Pharmaceutical packaging container with lubricant layer for removing the load

Abstract

To provide a receptacle for pharmaceutical packaging containing a charge and having a lubricant layer.SOLUTION: A receptacle for pharmaceutical packaging is provided, wherein: n. an axial position p+ is an axial position closest to pB at which a charge contacts a layer or an inner surface; o. an axial position p- is an axial position closest to pA at which the charge contacts the layer or the inner surface; p. a value of a distance between pB and p+ divided by a distance between p+ and pA is in the range of 0 to 2; q. the mean thickness of the layer determined between pA and p- is at least 10 nm; and r. one or more criteria selected from a group consisting of: i. a length LB is in the range of 3 to 20 cm; ii. the mean value of diameters of the interior determined over the range of pA to pB is in the range of 0.4 to 4 cm; iii. the mean thickness of a sidewall determined over the range of pA to pB is in the range of 0.3 to 4.5 mm; and iv. the volume of the interior is in the range of 0.1 to 150 ml are satisfied.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates generally to a pharmaceutical packaging container containing a charge and having a lubricant layer, and more particularly to the use of the lubricant layer in the container, the process for preparing a waste disposal product, and in the waste disposal process. [Background technology]

[0002] Pharmaceutical materials can be provided in many forms and can be placed in a variety of different containers. For liquid pharmaceutical materials, some common examples are ampoules, vials, cartridges and syringes. One widely used form uses a sliding plunger in the container to deliver the liquid from an opening. One approach is to provide a lubricating layer on the inside of the container to facilitate the sliding of the plunger.

[0003] US Pat. No. 4,767,414 describes plasma activation of the inner surface prior to deposition of the silicone lubricant layer.

[0004] EP 0 920 879 describes a formulation for a silicone-based mixture that contains reactive and non-reactive components.

[0005] The need for improved medication containers continues. Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENT EMBODIMENT An object of the present invention is to at least partially overcome one or more of the above mentioned problems.

[0007] SUMMARY OF THE PRESENT EMBODIMENT It is an object of the present invention to provide an improved pharmaceutical packaging container.

[0008] It is an object of the present invention to provide a pharmaceutical packaging container that allows improved fine control for withdrawing fluid.

[0009] It is an object of the present invention to provide a container for pharmaceutical packaging which exhibits improved transportability, in particular reduced tendency to contamination.

[0010] The object of the present invention is to provide a method for the preparation of a medicament for the treatment of a pulmonary edema, comprising the steps of: -Improved fine adjustment for administering fluids or withdrawing fluids or both - Improved transportability, especially with reduced tendency to pollute -Improved disposability The present invention aims to provide a drug packaging container which simultaneously achieves two or more of the above.

[0011] It is an object of the present invention to provide an improved disposal process for pharmaceutical packaging containers.

[0012] It is an object of the present invention to provide a pharmaceutical packaging container disposal process that has fewer steps, preferably one that does not require a crushing step.

[0013] It is an object of the present invention to provide a disposal process for pharmaceutical packaging containers, in which the risk of contamination, particularly based on pharmaceutical and body fluids, is reduced.

[0014] It is an object of the present invention to provide a pharmaceutical packaging container disposal process that reduces halogen emissions. [Means for solving the problem]

[0015] Each of the following embodiments, where the xth embodiment is referred to as |x|, represents a preferred apparatus for achieving the objectives of the present invention.

[0016] |1| A container for drug packaging, the container having an elongated cylindrical section, a. the container has a first end and a second end; b. the elongated tubular section has an elongated extension direction and an axis in the elongated extension direction; c. an axial position p is defined along the axis; d. The elongated cylindrical section is at an axial position p A From axial position p B It extends to e. Length L of the cylinder B p A andp B is the interval between f. the first end is p B than p A Close to g. the second end is A than p B Close to h. the container has a first opening at the first end and a second opening at the second end; i. the first aperture has a first aperture diameter and the second aperture has a second aperture diameter, the first aperture diameter being larger than the second aperture diameter, preferably at least 10% larger, more preferably at least 50% larger, more preferably at least 100% larger, and most preferably at least 500% larger; j. the container has a sidewall extending across the elongated tubular section, the sidewall having an interior surface defining an interior, the interior having a predetermined diameter; k. a lubricant layer disposed on at least a portion of the interior surface; lp A andp B At a given axial position p on the axis between i. the thickness of said side wall ii. the thickness of said layer, and iii. said internal diameter are defined as the average of angles in a transverse plane perpendicular to the axis at the axial position p, m. a charge disposed within said interior sealing a cross section of said interior between said inner surfaces of said side walls; n. The charge is pB The axial position p is the closest axial position to + in contact with the layer or the inner surface, o. The charge is p A The axial position p is the closest axial position to - in contact with the layer or the inner surface, p.p. B andp + The interval between p + andp A and the value divided by the interval between is in the range of 0 to 2, preferably 0.001 to 1, more preferably 0.01 to 0.7, more preferably 0.05 to 0.5, more preferably 0.1 to 0.4, and most preferably 0.2 to 0.3; qp A andp - the average thickness of said layer defined between is at least 10 nm, preferably at least 20 nm, more preferably at least 30 nm, most preferably at least 40 nm, most preferably at least 50 nm, r. one or more criteria are met, the criteria being: i. The length L B is in the range of 3 to 20 cm, ii.p A ~p B The average value of the diameter of the inner portion defined over the range is within a range of 0.4 to 4 cm; iii.p A ~p B The average thickness of the side wall defined over the range is within a range of 0.3 to 4.5 mm; iv. The internal volume is within the range of 0.1 to 150 ml; The compound is selected from the group consisting of:

[0017] |2| In the container according to embodiment |1|, p A andp - Said average thickness of said layer defined between is at most 300 nm, preferably at most 250 nm, more preferably at most 200 nm, more preferably at most 150 nm, and most preferably at most 100 nm.

