simulation study stability oxytocics michiel de goeje n.
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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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Presentation Transcript
study design
Study design

Simulation study of several products of several brands at several storage conditions

  • Ergometrine injection
  • Methylergometrine injection
  • Oxytocine injection
study design1
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
design
Design
  • Influence of light
  • Manufacturing characteristics
    • pH, oxygen, antioxidants
  • Colour changes
results and conclusion
Results and conclusion
  • Both Ergometrine as well as Methylergometrine are very sensitive to light.
difference in products
Difference in products

Average decrease in content after 1 year

Oxytocin is the most stable product

variability in stability of the different products
Variability in stability of the different products
  • Relative Standard deviation in content after one year
colour changes
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 !
design and manufacturing conditions
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
stability current suppliers ida
Stability current suppliers IDA

Average decrease in content after 1 year (%)

* Stability from a different brand

stability current suppliers ida1
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.
stability current suppliers ida2
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
stability current suppliers ida3
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
pharmacopoeial requirements
Pharmacopoeial requirements
  • On storage temperature
quality assurance
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
recommendation on storage ergometrine
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.
recommendation on storage methyl ergometrine
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.
recommendation on storage oxytocin
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.
simulation study stability oxytocics
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