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Simulation study stability Oxytocics Michiel de Goeje

Simulation study stability Oxytocics Michiel de Goeje. Study design. Simulation study of several products of several brands at several storage conditions Ergometrine injection Methylergometrine injection Oxytocine injection. Study design. Different brands 3 or 4 brands for each product

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Simulation study stability Oxytocics Michiel de Goeje

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  1. Simulation study stability Oxytocics Michiel de Goeje

  2. Study design Simulation study of several products of several brands at several storage conditions • Ergometrine injection • Methylergometrine injection • Oxytocine injection

  3. Study design • Different brands • 3 or 4 brands for each product • 2 batches of each brand • Different temperatures • 2-8°C, RT(21°), 25°, 30°, 40°, 50°C • Different times • 0; 0.5; 1; 2; 3; 6; 12; 24 months

  4. Design • Influence of light • Manufacturing characteristics • pH, oxygen, antioxidants • Colour changes

  5. Results and conclusion • Both Ergometrine as well as Methylergometrine are very sensitive to light.

  6. Influence of light

  7. Influence of light

  8. Influence of light

  9. Influence Temperature

  10. Influence Temperature

  11. Influence Temperature

  12. Difference in products Average decrease in content after 1 year Oxytocin is the most stable product

  13. Variability in stability of the different products • Relative Standard deviation in content after one year

  14. Colour changes • Both Ergometrine and Methylergometrine show discolouration if degradation is more then 10%. • Slight colour changes are not easy detectable in the field • Coloured injection should not be used !

  15. Design and manufacturing conditions • The stability of ergometrine and methylergometrine is sensitive to changes in manufacturing proces • Filling under nitrogen needed • Oxytocin is more predictable in behaviour

  16. Stability current suppliers IDA Average decrease in content after 1 year (%) * Stability from a different brand

  17. Stability current suppliers IDA • Oxytocin • Labeled storage temperature 2-8°C (cool). • The shelflife at this temperature is 3 years. • Advice for shelflife IDA products at higher temperature • at 25°C the shelflife is reduced to 1 years. • at 30°C the shelflife is reduced to 6 months. • at 40°C transport maximum 1 week.

  18. Stability current suppliers IDA • Methylergometrine • Labeled storage temperature 2-8°C or 25° depending on manufacturer • The shelflife at this temperature is 2 years. • Advice for shelflife IDA products at higher temperature (only for manufacturer Gland) • at 25°C the shelflife is 2 years • at 30°C the shelflife is reduced to 1 year • at 40°C transport maximum 4 weeks

  19. Stability current suppliers IDA • ergometrine • Labeled storage temperature 2-8°C The shelflife at this temperature is 2 years. • Advice for shelflife IDA products at higher temperature • at 25°C the shelflife is reduced to 6 months • at 40°C transport maximum 2 weeks

  20. Pharmacopoeial requirements on sensitivity to light

  21. Pharmacopoeial requirements • On storage temperature

  22. Quality assurance • Product should be procured through a reliable source. • BP assay is not specific for degradation products and therefore release and stability studies should be based on analysis by validated HPLC methods

  23. Recommendation on storage ergometrine • Protect from light • Store refridgerated. • Manufacturer should be able to guarantee 2 years shelflife at refridgerated conditions. • Storage outside refridgeration (up to 30°C) may limit the shelflife to less then half year but is dependent on manufacturer. • Do not use coloured products.

  24. Recommendation on storage methyl ergometrine • Protect from light • Store refridgerated, although some brand may guarantee it up to 25°C • Manufacturer should be able to guarantee 2-3 years shelflife at refridgerated conditions. • Storage outside refridgeration may limit the shelflife to a year but is dependent on manufacturer. • Do not use coloured products.

  25. Recommendation on storage Oxytocin • Recommended to store refridgerated. • It is expected to remain of sufficient quality if stored below 21°C up to 2 years. • When stored up to 30°C a loss of 15% in one year is expected. Thus shelflife is then limited to 6 months only.

  26. Simulation study stability Oxytocics Stability data simulation study are based on study performed in collaboration with WHO WHO/DAP/93.6 Michiel de Goeje Pharmacist IDA Foundation

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