RE: Argentina IFN trial29 Apr 2021 19:37
Matterhorn, here is an example of what is specific to sng001
The Rentschler composition, which is based on formulations disclosed in US 6,030,609 , has a pH of 6.5 and osmolarity of 290 mOsm/kg. The composition is preferably provided as a sterile, clear and colourless, ready-to-use aqueous nebuliser solution presented in a disposable glass syringe.
[0020]
In addition to the active ingredient, the composition preferably comprises a buffering system to maintain the pH at between 5 and 8, more preferably 5.5 and 7.5, especially 6.5. The composition also preferably comprises an antioxidant, for example, DL-methionine.
[0021]
A preferred composition comprises:
Ingredients Quantity (per mL) Function Monograph
Active substance
IFN-ß1a (RB) 11.3 MIU (40µg) Active ingredient HSE
Excipients
Sodium dihydrogen phosphate dihydrate 5.92 mg Buffer component Ph. Eur.
Disodium phosphate dihydrate 2.13 mg Buffer component Ph. Eur.
Sodium citrate 20.58 mg Chelating agent, buffer component Ph. Eur.
DL-methionine 0.30 mg Stabiliser, antioxidant Ph. Eur.
Water for injections to 1 mL Solvent Ph. Eur
As suspected, this is somehow linked to the original manufacturer (Rentschler). Now look what you made me do.