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The following message was posted to: PharmPK
Deal all,
Does anyone know how much amount of polyethyleneglycol
(PEG 400 or others) can be injected by IV into human
daily basis? Also I would like to know max % of PEG
can be injected as one time shot (infusion). Please
help me!
Norman
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The following message was posted to: PharmPK
Dear Norman,
According to the FDAs' Inactive Ingredient Guide the polyethylene
Glycol 400 (max) potency range for IM - IV injections is 18.0%
For the full list see the following link:
http://www.fda.gov/cder/drug/iig/default.htm
Itay Perlstein
The Children's Hospital of Philadelphia, PA
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The following message was posted to: PharmPK
The new database has appeared on FDA site through which the excipient
status and maximum allowable concentration of any excipient can be
searched easily ( Based on FDA approved drug Product).The higher
concentration can be used but the supportive toxicitity studies to be
submitted to FDA as per the FDA guidance).
POLYETHYLENE GLYCOL 400 IM - IV; INJECTION maximum used
concentartion in FDA approved drug products is 20.3% .For more
information please see the following site:
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
Kind Regards,
Pradeep Bhadauria
RANBAXY RESEARCH LABORATORIES.
INDIA.
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Dear Mr. Pradeep Bhadauria,
Your given information was very useful to me.
"POLYETHYLENE GLYCOL 400 IM - IV; INJECTION maximum used concentartion
in FDA approved drug products is 20.3% ",
Sir in this case on whatbasis we should calculate the maximum ammount
of PEG to be used in formulation, whether it is the 20.3% of total
volume/ weight of dosage form or quantity of drug....... or of body
weight...etc. In other word in what basis the percentage is defined ?.
I will be highly grateful if u help me to understand this better.
Waiting for your reply.
Thanx in advance.
Rabi S. Bhatta
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The following message was posted to: PharmPK
Dear Rabi,
The IIG always refers to the % or amount of any ingredient in dosage
form. Please look carefully in to the dosage form before arriving at a
conclusion regarding maximum % allowed.
Regards,
Sunil Vandse
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