[0018] |3| In the container according to embodiment |1| or |2|, p A andp - The maximum thickness of said layer, defined between is at least 20 nm, preferably at least 30 nm, more preferably at least 40 nm, and most preferably at least 60 nm.

[0019] |4| In a container according to any one of the embodiments |1| to |3|, p A andp - Said maximum thickness of said layer defined between is at most 400 nm, preferably at most 350 nm, more preferably at most 300 nm, most preferably at most 250 nm.

[0020] |5| In a container according to any one of the embodiments |1| to |4|, p A From p - p has a length that is at least 50%, preferably at least 60%, more preferably at least 70% of the length of A andp - The continuous portion X between has a minimum thickness of at least 5 nm, preferably at least 10 nm, more preferably at least 20 nm, and most preferably at least 40 nm.

[0021] |6| In a container according to any one of the embodiments |1| to |5|, A From p - p has a length that is at least 50%, preferably at least 60%, more preferably at least 70% of the length of A andp - The continuous portion X between has a minimum thickness of at most 300 nm, preferably at most 250 nm, more preferably at most 200 nm, most preferably at most 150 nm.

[0022] |7| In a container according to any one of the embodiments |1| to |6|, A From p -p has a length that is at least 50%, preferably at least 60%, more preferably at least 70% of the length of A andp - The continuous portion X between has a minimum thickness and a maximum thickness, the difference between said minimum thickness and said maximum thickness being at least 5 nm, preferably at least 10 nm, more preferably at least 20 nm, and most preferably at least 30 nm.

[0023] |8| In a container according to any one of the embodiments |1| to |7|, A From p - p has a length that is at least 50%, preferably at least 60%, more preferably at least 70% of the length of A andp - The continuous portion X between has a minimum thickness and a maximum thickness, the difference between said minimum thickness and said maximum thickness being at most 300 nm, preferably at most 250 nm, more preferably at most 200 nm, and most preferably at most 150 nm.

[0024] |9| In a container according to any one of the embodiments |1| to |8|, p A andp - The maximum thickness of the layer is defined between p A than p - It is located at an axial position close to

[0025] |10| In a container according to any one of the embodiments |1| to |9|, B andp + The average thickness of the layer is defined as A andp - and preferably at least 1.5 times, more preferably at least 2 times, and more preferably at least 3 times the average thickness of said layer defined between

[0026] |11| In a container according to any one of the embodiments |1| to |10|, B andp + The maximum thickness of the layer is defined as between p A andp- and preferably at least 1.5 times, more preferably at least 2 times, and more preferably at least 3 times, the maximum thickness of the layer defined between.

[0027] |12| In a container according to any one of embodiments |1| to |11|, the first opening diameter is at least 80% of the average diameter of the interior, preferably at least 90%, more preferably at least 95%, and most preferably at least 99%.

[0028] |13| In a container according to any one of embodiments |1| to |12|, the second opening diameter is at most 70% of the average diameter of the interior, preferably at most 50%, more preferably at most 40%, and most preferably at most 30%.

[0029] |14| In the container according to any one of embodiments |1| to |13|, the charge comprises a halogen, preferably F, Cl, Br or I, more preferably F, Cl or Br, more preferably Cl or Br, and most preferably Br.

[0030] |15| In the container according to embodiment |14|, the halogen is present in a polymer.

[0031] |16| In the container according to embodiment |14| or |15|, the halogen is present in a coating of the charge.

[0032] |17| In the container according to any one of embodiments |1| to |16|, the maximum force required to remove the charge from the container through the first opening is less than or equal to 10 N, preferably less than or equal to 8 N, more preferably less than or equal to 7 N. The maximum force is preferably defined based on the illustrated removal process.

[0033] |18| In the container according to any one of embodiments |1|k to |17|, the maximum force required to remove the charge from the container through the first opening is at least 4 N, preferably at least 5 N, more preferably at least 6 N. The maximum force is preferably defined based on the illustrated removal process.

[0034] |19| In the container according to any one of embodiments |1| to |18|, the maximum force required to remove the charge from the container through the first opening is such that the front of the charge is p B than p A The maximum force is preferably defined based on the illustrated removal process.

[0035] |20| A container according to any one of embodiments |1| to |18|, ap B From p A movement of the charge along the axis in a direction toward the load is resisted by kinetic friction g, where g is a function of the forward axial position of the charge; bg is the axial position p MAX At the maximum value g MAX It has cp + andp MAX The minimum value of g between the axial position p MIN In g MIN and d. The following criteria, namely: iF MAX is in the range of 2 to 10 N, preferably 3 to 8 N, more preferably 3.5 to 7 N, ii.F MIN is in the range of 0.5 to 5N, preferably 1 to 4N, more preferably 2 to 3N; iii.p MAX p B than p A Close to iv.p MIN p A than p B Close to vgMAX / g MIN is in the range of 1.1 to 4, preferably 1.2 to 3.5, and more preferably 1.5 to 3; One or more of the following is satisfied.

[0036] The dynamic friction is preferably determined based on the illustrated removal process.

