Drug delivery device

The disclosure relates to a drug delivery device including at least a housing, a drug container with a needle, and a cap, wherein the housing has an inner surface forming a cavity configured to retain the drug container, wherein the cap is configured to be releasably connected to the housing, and wherein a back end of the device opposite to a front end of the device directed to the cap includes a gripping lug axially protruding from the back end of the device. The disclosure further relates to an emergency pack including such a drug delivery device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is the national stage entry of International Patent Application No. PCT/EP2018/051230, filed on Jan. 18, 2018, and claims priority to Application No. EP 17152455.6, filed on Jan. 20, 2017, the disclosures of which are incorporated herein by reference.

TECHNICAL FIELD

The disclosure generally relates to a drug delivery device. More particularly, the disclosure relates to an emergency pack for use with a drug delivery device.

BACKGROUND

Conventionally, drug delivery devices include a housing or a shell in a shape of a pen which holds a drug cartridge or a drug container or a pre-filled syringe. Some drugs, e.g. emergency drugs like glucagon, are required in small quantities and have special requirements for a fast handling and assistance, in particular for a fast preparation, e.g. opening of the drug delivery device.

Thus, there is a need for an improvement of handling the drug delivery device containing a specific drug, in particular an emergency drug.

SUMMARY

The present disclosure meets the foregoing need by providing a drug delivery device according to claim1.

Exemplary embodiments are provided in the dependent claims.

In accordance with an aspect of the disclosure, a drug delivery device includes at least a housing, a drug container with a needle and a cap, wherein the housing has an inner surface forming a cavity configured to retain the drug container, wherein the cap being configured to be releasably connected to the housing, in particular at a front end of the device, and wherein a back end of the device opposite to the front end directed to the cap includes a gripping lug axially protruding from the back end of the device.

In an assembled state of the drug delivery device, the housing and the cap are releasably interconnected with each other to encapsulate the drug container.

The device is easy to handle. The gripping lug may include an eyelet or finger loop configured to be gripped by a finger of a user, in particular by index or middle finger. The gripping lug is configured such that a user easily knows how to pull out or open the drug delivery device. Further the gripping lug is configured such that, after a user removed the cap, he still holds the device in the hand. The gripping lug can potentially be used on all kind of drug delivery devices like pre-filled syringes, auto-injectors or pen-injectors.

According to a further embodiment, the gripping lug has an inner surface forming a cavity configured to be assembled onto the back end of the housing. In particular, the cavity includes a form, shape and/or size corresponding to the form, shape and size of the respective back end of the drug delivery device. For instance, the gripping lug is held on to the back end of the housing by at least one of a force-fit connection and form-fit connection.

According to another aspect, the gripping lug includes a retainer configured to be fixed onto the back end of the device, e.g. the housing. In particular, the retainer is formed on the inner surface of the gripping lug. For forming a fixed connection, the retainer includes at least one locking hook radially extending from the inner surface. In a possible embodiment, the retainer includes a plurality of locking hooks all-round protruded and bevelled locking hooks which grab into the outer surface of the housing of the drug delivery device. Hence, the gripping lug may be attached onto different kind of drug delivery devices.

In accordance with a further aspect, the cap has a length which corresponds with the length of the housing. In particular the cap has such a long length that it substantially full covers the drug delivery device, in particular the housing over its entire length including its distal or front end and the needle. Only a proximal end or the back end of the drug delivery device extends from the cap. This proximal end or back end of the drug delivery device is covered by the gripping lug.

In a possible embodiment, the cap and the device, in particular the housing include corresponding crimp interfaces. Alternatively, the cap is releasably coupled to a device, in particular to its housing.

Further, the needle sleeve may include a marker indicating the front end or distal end of the device. In particular, the needle sleeve may include an opening, for instance a triangular opening. The triangular opening points in the direction where the needle will project from the needle sleeve. The needle sleeve may include triangular openings on three sides of the sheath.

Alternatively the needle sleeve may include two or four or more triangular openings.

According to a further aspect, the cap includes a shield grabber connecting the front cap to an outer surface of a needle shield, in particular a so-called rigid needle shield (RNS shield) covering the needle. The needle shield usually made from rubber which seals and covers the needle and the drug container from ambient. Such an integrated shield grabber inside the cap holds the rigid needle shield in an assembled state of the drug delivery device. Thus, removing of the cap will also remove the needle shield from the needle and make the drug delivery device ready to be used. This reduces handling steps for preparation of the drug delivery device.

