Back to the Top
The following message was posted to: PharmPK
Dear group,
has anyone experience with solultol HS15 as a solvent in iv
formulations.
What is the maximal dose that can be given to humans?
What are the know adverse effects in humans?
Many thanks & regards
Sonja
Back to the Top
Dear Sonja,
Solutol HS15, is a solubilizer developed by BASF, which meets the
requirements of an effective non ionic solubilizer. it is approved for
aqueous parenteral applications.
It has just been monographed in the European Pharmacopoeia under the
monograph name "Macrogol 15 Hydroxystearate".
Chemical Name:
Polyethylene glycol-15-hydroxystearate
Synonyms:
Polyethylene glycol 660 12-hydoxystearate, Macrogol-15-hydroxistearate,
Macrogoli 15 hydroxystearas
CAS No:
70142-34-6
Chemical Structure:
Kind regards
Stephane
--
Beilles Stephane, Ph.D
Preformulation Study Manager
Fournier Pharma
42, Rue de Longvic
F-21300 CHENOVE
tel : +33 (0) 3 80 44 32 52
Fax : +33 (0) 3 80 44 32 70
s.beilles.-at-.fr.fournierpharma.com
Back to the Top
This excipient has been used for vitamins A, D, E and K, and a number
of other lipophilic pharmaceutical active agents, such as Propanidid,
Nifedipine, Miconazole, Piroxicam. Alfadolone, Alfaxalone etc.
However, to my information, no product has been approved in USA to date.
Solutol HS 15 does have moderate histamine elevation as most of
others surfactants produce however its tolerability is supposed to be
higher as compared to other well known surfactants used in practise.
Toxicological information is available in rodents and non-rodents but
chronic toxicologic information is not comprehensively reported to my
knowledge. EMEA (European agency for the evaluation of medicinal
products) document is available for this excipient and can be availed
from the web site.
regards,
Vaibhav
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)