A briefing note on the quality of misoprostol products, sampled and analysed in 2011 and 2014-2015 by Concept Foundation and Health Concepts International (HCI), has been published in WHO Drug Information, Volume 30, N°1, 2016.
The article presents findings from testing of misoprostol samples from a variety of countries, specifically regarding percentage of active ingredient over time in relation to the labelled content, for products in different types of blister packs.
This article is also available for viewing on our resources page, under ‘publications’. This study was conducted with support from Gynuity Health Projects, UNFPA Nigeria, IPPF, the David and Lucile Packard Foundation, Jhpiego, and the UNCoLSC.
Misoprostol is extremely susceptible to degradation, and this its shelf-life is ameliorated by using a 1% dispersion of misoprostol in hydroxypropyl methyl cellulose (HPMC). However, any exposure to moisture will lead to degradation, and this can occur through inadequate manufacturing conditions or depending on packaging (aluminium/aluminium vs. packaging consisting of plastic).
Key findings from this study include:
- 4/10 samples contained less than 90% of the labelled content of misoprostol.
- None of the samples packaged in plastic/aluminium was within specifications after one year. That being said, alu/alu packaging is not a guarantee against degradation if manufacturing conditions do not effectively control for exposure to moisture.
These findings reinforce the need to survey available misoprostol products within countries to remove sub-standard products, and procurers should only buy products that have passed stringent assessments and that are in alu/alu packaging.