DRUG PREPARATION KIT AND PROCESS OF PREPARING A DRUG

Abstract

A drug preparation kit is disclosed that includes an adapter and a funnel unit. The adapter has a stud section with an in-container side and an out-container side. The stud section of the adapter is dimensioned to tightly fit into an opening of a container. The adapter has an access passage extending from the out-container side to the in-container side through the stud section. The funnel unit has a neck portion dimensioned to tightly fit into the access passage of the adapter. The funnel unit has a degassing channel formation arranged to provide a degassing channel extending from the in-container side of the stud section of the adapter to the out-container side of the stud section of the adapter when the neck portion of the funnel unit is fitted into the access passage of the adapter.

Claims

1.-18. (canceled)

19. A drug preparation kit comprising: an adapter and a funnel unit, wherein the adapter has a stud section with an in-container side and an out-container side; wherein the adapter has an access passage extending from the out container side to the in-container side through the stud section; wherein the funnel unit has a neck portion dimensioned to fit into the access passage of the adapter; wherein the funnel unit has a degassing channel formation arranged to provide a degassing channel extending from the in-container side of the stud section of the adapter to the out-container side of the stud section of the adapter when the neck portion of the funnel unit is fitted into the access passage of the adapter; wherein the neck portion of the funnel unit has an outer boundary partially mating an inner boundary of the access passage of the adapter; and wherein the outer boundary of the neck portion of the funnel unit is partially not mating the inner boundary of the access passage of the adapter such that the degassing channel of the degassing channel formation of the funnel unit is formed between the inner boundary of the access passage of the adapter and the outer boundary of the neck portion of the funnel unit.

20. The drug preparation kit of claim 19, wherein the stud section of the adapter has a press-fit structure dimensioned and arranged to be tightly pressed into the opening of the container.

21. The drug preparation kit of claim 19, wherein the stud section of the adapter is essentially cylindrical.

22. The drug preparation kit of claim 19, comprising a container with an opening, wherein the stud section of the adapter is dimensioned to fit into the opening of the container.

23. The drug preparation kit of claim 22, wherein the container is a bottle or a vial.

24. The drug preparation kit of claim 22, comprising a solid drug arranged inside the container.

25. The drug preparation kit of claim 24, comprising a reconstitution medium for reconstituting the drug product.

26. The drug preparation kit of claim 25, wherein the reconstitution medium is controlled water.

27. The drug preparation kit of claim 24, wherein the drug is highly potent.

28. The drug preparation kit of claim 24, wherein the drug is a class 3B drug.

29. The drug preparation kit of claim 19, comprising a dispenser adapted to be coupled to the access passage of the adapter for withdrawing a content of the container.

30. The drug preparation kit of claim 29, wherein the dispenser is a syringe, an enteral tube or a gastric tube.

31. The drug preparation kit of claim 19, wherein the funnel unit has a seat adapted to stably hold the funnel unit on the adapter when the neck portion of the funnel unit is tightly fitted into the access passage of the adapter.

32. The drug preparation kit of claim 19, wherein the funnel unit has a cone portion being essentially frustum conically shaped.

33. The drug preparation kit of claim 19, wherein the access passage of the adapter is ENFit compliant or Luer Lock compliant.

34. The drug preparation kit of claim 19, wherein the partially not mating outer boundary of the neck portion of the funnel unit forms a planar surface as the degassing channel of the degassing channel formation of the funnel unit.

35. The drug preparation kit of claim 19, wherein the inner boundary of the access passage of the adapter has a circular cross section and the outer boundary of the neck portion of the funnel unit has a partially circular cross section.

36. The drug preparation kit of claim 35, wherein the partially circular cross section of the outer boundary of the neck portion of the funnel unit has a circular portion mating the circular cross section of the inner boundary of the access passage of the adapter and a non-circular portion not mating the circular cross section of the inner boundary of the access passage of the adapter.

37. The drug preparation kit of claim 36, wherein the non-circular portion of the partially circular cross section of the outer boundary of the neck portion of the funnel unit is a straight line such that the degassing channel of the degassing channel formation of the funnel unit has circle segment shaped cross section.