[0037] In some aspects of this embodiment, the following combinations of features are used: i., ii., i.+ii., iii., i.+iii., ii.+iii., i.+ii.+iii., iv., i.+iv., ii.+iv., i.+ii.+iv., iii.+iv., i.+iii.+iv., ii.+iii.+iv., i.+ii.+iii.+iv., v., i.+v., i. i.+v.,i.+ii.+v.,iii.+v.,i.+iii.+v.,ii.+iii.+v.,i.+ii.+iii.+v.,iv.+v.,i.+iv.+v.,ii.+iv. +v.,i.+ii.+iv.+v.,iii.+iv.+v.,i.+iii.+iv.+v.,ii.+iii.+iv.+v.,i.+ii.+iii.+iv.+v. is realized.

[0038] |21| In the container according to any one of embodiments |1| to |20|, the side wall comprises plastic or glass or both.

[0039] |22| In the container according to any one of embodiments |1| to |21|, the lubricant comprises one or more silicone oils. Preferably, the lubricant comprises a total of at least 5 wt.-%, more preferably at least 15 wt.-%, and most preferably at least 25 wt.-%, of one or more silicone oils, based on the total weight of the lubricant in the lubricant layer.

[0040] |23| In the container according to embodiment |22|, one or more silicone oils are at least partially contained within a matrix, the matrix being bonded to the inner surface.

[0041] |24| In the container according to embodiment |23|, the matrix is ​​a polymer, preferably a cross-linked polymer.

[0042] In the container according to embodiment |24|, the polymer comprises SiO comprising repeating units. A preferred polymer is a polysiloxane, more preferably a crosslinked polysiloxane.

[0043] 26|The container according to any one of embodiments |1| to |25|, wherein the interior is cylindrical or frusto-conical across the elongated tube section. A preferred frusto-conical has a conical opening in the range of 0.04° to 0.4°, preferably in the range of 0.08° to 0.25°, more preferably in the range of 0.1° to 0.2°.

[0044] |27| The container according to any one of the embodiments |1| to |26|, having an attachment means at one opening. Preferably, the attachment means is provided at one end, more preferably at the second end. Preferred attachment means are adapted and arranged to attach one or both selected from the group consisting of a needle and a tube. Some preferred attachment means are a thread, a latch, a luer fitting and a bayonet fitting.

[0045] A container according to any one of embodiments |1| to |27|, + andp B The liquid pharmaceutical composition is present in the interior space between the

[0046] |29| A process for preparing a waste treatment product, comprising the steps of: a. Providing a container according to any one of embodiments |1| to |28|; b. converting said container into a waste treatment product. Contains:

[0047] |30| A process according to embodiment |29|, comprising the following steps: - removing the charge from the container through the first opening; Contains:

[0048] |31| A process according to embodiment |29| or |30|, comprising a heating step.

[0049] |32| A process according to any one of embodiments |29| to |31|, comprising an oxidation step.

[0050] |33| In the process according to any one of embodiments |29| to |32|, the waste treatment product contains less than 50 ppm by mass of halogens, preferably less than 40 ppm, more preferably less than 30 ppm, more preferably less than 10 ppm, and most preferably less than 5 ppm.

[0051] |34| Use of a lubricant layer having an average thickness of at least 10 nm to improve disposal of used pharmaceutical containers.

[0052] |35| In the use according to embodiment |34|, waste treatment products having reduced halogen content are obtained from the waste treatment.

[0053] Diameter, layer thickness and roughness The axis of the container is used to define the axial position. At a given axial position, the sidewall, like the lubricant layer, is an interface having a thickness located in a cross-section perpendicular to the axis. The inner diameter, the thickness of the lubricant layer, the thickness of the sidewall and the surface roughness at a given point along the axis are preferably average values ​​defined over the entire circumference of the interface. One average over the entire circumference is an angular average. The angular average is preferably defined by measuring eight points separated by equal angles over the entire circumference.

[0054] container Suitable containers are adapted and arranged to hold a liquid pharmaceutical composition. Some suitable containers are syringes, syringe barrels, cartridges and vials.

[0055] In one embodiment, the container comprises the following steps: providing a container having a first end and a second end, containing a liquid pharmaceutical composition, the charge being disposed closer to the first end than to the second end; b. moving the charge to a position closer to the second end than to the first end, thereby delivering the liquid pharmaceutical composition from the second end. may be provided by

[0056] The container is preferably a used pharmaceutical container.

[0057] The preferred container has an attachment means, preferably at one end, more preferably at the second end. One preferred attachment means is adapted and arranged for attachment of a needle or tube. The needle or tube may be attached to the container of the assembly.

[0058] Long and thin tube section The container has an elongated cylindrical section. The elongated cylindrical section represents a portion of the container. The container may have other sections outside the elongated cylindrical section. Another name for the elongated cylindrical section is a tube section. One preferred elongated cylindrical section is tubular.

[0059] Possible embodiments of the elongated cylindrical section and axes are described herein in mathematical terms, such as, for example, axes of symmetry, axes of rotation or pivoting, planes and bodies of pivoting, and shapes such as cylinders and truncated cones. It is understood that these embodiments allow for several variations from these precise mathematical concepts. Suitable variations based on mathematical concepts do not prevent the elongated cylindrical section from functioning as a plunger system cooperating with the charge.

[0060] The elongated tube section has an axis. The axis may be a rotation axis of the elongated tube section. The axis may be a pivot axis of the elongated tube section. The side wall may be a body that pivots about the axis. The inner surface may be a surface that pivots about the axis. The layer may be a body that pivots about the axis.

[0061] The axis defines an axial position p, which is the axial location along the axis. In this specification, the symbol p represents the axial location in ordinary terms, and a specific axial location is represented by the letter p with a subscript.

[0062] The axial position p along the axis is used as a parameter that describes the position of a point or cross section along an elongated cylindrical section, for example in a side wall. The axial position of a point that is not on the axis is found by projecting the point onto the axis with a displacement vector perpendicular to the axis. A transverse plane is a plane perpendicular to the axis. The axial position of a transverse plane is found at the point where the transverse plane intersects the axis.

