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PQRI Update
ForDrug and Pharmaceutical Packaging
Committee MeetingJune 13, 2011
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Product Quality Research Institute (PQRI)
• Board of Directors
Steering Committee
Drug Product Technical Committee (DPTC)
Container Closure Working Group (CCWG)Dan Malinowski, Pfizer Dennis O’Reilly, GSK
Jim Bergum, BMS Chris Moreton, FinnBrit
Hugh Lockhart, MSU Rey Chern, Merck
Yisheng Chen, Novast Desmond Hunt, USP
Randy Glenn, sanofi-aventis Rich Hollander, Pfizer
R. Forster, Amgen John Bitner, Watson
Vicki Penn, PQRI
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Product Quality Research InstituteMember Organizations
• AAPS - American Association of Pharmaceutical Scientists
• CHPA – Consumer Healthcare Products Association• FDA/CDER – Food and Drug Administration/Center for
Drug Evaluation and Research• HC – Health Canada• IPAC- RS - International Pharmaceutical Aerosol
Consortium on Regulation & Science• IPEC–Americas – International Pharmaceutical
Excipients Council of the Americas• USP – United States Pharmacopeia
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January 2001DPTC to CCWG
Find a way to avoid unnecessary stability
testing if the water uptake of a new package
is the same as or better than the existing
package. Testing to be carried out at 40o C/75% RH
and at RT/60% RH
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December 2001Meeting of CCWG
• Focus on supporting Post Approval Packaging Change (PACPAC)
• Create a definition of “equivalence” for container closure systems
• Focus on Solid Oral Dosage forms (80% of marketed drug products)
• Formed 4 committees to review:
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December 2001Meeting of CCWG
• Four committees to review:Definitions of equivalence
Test methods for WVTR
Test methods for light transmission - dropped
Test methods for seal integrity - dropped
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December 2002
CCWG established five research objectives
• Establish clear definition of “equivalence”
• Develop a method of test; accuracy and sensitivity of current USP <671> are questionable
• Achieve differentiation among high barrier packages
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December 2002 (Continued)
Research objectives (continued)
• Utilize WVTR/unit – problem with volume for bottles vs dosage unit for blisters
This one became first priority
• Define when, during testing, WVTR steady state is reached
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December 2002: Decision Made
• to design an experiment that would meet the five research objectives.
– Data mining was not working.
• Began DOE for bottle and blister WVTR.
• WVTR/unit remains first priority.
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Jan-Feb 2005 (Slide 1 of 3)
Published in Pharmacopeial Forum, vol 31(1)
“Basis for Using Moisture VaporTransmission Rate per Unit Product inthe Evaluation of Moisture-BarrierEquivalence of Primary Packages forSolid Oral Dosage Forms”
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Jan-Feb 2005 (Slide 2 of 3)
Three points made in the paper1. MVTR/unit is the critical parameter for
equivalence2. Once an equivalent range is
established by stability test and MVTR/unit, then a substitute barrier package is an equivalent barrier if the MVTR/unit is within the qualified range
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Jan-Feb 2005 (Slide 3 of 3)
Three points made in the paper
3. A method with increased sensitivity is required in order to satisfy point 2.
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September, 2006
• PQRI bottle protocol finalized.
• Experiment under way in four laboratories to measure WVTR of bottles and blisters
• DOE included measure of variation within lab and between lab
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March, 2007
Research report published internally:
Statistical Summary of HDPE Container MVTR Measurements for Screening Study
Edited for 2010 publication on PQRI web site
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December 2009
Research Report published internally:
Statistical Summary of WVTR
Measurements – Blister Screening Study
Edited for 2010 publication on PQRI web site
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2010 – 3 research reports posted on PQRI web site
1. “Determination of Water Vapor Transmission Rate for High Density Polyethylene Screw-cap Bottles”
2. “Determination of Water Vapor Transmission Rates for Various High Barrier Blister Packs”
3. “Protocol for HDPE Container MVTR Measurement (DOC)”
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To Obtain the Reports
• Go to the web site at www.pqri.org
• Click on PQRI Structure
• Click on Working Groups
• Click on Container Closure Systems– In the Additional Material section, click on the
title of each report
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May, 2011
Published ASTM Standard D7709-11, “Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters”
Available from ASTM International (www.astm.org) at a cost of $39
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To Purchase a Copy of D7709
• Go to the ASTM web site www.astm.org– You get the home page
• Enter D7709 in the search window– You get a page showing title, price ($39) and
the “Significance and Use” and “Scope” sections of the method
– Instructions for completing the purchase are included there
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Some Features of D7709
• Test conditions: 40o C/75% RH
• Blanks: None used
• Length of test: 35 days
• Weighing Interval: 7 days
• Steady state: 5 data points
• Analytical method: Regression
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Sensitivity and Variation
Container WVTR
mg/day
S.D.
mg/day
C.V.
%
Bottle Intct 1.21 0.03 2.7
Bottle Bchd 8.18 0.98 12
PVC blist 3.06 0.106 3.5
PVdC blist 0.83 0.044 5.4
Aclar/PVC 0.14 0.0066 4.6
Foil/foil 0.004 0.0060 146
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June 7, 2011 Meeting of CCWG
1. Started planning to publish an article to
summarize and publicize:
(a) WVTR/unit concept
(b) bottle and blister studies
(c) ASTM Method
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June 7, 2011 Meeting of CCWG(Continued)
(d) how to apply these concepts and methods to reduce regulatory burden
for changes to container closure systems.
We will publish in a scientific journal and a
trade journal
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Thank You
Questions?