# US 11,896,809 B2 · Receptacle for pharmaceutical packaging with a thickness profile for a lubricant layer

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- Number: US 11,896,809 B2
- Document ID: US11896809B2
- Status: Granted
- Kind: B2
- Application number: 16/953,736
- Filed: 2020-11-20
- Published: 2021-05-27
- Granted: 2024-02-13
- Earliest claimed: 2019-11-21
- Assignees: SCHOTT Pharma AG & Co. KGaA
- Applicants: SCHOTT Pharma AG & Co. KGaA
- Inventors: Stephanie Mangold; Raymond Moser
- Web page: https://patentgrep.com/patent/US11896809B2

## CPC

- A61M 5/31548: {Mechanically operated dose setting member}
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take precedence)}
- A61M 5/31591: {Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means}
- A61M 2005/3131: {specially adapted for improving sealing or sliding}
- A61M 2205/02: characterised by a particular materials
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A receptacle includes: an elongate barrel section with an axial position p determined along an axis, the elongate barrel section extending from an axial position pA to an axial position pB; a side wall extending over the elongate barrel section and having an inner surface bordering an interior with a diameter; and a layer of a lubricant located on at least a part of the inner surface, a portion of the axis extends from a first axial position p1 to a second axial position p2; a mean thickness of the layer is determined in the portion; a position pm is the midpoint between p1 and p2; TA is a mean thickness of the layer for a section from p1 to pm; TB is a mean thickness of the layer for a section from pm to p2; a ratio TA:TB is in a range from 5:1 to 1:5.

## Claims

### Claim 1

A receptacle for pharmaceutical packaging, comprising:
an elongate barrel section having a direction of elongate extension and an axis in the direction of elongate extension, an axial position p being determined along the axis, the elongate barrel section extending from an axial position pA to an axial position pB, an elongate barrel section length LB being a distance between pA and pB;
a side wall extending over the elongate barrel section, the side wall having an inner surface bordering an interior, the interior having a diameter; and
a layer of a lubricant located on at least a part of the inner surface, at a given axial position p on the axis between pA and pB, a thickness of the side wall, a thickness of the layer, and the diameter of the interior are each determined as an angular mean in a cross-sectional plane perpendicular to the axis at the axial position p, a portion X of the axis extends from a first axial position p1 to a second axial position p2 such that the following criteria are satisfied:
both the first axial position p1 and the second axial position p2 lie between pA and pB;
a portion length LX is a distance between the first axial position p1 and the second axial position p2;
the portion length LX is at least a half of the elongate barrel section length LB; and
the layer extends over the entire portion X; a mean thickness Tmean of the layer is determined in the portion X; a position pm is the midpoint between p1 and p2; TA is a mean thickness of the layer for a section from p1 to pm; TB is a mean thickness of the layer for a section from pm to p2; a ratio TA:TB is in a range from 5:1 to 1:5; wherein the layer has a maximum layer thickness Tmax determined between p1 and p2, a minimum layer thickness Tmin determined between p1 and p2 and a value of Tmin/Tmax is at least 0.7, and one or more criteria are satisfied, the criteria being selected from the group consisting of:
the elongate barrel section length LB is in a range from 3 cm to 20 cm;
a mean value of the diameter of the interior determined over the range pA to pB is in a range from 0.4 cm to 4 cm;
a mean thickness of the sidewall determined over the range pA to pB is in a range from 0.3 mm to 4 mm; and
a volume of the interior is in a range from 0.1 mL to 150 mL.

### Claim 2 (depends on 1)

The receptacle of claim 1, wherein the mean thickness Tmean of the layer is in the range from 100 nm to 3000 nm.

### Claim 3 (depends on 1)

The receptacle of claim 1, wherein the inner surface of the side wall has a root mean squared surface roughness rrms and a ratio rrms:Tmean is in a range from 1:2 to 1:20.

### Claim 4 (depends on 3)

The receptacle of claim 3, wherein the ratio rrms:Tmean is in a range from 1:4 to 1:10.

### Claim 5 (depends on 1)

The receptacle of claim 1, wherein the value of Tmin/Tmax is at least 0.9.

### Claim 6 (depends on 1)

The receptacle of claim 1, wherein the side wall comprises at least one of a plastic or a glass.

### Claim 7 (depends on 1)

The receptacle of claim 1, wherein the lubricant comprises at least one silicone oil.

### Claim 8 (depends on 7)

The receptacle of claim 7, wherein the at least one silicone oil is at least partially contained in a matrix.

### Claim 9 (depends on 7)

The receptacle of claim 7, wherein the at least one silicone oil comprises at least 25 wt % of a total weight of the lubricant.

### Claim 10 (depends on 1)

The receptacle of claim 1, wherein the interior is cylindrical or truncated conical over the elongate barrel section.

### Claim 11 (depends on 1)

The receptacle of claim 1, further comprising a first aperture at a first end and a second aperture at a second end.

### Claim 12 (depends on 11)

The receptacle of claim 11, wherein the first aperture defines a surface area that is at least 50% greater than a surface area of the second aperture.

### Claim 13 (depends on 1)

The receptacle of claim 1, further comprising an attachment element at an aperture.

### Claim 14 (depends on 1)

The receptacle of claim 1, wherein the layer defines a mean thickness TA over a first half of the layer and a mean thickness TB over a second half of the layer, a ratio of the mean thicknesses TA:TB being in a range from 1:5 to 5:1.

