The Excipients Community recently had a knowledge exchange and the topic of DMSO in parental formulations brought up by @Robert Strickley. It is an excipient in 7 commercial products since 2017 at concentrations at 5% or greater for an intravenous infusion. There is no maximum IV infusion listed in the FDA Inactive Ingredients Database. Can anyone comment about using DMSO in these formulations?
|
Year
|
Product
|
Route of Administration
|
% DMSO Injected
|
Amount of DMSO Injected
|
Application
|
|
2017
|
Yescarta®
|
IV infusion
|
5.0%
|
~ 3.4 mL
|
CAR-T therapy
|
|
2017
|
KYMRIAH™
|
IV infusion
|
7.5%
|
~ 2.2-11 mL
|
CAR-T therapy
|
|
2020
|
Tecartus™
|
IV infusion
|
5.0%
|
~ 3.4 mL
|
CAR-T therapy
|
|
2021
|
BREYANZI
|
IV infusion
|
6.0%
|
|
CAR-T therapy
|
|
2021
|
Abecma®
|
IV infusion
|
5.0%
|
|
CAR-T therapy
|
|
2022
|
Skysona®
|
IV infusion
|
5.0%
|
~ 2.0 mL
|
CAR-T therapy
|
|
2023
|
Omisirge®
|
IV infusion
|
10%
|
~ 3.5 mL
|
CAR-T therapy
|
Thank you from the inquiring minds in the Excipients Community!
------------------------------
Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Rockville MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------