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Dear Sir:
Can someone out there update me on how much PEG400 can be
administered with IV run under GLP conditions for toxicity in human?
Thank you
Carol
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The following message was posted to: PharmPK
Carol,
Dosing of humans can only be done under GMP conditions.
Regards,
Frank
Frank Bales, Ph.D.
frankbales.aaa.msn.com
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Hi Carol,
To my knowledge, the way to deal with low molecular weight PEGs and
still be conforming with GLP is as follows:
PEG 400 is added to drug material and stirred until the test article
is completely dissolved. Then, the resulting solution is diluted to
the final volume using isotonic saline such that the final volume was
25% v/v PEG 400 in 0.9% sodium chloride. All solutions were stored at
almost
4*C. Of course, these stocks are sterilized through a 0.2 mcm syringe
filter under aseptic conditions and equilibrated to room temperature
prior to administration. I would do the Iv dose as a slow push (over
1-3 minutes) but you can do a bolus if you feel comfortable with the
safety and onset of toxicity of your drug.
I hope this helps.
Murad Melhem, Ph.D.
Cognigen Corporation
Buffalo, NY
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Dear Carol,
Hope that the reference below will be of help to you.
Pharmaceutical Excipients 2000 v1.0
In concentrations up to approximately 30% v/v, PEG 300 and PEG 400 have
been used as the vehicle for parenteral dosage forms.
Badrinath DR
Research Scientist,
Advinus Therapeutics Pvt Ltd,
Bangalore-58, India
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Carol, Please search FDA's Inactive ingredient guide for acceptable
limits of PEG 400 by IV route in human. Please follow
this link to search IIG:
http://www.accessdata.fda.gov/scripts/cder/iig/
for example enter 'polyethylene glycol 400'
Regards, Pradeep Bhadauria
Quoting carol.at.centerlab.com.tw:
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For Clarity: GMP describes the materials used. Actual dosing would be in
the clinical protocol and covered under GCPs
Ed O'Connor, PhD
Technical Director, Immunoanalytical
Tandem Laboratories
115 Silvia Street
West Trenton, New Jersey
609-228-0243
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The following message was posted to: PharmPK
For Clarity: GMP describes the materials used. Actual dosing would be in
the clinical protocol and covered under GCPs
Ed O'Connor, PhD
Technical Director, Immunoanalytical
Tandem Laboratories
115 Silvia Street
West Trenton, New Jersey
609-228-0243
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