In particular, the shield grabber is provided with an inner hook element configured and arranged to hook on to an outer surface of the needle shield. In particular, the shield grabber and the needle shield include corresponding crimp features to fixedly hold the shield grabber and the needle shield together, in particular during removing of the cap as well as of the needle shield from the drug delivery device, in particular away from the needle.

The disclosure provides a drug delivery device with a container or a syringe which is prefilled with a drug, in particular an emergency drug, e.g. an allergic drug or a diabetic drug, e.g. hypoglycemia. The drug delivery device is for instance an auto-injector, a pen-injector or a syringe.

In a further embodiment, the drug delivery device includes a piston which slides inside the container to inject the drug. Additionally, the drug delivery device includes actuator means for automatically injecting a patient with said drug.

The disclosure further provides an emergency pack including the above described drug delivery device.

According to a further embodiment, an outer surface of the emergency pack, in particular of the housing or the outer cap, is configured in at least one parameter such that a specific drug contained within the drug delivery device may be quickly and easily identified by a person. In particular, the outer surface of the housing or the outer cap is coloured, e.g. is coloured in orange, red or yellow. Furthermore the outer surface may include a shape or form which allows a fast and easy identification of the specific drug contained within the drug delivery device. For instance, the outer surface may include a pen-shape.

The drug delivery device, as described herein, may be configured to inject a medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector. The device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml. Yet another device can include a large volume device (“LVD”) or patch pump, configured to adhere to a patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a “large” volume of medicament (typically about 2 ml to about 5 ml).

In combination with a specific medicament, the presently described devices may also be customized in order to operate within required specifications. For example, the device may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for auto-injectors, and about 10 minutes to about 60 minutes for an LVD). Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, a drug delivery device will often include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 27 and 29 Gauge.

The delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.

The one or more automated functions of an auto-injector may be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component. Activation may be a one-step or multi-step process. That is, a user may need to activate one or more activation mechanism in order to cause the automated function. For example, a user may depress a needle sleeve against their body in order to cause injection of a medicament. In other devices, a user may be required to depress a button and retract a needle shield in order to cause injection.

In addition, such activation may activate one or more mechanisms. For example, an activation sequence may activate at least two of needle insertion, medicament injection, and needle retraction. Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur. Other devices may operate with sequence independent steps.

Some delivery devices can include one or more functions of a safety syringe, pen-injector, or auto-injector. For example, a delivery device could include a mechanical energy source configured to automatically inject a medicament (as typically found in an auto-injector) and a dose setting mechanism (as typically found in a pen-injector).

DETAILED DESCRIPTION

According to some embodiments of the present disclosure, an exemplary drug delivery device10is shown inFIGS.1A and1B.

Device10, as described above, is configured to inject a medicament into a patient's body.

Device10includes a housing11which typically contains a reservoir containing the medicament to be injected (e.g., a syringe or a container) and the components required to facilitate one or more steps of the delivery process.

Device10can also include a cap assembly12that can be detachably mounted to the housing11, in particular on a distal or front end D of the device10. Typically, a user must remove cap assembly or cap12from housing11before device10can be operated.

As shown, housing11is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. The housing11has a distal region20and a proximal region21.

The term “distal” refers to a location that is relatively closer to a site of injection, and the term “proximal” refers to a location that is relatively further away from the injection site.

Device10can also include a needle sleeve13coupled to the housing11to permit movement of the sleeve13relative to the housing11. For example, the sleeve13can move in a longitudinal direction parallel to longitudinal axis X. Specifically, movement of the sleeve13in a proximal direction can permit a needle17to extend from distal region20of housing11.

Insertion of the needle17can occur via several mechanisms. For example, the needle17may be fixedly located relative to housing11and initially be located within an extended needle sleeve13. Proximal movement of the sleeve13by placing a distal end of sleeve13against a patient's body and moving housing11in a distal direction will uncover the distal end of needle17. Such relative movement allows the distal end of needle17to extend into the patient's body. Such insertion is termed “manual” insertion as the needle17is manually inserted via the patient's manual movement of the housing11relative to the sleeve13.

