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Regular Visitor
Posts: 2
Registered: ‎05-06-2017
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Pfizerpen BUD

My facility currently uses a 20 million unit vial of Pfizerpen to make 2.5 million unit doses in NS 100 ml bags. We'll make a couple doses, then the vial will be given 7 day BUD refrigerated. Is this not a single dose vial? If it is a SDV, shouldn't we make 8 bags of 2.5 MU each and refrigerate those? If we did batch them, what kind of BUD would they have? 7 days? I've been looking for stability data/studies for 2 days and it's driving me crazy. Thanks in advance!
Expert
Posts: 1,049
Registered: ‎02-23-2010
0

Re: Pfizerpen BUD

Yes, the vial is a single-dose vial and all of the drug should be used.  The dating on the vial is for chemical stable but not microbial sterility.  II is very confusing but we need to always remember what type of vial we are using.  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Regular Visitor
Posts: 2
Registered: ‎05-06-2017
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Re: Pfizerpen BUD

Eric, thanks for the reply. I have been looking for stability data for Penicillin G potassium in PVC bags. I found a study from 2014 showing Penicillin G sodium to be stable in NS or D5W for 21 days under refeigeration at concentrations of 50,000 units/mL and 2,500 units/mL. Would it be suitable to say based on this study that if my institution changed from 100 mL bags to 50 mL bags (to achieve 50,000 units/mL) we could use the Pen G potassium 20 MU vial to make 8 bags of 2.5 MU each, and give them 7 days BUD under refrigeration? Thanks for the help!
Expert
Posts: 1,049
Registered: ‎02-23-2010
0

Re: Pfizerpen BUD

sboogs,

 

Since you have two concentration data points showing the same chemical stability, you can usually extrapolate and apply the same chemical stability.  This concept is known as drug concentration bracketing.  Penicillin is a molecule that you can apply this principle.  I don't believe you have to change your current practice.  If you are so inclined, you can read the attached FDA guidance of stability and bracketing.  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Advisor
Posts: 17
Registered: ‎02-27-2016
0

Re: Pfizerpen BUD

Eric,
Is it acceptable to apply penicillin g SODIUM BUD data to penicillin g POTASSIUM?