Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Evomela paper comparing stability against conventional PG melphalan (Thx Paolo for reference)

http://www.tandfonline.com/doi/full/10.1080/10837450.2016.1265557

While we all know that Evomela is more stable than conventional melphalan, this article did help in my understanding of what’s going on. For example, in a previous article there was mention of preparation of reconstituted solutions as well as admixture solutions which sounded like the same thing to me but the mystery solved when you add a little description to reconstituted and admixture solutions as in ‘reconstituted solutions in vials as well as admixture solutions prepared from normal saline in infusion bags’ That ‘splains’ the difference. Here’s something else about the reconstituted Evomela. You reconstitute using 8.6 mL of normal saline to obtain a nominal melphalan concentration of 5.0 mg/mL. You use this solution to prepare your admixture. But there is major flexibility here in that you can store this 5.0 mg/mL reconstituted solution for a couple of days in the frig (2 – 8°C). You can’t store conventional mel in the frig due to precipitate formation. You can also dilute reconstituted Evomela solution to any concentration you want and retain stability as an admixture whereas the label for conventional mel indicates admixtures of propylene glycol-based melphalan injection products should not be prepared at melphalan concentrations higher than 0.45 mg/ml. And where propylene glycol-based melphalan injection solutions must be diluted immediately to suppress formation of impurities from reaction with its diluent, Evomela (5.0 mg/mL) in vials is stable for at least 1 h and additionally 4 hr as admixture solution in bags at 0.45 mg/mL. A 2.0 mg/mL admixture solution of Evomela was found to be stable for at least 10 hr at 25 °C.

So an interesting article showing clarity on why Evomela is much more stable than conventional PG melphalan and interesting to see that this article was not generated by consultants but actual Spectrum employees; five were given credit and all from the Department of Pharmaceutical Operations. One thinks of Spectrum as a cut to the bone, using consultants all the time to generate date, but regarding Pharmaceutical Operations they appear to have a full fledged dept.