
2Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim/Rhein, Germany;
Alan Hendricker
3Becton Dickinson, Research Triangle Park, NC, USA;
James Castner
4Pharma Interface Analysis, LLC;
Tom Feinberg
5Scio Analytical Consulting, Chapel Hill, NC, USA;
Christopher Houston
6iuvo BioScience, Rush, NY, USA;
Desmond G. Hunt
7United States Pharmacopeoia, Rockville, MD, USA;
Michael Lynch
8Pfizer, Groton, CT, USA;
Kumudini Nicholas
9Bureau of Pharmaceutical Sciences, Health Canada, Ottawa, ON, Canada;
Daniel L. Norwood
5Scio Analytical Consulting, Chapel Hill, NC, USA;
Diane Paskiet
10West Pharmaceutical Services, Lionsville, PA, USA;
Michael Ruberto
11Materials Needs Consulting LLC, Montvale, NJ, USA;
Edward J. Smith
12Packaging Science Resources, King of Prussia, PA, USA;
Frank Holcomb
13United States Food and Drug Administration, Washington, DC, USA
Ingrid Markovic
13United States Food and Drug Administration, Washington, DC, USA
References
- 1.↵U.S. FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics-Chemistry, Manufacturing, and Controls Documentation, May 1999; http://www.fda.gov/downloads/Drugs/Guidances/ucm070551.pdf
- 2.↵U.S. FDA Guidance for Industry Nasal and Inhalation Solution Drug Products-Chemistry, Manufacturing, and Controls Documentation, July 2002; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070575.pdf
- 3.↵Draft U.S. FDA Guidance for Industry. Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products-Chemistry, Manufacturing and Controls Documentation, October 1998; http://www.fda.gov/downloads/Drugs/Guidances/ucm070573.pdf
- 4.↵Product Quality Research Institute Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, September 2006; http://www.pqri.org/pdfs/LE_Recommendations_to_FDA_09-29-06.pdf
- 5.↵
- Ball D. J.,
- Norwood D. L.,
- Stults C. L. M,
- Nago L. M.
- 6.↵
- Jenke D.
- 7.↵<1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. First Supplement to USP 38–NF 33; United States Pharmacopeial Convention, Inc.: Rockville, MD, August 1, 2015; pp 7166–7180.
- 8.↵<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. First Supplement to USP 38–NF 33; United States Pharmacopeial Convention, Inc.: Rockville, MD, August 1, 2015; pp 7181–7190.
- 9.↵
- Jenke D.,
- Castner J.,
- Egert T.,
- Feinberg T.,
- Hendricker A.,
- Houston C.,
- Hunt D. G.,
- Lynch M.,
- Shaw A.,
- Nicholas K.,
- Norwood D. L.,
- Paskiet D.,
- Ruberto M.,
- Smith E. J.,
- Holcomb F.
- 10.↵Study Protocol—Stage 2 “Experimental Protocol for Simulation Study of Blow-Fill-Seal (BFS) PODP Container Closure Systems.” PQRI Parenteral and Ophthalmic Drug Products (DODP) Leachables and Extractables Working Group, September, 2011. Available at http://www.pqri.org/commworking/minutes/pdfs/dptc/podpwg/Addl/StudyProtocolStage
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 68-87; DOI: 10.5731/pdajpst.2016.007229
Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Tom Feinberg, Christopher Houston, Desmond G. Hunt, Michael Lynch, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith, Frank Holcomb, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 68-87; DOI: 10.5731/pdajpst.2016.007229
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