[go: up one dir, main page]

WO2025222112A1 - Adaptateur pour récipient de médicament, kit de préparation comprenant un adaptateur et un récipient de médicament, et procédé de préparation d'un médicament liquide injectable - Google Patents

Adaptateur pour récipient de médicament, kit de préparation comprenant un adaptateur et un récipient de médicament, et procédé de préparation d'un médicament liquide injectable

Info

Publication number
WO2025222112A1
WO2025222112A1 PCT/US2025/025352 US2025025352W WO2025222112A1 WO 2025222112 A1 WO2025222112 A1 WO 2025222112A1 US 2025025352 W US2025025352 W US 2025025352W WO 2025222112 A1 WO2025222112 A1 WO 2025222112A1
Authority
WO
WIPO (PCT)
Prior art keywords
adapter
section
another
medicament
pass
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/025352
Other languages
English (en)
Inventor
Alexander ALLERDINGS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genzyme Corp
Original Assignee
Genzyme Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Genzyme Corp filed Critical Genzyme Corp
Publication of WO2025222112A1 publication Critical patent/WO2025222112A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • Adapter for a medicament container, preparation kit comprising an adapter and a medicament container and method of preparing an injectable liquid medicament
  • the present disclosure relates to an adapter for a medicament container.
  • the present disclosure relates to a preparation kit and to a method of preparing an injectable liquid medicament.
  • IV infusions Patients suffering from certain diseases like, for example, hemophilia or requiring enzyme replacement therapy have to take regular intravenous (IV) infusions.
  • IV infusions often have to be mixed and prepared, sometimes to the specific needs of the patient, (and sometimes a short time before drug administration) which may include reconstitution of the drug powder from multiple vials using an exact amount of sterile liquids like water and/or saline.
  • this preparation process is typically complex and tedious, it is usually performed by a health care professional in a clinic or pharmacy, potentially using lab equipment.
  • administering a medicament by way of infusion may require a rather clean or sterile environment.
  • a patient may therefore have to regularly visit an ambulance or health care center.
  • Self-medication or home-medication for administering a medicament through infusion or injection is and remains quite challenging but is very attractive for patients thereby avoiding problems and circumstances involved in visiting a health care center.
  • a patient or user e.g. intending to establish a vascular access to a patient's body, may be obliged to use only one hand, which might be rather cumbersome and thus challenging.
  • an adapter for a medicament container wherein the medicament container comprises a cavity for a medicament.
  • the adapter comprises an adapter body.
  • the adapter body comprises a first side of portion comprising a first adapter connecting portion.
  • the adapter body further comprises a second side portion comprising a second adapter connecting portion.
  • the adapter body further comprises third side of portion comprising a container attachment portion.
  • the adapter body further comprises a first flow channel comprising a first pass-through section and first branch section.
  • the first pass-through section extends inside the adapter body from the first side portion to the second side portion.
  • the first branch section extends inside the adapter body from the third side portion and merges into the first pass- through section.
  • the adapter Via the first adapter connecting portion the adapter can be connected, e.g. fastened or fixed, to another adapter, e.g. to a body of another adapter. Via the second adapter connecting portion the adapter can be connected, e.g. fastened or fixed, to another further adapter body of another further adapter.
  • an assembly of interconnected adapters can be configured for attaching multiple medicament containers.
  • the respective medicament container can be attached to the respective container attachment portion.
  • the first branch section and the first branch section may be protected from actions leading to a deformation of the respective section, e.g.
  • first pass-through section and the structural integrity of the first branch section may be enhanced or maintained, e.g. an inner cross-section of the respective section may be maintained even when handling the adapter or fastening the adapter to another adapter.
  • first flow channel may remain unaffected even when a force is acting on the adapter or when the adapter is connected to another adapter.
  • a fluid flow through the first pass-through section from the first side portion to the second side portion and vice versa may be ensured and a fluid flow through the first branch section from the first pass- through section to the third side portion and vice versa may be ensured.
  • the first pass- through section and the first branch section may remain unaffected irrespective from handling operations or interconnection operations with another adapter.
  • the first branch section may be inaccessible from at least one of the first side portion and the second side portion.
  • the first branch section may be inaccessible from the first side portion and from the second side portion. This way, actions that are carried out on at least one of the first side portion and the second side portion, e.g. connecting of another adapter, may not affect the first branch section. This way, the structural integrity of the first branch section may be enhanced or maintained.
  • the first pass-through section may extend entirely inside the adapter body from the first side portion to the second side portion. This way, no portion of the first pass-through section may be exposed.
  • the first branch section may extend entirely inside the adapter body from the third side portion to the first pass-through section. This way, no portion of the first branch section may be accessible from or exposed to the first side portion or the second side portion.
  • the first branch section may be located at a predefined non-zero first distance from the first side portion and at a predefined non-zero second distance from the second side portion. This way, the first branch section may be unaffected from actions that are carried out on at least one of the first side portion and the second side portion.
  • the respective distance may vary depending on the material of the adapter body and the forces to be expected when using the adapter.
  • the cavity may contain a lyophilized medicament. By introducing a liquid as outlined above, the lyophilized medicament may be reconstituted and by this a liquid medicament may be obtained in the cavity.
  • filling of a cavity of a medicament container and of another cavity of another medicament container may be conducted in a single filling procedure as follows: The medicament container is attached to the adapter and the another medicament container is attached to the another adapter. Further, the another first adapter connecting portion of the another adapter is connected to the second adapter connecting portion of the adapter. Filling of the cavities of both medicament containers may be conducted by providing a liquid flow through the first pass-through section of the adapter from the first side portion to the second side portion by introducing the liquid at the first side portion. As outlined above, a partial flow will branch off into the first branch section.
  • the remaining partial flow that passes the first branch section and thus is not branched off into the branch section, may flow to the second side portion.
  • This remaining partial flow is allowed to escape at the second side portion and to flow into the another first pass-through section of the another adapter that is connected to the second adapter connecting portion of the adapter.
  • the remaining partial flow may form another liquid flow through the another first pass- through section of the another adapter.
  • Another partial flow may be branched off from the another liquid flow by flowing into the another first branch section of the another first flow channel, escaping at another third side portion of the another adapter body and thus flowing into the another cavity of the another medicament container. This way, the cavities of both medicament containers may be filled simultaneously.
