cordarone (amiodarone ) oral compounding

[Dorothy Campbell]

I have an inquiry , about oral compounding of cordarone ( amiodarone ) – 200mg tabs to oral solution

we found that the tablet contains ( starch – lactulose- silica ) in its formation

so precipitation resulted
we used ora sweet: ora plus 1:1 – 80 ml — to 400 mg tabs

i tried simple syrup alone it is dissolved – but no data about stability ( we don’t have methylcellulose as well )

Is their any recommendation to solve that

NOTE : NICU Patient

[Alchemist]

The compounding of amiodarone oral solution from tablets generally involves adding methylcellulose or adding in a certain amount of 8.4% sodium bicarbonate (same as the injection) to balance the pH to around 7. This will likely solve the precipitation issues. You would have to add in enough to reach this balanced pH (testing with litmus paper or probe).

The PHYSICAL stability of these formulations are found in multiple studies as 90 days refrigerated. However the general USP 795 recommendations for compounded non-sterile aqueous formulations is limited to 14 days refrigerated, so set yours to match especially if giving to NICU patients. USP 795 accounts for the risks of MICROBIAL growth in making the BUD limit of 14 days even though the PHYSICAL stability can be longer.

Attached are compounding formulas for 5 different children’s hospitals that essentially say the same thing. Two do not say how much sodium bicarb to add but 2 others do, and it is about 4 mL with each three 200 mg tablets according to one formula, and 12 mL with each 5 tablets to another, so you could take an average of the two and work with that if you do not have any means to test pH.

https://mega.nz/file/2opmSLiA#6u8jcNrl8Ja7FlgrNeG_fCU8Ti_4G89ZD48ZTYDw_XU

If you have found the tablets to dissolve in simple syrup alone this could have a slightly different pH than what has been studied and may have shorter physical stability making it very hard to determine a uniform stability time for your batched product. Inspect the product each time you dispense to ensure it has not started to precipitate. I still think the physical stability would be longer than that USP 795 stability of 14 days so keep it at max 14 days refrigerated and you should be ok. Each of these formulas have the literature references you would be looking for.

Check the previously posted preparation here.

AMIODARONE SUSPENSION 40MG/ML

[Dorothy Campbell]

thank you Alchemist, for the helpful reply , I will follow up with the daily dose for any changes in color or precipitation , and I got chance when doctor change it to 5 days duration , then I make the stability for only 10 days , refrigerated , and protect from light , I will follow up the daily doses

[Author]

Posts