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The following message was posted to: PharmPK
Dear all, we need to administer testosterone propionate to male rats
(250-300 g) by means of alzet s.c. osmotic minipumps at the rate of 1
mg/day over 14 days. We estimated that needed concentrations in the
pump require methanol 40% as the vehicle (0.5 microL/h = 12 microL/
day x MeOH 40% x 14 days = about 53 mg MeOH (total dose per animal
over 14 days).
Has anyone data about:
- the compatibility of MeOH 40% with alzet minipumps over 14 days?
- the (toxic) effects of such an amount of MeOH in rats?
I will greatly appreciate answers to the above questions as well as
any suggestion concerning adequate solutions to our problem.
Many thanks in advance,
Marco Cosentino
****************************************
Marco Cosentino, MD PhD Associate Professor of Pharmacology Faculty
of Medicine Department of Clinical Medicine Section of Experimental
and Clinical Pharmacology University of Insubria Via Ottorino Rossi
n. 9 21100 Varese VA - Italy Phone (direct) +39 0332 217410/397410
Phone (exchange) +39 0332 217401/397401 Fax +39 0332 217409/397409 E-
mail marco.cosentino.aaa.uninsubria.it
[Why not ethanol? - db]
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The following message was posted to: PharmPK
Dear Marco,
For steroid solubilization, I suggest using of cyclodextrins, such as
HPBCD. In addition, cyclodextrins are fully compatible with ALZET pumps
and are an appropriate option trying to dissolve an agent for
continuous infusion. Additional technical information available on ALZET
homepage:
http://www.alzet.com/products/cyclodextrins.php
I hope it will help to your problem,
Best regards,
Maria Vikmon
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The following message was posted to: PharmPK
Dear Marco,
For steroid solubilization, I suggest using of cyclodextrins, such as
HPBCD. In addition, cyclodextrins are fully compatible with ALZET pumps
and are an appropriate option trying to dissolve an agent for
continuous infusion. Additional technical information available on ALZET
homepage:
http://www.alzet.com/products/cyclodextrins.php
I hope it will help to your problem,
Best regards,
Maria Vikmon
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Dear Marco,
As per ICH residual solvent guidelines (for humans) methanol is
class II organic solvent (limit is 3000 PPM) and it is lways better
to avoid use of organic solvent for the said purposes. You can
dissolve testosterone in any of the vegetable oil (e.g., soya oil) or
you can enhance the solubility by any other available method (Like
solid dispersion, complexation or co-solvet approach). This will be
much better approach as this will avoid solvent toxicity and further
if you have to proceed your studies in humans you can use these data
for getting approval of clinical studies from FDA,
Tushar Nahata
Deptt of Pharmacy
Shri GS Institute of Technology and Science
Indore (MP)India
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