  • This concept may be used for simultaneous filling of the cavities of two or more medicament containers by using two or mor interconnected adapters.
  • the filling procedure may also be conducted by providing a liquid flow through the another first pass-through section of the another adapter from the another second side portion to the another first side portion by introducing the liquid at the another second side portion.
  • the filling of the cavity of each medicament container with a liquid is conducted separately. This is rather time consuming and each filling procedure bears the risk of a contamination.
  • the time for filling the cavities of two or more medicament containers may be reduced and facilitated. Further, the risk of a contamination may be reduced.
  • Withdrawing of a liquid, e.g., a liquid medicament, from the cavity may also be conducted from at least one of the first side portion and the second side portion and thus via the first pass- through section.
  • the liquid contained in the cavity may flow through the first branch section into the first pass-through section and may escape the adapter at at least one of the first side portion and the second side portion.
  • withdrawing a liquid from a cavity of a medicament container and of another cavity of another medicament container may be conducted in a single withdrawing procedure as follows: The medicament container is attached to the adapter and the another medicament container is attached to the another adapter. Further, the another first adapter connecting portion of the another adapter is connected to the second adapter connecting portion of the adapter such that a liquid is allowed to flow from the first pass-through section of the adapter into the another first pass-through section of the another adapter. Withdrawing the liquid from the cavities of both medicament containers may be conducted by withdrawing the liquid from the another second side portion of the another adapter, e.g. by providing a negative pressure at the another second side portion.
  • the liquid from the cavity of the medicament container may flow through the first branch section into the first pass-through section, escape at the second side portion, enter the another first pass-through section of the another adapter and flow to the another second side portion of the another adapter. Similar, the liquid from the another cavity of the another medicament container may flow through the another first branch section into the another first pass-through section and flow to the another second side portion of the another adapter thereby mixing with the liquid flow stemming from the adapter. This way, the liquids from the cavities of both medicament containers may be withdrawn simultaneously.
  • This concept may be used for simultaneous withdrawing the liquids from the cavities of two or more medicament containers by using two or mor interconnected adapters.
  • the withdrawing procedure may also be conducted by withdrawing the liquid from the first side portion of the adapter, e.g. by providing a negative pressure at the first side portion.
  • the liquid from each medicament container is withdrawn separately. This is rather time consuming and each withdrawing procedure bears the risk of a contamination of the liquid.
  • the time for withdrawing liquid from the cavities of one or more medicament containers may be reduced and facilitated. Further, the risk of contamination of the liquid may be reduced.
  • filling of multiple medicament containers with a liquid diluent e.g. for reconstituting a lyophilized medicament contained in the respective cavity, may be facilitated.
  • withdrawing of a liquid e.g.
  • a liquid reconstituted medicament, from the cavities of the medicament containers connected to interconnected adapters may be conducted simultaneously by a single withdrawing procedure, e.g. from the first side portion of the adapter body or from the another second side portion of the another adapter body, because the flow channels and thus the first branch sections may be fluidically interconnected via fluidically interconnected first pass-through sections.
  • interconnected adapters filling of the cavities of multiple medicament containers by a single filling procedure and withdrawing of a liquid from the cavities of multiple medicament containers by a single withdrawing procedure may be achieved.
  • preparation of a liquid medicament that includes reconstitution of lyophilized medicaments contained in different medicament containers, e.g. vials, and pooling or mixing of the reconstituted medicaments prior to administration may be facilitated by establishing an assembly of interconnected adapters, wherein each medicament container is attached to one of the adapters.
  • the reconstitution of the lyophilized medicament contained in each cavity can be conducted at once.
  • a the reconstituted liquid medicament may be obtained in each cavity.
  • This liquid medicament can be withdrawn and thereby pooled at once using the same adapter assembly as used for the filling procedure and there is no need to detach the medicament containers from the adapters.
  • this assembly may serve for both procedures, filling and withdrawing.
  • the adapter may be fastenable to another adapter as described above via directly or indirectly fastening the second adapter connecting portion of the adapter body of the adapter to the another first adapter connecting portion of the another adapter body of the another adapter to form a fastened configuration.
  • the adapter may be configured such that in the fastened configuration the first pass-through section of the adapter body directly or indirectly merges into the another first pass-through section of the another adapter body. This way, a flow of liquid from the first side portion of the adapter body into the first flow channel of the adapter body can directly merge into the another first flow channel of the another adapter body and vice versa.
  • the adapter may be configured such that in the fastened configuration the first branch section of the adapter body and the another first branch section of the another adapter body remain unaffected. This way a flow of liquid from the first pass-through section to the third side portion via the first branch section and vice versa may remain possible in the fastened configuration and a flow of liquid from the another first pass-through section to the another third side portion via the another first branch section and vice versa may remain possible in the fastened configuration.
  • the cavity of a medicament container connected to the adapter and another cavity of a another medicament container connected to the another adapter may be filled parallel and simultaneously via a single filling procedure.
  • the adapter body may be rigid. By this, interconnecting multiple medicament containers and attaching of a medicament container to the adapter body may be facilitated. Further, by this an assembly of interconnected adapters may be formed that is mechanically stable. By this, a risk of a leakage of liquid or even breakage of the assembly when handling the assembly, e.g. for gently shaking or swinging the assembly or transferring of the assembly, is reduced. Thus, gently shaking or swinging the assembly and thus of all containers at once may be conducted for enhancing or accelerating the solving process of a lyophilized medicament in the introduced liquid diluent.
  • the adapter body may be monolithic.
  • the first pass-through section may extend from the first adapter connecting portion to the second adapter connecting portion. This way, an interconnection between the first pass-through sections of interconnected adapters may be achieved in a simple manner.
  • the first branch section may extend from the container attachment portion. This way, merging of the first branch section into the cavity of a medicament container that is attached to the container attachment portion may be achieved in a simple manner.
  • a material of the adapter body may comprise a dimensionally stable plastic material which is pharmaceutically and/or physiologically inert.
