Pre-filled syringe containing sugammadex
A method for providing a sterile pharmaceutical composition in a pre-filled syringe, the method including solubilizing an active agent and a pH adjusting agent in a solvent to provide a pharmaceutical composition, filtering the pharmaceutical composition through a membrane to provide a sterile pharmaceutical composition, and providing the sterile pharmaceutical composition in a pre-filled syringe having a labeled size, wherein the active agent includes sugammadex, the pre-filled syringe has a headspace volume that is less than 7.5% of the labeled size, and the method is free of a heat-based sterilization process. Also provided are sterile pharmaceutical compositions prepared according to the method.
1. A sterile pharmaceutical product provided in a pre-filled syringe, wherein the sterile pharmaceutical product is prepared by a method comprising:
solubilizing an active agent and a pH adjusting agent in a solvent to provide a pharmaceutical composition,
filtering the pharmaceutical composition through a membrane to provide a sterile pharmaceutical composition, and
providing the sterile pharmaceutical composition in a pre-filled syringe having a labeled size, wherein:
the active agent comprises sugammadex,
the pre-filled syringe has a headspace volume that is less than 7.5% of the labeled size, and
the method is free of a heat-based sterilization process.
2. The sterile pharmaceutical product of claim 1 , wherein the active agent is sugammadex sodium.
3. The sterile pharmaceutical product of claim 1 , wherein the pH adjusting agent comprises hydrochloric acid, sodium hydroxide, or a combination thereof, and wherein the solvent comprises WFI.
4. The sterile pharmaceutical product of claim 1 , wherein the heat-based sterilization process comprises subjecting the pharmaceutical composition to a temperature of 120° C. or greater.
5. The sterile pharmaceutical product of claim 1 , wherein the sterile pharmaceutical composition has an initial total impurity concentration of no more than about 1.0% (w/w).
6. The sterile pharmaceutical product of claim 1 , wherein the sterile pharmaceutical composition has a total impurity concentration of no more than about 1.0% (w/w) after one month of storage in long term storage conditions.
7. The sterile pharmaceutical product of claim 1 , wherein the membrane has an average pore size of about 0.2 μm.
8. The sterile pharmaceutical product according to claim 1 , wherein the sterile pharmaceutical product has a shelf life of at least three months.