Another form of insertion is “automated,” whereby the needle17moves relative to housing11. Such insertion can be triggered by movement of sleeve13or by another form of activation, such as, for example, a button22. As shown inFIGS.1A &1B, button22is located at a proximal or back end P of the housing11. However, in other embodiments, button22could be located on a side of housing11. In further embodiments, the button22has been deleted and is replaced for instance by a sleeve trigger mechanism, e.g. provided by pushing the needle sleeve13inside the housing when the drug delivery device is put onto an injection side.

Other manual or automated features can include drug injection or needle retraction, or both. Injection is the process by which a bung or piston23is moved from a proximal location within a container or syringe24to a more distal location within the syringe24in order to force a medicament from the syringe24through needle17.

In some embodiments, a drive spring (not shown) is under compression before device10is activated. A proximal end of the drive spring can be fixed within proximal region21of housing11, and a distal end of the drive spring can be configured to apply a compressive force to a proximal surface of piston23. Following activation, at least part of the energy stored in the drive spring can be applied to the proximal surface of piston23. This compressive force can act on piston23to move it in a distal direction. Such distal movement acts to compress the liquid medicament within the syringe24, forcing it out of needle17.

Following injection, the needle17can be retracted within sleeve13or housing11. Retraction can occur when sleeve13moves distally as a user removes device10from a patient's body. This can occur as needle17remains fixedly located relative to housing11. Once a distal end of the sleeve13has moved past a distal end of the needle17, and the needle17is covered, the sleeve13can be locked. Such locking can include locking any proximal movement of the sleeve13relative to the housing11.

Another form of needle retraction can occur if the needle17is moved relative to the housing11. Such movement can occur if the syringe within the housing11is moved in a proximal direction relative to the housing11. This proximal movement can be achieved by using a retraction spring (not shown), located in the distal region20. A compressed retraction spring, when activated, can supply sufficient force to the syringe24to move it in a proximal direction. Following sufficient retraction, any relative movement between the needle17and the housing11can be locked with a locking mechanism. In addition, button22or other components of device10can be locked as required.

In some embodiments, the housing may include a window11athrough which the syringe24can be monitored.

FIG.1Cshows a schematic view of another well-known drug delivery device10. The drug delivery device10includes a cap12attached to the housing11on a distal end or front end D of the device10. A back end P of the device10, in particular of the housing11has a curved or dome shape.

The cap12has an enlarged distal end. In particular, the cap12is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. At a distal end the diameter of the cap12increases and forms an enlarged front end D of the device10.

FIG.2is a schematic perspective view of an embodiment of a drug delivery device10with an integrated gripping lug30at a proximal region21of the drug delivery device10.

The drug delivery device10is provided with a container24which is prefilled with a drug, in particular an emergency drug, e.g. an allergic drug or a diabetic drug, e.g. hypoglycemia or epinephrine. The drug delivery device10is for instance an auto-injector, a pen-injector or a syringe. The drug delivery device10is finally assembled and a final device which is ready to use.

As shown, the device10includes a housing11which is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. Further, the housing11includes a round cross section. Alternatively, the housing11may include a rectangular, circular or oval cross section.

The drug delivery device10with the gripping lug30and the cap assembly12serves as an emergency medical kit or pack50. The housing11is for instance coloured and labelled according to the emergency medical product. In particular, the housing11includes at least an identification portion, e.g. a window, recess, marking or opening. This allows the user to immediately intuitively assess and locate the drug delivery device10with the specific emergency medical product without searching devices and medications. The disclosure allows using known and usual drug delivery devices10, in particular auto-injectors in various styles, for emergency drugs. The housing11is configured as strong lightweight outer housing or encapsulation device. In particular, the housing11is formed as an outer shell which is closed by the cap assembly12.

The cap assembly12and the gripping lug30are tightly closed in an assembled state. In particular, the assembled emergency pack50is hermetically sealed or tightly closed.

The gripping lug30is configured as one of the easiest mouldable one-part solutions. The gripping lug30serves as a de-capping aid, described below in more detail.

The drug delivery device10, in particular the housing11is closed at its distal region20by the cap assembly12which is formed as a short sleeve. The cap assembly12includes an inner needle shield12.1and a cap12.2.

The cap12.2includes a shield grabber75connecting to an outer surface of the needle shield12.1which covers the needle17. The shield grabber75is provided with inner hook element75.1configured and arranged to hook on to the outer surface of the needle shield12.1.