38. A process of preparing a drug product, in particular a highly potent drug product, by means of a drug preparation kit according to claim 19, comprising: obtaining a powder of a highly potent drug in a container with an opening; fitting an adapter of the drug preparation kit into the opening of the container, wherein the adapter has a stud section with an in-container side and an out-container side, the stud section being dimensioned to fit into the opening of the container, and an access passage extending from the in-container side to the out-container side through the stud section; fitting a neck portion of a funnel unit of the drug preparation kit into the access passage of the adapter; and providing a reconstitution medium into the container via the funnel unit, wherein the funnel unit has a degassing channel formation arranged to provide a degassing channel extending from the in-container side of the stud section of the adapter to the out-container side of the stud section of the adapter such that a gas can exit the container during reconstitution of the drug product inside the container via the degassing channel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The drug preparation kit, the process of preparing a drug product and the use of the preparation kit according to the invention are described in more detail herein below by way of an exemplary embodiment and with reference to the attached drawings.

[0041] FIG. 1 shows a first embodiment of a drug preparation kit according to the invention.

[0042] FIG. 2 shows a bottom view of a bottle of the drug preparation kit of FIG. 1.

[0043] FIG. 3 shows a top view of an adapter of the drug preparation kit of FIG. 1.

[0044] FIG. 4 shows a cross sectional view of the adapter of FIG. 3.

[0045] FIG. 5 shows a perspective view of a funnel of the drug preparation kit of FIG. 1 fitted into the adapter of the drug preparation kit of FIG. 1 mounted to the bottle of the drug preparation kit of FIG. 1.

[0046] FIG. 6 shows a side view and cross section of the funnel of the drug preparation kit of FIG. 1 fitted into the adapter of the drug preparation kit of FIG. 1.

[0047] FIG. 7 shows a perspective view of a detail of a funnel of a second embodiment of a drug preparation kit according to the invention.

[0048] FIG. 8 shows a perspective view of a dispenser of the drug preparation kit of FIG. 6.

DESCRIPTION OF EMBODIMENTS

[0049] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under” and “above” refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below”, or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the exemplary term “below” can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes includes various special device positions and orientations.

[0050] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.

[0051] FIG. 1 shows a first embodiment of a drug preparation kit 1 according to the invention. The kit 1 comprises a plastic adapter 2, a funnel 3 as funnel unit, a glass bottle 4 as container, a syringe 5 as dispenser and a box 6. The box 6 is shaped and dimensioned to house all the other components of the kit 1 as well as a container with an appropriate amount of reconstitution medium (not visible in the Figs.).

[0052] The bottle 4 is made of glass and has a body 42, a bottom 45, a neck 43 neighbouring the body 42 opposite to the bottom 45 and an outer thread 44 at a periphery of the neck 43. As can be seen in FIG. 2 the bottom 45 has a circular shaped base and the body 42 is essentially circular cylindrical.

[0053] Turning back to FIG. 1, the neck 43 forms an opening 41 at the top end of the bottle 4 through which an interior of the body 42 is accessible. The thread 44 is a portion of a child resistant closure (CRC) which additionally comprises a cap (not visible in the Figs.) for closing the opening 41 of the bottle 4. In the interior of the body 42 a solid high potent drug is arranged.

[0054] The adapter 2 has a stud section 21 with an in-container side 211 (not visible in FIG. 1) and an out-container side 212. The stud section 21 comprises a cylinder portion 214 and three ring shaped and axially spaced press fit projections 213 outwardly extending from the cylinder portion 214 as press-fit structure. At its top end the stud section 21 is equipped with a disk shaped lid portion 215 which also outwardly projects from the cylinder portion 214 to a similar extent as the press fit projections 213.

[0055] The stud section 21 of the adapter 2 is dimensioned to tightly fit into the opening 41 of the bottle 4. In particular, the press fit projections 213 are dimensioned to be slightly deformed when the adapter 2 is pressed into the opening 41 of the bottle 4. Thereby, the press fit projections 213 tightly seal and close the opening 41. Like this the adapter 2 is embodied as a press in bottle adapter (PIBA). When being completely pressed into the opening 41 of the bottle 4 the lid portion 215 of the stud section 21 abuts the upper end or border of the opening 41.

[0056] As can be seen in FIG. 3 and FIG. 4 illustrating a top view and a cross section of the adapter 2, the adapter 2 has a vertical central access passage 22 which is closed at its top end by a septum 23. The in-container side 211 of the stud section 21 is particularly formed by the lower or inner surface of the lid portion 215. When the adapter 2 is mounted onto the bottle 4, the in-container side 211 is adjoining the opening 41 of the bottle 4 and, thus, oriented towards the interior of the bottle 4. The opposite upper surface of the lid portion 215 forms the out-container side 212 of the stud section 21 which is oriented away from the interior of the bottle 4. The access passage 23 extends from the in-container side 211 to the out-container side 212 through the lid portion 215 of the stud section 21.

