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Could anyone provide references to any current thinking regarding
dissolution testing in diluted ethanol regarding dose dumping from
extended/sustained release products?
I know there were some issues with Palladone and this issue if I am not
mistaken.
Peter Underwood, PharmD
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Hi Peter,
At the FDA's ACPS Meeting, October 2005, the worst case dissolution
test (40% V/V EtOH) was proposed for certain products.
The meeting was held after the Palladone withdrawal from the market
by Purdue Pharma and I have not heard any updates after the meeting.
Please see below.
Joseph Kim, Ph.D., RPh.
Clinical Pharmacokineticist
CPK/Modelling & Simulation
CPDM, R&D
GlaxoSmithKline
Research Triangle Park
North Carolina 27709
FDA's ACPS Meeting, October 2005
Awareness Topic: Mitigating the Risks of Ethanol Induced Dose Dumping
from Oral Sustained/Controlled Release Dosage Forms
Robert J. Meyer, M.D. and Ajaz S. Hussain, Ph.D.
Office of New Drugs and Office of Pharmaceutical Science
Center for Drug Evaluation and Research, FDA
http://www.fda.gov/OHRMS/DOCKETS/AC/05/briefing/2005-4187B1_01_08-
Alcohol-Induced.pdf
Preventing Alcohol Induced Dose Dumping is a Desired Product Design
Feature
Ajaz S. Hussain, Ph.D. Deputy Director, OPS/CDER/FDA
http://www.fda.gov/ohrms/dockets/AC/05/slides/2005-4187S2_02_Hussain.ppt
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