[0063] The elongated cylindrical section is at the axial position p A From axial position p B The long and narrow cylindrical section extends to p A Cross section at and p B and a cross-section at

[0064] The container has a sidewall extending over an elongated cylindrical section. The sidewall has an inner surface. The inner surface defines an interior. Preferred shapes for the sidewall are a hollow cylinder, a hollow prism, and a hollow frustum. A preferred hollow frustum is a p A From p B The preferred internal shapes are cylinders, prisms and truncated cones. The preferred truncated cones are p A From p B The diameter of the slit is reduced to

[0065] The inner surface is preferably smooth, but may have some roughness.

[0066] The thickness of the sidewall is preferably measured as the difference in radial distance from the axis between the inner and outer surfaces of the sidewall.

[0067] Preferred materials for the sidewalls are polymers and glasses.

[0068] In one embodiment, the sidewall comprises, and preferably consists of, a polymer, preferably one or both selected from the group consisting of one or more cyclic olefin copolymers and one or more cyclic olefin polymers. In one aspect of this embodiment, the polymer is preferably at least 30% by weight, more preferably at least 50% by weight, more preferably at least 80% by weight, and most preferably approximately 100% by weight of the sidewall.

[0069] In one embodiment, the sidewall comprises glass, and preferably consists of glass. Preferred glasses in this context include one or more selected from the group consisting of silicon, boron and aluminum. One preferred glass includes boron and silicon. One preferred glass is a borosilicate glass. One preferred glass includes aluminum and silicon. One preferred glass is an aluminosilicate glass. In one aspect of this embodiment, the glass is preferably at least 30% by weight, more preferably at least 50% by weight, more preferably at least 80% by weight, and most preferably approximately 100% by weight of the sidewall.

[0070] Lubricant Layer A layer of lubricant is disposed on the inner surface of the sidewall. The layer of lubricant may extend across the entire elongated cylindrical section or only a portion of it.

[0071] The preferred lubricants are silicone-based lubricants.

[0072] Suitable lubricants include one or more polysiloxanes.

[0073] A preferred lubricant comprises one or more silicone oils, the total content of the silicone oils being preferably in the range of 10-50 wt%, more preferably in the range of 20-40 wt%, most preferably in the range of 25-35 wt%, based on the total weight of the lubricant. A preferred silicone oil is polydimethyl silicone.

[0074] One preferred lubricant comprises a crosslinked polysiloxane matrix, the total content of which is preferably in the range of 50 to 90% by weight, more preferably in the range of 60 to 80% by weight, and most preferably in the range of 65 to 75% by weight, based on the total weight of the lubricant.

[0075] One suitable lubricant is -Reactive polysiloxane -Non-reactive polysiloxane -catalyst -Diluent The composition may be prepared from a mixture including one or more, preferably all, of:

[0076] One suitable reactive polysiloxane is adapted and arranged to undergo a crosslinking reaction to form a crosslinked network. The crosslinking can be catalyzed by a catalyst.

[0077] A preferred non-reactive polysiloxane does not crosslink. A preferred non-reactive polysiloxane contains one or more alkyl groups. A preferred non-reactive polysiloxane is fully substituted with alkyl groups.

[0078] One suitable catalyst catalyzes the crosslinking reaction of polysiloxanes.

[0079] A suitable diluent dissolves one or more other components of the mixture. A suitable diluent is silicon-based. A suitable diluent is a short-chain polysiloxane, preferably having 6 or less repeat units. A suitable diluent is hexamethyldisiloxane.

[0080] A suitable lubricant does not contain more than 10% by weight water, preferably more than 5% by weight, more preferably more than 1% by weight water, based on the total weight of the lubricant.

[0081] In one embodiment, the layer extends over at least 70%, more preferably at least 80%, more preferably at least 90%, and most preferably approximately 100% of the length of the elongated tubular section. B It extends over 20-60% of the

[0082] A preferred method of layer application is painting and wiping, preferably with a suitable tool.

[0083] The thickness of the layer is preferably measured as the difference in radial distance from the axis between the inner surface of the layer and the inner surface of the sidewall.

[0084] The lubricant layer may be cured after deposition. Suitable curing may be effected by heat or radiation or a combination of both. Some suitable curing means are the application of ultraviolet light and the application of infrared light.

[0085] Liquid pharmaceutical composition The container is for pharmaceutical packaging. A suitable container is adapted and arranged to contain a liquid.

[0086] The liquid pharmaceutical composition preferably comprises an active compound.

[0087] A liquid pharmaceutical composition is fluid.

[0088] The preferred amount of the liquid pharmaceutical composition is in the range of 0.001 to 10 ml, preferably in the range of 0.01 to 5 ml, more preferably in the range of 0.05 to 1 ml, most preferably in the range of 0.1 to 0.8 ml, and most preferably in the range of 0.2 to 0.5 ml.

[0089] charge The elongated barrel section is adapted and arranged to house a charge. One preferred charge is adapted and arranged to be housed within the elongated barrel section. The elongated barrel section and the charge are preferably complementary such that the charge is movable therein in a direction parallel to the axis.

[0090] One preferred charge comprises or includes a portion comprised of an elastic material. The charge is preferably adapted and arranged to seal the interior cross section. The charge is preferably adapted and arranged to move inside the container, preferably along an axis defined by the elongate extension of the container. When inside the container, movement of the charge is preferably prevented by frictional forces between the charge and the interior surface of the container.

[0091] The load may be attached to an elongated rod adapted and arranged to push or pull the load in a direction parallel to the axis.