The cap12.2is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. In the distal direction the diameter of the cap12.2increases and forms an enlarged distal portion52of the pack50. The cap12.2is releasably coupled to the housing11at the distal region20of the device10.

A user must remove the cap12.2from the housing11before the drug delivery device10can be operated and used.

The cap12.2is for example configured to remove the needle shield12.1, e.g. a rigid needle shield (RNS shield), from the drug delivery device10, too. In particular, the cap12.2and the needle shield12.1are fixedly coupled to each other. Due to coupling of the cap12.2with the inner needle shield12.1, the needle shield12.1is simultaneously removable from the drug delivery device10while the cap12.2is removed from the device10. After removing of the cap12.2together with the needle shield12.1, the needle17of the drug delivery device10is further covered by the sleeve13.

The cap12.2and the inner needle shield12.1may include corresponding crimp interfaces70. In particular the crimp interfaces70may be formed as a corresponding crimp parts, e.g. a metal crimp and a nut, in particular as a slitted metal crimp engaging a nut. Crimp interfaces70allow a holding and fixation of the cap12.2together with the inner needle shield12.1by its crimp or clamp forces.

Allowing an intuitive gripping and an easy handling of the device10, in particular in emergency cases, the gripping lug30may include an eyelet31or a finger loop. The eyelet31is formed for example as a gripping ring or finger loop extending from a proximal portion51of the pack50. The gripping lug30is configured so that it could be intuitively gripped by an index finger or a middle finger as it is shown inFIG.3.

The gripping lug30allows an intuitive gripping and, thus, a fast decoupling of the cap12.2from the device10and, thus, an easy and fast opening of the emergency pack50to use the drug delivery device10e.g. in an emergency case.

However, in further embodiments, the gripping lug30may additionally be configured with a gripping material on the outer surface of the lug30and/or as a structured, e.g. profiled outer surface of the lug30.

FIG.4is a schematic perspective view of another embodiment of a drug delivery device10with a gripping lug30and a large outer cap40.

In particular,FIG.4shows an embodiment of an emergency pack50including a drug delivery device10encapsulated by a gripping lug30and an outer cap40. The outer cap40and the gripping lug30are configured to form an encapsulation of the drug delivery device10, in particular in the form of the emergency pack50.

The drug delivery device10is also provided with a container24which is prefilled with a drug, in particular an emergency drug, e.g. an allergic drug or a diabetic drug, e.g. Hypoglycemia, as described above.

The drug delivery device10is for instance an auto-injector, a pen-injector or a syringe. The drug delivery device10is finally assembled and a final device which is ready to use.

As shown, the emergency pack50is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. Further, the emergency pack50includes a round cross section. Alternatively, the emergency pack50may include a rectangular, circular or oval cross section. The emergency pack50has a proximal portion51and a distal portion52.

The emergency pack50serves as an emergency medical kit including the drug delivery device10, with e.g. a prefilled syringe or container24in various styles with an emergency medical product or drug, e.g. epinephrine.

The emergency pack50is for instance coloured and labelled according to the emergency medical product. In particular, the emergency pack50includes at least an identification portion, e.g. a window11a, recess, marking or opening. This allows the user to immediately intuitively assess and locate the drug delivery device10with the specific emergency medical product without searching devices and medications. The disclosure allows using known and usual drug delivery devices10, in particular auto-injectors in various styles, for emergency drugs.

The emergency pack50is configured as strong lightweight outer housing or encapsulation device. In particular, the outer cap40is formed as an outer shell which is closed by the gripping lug30. The outer shell can individually change and is adapted to accommodate the drug delivery device10so that no parts of the drug delivery device10extend through the emergency pack50.

The outer cap40and the gripping lug30are tightly closed in an assembled state. In particular, the assembled emergency pack50hermetically seals or tightly closes the drug delivery device10. Further the emergency pack50is reinforced by e.g. reinforcement elements like inner ribs or reinforcement material like reinforced plastic, e.g. fiber-reinforced plastic. The emergency pack50is impact-resistant and heat resistant. Hence, the drug delivery device10encapsulated by the emergency pack50is protected against impacts, heat and/or fluids.

Each component or part, e.g. the outer cap40and the gripping lug30are conceivable depending on the usability needs. The gripping lug30as well as the outer cap40is configured as one of the easiest mouldable one-part solutions.

