Back to the Top
The following message was posted to: PharmPK
Hi,
Do you think that solutol can be use for preclinical tox studies in
mice and rhesus??
Dominique
Back to the Top
Dear Domnique
yes we can use Solutol in Preclinical studies in fact we have been
using Solutol in combination with ethanol in our Dog studies for IV
Dosing
K.Harish Kaushik
Back to the Top
The following message was posted to: PharmPK
Can we use solutol for 14 day tox studies in rat, dog and primate?
Thanks,
Dominique
Back to the Top
Dear Kaushik
Did you use Solutol for acute dosing in the Dog or for chronic say for
7 days or 28 days, we are also planning to use the same but have
concerns regarding the safety of the same especially in dogs. Please
also could you tell me what was the amount of Solutol going into the
animal per kg of the body weight and for how many days did you dose it.
Thanks
Maninder
iTherx Pharmaceuticals Inc
San Diego
Back to the Top
The following message was posted to: PharmPK
Check out the BASF site. As with water and anything else
concentration/volume/time. There are also citations indicating a
change in
the metabolism, distribution and clearance of drugs with solutol.
Ed F. O'Connor,PhD
email: efoconnor.aaa.cox.net
Back to the Top
The following message was posted to: PharmPK
Dear Maninder,
Reports in literature indicate that for Toxicity studies in several
nonhuman mammalian species in vivo 200-750
mg/kg body weight of solutol can be given repeatedly, i.v.., for eight
weeks without ill effects.
The i.v. 50% lethal dose in beagles was found to be 3.1 g/kg body weight
Reference: _CANCER RESEARCH 51, 897-902, February 1, 1991__
Hope this helps.
Regards
Tausif Ahmed, Ph.D.
Principal Scientist
DMPK, Sai Advantium Pharma Ltd.,
Pune, India
Back to the Top
Dear Maninder,
we have used solutol & ethanol combination (1:1) 6% for acute dosing
in dog studies for IV Dosing in fact in the literature it was given as
safe ,then we made the volume with saline after dissolving the NCE
basing on the bodyweight of the animal and dosing volume if you want
any further information on it i can share with you on this issue
Thanks
K.Harish Kaushik
Asst Research Scientist
ADVINUS THERAPEUTICS
BANGALORE
Back to the Top
The following message was posted to: PharmPK
Dear Maninder,
NOEL for solutol in dogs for iv route is 25 mg/kg/d (EMEA, 2003).
Based on my
experience, even at this dose level most dogs experienced histamine-like
reactions. Most likely the sensitivity of the dog colony/population
that you
are planning to use is important. I recommend using a couple of dogs
to check
this out first. 200 to 750 mg/kg/d mentioned by another colleague
appears to be
very high and most likely associated with clinical signs, if not
lethal, to the
dog.
Rostam
Back to the Top
The detailed chronic safety information can be recieved by the
supplier upon request and we have found them very supportive in
sharing the same. You can surely use this excipient for IV dosing,
however I have yet to get convinced to use it for oral route.
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Solutol for preclinical tox studies" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)