[0092] One suitable charge is a plunger.

[0093] A preferred charge comprises a halogen, preferably F, Cl, Br or I, more preferably F, Cl or Br, more preferably Cl or Br, most preferably Br. A preferred charge may comprise two or more of said halogens. The halogen may be present in a polymeric compound, for example in a brominated or chlorinated polymer. A preferred polymer may have one or more isobutylene structural units, the isobutylene structural units being halogenated or non-halogenated, preferably halogenated. A preferred polymer may have one or more isoprene structural units, the isoprene structural units being halogenated or non-halogenated, preferably halogenated. A preferred polymer is a chlorinated or brominated isobutylene isoprene copolymer, preferably a brominated isobutylene isoprene copolymer. In this context, the isobutylene-isoprene copolymer preferably comprises 95-99.5% by weight, preferably 96-99% by weight, most preferably 97.5-98.5% by weight of isobutylene structural units and 0.5-5% by weight, preferably 1-4% by weight, most preferably 1.5-2.5% by weight of isoprene structural units.

[0094] In one embodiment, the halogen moiety may be present in a coating on the charge, preferably a coating adapted and positioned to contact the inner surface of the sidewall.

[0095] Load axial position When positioned within the vessel, the charge contacts the layer or the interior surface or both. The front end of the charge is the forward-most point of contact of the charge with the layer or the interior surface. The rear end of the charge is the rear-most point of contact of the charge with the layer or the interior surface. The front end is closer to the surface of the charge than the rear end. B The front end is closer to p than the rear end. A The charge axial position is the axial position of the front end.

[0096] The distance between the front and rear ends of the charge is the charge length L C It is.

[0097] friction force Movement of a load within a container is accompanied by frictional forces between the load and the inner surface and / or layer of the sidewall, including both static friction, which resists the load's relative motion with respect to the container, and kinetic friction, which acts during load movement.

[0098] The kinetic friction depends on the load axial position. The kinetic friction at a given load axial position p is preferably + The charge starts at p + at a constant speed of 100 mm / min. A The value of kinetic friction at a charge axial position p is the force required to maintain a charge velocity of 100 mm / min when the charge is at charge axial position p. The method of determining kinetic friction is shown in the drawings.

[0099] Lure Fitting A suitable container preferably has a luer fitting at the second end. One suitable luer fitting conforms to ISO 80369. Suitable luer fittings are luer lock fittings and slip tip fittings, preferably luer lock fittings. In one embodiment, the container has a luer lock fitting. In another embodiment, the container has a slip tip fitting. One suitable luer fitting is a male luer fitting. Suitable luer lock fittings are one piece luer lock fittings and two piece luer lock fittings. In one embodiment, the container has a one piece luer lock fitting. In another embodiment, the container has a two piece luer lock fitting.

[0100] Disposal The process for preparing a waste treatment product that contributes to achieving the object of the present invention comprises the following steps: a. providing a container; b. converting the container into a waste treatment product Includes.

[0101] In one embodiment, the charge is removed from the container, preferably through the first opening.

[0102] In one embodiment, the process includes one or more selected from the following: oxidation, heating, combustion, incineration. Once the charge is removed from the vessel, preferably at least one of the above elements is performed on the vessel.

[0103] A preferred waste treatment product is a combustion product. A preferred product is a gas, preferably containing suspended solid particles. A preferred waste treatment product contains less than 5 ppm, preferably less than 4 ppm, more preferably less than 3 ppm halogen by mass.

[0104] In one embodiment, the conversion of the container into a waste treatment product comprises the following steps: c. Removing the charge from the container; d. Combusting the empty vessel Includes:

[0105] The invention will now be further explained with reference to the drawings, which are exemplary and do not limit the scope of the invention, and in which some features are illustrated. [Brief description of the drawings]

[0106] [Figure 1] 1 is a cross-sectional view of an embodiment of a cartridge of a container according to the present invention; [Diagram 2] 1 is a cross-sectional view of an embodiment of a syringe of a container according to the present invention. [Diagram 3] 1 is a cross-sectional view of a container at an axial position p along the axis. [Figure 4a] FIG. 1 illustrates the process of removing the load from the container. [Figure 4b] FIG. 1 illustrates the process of removing the load from the container. [Figure 4c] FIG. 1 illustrates the process of removing the load from the container. [Figure 4d] FIG. 1 illustrates the process of removing the load from the container. [Figure 4e] FIG. 1 illustrates the process of removing the load from the container. [Figure 4f] FIG. 1 illustrates the process of removing the load from the container. [Diagram 5] FIG. 1 is a schematic diagram showing a waste treatment process. [Figure 6] FIG. 13 illustrates the dynamic force profile of Example 1 of the Example Section. [Figure 7a] FIG. 13 shows the process of preparing the container for each example. [Figure 7b] FIG. 13 shows the process of preparing the container for each example. [Figure 7c] FIG. 13 shows the process of preparing the container for each example. [Figure 7d] FIG. 13 shows the process of preparing the container for each example. [Figure 7e] FIG. 13 shows the process of preparing the container for each example. [Figure 7f] FIG. 13 shows the process of preparing the container for each example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0107] In Fig. 1, a cross-sectional view of an embodiment of a cartridge of a container 100 according to the invention is shown. The container 100 has a first end 119 and a second end 120. At the first end 119 there is a first opening 102. At the second end 120 there is a second opening 103. At the second end 120 there may be attachment means 104 (not shown), preferably of the Luer lock type, for attaching a needle mounting member. The container 100 is disposed at an axial position p A From axial position p B The elongated cylindrical section 501 extends to the A andp B The distance between the two is the length L of the elongated cylindrical section 501. BFor simplicity, the elongated cylindrical section 501 is shown as a hollow cylinder. In one preferred alternative embodiment, the elongated cylindrical section 501 is A The diameter at p B The container 100 may have a hollow frusto-conical shape with a diameter greater than that at the end p. The axis 101 is oriented in the direction of the elongated extension of the container 100 and is the axis of rotation of the elongated cylindrical section 501. The sidewall 107 has an inner surface 118 on which the lubricant layer 106 is disposed. The sidewall 107 defines an interior 121. The layer 106 extends over some but not all of the sidewall 107 and is spaced apart from the end p. A and p B Each axial position along the vessel 100 is measured along the axis 101. The axial positions are determined by taking p + The normal axial position p and the inside diameter d between the inner surfaces 118 of the side walls 107 at this axial position are shown. The thickness t is shown relative to the normal position. The charge 203, in this case a bromobutyl rubber stopper, has its front end at the axial position p. + and its rear end is at axial position p - The inner part 121 is provided so as to be located at the position of p + andp B The layer 106 provided in the inner section between - andp A The thickness of the layer 106 is greater than that of the layer 106 in the inner section between the - andp A The thickness of the layer 106 in the section between meets the requirements of the claims. + andp B In the section between, there may be some liquid pharmaceutical composition (not shown).

