Devices and methods for overfilling drug containers
Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.
1. A drug product, comprising:
a primary packaging component having a nominal volume, wherein the primary packaging component includes a body and a flange;
a volume of formulated drug substance in the primary packaging component, wherein the volume of formulated drug substance is greater than the nominal volume, and wherein the volume of formulated drug substance is within an interior of the body of the primary packaging component;
a stopper, wherein the stopper is sized and configured to fit snugly within a wall of the interior of the body; and
a plunger rod connected to the stopper,
wherein the stopper is positioned within the primary packaging component at a stopper position that is at a distance distal to the flange that restricts the plunger rod from tilting to deform the stopper to an extent that compromises a seal formed by the stopper.
2. The drug product of claim 1 , wherein the nominal volume is about 1 mL.
3. The drug product of claim 1 , wherein the flange surrounds an opening in the body.
4. The drug product of claim 1 , wherein the formulated drug substance comprises a protein, a nucleic acid, a blood component, a vaccine, an anti-allergenic, a gene therapy medicament, an antibiotic, a pain management medication, an anesthetic, and/or a hormone.
5. The drug product of claim 1 , wherein the formulated drug substance comprises an antibody.
6. The drug product of claim 1 , wherein the formulated drug substance comprises an antibody solution comprising an antibody and at least one excipient.
7. The drug product of claim 1 , wherein the formulated drug substance comprises an antibody solution comprising an antibody and at least one excipient, and wherein the antibody is present in the antibody solution at a concentration of at least 100 mg/mL.
8. The drug product of claim 1 , wherein the formulated drug substance comprises an antibody having a viscosity of at least 5 cPoise.
9. The drug product of claim 1 , wherein the stopper position is distal from a proximal end of the primary packaging component.
10. The drug product of claim 1 , wherein the stopper position is distal from a proximal end of the primary packaging component, and wherein the stopper position is at a position in which the plunger rod is limited by the wall of the interior of the body to a maximum tilting angle of the plunger rod, with respect to a longitudinal axis of the body.
11. The drug product of claim 10 , wherein the maximum tilting angle of the plunger rod is an angle that is not sufficient to pull the stopper away from the wall of the interior the body.
12. The drug product of claim 10 , wherein the maximum tilting angle of the plunger rod is 20°.
13. The drug product of claim 1 , wherein the distance is at least 2.5 mm distal to the flange.
14. The drug product of claim 1 , wherein the distance is between about 2.5 mm and about 5.0 mm distal to the flange.
15. The drug product of claim 1 , wherein the volume of the formulated drug substance is at least 0.05 mL greater than the nominal volume of the primary packaging component.
16. The drug product of claim 1 , wherein the volume of formulated drug substance is at least 1.05 mL.
17. The drug product of claim 1 , wherein the volume of formulated drug substance in the packaging component corresponds to a pre-determined theoretical fill volume.
18. The drug product of claim 1 , wherein the volume of formulated drug substance in the packaging component corresponds to a pre-determined theoretical fill volume, and wherein the theoretical fill volume is a sum of a theoretical lost volume and a theoretical administered drug volume.
19. The drug product of claim 1 , wherein the primary packaging component is a syringe.
20. The drug product of claim 1 , wherein the primary packaging component is a prefillable syringe.