WO2019141573A1

WO2019141573A1 - Clipless drug delivery device

Info

Publication number: WO2019141573A1
Application number: PCT/EP2019/050501
Authority: WO
Inventors: Paul Jansen; Konrad BETZLER
Original assignee: Haselmeier Ag
Priority date: 2018-01-17
Filing date: 2019-01-10
Publication date: 2019-07-25

Abstract

A pen shaped injection device comprising a medicament container containing a medicament, a dose delivery mechanism connected to the medicament container and configured to allow a user of the injection device to deliver a set dose of medicament from the medicament container to an injection site and a removable cap that releasably connects to the medicament container or the dose delivery mechanism, wherein the injection device does not have any structural component that would allow the injection device to be attached or connected to an article of clothing.

Description

SPECIFICATION

TITLE

CLIPLESS DRUG DELIVERY DEVICE

TECHNICAL FIELD

In general, the present invention relates to systems and methods for preventing degradation of drugs prior to delivery to a patient. In particular, embodiments of the present invention relate to designs of delivery device systems for injections of a medicament that are susceptible to drug degradation. Our device designs can improve the effectiveness of the injected drugs.

BACKGROUND Drug injection by syringe, pen injectors and other devices are used regularly for subcutaneous injections of therapeutic fluids, drugs, proteins, and other compounds. Typical drug delivery devices, e.g. pen-type injectors comprise numerous components, such as a housing, a cartridge holder and a dose setting and drive mechanism, wherein the drive mechanism is adapted to apply thrust on a slidable piston inside a cartridge containing the medicinal product or drug to be dispensed in doses by the device. At least some of the components of such drug delivery devices, in particular a removable cap, a housing and/or a cartridge holder are manufactured as injection molded plastic parts that are generally demanded to fulfil requirements regarding mechanical stability and rigidity and yet generally have to comply with low cost demands regarding the manufacture of such devices. Such delivery systems and methods are used routinely for insulin delivery. In conventional insulin injection pens, the pen is typically configured to include a disposable insulin reservoir and a disposable needle through which insulin is injected into the tissue. Although it is recommended that the needle is for single use, users are known to use the needle multiple times. This is likely because the insulin reservoir can be used for two to three days.

Those of skill in injection device design know that most drug formulations are sensitive to elevated temperatures. Prolonged exposure to a drug at elevated temperatures can reduce its effectiveness and bioavailability. Conventional designs of pen-type injectors typically have a removable cap that covers the portion of the device holding a cartridge containing the drug. These caps all contain some form of a clip mechanism design to allow the injection device users to place the drug delivery device in a shirt pocket on in an inner jacket pocket. This in turn results in the injection device being placed close to the body for prolonged periods of time, which in turn causes the drug in the device to be subjected to elevated temperature. This prolonged exposure to temperatures above ambient room temperature can have an adverse impact on the drug formulation. Therefore, it is desirable to provide an injection device design that discourages, inhibits, and makes it difficult to for a user of the injection device to store, carry or hold the injection device in a location where the temperature of the drug contained within the injection device can exceed ambient temperature conditions. SUMMARY

The drug delivery device according to the present invention is adapted for dispensing of a medicinal product in a well-defined way, in particular of a liquid drug, like heparin or insulin. Typically such devices are pen-shaped. The device is particularly adapted to dispense predefined amounts of the medicinal product by setting and subsequently dispensing of a predefined dose of the medicinal product. The drug delivery device comprises at least one housing component, which is particularly adapted to house a drive mechanism and respective drive mechanism components, wherein at least one of the drive mechanism components is operably engageable with a piston of a cartridge containing the medicinal product to be dispensed. The injection device can be either disposable or reusable, manually operable or triggered to automatically deliver the set dose, i.e., a so called "auto-injector."

The drug delivery device further comprises a cartridge holder component, which is adapted to receive and to hold the product-containing cartridge. The cartridge, typically of substantially cylindrical shape, comprises a slidable piston being displaceably arranged therein. Under the impact of distally applied thrust, the piston moves in proximal direction, thereby expelling a predefined dose of the liquid medicinal product from the cartridge. In the case of a reusable injection device the cartridge holder is removably connected to the dose setting and drive mechanism such that a used (or empty) cartridge of medicament can be removed and replaced with a new, full cartridge of medicament. The dose setting and dose delivery mechanism is then mechanically reset and the new cartridge inserted into the cartridge holder. The injection device can then be reused to set and deliver multiple doses of medicament until the replaced cartridge is empty. The cartridge replacement procedure is then repeated. In the case of an auto-injector, typically the entire contents of the medicament container is automatically all delivered in one single injection.

A proximal outlet of the cartridge can be coupled with a needle, a cannula, an infusion tube or with similar delivery devices in a fluid-transferring way. The cartridge itself can be designed as replaceable or disposable ampoule, carpoule, syringe or as a similar, medicinal product-containing container.

