Dead end container and container assembly with dead end container
A container for accommodating pharmaceutical compositions, which is installable in a medical device, is provided. The container includes a hollow cylindrical body having an open end and a dead end opposite to the open end. The dead end is closed by a bottom portion. The hollow cylindrical body and the bottom portion are formed integrally and of the same material. The bottom portion transitions into the hollow cylindrical body via a curved heel that is defined by an outer radius r o , an inner radius r i and a thickness d h in a center portion of the curved heel, wherein the following condition is fulfilled: r i +d h −r o >0 mm.
1. A container for accommodating pharmaceutical compositions, the container comprising:
a hollow cylindrical body having an open end and a dead end opposite to the open end,
the open end being configured to receive a plunger that is slidable relative to the hollow cylindrical body from the open end towards the dead end;
a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer;
a curved heel between the bottom portion and the hollow cylindrical body,
wherein the curved heel is defined by an outer radius (r o ) in mm, an inner radius (r i ) in mm, and a thickness (d h ) in mm in a center portion of the curved heel, and
wherein the curved heel fulfills: r i +d h −r o >0.1 mm; and
a burst pressure of at least 110% compared to a comparative container which only differs from the container in that the comparative container does not fulfill r i +d h −r o >0 mm.
2. The container of claim 1 , wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D o ) in mm, an inner diameter (D I ) in mm, a difference (D) between the outer diameter (D o ) and the inner diameter (D I ) in mm,
wherein the common material has a tensile strength (Ts) in MPa, and
wherein 1.00 MPa≤A≤12.00 MPa, where A=D×Ts÷L.
3. The container of claim 1 , wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D o ) in mm, an inner diameter (D I ) in mm, a difference (D) between the outer diameter (D o ) and the inner diameter (D I ) in mm,
wherein the common material has a Young's modulus (E) in GPa, and
wherein 0.10 GPa.≤B≤10.00 GPa, where B=D×E÷L.
4. The container of claim 1 , further comprising a pressure compliance of at least 0.64 N/mm 2 ×(inner diameter) 2 .
5. The container of claim 1 , wherein the hollow cylindrical body has a wall thickness (d w ) in mm, a length (L) between 35 mm and 120 mm, an outer diameter (D o ) between 8.65 mm and 30 mm, an inner diameter (D I ) between 4.65 mm and 27 mm, and a ratio of the length (L) to the outer diameter (D o ) of between 3:1 and 15:1.
6. The container of claim 1 , wherein the hollow cylindrical body has an outer diameter (D o ) in mm, an inner diameter (D I ) in mm, and a length (L) in mm, wherein the outer diameter (D o ) and/or the inner diameter (D I ) varies not more than 5% over the length (L).
7. A container for accommodating pharmaceutical compositions, the container comprising:
a hollow cylindrical body having an open end and a dead end opposite to the open end,
the open end being configured to receive a plunger that is slidable relative to the hollow cylindrical body from the open end towards the dead end;
a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer;
a curved heel between the bottom portion and the hollow cylindrical body,
wherein the curved heel is defined by an outer radius (r o ) in mm, an inner radius (r i ) in mm, and a thickness (d h ) in mm in a center portion of the curved heel, and
wherein the curved heel fulfills: r i +d h −r o >0.1 mm; and
a vertical load strength of at least 110% compared to a comparative container which only differs from the container in that the comparative container does not fulfill r i +d h −r o >0 mm.
8. The container of claim 1 , wherein the hollow cylindrical body has a wall thickness (d w ) in mm, and wherein one or more of the following conditions is/are fulfilled:
d h 3 ±(r o ×d w )>0.8 mm,
[(100×d h 3 ×r i )÷(d w ×D o 2 )]+(4.4 mm 2 ÷D o )>0.55 mm, and
r i >0.7 mm.
9. The container of claim 1 , wherein the bottom portion is a circular bottom having a minimum thickness (d b,min ), and wherein d h ÷d b,min <3.0.
10. The container of claim 1 , wherein the common material is cycloolefin copolymer or cycloolefin polymer.
11. The container of claim 1 , further comprising an inner surface having an average Zn-leachability of 0.00085 μg/cm 2 or less.
12. The container of claim 1 , further comprising an inner surface having an average Zn-leachability of 0.00055 μg/mm 2 or less.
13. A container assembly for accommodating pharmaceutical compositions, the container assembly comprising:
a plunger configured to be pierceable by a cannula;
a hollow cylindrical body having an open end and a dead end opposite to the open end,
the open end receiving the plunger at the open end so as to sealingly close the open end, the plunger being slidable relative to the hollow cylindrical body from the open end towards the dead end;
a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer;
a curved heel between the bottom portion and the hollow cylindrical body,
wherein the curved heel is defined by an outer radius (r o ) in mm, an inner radius (r 1 ) in mm, and a thickness (d h ) in mm in a center portion of the curved heel, and
wherein the curved heel fulfills: r i +d h −r o >0.1 mm; and
a burst pressure of at least 110% compared to a comparative container which only differs from the container in that the comparative container does not fulfill r i +d h −r o >0 mm.
14. A container assembly for accommodating pharmaceutical compositions, the container assembly comprising:
a plunger configured to be pierceable by a cannula;
a hollow cylindrical body having an open end and a dead end opposite to the open end,
the open end receiving the plunger at the open end so as to sealingly close the open end, the plunger being slidable relative to the hollow cylindrical body from the open end towards the dead end;
a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer;
a curved heel between the bottom portion and the hollow cylindrical body,
wherein the curved heel is defined by an outer radius (r o ) in mm, an inner radius (r i ) in mm, and a thickness (d h ) in mm in a center portion of the curved heel, and
wherein the curved heel fulfills: r i +d h −r o >0.1 mm; and
a vertical load strength of at least 110% compared to a comparative container which only differs from the container in that the comparative container does not fulfill r i +d h −r o >0 mm.
15. The container assembly of claim 13 , wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D o ) in mm, an inner diameter (D I ) in mm, a difference (D) between the outer diameter (D o ) and the inner diameter (D I ) in mm,
wherein the common material has a tensile strength (Ts) in MPa and a Young's modulus (E) in GPa,
wherein 1.00 MPa≤A≤12.00 MPa, where A=D×Ts÷L, and/or
wherein 0.10 GPa.≤B≤10.00 GPa, where B=D×E÷L.
16. The container assembly of claim 13 , further comprising a pharmaceutical composition in the hollow cylindrical body.
17. A medical device for expelling or injecting pharmaceutical compositions, comprising:
the container assembly of claim 16 ;
a cannula for expelling the pharmaceutical composition from the container assembly through the cannula, wherein the cannula is arranged so as to pierce the plunger upon actuation, and
an actuation mechanism configured to move the container and the plunger relative to each other in a substantially axial direction to apply pressure to the pharmaceutical composition accommodated in the container for expelling the pharmaceutical composition through the cannula.