[e-drug] Heat stable oxytocin? (8)

["Richard Prankerd" <Richard.Prankerd@vcp.monash.edu.au>]

E-DRUG: Heat stable oxytocin? (8)
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I concur with the assessment given by Murtada Sesay of Larry Callahan's very informative .ppt on injectable oxytocin specifications, and the subsequent difficulty for procurement officers in determining the quality and stability of oxytocin injection from various sources. 

DO NOT purchase this material unless you are totally satisfied that the stability claims are fully supported by the experimental data, which must relate to your expected conditions of use. 

During several years' experience in assessing marketing applications to the Therapeutic Goods
Administration (Australia's FDA) for new injectable products by reputable pharmaceutical companies, I nearly always found that there were some stability issues which required further explanation before marketing approval could be finally given.

As I outlined in my previous post, oxytocin is a relatively stable member of what is an inherently unstable class of drugs. Solution formulations can be designed, but thorough and unbiased assessment of the stability data is essential. 

The published scientific literature on oxytocin stability is quite sparse, especially the effects of
temperature on the several pathways for degradation. Where there are several pathways with differing temperature coefficients, it is very unwise to extrapolate from other temperatures. This applies especially where products may be exposed for short durations to relatively high
temperatures (>30 degrees).

Rgds
Richard

Richard J. Prankerd, PhD
Senior Lecturer
Victorian College of Pharmacy, Monash University
381 Royal Pde., Parkville VIC 3052

Phone: INT+613-9903-9003
Phax:   INT+613-9903-9583
Richard Prankerd <Richard.Prankerd@vcp.monash.edu.au>