  • the material may be or comprise Cyclic Olefin Polymer (COP) or Cyclic Olefin Copolymer (COCP).
  • the first side portion and the second side portion may be opposing side portions of the adapter body.
  • a linear row of interconnected adapters can be assembled.
  • the respective orientation of the third side portions of the adapters of the row may be identical and thus the respective orientation of the containers attached to the adapters.
  • the row of the interconnected adapters may be oriented such that the third side portions are facing downward in vertical direction.
  • filling of the cavities may be conducted such that the flow of liquid through the first branch section into the cavity is assisted by gravity. Further, a proper filling of the cavities may be assured, especially when a certain filling level of the cavities should be obtained.
  • identical orientations of the containers attached to the adapters may also facilitate checking and monitoring the filling level of each cavity during the filling procedure or after completion of the filling procedure, e.g. by orienting the row in horizontal direction with the medicament containers facing downward.
  • the length of an assembly forming a linear row may be a measure for the total amount or dose of a liquid medicament provided by this assembly, especially when each container contains the same amount or dose of a medicament.
  • the first adapter connecting portion may comprise a first end face with a first surface normal vector pointing in a first direction and the second adapter connecting portion may comprise a second end face with a second surface normal vector pointing in a second direction opposite to the first direction.
  • the adapter may be connected to another adapter along the first direction and second direction.
  • a row assembly of interconnected adapters may be formed.
  • the first pass-through section may be flush with at least one of the first end face and the second end face.
  • the first end face of the adapter body when connected to another adapter, may abut the another second end face of the another adapter.
  • the third side portion may comprise a third end face with a third surface normal vector pointing in a third direction inclined to the first direction. This way, the connecting of the adapter to another adapter may be conducted in a direction inclined to a direction of attaching of the adapter to the medicament container. This way, forming of an assembly of interconnected adapters and medicament containers can be facilitated.
  • the third direction may be perpendicular to the first direction.
  • the attachment portion may be shaped differently to at least one of the first adapter connecting portion and the second adapter connecting portion. By this, an unintentional attachment of the medicament container to at least one of the first adapter connecting portion and the second adapter connecting portion may be prevented.
  • first adapter connecting portion and the second adapter connecting portion may be shaped differently. By this, an unintentional incorrect assembling of adapters may be prevented.
  • the adapter further comprises a first fastener at the first adapter connecting portion and a second fastener at the second adapter connecting portion, wherein the second fastener may be complementary to the first fastener.
  • the adapter may be fastenable to another adapter as described above by the first fastener at the first adapter connecting portion of the adapter directly or indirectly engaging the another second fastener at the another second adapter connecting portion of the another adapter.
  • the first fastener may comprise a first engaging structure and the second fastener may comprise a second engaging structure, the first engaging structure being complementary to the second engaging structure for providing at least one of a positive-locking fit and a frictional fit between the first fastener of the adapter body and the another second fastener of the another adapter body.
  • the first engaging structure may comprise a bayonet structure and the second engaging structure may comprise a bayonet counter-structure for providing a bayonet joint between the first fastener of the adapter body and the another second fastener of the another adapter body. This way, a simple and safe engagement between adapters may be obtained.
  • the container attachment portion may comprise a third fastener for providing at least one of a positive-lock fit and a frictional fit with an adapter attachment portion of the medicament container.
  • the third fastener may be elastically deformable, e.g. to cause a snap coupling and/or frictionally engaged connection with an adapter attachment portion of the medicament container.
  • a secure connection between the medicament container and the adapter may be obtained for medicament containers showing different adapter attachment portion or medicament containers showing rather high manufacturing tolerances in the region of the adapter attachment portion.
  • the adapter body may comprise a degassing channel extending inside the adapter body from the third side portion through the adapter body. Via the degassing channel a gas exchange between the cavity of the container and the environment may be possible. This may be needed during filling of the cavity with a liquid diluent via the adapters to ensure proper filling and/or to avoid overpressure in the cavity.
  • a gas exchange may also be needed during withdrawing liquid from the cavity via the adapters to ensure proper withdrawing and/or to avoid negative pressure in the cavity.
  • the degassing path may also provide a pressure balancing during at least one of a filling and a withdrawing of the liquid.
  • the degassing channel may protrude into the cavity.
  • the elongation of a degassing path into the cavity e.g. the distance of an end of the degassing path from a wall, e.g. a bottom portion of the wall, may limit a filling level of the cavity.
  • the degassing channel extends from the third side portion to a fourth side portion opposite to the third side portion.
  • the adapter may comprise a degassing tube protruding from the third side portion, wherein the degassing tube comprises a degassing tube channel merging into the degassing channel. This way, a degassing path can be elongated beyond the third side portion of the adapter body.
  • the adapter may comprise a degassing needle fixed to the adapter body, wherein the degassing needle comprises the degassing tube.
  • the degassing needle may at least partially pass through the degassing channel into the adapter body.
  • the degassing channel may comprise a filter section, wherein the filter section is provided with a filter material.
  • contamination of a medicament within the cavity of the medicament container may be avoided, e.g. contamination of a liquid medicament during withdrawing of the liquid medicament from the cavity, because the gas that may inflow into the cavity via the degassing channel is filtered by the filter material.
  • the filter material may be at least one of a hydrophobic and/or pyrogen filter material. A hydrophobic filter material may prevent a liquid flow from the cavity through the degassing channel outward, thereby preventing loss of liquid.
  • the adapter may comprise a first actuatable valve arranged in the first pass- through section.
  • the actuatable valve is transferable between a closed state preventing a fluid flow through the first pass-through section to an open state allowing a fluid flow through first pass-through section.
  • this assembly comprises a first end adapter at a first end of the assembly and a second end adapter at a second end of the assembly.
  • the liquid may be introduced into the first pass-through section of one of the first and the second end adapters.
  • the first actuatable valve of this adapter may be in the closed state. If appreciable, the first actuatable valves of the remaining adapters should be in the open state during the filling process. The same applies when a withdrawing process is conducted.
  • the actuatable valve may be transferable from the closed state to the open state by connecting another adapter body of another adapter to the first adapter connecting portion or the second adapter connecting portion of the adapter body of the adapter. This way, a separate transfer operation for transferring the valve to the open state is obsolete.
