One of the more interesting technologies on display in the MCM exhibit hall was a compounding system for personalized medication doses that looked a lot like a 3-D printer but was not. Rather, it consumes a mixture of drug and compounding base and extrudes the required amount of the mixture into formed cups that produce individual doses of drug. The base that was used at the show produced a gummy. Learn more about the device at curitylabs.com.
Their approach appears to presume that the pharmacy has access to active pharmaceutical ingredient (API) that it can mix with the appropriate base to produce a mixture from which individual doses can be molded into individualized dosage forms.
This got me thinking about our regulatory environment and how such a device would fit into it.
If we were to make liquid doses from oral capsules today, we would (leaving out a LOT of detail)
- Count out a number of capsule of a specific strength
- Empty the powder from those capsules into a container
- Pour the powder into a measured amount of a liquid base
- Agitate to ensure complete mixture
- Package it in a bottle
- Dispense it.
Just for fun, I took a look at the USP monograph for Omeprazole 20 mg delayed-release capsules. To be considered accurately prepared, the USP says each capsule must deliver between 90% and 110% of the labeled dose. That's a pretty broad range. And there is a lot of stuff in that powder that is not Omeprazole.
But, it's the best we can do with current technology and it is permissible as compounding as long as the preparation is intended to fulfill a prescription (as opposed to manufacturing). As such, it would not require compliance with cGMP.
But what if we were to use this new device using Omeprazole API?
- If we were to crush tablets or empty capsules as we do now, would it still be compounding?
- If we were to use API, would it still be compounding?
It seems obvious to me that using API would likely result in a more accurate preparation than using crushed tablets or emptied capsules.
Of course, in either case we have to know (or demonstrate) that the drug is stable in the resulting preparation. But would we be required to conform to cGMP (21 CFR 210,211) and have all sorts of batch controls? Would we have to assay the mixture from which doses would be made to ensure that the concentration was within acceptable limits?
Would the "juice" be worth the "squeeze"?
What do you think?
As always, these thoughts are my own, and not those of ASHP or anyone else.
Dennis A. Tribble, PharmD, FASHP
Retired
tribbledennis@gmail.com