[0108] In Fig. 2, a cross-sectional view of a syringe embodiment of a container 100 according to the invention is shown. The container 100 has a first end 119 and a second end 120. At the first end 119 there is a first opening 102 and an outwardly extending flange 105. At the second end 120 there is a second opening 103. At the second end 120 there may be attachment means 104 (not shown), preferably of the Luer lock type, for attaching a needle mounting member. The container 100 is disposed at an axial position p A From axial position p B The elongated cylindrical section 501 extends to the A andp B The distance between the two is the length L of the elongated cylindrical section 501. B For simplicity, the elongated cylindrical section 501 is shown as a hollow cylinder. In one preferred alternative embodiment, the elongated cylindrical section 501 is A The diameter at p B The container 100 may have a hollow frusto-conical shape with a diameter greater than that at the end p. The axis 101 is oriented in the direction of the elongated extension of the container 100 and is the axis of rotation of the elongated cylindrical section 501. The sidewall 107 has an inner surface 118 on which the lubricant layer 106 is disposed. The sidewall 107 defines an interior 121. The layer 106 extends over some but not all of the sidewall 107 and is spaced apart from the end p. A and p B Each axial position along the vessel 100 is measured along the axis 101. The axial positions are determined by taking p + The normal axial position p and the inside diameter d between the inner surfaces 118 of the side walls 107 at this axial position are shown. The thickness t is shown relative to the normal position. The charge 203, in this case a bromobutyl rubber stopper, has its front end at the axial position p. + and its rear end is at axial position p - The charge 203 is mounted in the interior 121 so as to be positioned at the axis 101. The charge 203 has an elongated rod 202 attached thereto for pushing or pulling the charge 203 along the axis 101. + andp BThe layer 106 provided in the inner section between - andp A The thickness of the layer 106 is greater than that of the layer 106 in the inner section between the - andp A The thickness of the layer 106 in the section between meets the requirements of the claims. + andp B In the section between, there may be some liquid pharmaceutical composition (not shown).

[0109] 3 shows a cross-sectional view of the container 100 at an axial position p along the axis 101. The sidewall 107 and the lubricant layer 106 are shown as concentric circular bands. The thickness 301 of the sidewall 107 and the thickness 302 of the lubricant layer 106 are shown at eight equidistant points around the circumference, respectively. The thickness of the sidewall 107 or the lubricant layer 106 at the axial position p is the average of the thicknesses around the circle. It is measured as the average of a number of sample points, in this case eight, equally spaced around the circle.

[0110] In Figures 4a-4f the process of removing the load 203 from the container 100 is shown. The series of figures shows how the load 203 can be pulled in one motion along the axis 101 of the container 100 at a constant speed of 100 mm / min. The illustrated process can be used to construct the profile of kinetic friction between the load 203 and the sidewall 107 / lubricant layer 106 as a function of axial position along the axis 101, since the movement is done in one push and the static friction forces are only important for the starting point. Throughout the series of figures the axial position of the load is the axial position of its front end.

[0111] In Figure 4a, a container 100 according to the invention is shown ready for removal of a load 203. The container 100 is the same as that described in Figure 2. The load 203 is held at an axial position p + is located.

[0112] 4b illustrates the container 100 shown in FIG. 2, where a traction force 207 is applied to the elongated rod 202 in a direction along the axis 101 towards the first end 119. The force 207 is transferred to the charge 203. In this illustration, the force 207 is applied from an initial axial position p + At the axial position p, the load 203 is stationary due to the lack of static friction, and the pressing force 207 is offset by the static friction force between the load 203 and the side wall 107 / lubricant layer 106. + The static friction force at is defined as the force 207 at which the load 203 begins to move along the axis 101.

[0113] FIG. 4c shows that the pressing force 207 moves the load 203 to an axial position p + The container 100 is shown just after the static friction force at p has been exceeded. The charge 203 is still at the axial position p + , but during a movement 208 along the axis 101. The pushing force 207 is + equal to the kinetic friction at θ, the load 203 is at a constant velocity along the axis 101.

[0114] In FIG. 4d, a container 100 subsequent to the container 100 shown in FIG. 4c is shown, in which the charge 203 is aligned along the axis 101 at an axial position p + The charge 203 has moved a distance from axial position p1 to axial position p1. The charge 203 is still moving 208 at a constant speed with a tractive force 207 that is equal to the kinetic friction at axial position p1. Thus, the tractive force is a measure of the kinetic friction at axial position p1.