  • the actuatable valve may be a disposable valve.
  • the initial state of the actuatable valve may be the closed state. By this, unintentional outflow of liquid may be prevented.
  • the actuatable valve may be configured to maintain the open state when transferred from the closed state to the open state.
  • the actuatable valve may not be retransferable from the open state to the closed state once transferred from the closed state to the open state.
  • the adapter body may comprise a second flow channel separate from the first flow channel, the second flow channel comprising a second pass-through section extending inside the adapter body from the first side portion to the second side portion and a second branch section extending inside the adapter body from the third side portion and merging into the second pass-through section.
  • the second flow channel may be used the same way as the first flow channel. Insofar all effects, features and benefits as described above in connection with the first flow channel equally apply to the second flow channel and vice versa.
  • one of the first and the second flow channel can be used for inflow of a liquid and the other one of the first and the second flow channel may be used for withdrawing of the liquid. E.g. by using the first flow channel for inflow and the second flow channel for outflow of a liquid a flushing of the cavity of the attached medicament container may be conducted.
  • the adapter may be fastenable to another adapter as described above via directly or indirectly fastening the second adapter connecting portion of the adapter body to the another first adapter connecting portion of the another adapter body to form a fastened configuration, wherein the adapter is configured such that in the fastened configuration the second pass-through section directly or indirectly merges into the another second pass-through section of the another adapter body.
  • At least one of the first pass-through section, the first branch section, the second pass-through section and the second branch section may comprise an elongated straight geometric structure. By this, manufacturing of the adapter body is facilitated. At least one of the first pass-through section, the first branch section, the second pass-through section and the second branch section may be provided by a bore in the adapter body.
  • the first branch section may extend substantially perpendicular to the first pass-through section.
  • the second branch section may extend substantially perpendicular to the second pass-through section. This way, the adapter may be oriented such that the first pass-through section is horizontal and the first branch section is vertical. The same applies to the second pass-through and the second branch section.
  • the adapter may comprise a first tube protruding from the third side portion, wherein the first tube comprises a first tube channel merging into the first branch section.
  • the first branch section can be elongated beyond the third side portion of the adapter body, e.g. to protrude into the cavity.
  • the liquid that remains in the cavity after withdrawing may be reduced, especially when the medicament container is oriented such that the container faces downward from the adapter. Such kind of orientation may be reasonable for monitoring the filing level during the withdrawing procedure.
  • the adapter may comprise a second tube protruding from the third side portion, wherein the second tube comprises a second tube channel merging into the second branch section.
  • the second branch section can be elongated beyond the third side portion of the adapter body, e.g. to protrude into the cavity.
  • At least one of the first and the second tube may be rigid. This way, insertion of the respective tube into the cavity may be facilitated and alignment of the tube in the cavity may be fixed and reproducible.
  • the adapter may comprise at least one of a first needle fixed to the adapter body, wherein the first needle comprises the first tube, and a second needle fixed to the adapter body, wherein the second needle comprises the second tube.
  • At least one of the first tube and second tube may comprise a needle tip or a spike. This needle tip or spike may be used to pierce or break a closure of the medicament container closing an access opening of the medicament container that opens into the cavity.
  • one of the first adapter connecting portion and the second adapter connecting portion may comprise a receptacle and the other one of the first adapter connecting portion and the second adapter connecting portion may comprise a protrusion complementary to the receptacle.
  • the present disclosure relates to a fastened configuration, the fastened configuration comprising: an adapter as described above, another adapter as described above, wherein the adapter is fastened to another adapter via directly or indirectly fastening the second adapter connecting portion of the adapter body of the adapter to the another first adapter connecting portion of the another adapter body of the another adapter to form the fastened configuration, wherein the adapter is configured such that in the fastened configuration the first pass-through section of the adapter body directly or indirectly merges into the another first pass- through section of the another adapter body.
  • the present disclosure relates to a preparation kit, wherein the preparation kit comprises an adapter as described above and a medicament container.
  • the medicament container comprises a wall enclosing a cavity for a medicament and an adapter attachment portion, wherein the adapter attachment portion is configured for attaching the container attachment portion of the adapter body to the medicament container.
  • the medicament container further comprises an access opening, wherein the access opening opens into the cavity.
  • the medicament container may contain a medicament.
  • the medicament may be at least one of a lyophilized medicament and a medicament powder.
  • the preparation kit may be used to reconstitute a lyophilized medicament contained in the cavity of the container by attaching the container to the adapter body and introducing the liquid diluent into the first pass-through section at the first or second side portion, thereby filling the cavity via the first branch section as described above. Withdrawing of the liquid medicament from the cavity may be performed as described above.
  • the medicament container may comprise a barrel, a bottle, a cartridge, a vial or a carpule.
  • a material of the medicament container may comprise a glass material, a vitreous material or a plastic material a Cyclic Olefin Polymer (COP) or Cyclic Olefin Copolymer (COCP).
  • a material of the medicament container may be pharmaceutically and/or physiologically inert.
  • the medicament container may comprise a barrel comprising the wall.
  • the barrel may comprise a top portion, wherein the top portion comprises the adapter attachment portion.
  • the top portion may comprise a shoulder portion, a head portion and a neck portion, wherein the neck portion is located between the head portion and the shoulder portion, wherein the neck portion may be narrowed in relation to the shoulder portion and the head portion. This way, a recess may be provided by the neck portion. This recess may interact with the container attachment portion of the adapter to provide a positive-locking fit.
  • the head portion may comprise the access opening.
  • the barrel may comprise a bottom portion opposite to the top portion, wherein the at least one of the first branch section, the second branch section, the first tube and the second tube extends into the barrel up to the bottom portion.
  • the medicament container may comprise a closure closing the access opening, wherein the closure is at least one of breakable and pierceable by a first breaking or piercing feature to allow a fluid flow from the first branch section into the cavity.
  • the adapter comprises the first breaking or piercing feature at the third side portion. This way, breaking or piercing of the closure may occur when attaching the medicament container to the adapter body, thereby maintaining integrity of the cavity until attaching the medicament container to the adapter. This way, a separate step to break or pierce the closure to get access to the cavity may not be needed.
