[e-drug] Heat stable oxytocin? (6)

["Murtada Sesay" <msesay@unicef.org>]

E-DRUG: Heat stable oxytocin? (6)
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Since the discovery of oxytocic activity by Dale in 1909, and its
subsequent synthesis by Vigneaud in 1953 ( the older e-druggers will
remember Vigneaud won the Nobel prize in 1955!), much debate has followed
the use and stability of this life-saving drug. (Note: Oxytocin is a
component of the Inter Agency Emergency Health Kit 2006).

There is a very useful power point presentation by Larry Callahan Ph.D (U.
S Pharmacopoeia), accessible on the web, 

www.pphprevention.org/documents/ 05_10_2006Oxytocin-LCJC-final3-20-06.ppt

which gives a history of how the oxytocin injection monograph has evolved over the years, from no temperature requirement for storage, to the current one of 2- 8 degrees C,
depending on the assigned shelf life which, it seems to me,  in turn depends on who you buy from! 

 I had  the challenge last year of technically  evaluating  two bids  for
oxytocin; one with full stability data and an assigned shelf life of 2
years at a recommended storage of "2 - 8 degrees C"  and the other, with full
stability data and the same assigned shelf life, but with recommended
storage temperature of "below 25 degrees C "!  I know this raises the question of
robustness of the stability data of course, but I share this with
e-druggers to reinforce the fact this and similar issues are real problems
on a pharmaceutical buying practitioner's hands. Add to this the ambiguity
of whether or not a given oxytocin injection administered to a
haemorrhaging woman will act the way we expect, makes it understandably
scary.

Murtada M. Sesay
Technical Officer (Pharmaceuticals)
UNICEF Supply Division

Tel: +45 3527 3098
Mobile: +45 28 23 28 07
E-mail: msesay@unicef.org
Web: www.unicef.org/supply