[0115] In Figure 4e the container 100 is shown after the situation in Figure 4d. The charge 203 has moved further along the axis 101 a distance from axial position p1 to p2, which is closer to the first opening 102 at the first end 119. The charge is still moving at a constant speed with the pushing force 207 being equal to the kinetic friction. Thus, the pushing force 207 is a measure of the kinetic friction at the axial position p2.

[0116] FIG. 4f shows the container 100 after the charge 203 has passed through the first opening 102.

[0117] The kinetic friction at any point along the axis 101 is directly reflected as the pushing force 207 required at that point to maintain a constant velocity (100 mm / min) of the load 203 along the axis 101. + , p1, and p2 are measured at each stage in Figures 4c, 4d, and 4e.

[0118] In Fig. 5 a schematic diagram of the waste treatment process is shown. In a first step 2003 a container according to the invention is provided. In a second step 2004 the charge 203 is removed from the container. Then in step 2005 the container 100 without the charge 203 is incinerated, resulting in a waste treatment product 2001 which is a gas combustion product. In step 2006 the charge 203 containing butyl rubber can be separately disposed of, resulting in another waste treatment product 2002. Step 2006 is preferably not a combustion step. This process allows for a gas combustion product 2001 which is halogen-free or has a reduced halogen content.

[0119] FIG. 6 shows the dynamic force profile for ten runs of Example 1 in the Examples section. + With p as the zero point B From p A The maximum value of about 4.5 to 6 N is shown at about 50 mm from the starting point. The minimum value of about 2.5 to 3 N is shown at the starting point of the run.

[0120] 7a-7f show the preparation process of the container for each example. In FIG. 7a, an empty container is shown with a plastic side wall 107, a first opening 102 and a second opening 103. As shown in FIG. 7b, a relatively thin lubricant layer 106, in this case with an average thickness of 20 nm, is applied to the inner surface of the side wall 107. The 20 nm lubricant layer is applied by spraying. A charge 203 is provided. The charge 203 has a flexible bromobutyl rubber surface and an elongated rod 202 attached by a screw fastener. The charge 203 and the elongated rod 202 act together as a plunger. As shown in FIG. 7c, the elongated rod 202 is used to push the charge 203 into the container through the first opening 102 and reach the vicinity of the second opening 103 in the container. The lubricant layer 106 facilitates the movement of the load 203 in the container by reducing friction with the sidewall 107. Some lubricant may be pushed forward by the load 203 and accumulate in front of the load 203. An excessive increase in the thickness of the lubricant layer 106 in front of the load 203 is illustrated in FIG. 7c. Thus, the thickness of the lubricant layer 106 behind the load is reduced below the original value of 20 nm. As shown in FIG. 7d, the elongated rod 202 is unscrewed from the load 203 to facilitate access to the inside of the container, in this case the load 203 is still near the second opening 103 in the container, but the elongated rod 202 is removed. The thickness of the lubricant layer 106 is then adapted by adding or removing lubricant material. The lubricant material is added by spraying. The lubricant material is removed using a wiping means such as a tampon. The thickness profile of the lubricant layer 106 is adapted to the profile shown in each example. Figure 7e shows the case where the thickness of the lubricant layer 106 is increased by adding more lubricant. Once the required thickness profile is achieved, the lubricant layer is cured by heating at 175°C for 20 seconds. Figure 7f shows the container with the elongated rod 202 now threaded back onto the charge 203 to act as a plunger.

[0121] Test Method Layer Thickness The layer thickness is determined by optical interferometry using a RapID Explorer available from rap.ID Particle Systems GmbH. The measurement is performed from the outside of the container through the side wall. The instrument is operated using proprietary software and according to the proprietary instruction manual of 2014.

[0122] resistance The resistance force is measured using a commercially available device TesT 106.2 kN from TesT GmbH, Germany. The load was moved at a speed of 100 mm / min.

[0123] example The following examples are intended to further illustrate the invention and are not intended to limit the scope of the invention as claimed.

[0124] The lubricant was prepared as follows: 10 g of vinyl-functionalized polydimethylsiloxane was first charged into a reaction vessel and mixed with 65 g of decamethylcyclopentasiloxane. Under constant stirring at 800 rpm, 0.5 g of methylhydrosiloxane / dimethylsiloxane copolymer, 6.25 g of liquid polydimethylsiloxane, 0.01 g of 10% hexachloroplatinic acid in isopropanol as catalyst and 0.05 g of 2,4,7,9-tetramethyl-5-decyne-4,7-diol as inhibitor were added to the reaction mixture. After a stirring time of 60 seconds, the reaction solution was used. Using the method shown in Figures 7a-7f, a container according to Figure 2 was provided. The container was a 1 ml 1 g TopPac available from Schott AG, Germany. The thickness profile of the deposited layer is given in Table 1. The charge was a bromobutyl rubber stopper FM257 / 2 available from Dedecke GmbH, Germany. A process similar to that shown in Figure 4a-f was performed to define the kinetic friction along the cylinder. A commercially available device TeS 106.2 kN from TeS GmbH, Germany was used. Values ​​for 10, 20, 50 and 60 mm along the cylinder are given in Table 2. The constant speed of the charge during the measurement movement was 100 mm / min. The axial position in the cylinder was p + The values ​​are plotted from pB to pA with p at zero. For each of Examples 1 to 5, a batch of 50 syringes was tested.