  • the first tube may comprise the first breaking or piercing feature, e.g. by comprising a needle tip.
  • the closure is at least one of breakable and pierceable by a second breaking or piercing feature to allow a fluid flow from the cavity into the second branch section, wherein the adapter comprises the second breaking or piercing feature at the third side portion.
  • the preparation kit may further comprise at least one further medicament container and at least one further adapter as described above.
  • the preparation kit may comprise multiple adapters and multiple medicament containers.
  • each medicament container contains one dose or multiple doses of a medicament, e.g. to form an injectable liquid medicament customized for a patient.
  • Preparing of the injectable liquid medicament using the preparation kit may facilitate the preparation procedure as described below.
  • the present disclosure relates to a method of preparing an injectable liquid medicament by use of a preparation kit as described above. All effects, features and benefits as described above in connection with the preparation kit, the adapter and the medicament container equally apply to the method and vice versa.
  • the method comprises:
  • the medicament container containing the medicament containing the medicament
  • the preparation kit may comprise at least one further medicament container and at least one further adapter.
  • the method may comprise:
  • attaching the medicament containers to the adapters may be carried out before fastening the adapters to one another. Further, when fastening the adapters to one another, only one or both or none of the adapters may be attached to a medicament container.
  • the method may comprise withdrawing the injectable liquid medicament from the cavities by at least one of withdrawing the injectable liquid medicament simultaneously from the cavities via the first flow channels being in fluid connection by the merging first pass-through sections, withdrawing the injectable liquid medicament simultaneously from the cavities via the merging second flow channels being in fluid connection by the merging second pass-through sections.
  • drug or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier.
  • An active pharmaceutical ingredient (“API”) in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.
  • a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases.
  • API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
  • the drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device.
  • the drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs.
  • the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days).
  • the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C).
  • the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber.
  • the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body.
  • the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing.
  • the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.
  • the drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders.
  • disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
  • ACS acute coronary syndrome
  • APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
  • APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof.
  • an insulin e.g., human insulin, or a human insulin analogue or derivative
  • GLP-1 glucagon-like peptide
  • DPP4 dipeptidyl peptidase-4
  • analogue and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue.
  • the added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues.
  • Insulin analogues are also referred to as "insulin receptor ligands".
  • the term ..derivative refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids.
  • one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.
  • insulin analogues examples include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-g
  • GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1 , GSK
  • oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
  • DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
  • hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Nafarelin
  • Goserelin Goserelin.
  • polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.
  • antibody refers to an immunoglobulin molecule or an antigenbinding portion thereof.
  • antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen.
  • the antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody.
  • the antibody has effector function and can fix complement.
  • the antibody has reduced or no ability to bind an Fc receptor.
  • the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region.
  • the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
  • TBTI tetravalent bispecific tandem immunoglobulins
  • CODV cross-over binding region orientation
  • fragment refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen.
  • Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments.
  • Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains.
  • SMIP small modular immunopharmaceuticals
  • immunoglobulin single variable domain (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain.
  • immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain.
  • the binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain).
  • VH domain or VHH domain single heavy chain variable domain
  • VL domain single light chain variable domain
  • An immunoglobulin single variable domain can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH.
  • the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb” or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof.
  • Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.
  • VHH domains also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e. , of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448).
  • VHH domain has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”).
  • VHH domains For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).
  • CDR complementarity-determining region
  • framework region refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding.
  • framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.
  • antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • PCSK-9 mAb e.g., Alirocumab
  • anti IL-6 mAb e.g., Sarilumab
  • anti IL-4 mAb e.g., Dupilumab
  • Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
  • the container may be a replaceable container or an integrated non-replaceable container.
  • a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • a single-dose container system may involve a needle-based injection device with a replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • Fig. 1 schematically illustrates a first example of an adapter in a sectional view
  • Fig. 2 illustrates another medicament container substantially identical to the adapter shown in Fig.1 ,
  • Fig. 3 schematically illustrates an example of a medicament container in a sectional view
  • Fig. 4 illustrates multiple adapters substantially identical to the adapter shown in Fig. 1 after connecting to one another in a row assembly
  • Fig. 5 illustrates the row assembly of Fig. 4 with medicament containers attached to the adapters
  • Fig. 6 illustrates the row assembly of Fig. 5 after introducing a liquid diluent into the row assembly
  • Fig. 7 schematically illustrates a second example of an adapter in a sectional view
  • Fig. 8 schematically illustrates a third example of an adapter in a sectional view
  • Fig. 9 schematically illustrates a fourth example of an adapter in a sectional view
  • Fig. 10 illustrates an assembly of interconnected adapters comprising an adapter according to the fourth example and a first terminating adapter and a second terminating adapter.
  • Figs. 1 , 2 and 4-6 illustrate a first example of an adapter 1000, wherein Figs. 4-6 illustrate a set of adapters 1000 according to the first example in a status after interconnecting the adapters 1000 to form a row assembly of adapters 1000.
  • the adapter 1000 may be attached to a medicament container 10 as shown in Fig. 2.
  • the adapter 1000 comprises an adapter body 100.