Additionally, a seal element60, e.g. an O-ring seal or a flexible seal, may be arranged between the outer cap40and the gripping lug30.

The emergency pack50is designed to contain at least a drug delivery device10, e.g. an auto-injector containing a pre-filled syringe or container24, the outer cap40(e.g. a shell) and the gripping lug30(e.g. as de-capping aid), described below in more detail.

The drug delivery device10is encapsulated by the outer cap40which is formed as a long sleeve. The outer cap40is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. The outer cap40is releasably coupled to the gripping lug30at the back end P of the pack50and/or to the housing11at its proximal region21. A user must remove the outer cap40from the device10, in particular from the gripping lug30and/or the housing11before the drug delivery device10can be operated.

The outer cap40is for example configured to remove the cap assembly12, e.g. a rigid needle shield12.1(RNS shield) in combination with a cap12.2of the drug delivery device10, too. After removing of the outer cap40together with the cap assembly12and thus with the cap12.2and the rigid needle shield12.1from the drug delivery device10, the needle17of the drug delivery device10is further covered by the sleeve13.

De-capping of the emergency pack50can occur via several mechanisms. For example, the outer cap40may be removed alone from the drug delivery device10and the cap assembly12may be subsequently removed from the drug delivery device10. According to another example, due to coupling of the outer cap40with the inner cap assembly12, the cap assembly12is simultaneously removable from the drug delivery device10while the outer cap40is removed from the device10.

The outer cap40and the inner cap assembly12may include corresponding crimp interfaces70. In particular the crimp interfaces70may be formed as corresponding crimp parts, e.g. a metal crimp and a nut, in particular as a slitted metal crimp engaging a nut. Crimp interfaces70allow a holding and fixation of the outer cap40together with the inner cap assembly12by its crimp or clamp forces.

In particular, the crimp interfaces70include pins or hooks71which snap-in into pockets72(or windows, recesses, opening) of the cap assembly12of the drug delivery device10. The hooks71or pins eliminate free play tolerances between plastic components of the drug delivery device10and the emergency pack50.

Allowing an intuitive gripping and an easy handling of the device10, in particular in emergency cases, the gripping lug30may include the eyelet31or a finger loop. The eyelet31is formed for example as a gripping ring or finger loop extending from the proximal portion51of the pack50. However, in further embodiments, the gripping lug30may additionally be configured as a gripping material on the outer surface of the lug30and/or as a structured, e.g. profiled outer surface of the lug30.

The gripping lug30allows an easy and fast decoupling of the long outer cap40from the device10at the proximal portion51of the pack50, in particular in the region of seal element60. While removing the long outer cap40from the drug delivery device10, in particular from the gripping lug30the seal element60breaks, as it is shown inFIG.5.

FIGS.6A,6Bshow schematic views of an alternative embodiment for a long outer cap40for removing an inner cap assembly12from the drug delivery device10. The long outer cap40is coupled to the inner cap assembly12of the drug delivery device10.

The outer cap40may include an end stop80at its inner distal end. The end stop80serves as an interface to the distal region20or front end D of the drug delivery device10, in particular to the distal end of the cap assembly12during handling and assembly.

FIG.6Ashows the emergency pack50in an assembled state with the cap assembly12attached to the drug delivery device10.FIG.6Bshows the emergency pack50in a state in which the outer cap40together with the cap assembly12is partially removed from the drug delivery device10. The needle17is still covered by the needle sleeve13.

The crimp interface70is configured to fixedly hold the outer cap40onto the cap assembly12. In particular, the crimp interface70includes one or more locking arms71axially extending from the distal end of the outer cap40inwards.

For instance, the arms71include fastener72, e.g. locking hook or snap interface which locks onto the enlarged distal portion of the cap assembly12or into a pocket or opening (not shown) of the cap assembly12. The fasteners72are configured to be locked in a friction-fit or force-fit manner.

FIG.7shows is an enlarged sectional view of the distal portion52of the pack50with an alternative integrated crimp interface70of the outer cap40with the inner cap assembly12of the drug delivery device10. The crimp interface70of the outer cap40and thus the outer cap40are formed as one piece with the inner cap assembly12. For instance, the outer cap40and the inner cap assembly12are formed as one-piece part, e.g. as an injection-moulded part.

FIG.8is a sectional view of an embodiment of a drug delivery device10with the proximal gripping lug30. The gripping lug30has an inner surface32forming a cavity33configured to be assembled onto the back end P of the housing11of the device10.

