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Simulation study stability Oxytocics Michiel de Goeje.

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Presentation on theme: "Simulation study stability Oxytocics Michiel de Goeje."— Presentation transcript:

1 Simulation study stability Oxytocics Michiel de Goeje

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

3 - 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 - 4 - Design Influence of light Manufacturing characteristics pH, oxygen, antioxidants Colour changes

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

6 - 6 - Influence of light

7 - 7 - Influence of light

8 - 8 - Influence of light

9 - 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 D4-8D21LrmD25D30 Ergometrine 5,1%21%91%27%31% Methyl- ergometrine 3,7%14%91%15%18% Oxytocin 0,0%4,1%7% 14%

13 Variability in stability of the different products Relative Standard deviation in content after one year D4-8D21LrmD30 Ergometrine6%27%87%24% Methylergmetrine5%15%NA18% Oxytocin1.1%1.5%2.5%3.8%

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

16 Stability current suppliers IDA Simulation studyD4-8D21LrmD25D30 Ergometrine5%21%91%27%31% Methylergometrine4%14%91%15%18% Oxytocin1.4%5%7% 15% Average decrease in content after 1 year (%) Current suppliersD4-8D21D25 Ergometrine2 % 19 % Methylergometrine 5 %*2,4 % Oxytocin2 %4 % * 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 BP2005USP26 Ergometrine protect from light in a light resistant container Methyl- ergmetrine Not included in a light resistant container Oxytocin No require- ments

21 On storage temperature Pharmacopoeial requirements BP2005USP26 Ergometrine2° to 8 °C8-15 ºC Methyl- ergometrineNot includedNo requirements OxytocinNo requirements2° to 8 °C

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 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 ergometrine

24 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 methyl ergometrine

25 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. Recommendation on storage Oxytocin

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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