  • the adapter body 100 comprises an elongated shape, elongated in a longitudinal direction, wherein the adapter body 100 has a distal end and a proximal end, wherein the distal end and the proximal end are opposing in the longitudinal direction of the adapter body 100.
  • the adapter body 100 comprises a first side portion 110 at the proximal end.
  • the first side portion 110 comprises a first adapter connecting portion 111 for connecting the adapter 1000 to another substantially identical adapter 1000’.
  • the adapter body 100 comprises a second side portion 120, located at the distal end, comprising a second adapter connecting portion 121 for connecting the adapter 1000 to another substantially identical adapter 1000’.
  • the first adapter connecting portion 111 comprises a first end face 113 with a first surface normal vector pointing in a first direction D1 and the second adapter connecting portion 121 comprises a second end face 123 with a second surface normal vector pointing in a second direction D2 opposite to the first direction D1.
  • the adapter 1000 may be connected to another adapter 1000’ along the first direction D1 and so on.
  • a row assembly of interconnected adapters 1000 may be assembled as shown in Fig. 4.
  • the adapter body 100 further comprises a first fastener 112 at the first adapter connecting portion 111 and a second fastener 122 at the second adapter connecting portion 121 , the second fastener 122 being complementary to the first fastener 112, e.g. for providing a bayonet fitting.
  • the adapter 1000 is fastenable to another adapter 1000’ substantially identical to the adapter 1000, at least with respect to the adapter connecting portions 111, 121.
  • the another adapter body 100’ of the another adapter 1000’ comprising another first fastener 112’ at the another first adapter connecting portion 11 T of the another adapter body 100’ and another second fastener 122’ at the another second adapter connecting portion 12T of the another adapter body 100’, wherein the adapter 1000 is fastenable to another adapter 1000’ by the first fastener 112 at the first adapter connecting portion 111 of the adapter 1000 directly engaging the another second fastener 122’ at the another second adapter connecting portion 12T of the another adapter 1000’.
  • the adapter body 100 further comprises a third side portion 130 comprising a container attachment portion 131 for attaching the medicament container 10.
  • the container attachment portion 131 comprises an elastically deformable third fastener 132 for providing at a frictional fit with an adapter attachment portion 40 of the respective medicament container 10.
  • the medicament container 10 comprises an adapter attachment portion 40.
  • the adapter attachment portion 40 is provided by the top portion of a wall 20 formed by a barrel.
  • the top portion of the wall 20 comprises a head portion 24 and neck portion 23 and a shoulder portion 22.
  • the neck portion at 23 is located between the head portion 24 and the shoulder portion 22
  • the neck portion 23 is narrowed in relation to the shoulder portion 22 and the head portion 24. This way, a recess is provided by the neck portion 23.
  • the head of portion 24 comprises an access opening 50, wherein the access opening 50 opens into a cavity 30, which is enclosed by the wall 20.
  • a lyophilized medicament 1 is contained in the cavity 30 and the access opening 50 is closed by a pierceable or breakable closure 60.
  • the third side portion 130 comprises a third end face 133 with a third surface normal vector pointing in a third direction D3 perpendicular to the first direction D1 and the second direction D2.
  • the adapter 1000 may thus be connected to the medicament container 10 along the third direction D3. Thereby, attaching of the medicament container 10 to the adapter 1000 and connecting the adapter 1000 to another adapter 1000 are conducted in perpendicular directions, thereby facilitating the attachment procedure and the interconnection procedure.
  • the adapter 1000 is configured such that a liquid can be introduced into the cavity 30 and withdrawn from the cavity 30 when medicament container 10 is attached to the adapter body 100.
  • the adapter body 100 comprises a first flow channel 200.
  • the first of flow channel 200 comprises a first pass-through section 210 extending inside the adapter body 100 from the first side portion 110 to the second side portion 120.
  • the first pass-through section 210 serves for transferring a liquid from the adapter 1000 to another adapter 1000’ connected to the adapter 1000. This concept is described below in further detail.
  • the first of flow channel 210 comprises a first branch section 220.
  • the first branch section 220 extends inside the adapter body 100 from the third side portion 130 and merges into the first pass-through section 210.
  • the first branch section 220 may be located at a predefined nonzero first distance DS1 from the first side portion 110 and at a predefined nonzero second distance DS2 from the second side portion 120.
  • the first branch section 220 serves for allowing a liquid flow between the cavity 30 and the first pass-through section 210, e.g. for filling the cavity 30 with a liquid via the first pass-through section 210 or withdrawing a liquid from the cavity 30 via the first pass- through section 210.
  • the first branch section 220 extends substantially perpendicular to the first pass-through section 210.
  • the first pass-through section 210 is flush with the first end face 113 located at the first adapter connecting portion 111 and is flush with the second end face 123 located at the second adapter connecting portion 121 .
  • the first pass-through section 210 is configured such that, when the adapter 1000 is fastened to another adapter 1000’ via the first adapter connecting portion 111 or the second adapter connecting portion 121 , the first pass-through section 210 merges into the another first pass- through section 210’ of the another first channel 200’ of the another adapter body 100’, thereby providing a continuous channel through the assembly of the adapters 1000, 1000’.
  • Such kind of assembly is exemplary shown in Fig. 4.
  • the assembly shown in Fig. 4 allows simultaneous, in other words parallel, filling the cavities 30 of multiple medicament containers 10 with a liquid in a single filling step or procedure.
  • each of the interconnected adapters 1000, 1000’ is attached to one of the medicament containers 10. This configuration is shown in Fig. 5.
  • the filling procedure is schematically illustrated in Fig. 5.
  • the most left adapter 1000 in Fig. 5 forms a first end adapter of the assembly and the most right adapter 1000 in Fig. 5 forms a second end adapter of the assembly.
  • a liquid diluent 3 may be introduced into the first pass- through section 210 at the first side portion 110 of the first end adapter in order to fill all cavities 30 at once.
  • the flow of the liquid diluent 3 within the assembly is indicated by an arrow A1 in Fig. 5.
  • each adapter body 100 As the first branch section 120 of each adapter body 100 merges into the first pass- through section 210, a partial flow of the liquid diluent 3 within each adapter body 100 will branch off, flow into the first branch section 220 and will escape at the third side portion 130 and thus into the cavity 30 of the container 10 attached to the adapter 1000. The remaining partial flow of the liquid diluent 3 within each adapter body 100 will flow through the first pass-through section 210 of the adapter 1000 and then into the first pass-through section 210 of the proceeding adapter 1000 and so on. By this, the cavities 30 of the medicament containers 10 attached to interconnected adapters 1000 of the assembly will be filled with the liquid diluent 3 simultaneously. This way, a single filling procedure is sufficient in order to fill all cavities 30 at once, thereby reducing time consumption for filling the cavities 30.
  • the lyophilized medicament 1 contained in the respective medicament container 10 will be reconstituted by the liquid diluent 3 introduced into the respective cavity 30 and a reconstituted liquid medicament 2 will be obtained in the respective cavity 30.
  • the adapter body 100 comprises a degassing channel 410 located inside the adapter body 100 and extending from the third side portion 130 through the adapter body 100 to a fourth side portion 140 opposite to the third side portion 130.
