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Dear All,
Has any regulatory agency required you recently to demonstrate the
effect of alcohol on the in vitro dissolution of any controlled/
sustained release formulations?
Thanks very much!
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Palladone, a sustained release pain killer was pulled from market due
to alcohol interactions. Patients taking the drug with alcohol had
significantly higher Cmax. I am unaware of specific FDA
requirements, but it is certainly something to consider.
http://www.washingtonpost.com/wp-dyn/content/article/2005/07/13/
AR2005071302286.html
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The following message was posted to: PharmPK
pls refer the following, it may help you some.
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4187B1_01_08-
Alcohol-Induced.pdf
with regards
Srinivasa Reddy.
Research Analyst
Pharmacokinetics and Statistics
Bioserve Clinical Research
Hyderabad
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The following message was posted to: PharmPK
s.o.o
That is serious however one can study the effect of taking alcohol on
any drug but on dissolution
not that I know of . Dissolution tests simulates the conditions in
the intestine and stomach
that why PH 5.6 phosphate buffer or 0.1m HCL is used as a vehicle in
the test.
Where you use alcohol as a drug for treatment of some disease it
would be okay. However I have never known of any disease in the
gastro-intestinal tract where medically alcohol is recommended for
its treatment. It can be used as a disinfetantexternally.
But however it would be intersting to do the test cause some liquid
preperation for instance cough remedies also contain a little bit of
alcohol.
Also the other thing is internationally there are patients who are
known alcoholics
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