### Claim 15 (depends on 1)

The receptacle of claim 1, wherein the layer has a first thickness t1 at the first axial position p1 and a second thickness t2 at the second axial position, a ratio of the second thickness t2: the first thickness t1 being in a range from 5:1 to 1:5.

### Claim 16 (depends on 1)

The receptacle of claim 1, wherein the layer has a minimum thickness tmin between the first axial position p1 and the second axial position p2 that is greater than a mean roughness of the sidewall between the first axial position p1 and the second axial position p2.

### Claim 17

A kit, comprising:
a receptacle, the receptacle comprising:
an elongate barrel section having a direction of elongate extension and an axis in the direction of elongate extension, an axial position p being determined along the axis, the elongate barrel section extending from an axial position pA to an axial position pB, an elongate barrel section length LB being a distance between pA and pB;
a side wall extending over the elongate barrel section, the side wall having an inner surface bordering an interior, the interior having a diameter; and
a layer of a lubricant located on at least a part of the inner surface, at a given axial position p on the axis between pA and pB, a thickness of the side wall, a thickness of the layer, and the diameter of the interior are each determined as an angular mean in a cross-sectional plane perpendicular to the axis at the axial position p, a portion X of the axis extends from a first axial position p1 to a second axial position p2 such that the following criteria are satisfied:
both the first axial position p1 and the second axial position p2 lie between pA and pB;
a portion length LX is a distance between the first axial position p1 and the second axial position p2;
the portion length LX is at least a half of the elongate barrel section length LB; and
the layer extends over the entire portion X; a mean thickness Tmean of the layer is determined in the portion X; a position pm is the midpoint between p1 and p2; TA is a mean thickness of the layer for a section from p1 to pm; TB is a mean thickness of the layer for a section from pm to p2; a ratio TA:TB is in a range from 5:1 to 1:5; wherein the layer has a maximum layer thickness Tmax determined between p1 and p2, a minimum layer thickness Tmin determined between p1 and p2 and a value of Tmin/Tmax is at least 0.7, and one or more criteria are satisfied, the criteria being selected from the group consisting of:
the elongate barrel section length LB is in a range from 3 cm to 20 cm;
a mean value of the diameter of the interior determined over the range pA to pB is in a range from 0.4 cm to 4 cm;
a mean thickness of the sidewall determined over the range pA to pB is in a range from 0.3 mm to 4 mm; and
a volume of the interior is in a range from 0.1 mL to 150 mL; and a charge adapted and arranged to be positioned in the interior such that:
the charge seals a cross section of the interior between inner surfaces of the side walls;
the charge has a front end at the axial position closest to pB at which the charge contacts the layer or the inner surface;
the charge has a back end at the axial position closest to pA at which the charge contacts the layer or the inner surface;
a length of the charge LC is a distance between the front end and the back end;
the charge has a charge axial position that is an axial position of the front end; and
the charge is movable in a direction parallel to the axis with a dynamic friction g that is a function of the charge axial position.

### Claim 18 (depends on 17)

The kit of claim 17, wherein for charge axial positions in a range from the first axial position p1+the length of the charge LC to the second axial position p2, the dynamic friction g has a standard deviation gSD less than 2 N.

### Claim 19

An assembly, comprising:
a receptacle, the receptacle comprising:
an elongate barrel section having a direction of elongate extension and an axis in the direction of elongate extension, an axial position p being determined along the axis, the elongate barrel section extending from an axial position pA to an axial position pB, an elongate barrel section length LB being a distance between pA and pB;
a side wall extending over the elongate barrel section, the side wall having an inner surface bordering an interior, the interior having a diameter;
an aperture; and
a layer of a lubricant located on at least a part of the inner surface, at a given axial position p on the axis between pA and pB, a thickness of the side wall, a thickness of the layer, and the diameter of the interior are each determined as an angular mean in a cross-sectional plane perpendicular to the axis at the axial position p, a portion X of the axis extends from a first axial position p1 to a second axial position p2 such that the following criteria are satisfied:
both the first axial position p1 and the second axial position p2 lie between pA and pB;
a portion length LX is a distance between the first axial position p1 and the second axial position p2;
the portion length LX is at least a half of the elongate barrel section length LB; and
the layer extends over the entire portion X; a mean thickness Tmean of the layer is determined in the portion X; a position pm is the midpoint between p1 and p2; TA is a mean thickness of the layer for a section from p1 to pm; TB is a mean thickness of the layer for a section from pm to p2; a ratio TA:TB is in a range from 5:1 to 1:5; wherein the layer has a maximum layer thickness Tmax determined between p1 and p2, a minimum layer thickness Tmin determined between p1 and p2 and a value of Tmin/Tmax is at least 0.7, and one or more criteria are satisfied, the criteria being selected from the group consisting of:
the elongate barrel section length LB is in a range from 3 cm to 20 cm;
a mean value of the diameter of the interior determined over the range pA to pB is in a range from 0.4 cm to 4 cm;
a mean thickness of the sidewall determined over the range pA to pB is in a range from 0.3 mm to 4 mm; and
a volume of the interior is in a range from 0.1 mL to 150 mL;
a charge positioned in the interior sealing a cross section of the interior; and
a liquid pharmaceutical composition contained in the interior and located between the sealed cross section and the aperture, the assembly being adapted and arranged for the liquid pharmaceutical composition to be ejected through the aperture by movement of the charge in a direction parallel to the axis.