[0125] [Table 1]

[0126] [Table 2]

[0127] The container was used to aspirate and expel small amounts of liquid. The load was then removed from the container to prepare it for incineration. The force profile of Example 1 provided useful tactile feedback that allowed fine adjustment of the syringe without having to look at the syringe while aspirating. This is particularly useful for blending the drug fluid with bodily fluids when introducing the drug fluid into a patient's body. The load could be easily removed from the syringe of Example 1 prior to incineration. The empty container could then be incinerated without any halogens in the waste treatment gases.

[0128] The syringe of Example 2 provided excessive resistance to controlling the intake of liquid into the syringe. The charge was difficult to remove from the container and occasionally became stuck. Containers with the charge still inside had to be crushed and hand sorted to remove the charge prior to incineration to avoid halogens being included in the waste treatment gases.

[0129] The syringes of Examples 3 and 4 allowed for the intake of liquid into the syringe. In both cases, regulating the intake of liquid was more difficult than in Example 1 due to the lack of tactile feedback. It was not possible to regulate the intake while not watching the syringe. The loads were easily removable in both Examples 3 and 4. However, during storage of the syringes of Examples 2 and 3, some loads fell out of the container, spilling the remaining liquid medicine. [Explanation of symbols]

[0130] 100 containers 101 axis 102 First opening 103 Second Opening 104 Attachment means provided at the front end of the container 105 Flanges extending outside the container 106 Lubricant layer 107 Container Side Wall 118 Inner surface of side wall 119 First end of container 120 Second end of container 121 Inside the container 202 A long thin rod for pushing the load 203 Charges 207 Traction force 208 Load movement along an axis 501 Long and thin tube section 2001 Waste processing products (combustion products) 2002 Other waste processing products (non-combustion products) 2003 Container supply 2004 Removal of the load from the vessel 2005 Burning of Empty Containers 2006 Separate disposal of charges

Claims

1. A container (100) for packaging medicine, said container (100) having an elongated cylindrical section (501), a. the container (100) has a first end (119) and a second end (120); b. the elongated tubular section (501) has an elongated extension direction and an axis (101) in the elongated extension direction; c. An axial position p is defined along said axis (101); d. The elongated cylindrical section (501) is Ａ From the axial position p Ｂ It extends to e. Cylinder length L Ｂ , p Ａ and Ｂ is the interval between f. The first end (119) is Ｂ More than p Ａ Close to g. The second end (120) is Ａ More than p Ｂ Close to h. said container (100) having a first opening (102) at said first end (119) and a second opening (103) at said second end (120); i. the first aperture (102) has a first aperture diameter (601) and the second aperture (103) has a second aperture diameter (602), the first aperture diameter (601) being greater than the second aperture diameter (602); j. said container (100) having a sidewall (107) extending across said elongated cylindrical section (501), said sidewall (107) having an inner surface (118) defining an interior (121), said interior (121) having a predetermined diameter (113); k. a layer of lubricant (106) disposed on at least a portion of said inner surface (118); l.p Ａ and Ｂ At a given axial position p on the axis (101) between i. the thickness of said sidewall (107); ii. the thickness of said layer (106); iii. the inner diameter (113); are defined as the average of angles in a transverse plane perpendicular to the axis (101) at the axial position p, respectively; m. a charge (203) disposed in said interior (121) sealing a cross section of said interior (121) between said inner surfaces (118) of said side walls (107); n. Axial position p + is where the charge (203) is in contact with the layer (106) or the inner surface (118), p Ｂ is the axial position closest to o. Axial position p - is where the charge (203) is in contact with the layer (106) or the inner surface (118), p Ａ is the axial position closest to p.p Ｂ and ＋ The interval between ＋ and Ａ The value divided by the interval between is in the range of 0 to 2, q.p Ａ and － the average thickness of the layer (106) defined between is at least 10 nm; r. one or more criteria are met, said criteria being: i. The length L Ｂ is in the range of 3 to 20 cm, ii.p Ａ ~p Ｂ the average value of the diameter (113) of the interior (121) defined over a range of 0.4 to 4 cm; iii.p Ａ ~p Ｂ the average thickness of the side wall (107) defined over the range is in the range of 0.3 to 4.5 mm; iv. The volume of the interior (121) is in the range of 0.1 to 150 ml; and selected from the group consisting of: s. the average thickness of the layer (106) defined between p B and p + is at least 1.5 times the average thickness of the layer (106) defined between p A and p − ; Container (100).

2. p Ａ and － and the average thickness of the layer (106) defined between is at most 300 nm; The container (100) of claim 1.

3. p Ａ and － The maximum thickness of the layer (106) is defined between p Ａ More than p － Located at an axial position close to The container (100) of claim 1 or 2.

4. The charge (203) contains a halogen. The container (100) according to any one of claims 1 to 3.

5. the maximum force required to remove the charge (203) from the container (100) through the first opening (102) is less than or equal to 10 N; The container (100) of any one of claims 1 to 4.

6. The maximum force required to remove the load (203) from the container (100) through the first opening (102) is when the front of the load (203) is Ｂ More than p Ａ occurs when close to The container (100) of any one of claims 1 to 5.

7. The lubricant comprises one or more silicone oils. The container (100) of any one of claims 1 to 6.

8. The container (100) is ＋ and Ｂ and a liquid pharmaceutical composition present in the interior section between the The container (100) according to any one of claims 1 to 7.

9. 1. A method for preparing a waste treatment product, the method comprising: a. providing a container (100) according to any one of claims 1 to 8; b. converting said container (100) into a waste treatment product; The method includes:

10. The method comprises: - removing said charge (203) from said container (100) through said first opening (102), 10. The method of claim 9.

11. The method includes a heating step.

11. The method according to claim 9 or 10.

12. The waste treatment products contain less than 50 ppm halogen by mass.

12. The method according to any one of claims 9 to 11.

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