  • the degassing channel 410 is provided by a tube extending through the adapter body 100 and protruding beyond the third side portion 130 and thus into the cavity 30 via piercing the closure 60.
  • a maximum filling level of the cavity 30 is set by the distance of the end of the degassing channel 410 from the bottom 21 of the barrel, when the medicament containers 10 are oriented in an upright position.
  • the degassing channel 410 comprises a filter section, wherein the filter section is provided with a filter material 430. In the examples shown in the figures, the degassing channel 410 is completely filled with the filter material 430. Further, the degassing channel 410 is liquid tight but not gas tight closed by a plug 412. The plug comprises a hydrophobic filter material 430.
  • the adapter 1000 comprises a first tube 500 protruding from the third side portion 130, wherein the first tube 500 comprises a first tube channel 520 merging into the first branch section 220.
  • the adapter 1000 comprises a first needle fixed to the adapter body 100, wherein the first needle comprises the first tube 500.
  • the first needle comprises a needle tip 521 for piercing or breaking the closure 60 of the medicament container 10, when the medicament container 10 is attached to the container attachment portion 131.
  • the adapter 1000 comprises a first actuatable valve 700 arranged in the first pass-through section 210 between the merging point of the first branch section 220 and the second end face 123.
  • the actuatable valve 700 is transferable between an initial closed state preventing a fluid flow through the first pass-through section 210 to an open state allowing a fluid flow through first pass-through section 210.
  • the actuatable valve 700 is transferable from the closed state to the open state by connecting another adapter body 100’ of another adapter 1000’ to the second adapter connecting portion 121 of the adapter body 100 of the adapter 1000.
  • the valve 700 of the second end adapter 1000 at the right end of the assembly is in the closed state.
  • Withdrawing of the reconstituted liquid medicament 2 from each cavity 30 of the assembly shown in Fig. 6 can be conducted by withdrawing the reconstituted liquid medicament 2 via the merging first pass-through sections 210. This can be conducted from one of the end adapters of the assembly.
  • the valve 700 of the second end adapter must be transferred to the open state prior to withdrawing the reconstituted liquid medicament 2.
  • the first pass-through section 210 of the first end adapter 1000 at the left end of the assembly may be sealed or closed prior to withdrawing the reconstituted liquid medicament 2.
  • the assembly allows withdrawing the liquid medicament 2 from each cavity 30 simultaneously through the interconnected first flow channels 200 at once a single withdrawing procedure is sufficient for withdrawing the liquid medicament 2 from each cavity 30.
  • the withdrawing may be conducted such that the liquid medicament 2 is directly transferred into a container configured for administrating the liquid medicament 2 to a patient.
  • This container may comprise an infusion bag.
  • the adapter 1000 is substantially identical to the first example, but comprises a multi-channel needle providing both, the degassing channel 430 and the first branch section 220.
  • the adapter 1000 is substantially identical to the first example shown in Fig. 1, but does not comprise a first tube 500.
  • the first branch section 220 is flush with the third end face 133 and will not protrude into the cavity 30 of an attached medicament container 10.
  • the degassing channel 410 is also flush with the third end face 133.
  • the adapter body 100 is substantially identical to the first example shown in Fig. 1, but, in contrast to the first example, the adapter 1000 shown in Fig. 9 does not comprise a valve 700. Furthermore, the adapter body 100 shown in Fig. 9 comprises a second flow channel 300 separate from the first flow channel 200.
  • the second flow channel 300 comprises a second pass-through section 310 extending inside the adapter body 100 parallel to the first pass-through section 210 through the adapter body 100 from the first side portion 110 to the second side portion 120.
  • the second flow channel 300 comprises a second branch section 320 extending inside the adapter body 100 parallel to the first branch section 220 from the third side portion 130 and merging into the second pass-through section 310.
  • the fourth example further comprises a second tube 600 protruding from the third side portion 130, wherein the second tube 600 comprises a second tube channel 620 merging into the second branch section 320.
  • the second tube 600 is provided by a second needle, that is affixed to the adapter body 100.
  • the filling of the cavity 30 may be performed via the first flow channel 200 and the withdrawing may be performed via the second flow channel 300.
  • the first pass-through section 210 and the second pass-through section 310 are open on both, the first side portion 110 and the second side portion 120, terminating adapters 2000, 2000’ may be used to prevent loss of liquid diluent 3 during the filling process and/or to prevent contamination of the medicament via the open ended pass-through sections 210, 310, e.g. when withdrawing the liquid medicament 2 through the second flow channel 300.
  • Fig. 10 illustrates an assembly of interconnected adapters 1000 comprising an adapter 1000 according to the fourth example and a first terminating adapter 2000 and a second terminating adapter 2000’.
  • the first terminating adapter 2000 is substantially identical to the adapter 1000 according to the fourth example apart from the second flow channel 300. Instead of a branched second flow channel 300, the first terminating adapter 2000 comprises a first terminating channel 800 extending inside the adapter body 100 from the third side portion 130 to the second side portion 120 without a branch to the first side portion 110. Thus, the first terminating adapter 2000 has a first side portion 110 giving access to only one channel, namely to the first pass-through channel 210 for filling the cavities 30 of the assembly.
  • the second terminating adapter 2000’ is substantially identical to the adapter 1000 according to the fourth example apart from the first flow channel 200.
  • the second terminating adapter 2000’ comprises a second terminating channel 900 extending inside the adapter body 100 from the first side portion 110 to the third side portion 130 without a branch to the second side portion 120.
  • the second terminating adapter 2000’ has a second side portion 120 giving access to only one channel, namely to the second pass-through channel 220, for withdrawing the liquid medicament 2 from the cavities 30 of the assembly.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente divulgation concerne un adaptateur (1000) pour un récipient de médicament (10), le récipient de médicament (10) comprenant une cavité pour un médicament (1), l'adaptateur (1000) comprenant un corps d'adaptateur (100), le corps d'adaptateur (100) comprenant : - une première partie latérale (110) comprenant une première partie de connexion d'adaptateur (111), - une deuxième partie latérale (120) comprenant une seconde partie de connexion d'adaptateur (121), - une troisième partie latérale (130) comprenant une partie de fixation de récipient (131) , - un premier canal d'écoulement (200), le premier canal d'écoulement (200) comprenant : - une première section de passage (210) s'étendant à l'intérieur du corps d'adaptateur (100) de la première partie latérale (110) à la deuxième partie latérale (120), - une première section de ramification (220) s'étendant à l'intérieur du corps d'adaptateur (100) depuis la troisième partie latérale (130) et fusionnant dans la première section de passage (210).
PCT/US2025/025352 2024-04-19 2025-04-18 Adaptateur pour récipient de médicament, kit de préparation comprenant un adaptateur et un récipient de médicament, et procédé de préparation d'un médicament liquide injectable Pending WO2025222112A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24171232 2024-04-19
EP24171232.2 2024-04-19