The cavity33includes a form, shape and/or size corresponding to the form, shape and size of the respective back end P of the drug delivery device10. For instance, the back end P of the device10has a convex form and the cavity33of the lug30has a concave form.

Further, the gripping lug30is hold on to the back end P of the housing11by at least one of a force-fit connection and form-fit connection. For instance, the gripping lug30includes an inner retainer34configured to be fixed onto the back end P. The retainer34is formed on the inner surface32of the gripping lug30. For forming a fixed connection, the retainer34includes locking hooks35radially extending from the inner surface32. The locking hooks35are bevelled and grab into the outer surface of the housing11.

FIGS.9A to9Dare different perspective views showing a removing sequence of a long outer cap40from a drug delivery device10.

FIG.9Ashows a delivery state of pack50in which the drug delivery device10is encapsulated by the outer cap40and the gripping lug30.

FIG.9Bshows a pre-use state in which a user takes the pack50and optionally checks condition of drug and label and grips with his index finger of one hand into the eyelet31of the gripping lug30and with his outer hand the outer cap40. Arrow F1 shows how the user can pull the outer cap40from the device10and the gripping lug30.

FIG.9Cshows the de-capped pack50with the inner drug delivery device10which is now ready to use.

FIG.9Dshows the device10in a used state or delivery state in which it is pressed against an injection site90.

FIGS.10A,10Bare different perspective views of an alternative embodiment of a drug delivery device10with a different cap or needle sleeve design. In particular, the inner needle sleeve13of the device10includes a marker91indicating the front end D or distal end of the device10. The needle sleeve13includes an opening91.1, for instance a triangular opening. The triangular opening91.1points in the direction where the needle17projects from the needle sleeve13.

Additionally, the outer cap40may also include such a marker. Other forms, shapes or sizes of markers can be provided for indicating the front end D of the device10as well as of the pack50.

The terms “drug” or “medicament” are used herein to describe one or more pharmaceutically active compounds. As described below, a drug or medicament can include at least one small or large molecule, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Exemplary pharmaceutically active compounds may include small molecules; 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 of these drugs are also contemplated.

The term “drug delivery device” shall encompass any type of device or system configured to dispense a drug into a human or animal body. Without limitation, a drug delivery device may be an injection device (e.g., syringe, pen injector, auto injector, large-volume device, pump, perfusion system, or other device configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), skin patch (e.g., osmotic, chemical, micro-needle), inhaler (e.g., nasal or pulmonary), implantable (e.g., coated stent, capsule), or feeding systems for the gastro-intestinal tract. The presently described drugs may be particularly useful with injection devices that include a needle, e.g., a small gauge needle.

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 vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more pharmaceutically active compounds. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g.,1to at least 30 days). In some instances, 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.). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components of the drug or medicament prior to and/or during dispensing into the human or animal body. For example, 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. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

The drug delivery devices and drugs described herein can be used for the treatment and/or prophylaxis of many different types of disorders. Exemplary 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 exemplary disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.

Exemplary drugs for the treatment and/or prophylaxis of diabetes mellitus or complications associated with 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. As used herein, the term “derivative” refers to any substance which is sufficiently structurally similar to the original substance so as to have substantially similar functionality or activity (e.g., therapeutic effectiveness).

An exemplary oligonucleotide is, for example: mipomersen/Kynamro, a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia.

The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab′)2fragments, 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. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, 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 compounds described herein may be used in pharmaceutical formulations including (a) the compound(s) or pharmaceutically acceptable salts thereof, and (b) a pharmaceutically acceptable carrier. The compounds may also be used in pharmaceutical formulations that include one or more other active pharmaceutical ingredients or in pharmaceutical formulations in which the present compound or a pharmaceutically acceptable salt thereof is the only active ingredient. Accordingly, the pharmaceutical formulations of the present disclosure encompass any formulation made by admixing a compound described herein and a pharmaceutically acceptable carrier.

Pharmaceutically acceptable salts of any drug described herein are also contemplated for use in drug delivery devices. Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl or HBr salts. Basic salts are e.g. salts having a cation selected from an alkali or alkaline earth metal, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are known to those of skill in the arts.

Pharmaceutically acceptable solvates are for example hydrates or alkanolates such as methanolates or ethanolates.

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