[0057] Turning back to FIG. 1, the funnel 3 has an upper cone portion 33 and a lower neck portion 31. The cone portion 33 is frustum conically shaped and narrows in a downward direction towards the neck portion 31. The interiors of the cone portion 33 and the neck portion 31 form a main duct 34 which has a wide input aperture 341 at its top end and a narrow output aperture at its bottom end. Starting from the bottom end of the neck portion 31 and extending about up to halfway of the neck portion 31 a degassing channel formation 32 is embodied. More specifically, the neck portion 31 is provided with a planar surface as the degassing channel formation 32. The neck portion 31 is thereby not entirely circle cylindrical at its lower half.

[0058] The syringe 5 is conventionally embodied with a syringe body 51 into which a plunger rod 52 extends on one longitudinal end side and which passes over into a dispensing orifice 53 at another longitudinal end side.

[0059] FIG. 5 shows the adapter 2 being mounted to the bottle 4 and the funnel 3 being fitted into the adapter 2. In particular, the adapter 2 is press fitted into the opening 41 of the bottle 4 such that it is tightly closed. Then the neck portion 31 of the funnel 3 is fitted into the access passage 23 of the adapter 2 such that it extends from the out-container side 212 of the stud section 21 to its in-container side 211. More specifically it slightly projects below the in-container side into the interior of the bottle 4.

[0060] As can be seen in FIG. 6, the planar surface of the degassing channel formation 32 located at the neck portion 31 provides a degassing channel 321 along the neck portion 31 between the adapter 2 and the funnel 3. Except for where the degassing channel formation 32 is located, the neck 31 of the funnel 3 is tightly fitted and connected to the access passage 23 of the adapter 2. The liquid reconstitution medium is poured into the input aperture 341 and flows through the main duct 34 into the interior of the body 42 of the bottle 4. There, the drug powder is reconstituted. The gases generated or displaced during reconstitution smoothly exit via the degassing channel 321 formed by the degassing channel formation 32 as a portion of the access passage 22.

[0061] The kit 1 can be used in an embodiment of a process of preparing a highly potent drug product according to the invention as follows: A powder of a highly potent drug is obtained in the bottle 4. The adapter 2 is tightly fitted into the opening 41 of the bottle 4. The neck portion 31 of the funnel 3 is tightly fitted into the access passage 22 of the adapter 2. The reconstitution medium is provided into the bottle 2 via the funnel 3, wherein the degassing channel 321 generated by the degassing channel formation 32 extends from the in-container side 211 of the stud section 21 to its out-container side 212 such that the gas can exit the bottle 4 during reconstitution of the drug product inside the bottle 4 via the degassing channel 321.

[0062] After reconstitution, the funnel 3 is removed from the adapter 2 and the orifice 53 of the syringe 5 is fitted through the access passage 22 of the adapter 2. The bottle is then turned upside down and the liquid drug is withdrawn into the syringe 5 at a precise amount. Then the syringe 5 is removed from the adapter 2 and the liquid drug product is delivered via the orifice 53 to a patient.

[0063] In FIG. 7 a second embodiment of a drug preparation kit 10 according to the invention is shown. Where not explicitly described below the kit 10 is essentially identical to the kit 1 described above in connection with FIGS. 1-5. The kit 10 comprises a funnel 30 which is embodied with a cone portion 330, a neck portion 310 and a degassing channel formation 320 comprising a planar surface at the neck portion 310. Further, the funnel 30 comprises a seat 340 adapted to stably hold the funnel 30 on the adapter, when the neck portion 310 is tightly fitted into an access passage of the adapter. The seat 340 has two opposite, wing like, vertical wall sections which outwardly project from the neck portion 310. When fitted in the access passage of the adapter, a lower end of the wall sections abut an out-container side of the adapter and allow the funnel 30 to be stably held.

[0064] FIG. 8 shows a dispenser of the kit 10 being an enteral tube 50. The tube 50 comprises a hollow interior, a delivery orifice 530 and a plunger 520. Between the plunger 520 and the orifice 530 a dosage chamber is formed. Around the delivery orifice 530 a male part of an ENFit connector 550 is arranged. An access passage of the adapter of the kit 10 is equipped with a corresponding female part of the ENFit connector such that the enteral tube 50 can be safely connected to the adapter when it is mounted to a bottle of the kit 10.

[0065] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims.

[0066] The disclosure also covers all further features shown in the Figs. individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.

[0067] Furthermore, in the claims the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.