Publications (1)

Publication Number Publication Date
WO2025222112A1 true WO2025222112A1 (fr) 2025-10-23

Family

ID=90810155

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/025352 Pending WO2025222112A1 (fr) 2024-04-19 2025-04-18 Adaptateur pour récipient de médicament, kit de préparation comprenant un adaptateur et un récipient de médicament, et procédé de préparation d'un médicament liquide injectable

Country Status (1)

Country Link
WO (1) WO2025222112A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5562616A (en) * 1995-03-01 1996-10-08 Habley Medical Technology Corporation Semi-automatic reconstituting system for binary oncolytic pharmaceuticals
WO2004068820A2 (fr) 2003-01-23 2004-08-12 Unspam, Llc. Procede et appareil destines a un systeme de liste de numeros interdits a ne pas divulguer
WO2005018629A1 (fr) 2003-08-12 2005-03-03 Yarbrough William M Traitement de l'acne simple et procede d'utilisation
WO2006003388A2 (fr) 2004-06-30 2006-01-12 Domantis Limited Compositions et procedes pour le traitement de troubles inflammatoires
WO2006030220A1 (fr) 2004-09-17 2006-03-23 Domantis Limited Compositions monovalentes pour la liaison au cd40l et procedes d'utilisation
US8973622B2 (en) * 2009-07-29 2015-03-10 Icu Medical, Inc. Fluid transfer devices and methods of use
US20150083950A1 (en) * 2012-04-26 2015-03-26 Jms Co., Ltd. Medical connector
US20180161244A1 (en) * 2011-12-22 2018-06-14 Icu Medical, Inc. Fluid transfer devices and methods of use
US20200214937A1 (en) * 2017-02-08 2020-07-09 Hubertus Goller Gesellschaft M.B.H. Mixing device
CN117281730A (zh) * 2023-11-09 2023-12-26 常熟市精亮微医疗器械科技有限公司 一种高效配药器

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5562616A (en) * 1995-03-01 1996-10-08 Habley Medical Technology Corporation Semi-automatic reconstituting system for binary oncolytic pharmaceuticals
WO2004068820A2 (fr) 2003-01-23 2004-08-12 Unspam, Llc. Procede et appareil destines a un systeme de liste de numeros interdits a ne pas divulguer
WO2005018629A1 (fr) 2003-08-12 2005-03-03 Yarbrough William M Traitement de l'acne simple et procede d'utilisation
WO2006003388A2 (fr) 2004-06-30 2006-01-12 Domantis Limited Compositions et procedes pour le traitement de troubles inflammatoires
WO2006030220A1 (fr) 2004-09-17 2006-03-23 Domantis Limited Compositions monovalentes pour la liaison au cd40l et procedes d'utilisation
US8973622B2 (en) * 2009-07-29 2015-03-10 Icu Medical, Inc. Fluid transfer devices and methods of use
US20180161244A1 (en) * 2011-12-22 2018-06-14 Icu Medical, Inc. Fluid transfer devices and methods of use
US20150083950A1 (en) * 2012-04-26 2015-03-26 Jms Co., Ltd. Medical connector
US20200214937A1 (en) * 2017-02-08 2020-07-09 Hubertus Goller Gesellschaft M.B.H. Mixing device
CN117281730A (zh) * 2023-11-09 2023-12-26 常熟市精亮微医疗器械科技有限公司 一种高效配药器

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
"Rote Liste", 2014
HAMERS-CASTERMAN ET AL., NATURE, vol. 363, 1993, pages 446 - 448
HOLT ET AL., TRENDS BIOTECHNOL, vol. 21, 2003, pages 484
MUYLDERMANS, REVIEWS IN MOLECULAR BIOTECHNOLOGY, vol. 74, 2001, pages 277 - 302
WARD ET AL., NATURE, vol. 341, 1989, pages 544

Similar Documents

Publication Publication Date Title
US20210308378A1 (en) Medicament injection device
JP6884147B2 (ja) 注射装置
US12213944B1 (en) Fluid transfer device
US10918798B2 (en) Medicament injection device
US12171719B1 (en) Fluid transfer device
US20190231971A1 (en) Medical Device Packaging
US12226371B1 (en) Fluid transfer device
WO2025222112A1 (fr) Adaptateur pour récipient de médicament, kit de préparation comprenant un adaptateur et un récipient de médicament, et procédé de préparation d'un médicament liquide injectable
US12377023B1 (en) Fluid transfer device
US12280011B1 (en) Multi-vial adapters for reconstituting or diluting lyophilized or concentrated drug products
US12357539B1 (en) Vial adapter and injection kit for withdrawing a liquid medicament from an injection vial
WO2025221983A1 (fr) Contenant de médicament, ensemble de contenants de médicament, kit comprenant un contenant de médicament et un adaptateur, procédés de préparation d'un médicament liquide injectable
US12357538B1 (en) Vial adapter and injection kit for withdrawing a liquid medicament from an injection vial
US12459683B1 (en) Apparatus for filling a medicament preparation vial
WO2025212970A1 (fr) Adaptateurs multi-flacons pour la reconstitution ou la dilution de produits médicamenteux lyophilisés ou concentrés
CN103619379B (zh) Z形流体通道配置
WO2025222101A1 (fr) Kit de reconstitution pour la préparation d'un médicament liquide injectable, système de préparation d'un médicament liquide injectable, méthodes de préparation d'un médicament liquide injectable
WO2025221761A2 (fr) Récipient de médicament et kit de reconstitution d'un médicament lyophilisé
US20250312527A1 (en) Fluid guide system usable for drug handling, e.g. for reconstitution, corresponding medical device, method and computer related items
US20250177636A1 (en) Mechanical connector for injection devices
US20250205430A1 (en) Cartridge assembly and fixing member
US20250195775A1 (en) Cartridge holder and cartridge assembly for an injection device
US20250229027A1 (en) Cartridge assembly and fixing member
US20250186697A1 (en) Workpiece carrier for an injection device
WO2025207599A1 (fr) Récipient de médicament pour médicament lyophilisable

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25723777

Country of ref document: EP

Kind code of ref document: A1