CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to European Patent Application EP 19163313.0 filed on Mar. 15, 2019, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to pharmaceutical containers for drug delivery, and liquid compositions.

2. Description of the Related Art

Pharmaceutical containers for drug delivery are as such known in the prior art. These containers usually feature a stopper useful for eluting the contents of the container through an outlet. The stopper must slide within the container.

In most of these containers, the stopper is moved from a proximal start position to a distal end position using finger force. Finger force is limited so that the force needed to remove the stopper from its start position (break loose force) cannot be too high. Also it cannot be too low so that the stopper is not moved accidentally before the intended application of the drug. Further, the force needed to move the stopper from its start position to its end position (glide force) should not be too high for the same reasons.

Generally, very low break loose and glide force values can be achieved by choosing a stopper with a very small outer diameter relative to the container's inner diameter. However, if the stopper's outer diameter is too small, it will not seal the container sufficiently so that the contents of the container, i.e., the drug composition, might leak past the stopper.

WO 2018/157097 A1 teaches stoppers for pharmaceutical containers. The stoppers have very large outer diameters relative to the container's inner diameter in order to achieve adequate sealing of the container. The stoppers taught in this prior art document have to be plasma treat-ed or autoclaved to achieve adequate break loose and glide forces, which includes increased production costs. Further, the strong compression needed to set the stopper into the container increases the risk of tilting the stopper within the container so that production processes may be interrupted.

What is needed in the art is pharmaceutical containers that overcome at least some of the drawbacks of the prior art.

SUMMARY OF THE INVENTION

In some exemplary embodiments provided according to the invention, a pharmaceutical container for drug delivery includes a barrel configured to slidably receive a stopper. The pharmaceutical container exhibits a ratio of a break loose force (BLF) relative to a glide force (GF) of BLF/GF≤2 during a break loose and glide force test and a total glide force variation TGFV=GFmax−GFminmeasured when the stopper is moved from a start position to its end position is TGFV<2 N. The stopper has a proximal end suitable for contacting a plunger rod, a distal end suitable for contacting a pharmaceutical composition, a circumferential surface at least partially suitable for contacting an inner surface of the barrel, and one or more annular protrusions contacting the inner surface of the barrel when the stopper moves in a distal direction, the one or more annular protrusions each having a rising edge and a falling edge in a proximal-distal direction. The rising edge of a most proximal annular protrusion and the inner surface of the barrel span angle X in the distal direction, the falling edge of a most distal annular protrusion and the inner surface span an angle A in a proximal direction, and the ratio X/A is at least 1.05.

In some exemplary embodiments provided according to the invention, a pharmaceutical container for drug delivery includes a barrel configured to slidably receive a stopper. The pharmaceutical container exhibits a ratio of a break loose force (BLF) relative to a glide force (GF) of BLF/GF≤2 during a break loose and glide force test and a total glide force variation TGFV=GFmax−GFminmeasured when the stopper is moved from a start position to its end position is TGFV<2 N.

In some exemplary embodiments provided according to the invention, method of treatment includes administering to a subject an effective amount of an active ingredient using a pharmaceutical container. The pharmaceutical container includes a barrel configured to slidably receive a stopper. The pharmaceutical container exhibits a ratio of a break loose force (BLF) relative to a glide force (GF) of BLF/GF≤2 during a break loose and glide force test and a total glide force variation TGFV=GFmax−GFminmeasured when the stopper is moved from a start position to its end position is TGFV<2 N. The stopper has a proximal end suitable for contacting a plunger rod, a distal end suitable for contacting a pharmaceutical composition, a circumferential surface at least partially suitable for contacting an inner surface of the barrel, and one or more annular protrusions contacting the inner surface of the barrel when the stopper moves in a distal direction, the one or more annular protrusions each having a rising edge and a falling edge in a proximal-distal direction. The rising edge of a most proximal annular protrusion and the inner surface of the barrel span angle X in the distal direction, the falling edge of a most distal annular protrusion and the inner surface span an angle A in a proximal direction, and the ratio X/A is at least 1.05.