For the purpose of applying thrust to the cartridge's piston, the drive mechanism may comprise a piston rod, a lead screw or a drive sleeve adapted to abut the proximal end face of the piston either directly or by means of interposition of a pressure piece.

In order to discourage a user from storing or placing the injection device in a pocket or other article of clothing, the cap is purposefully designed and manufactured without any component that could be used as a clip or fastener by a user to hold the injection device close or near the body. Likewise, the entire outer body of the injection device is purposefully designed and manufacture without any form of attachment components, including clips, hooks, fasteners, bands, or the like. In one embodiment of the present invention, a clipless cap is used to cover the cartridge holder or the cartridge itself. However, a clipless outer body surface of the injection device also falls within the scope of the invention.

Furthermore, and according to another preferred embodiment, the drug delivery device comprises a cartridge filled with the medicinal product. As mentioned, the device may be of reusable and/or disposable type. Preferably, the device is to be commercially distributed with a filled cartridge readily disposed therein and is of disposable type. In this way, after consumption of the medicinal product, the entire device can be discarded and/or supplied to a recycling process. Furthermore, in the process of discarding of a used drug delivery device, biodegradable and non-biodegradable components of the device can be separated and can thus be separately treated as bio-compatible litter and/or as reusable recycling material.

The term "medicament" or "medicinal product", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to

1500 Da and/or is a peptide, a protein, a polysaccharide, a vaccine, a DNA, a RNA, an antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound. The pharmaceutical compound can be useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary

thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. The pharmaceutically active compound can comprise at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-l) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4. Furthermore, the pharmaceutically active compound can also comprise a hormone, for example, hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin. In some embodiments, the present invention relates to systems, devices and methods for injecting drug(s), substances and/or chemicals into a patient where the device is designed to discourage or inhibit the storage of the injection device where the drug contained within the device can be subjected to an elevated temperature for a period time whereby the drug may become degraded or rendered less potent. The device, according to some embodiments of the present invention, provides for a device for improving performance of drug delivery by injections, where a removable cap is designed and manufactured without the conventional pocket clip or any other mechanical fastener that could be used to attach the injection device to an article of clothing. Stated differently, a preferred embodiment of the injection device of this disclosure has a clipless cap and/or a clipless outer body housing, where the cap is a distinct and removable component that releasably attaches to the outer body housing. Such a cap design and/or outer body housing design allows the drug to maintained at desired or recommended low temperature such that the delivery of the drug through injection can be achieve optimum drug pharmacokinetic ("PK") and/or

pharmacodynamic ("PD") profile.

In one example embodiment, a pen shaped injection device contains a medicament container containing a medicament, a dose delivery mechanism connected to the medicament container, where the container is configured to allow a user of the injection device to deliver a set dose of medicament from the medicament container to an injection site, and a removable cap that releasably connects to the medicament container or the dose delivery mechanism. The injection device must not and does not have any structural component associated with the device that would allow the injection device to be attached or connected to an article of clothing. For example, the injection device could have a removable cap that does not contain any structural component that would allow the injection device to be attached or connected to an article of clothing.

The injection device of can contain a cartridge containing multiple doses of medicament and the dose delivery mechanism is configured to allow the user to set a dose of the medicament for injection. In some embodiments, the cartridge is located in medicament container, i.e., a cartridge holder, that is permanently connected to the dose delivery mechanism such that the medicament container cannot be removed without damaging the dose delivery mechanism or the medicament container. In other words, there is no mechanism to allow a user to easily disassemble the cartridge holder from the dose delivery mechanism without physically breaking the permanent connection or stressing the parts of injection device.

The injection device can be designed such that the dose delivery mechanism is configured to deliver only a single predetermined dose of medicament to an injection site and cannot be reused afterwards. In some cases it is beneficial if the injection device is an auto-injector, where the user must activate the injection device before triggering a tensioned basing member to release a force to automatically deliver a dose of the medicament. The absence of any structural component associated with the device that would allow the injection device to be attached or connected to an article of clothing can present issue where the injection device, the cap or the dose delivery mechanism could freely roll on a flat or angled surface. To prevent unwanted rolling, the outer surface of the cap can include a radial protrusion that prevents the device from rolling on a flat surface. Alternatively, or in addition, a portion of the cap or a portion of an outer surface of the dose delivery mechanism can be non-circular in shape and configured to prevent the device from rolling on a flat surface.

Preventing the drug from exposure to elevated temperatures will accommodate the drug's temperature sensitivity so as to avoid protein denaturization. In some

embodiments, the delivered drug is insulin. Insulin is a temperature-sensitive protein. Thus, to avoid damage to insulin during the residence in the injection device excessive heat should be limited so as to ensure efficacy of the delivered drug. Eliminating any means to attach the injection device to the user's clothing will assist in controlling the temperature of the drug within the injection device so as to not damage the drug. For instance, heating some types of insulin above 37°C might damage the insulin.

In some embodiments, the present invention relates to a method for administering a temperature sensitive drug into a tissue on the body of a patient at a drug injection site using an injection device having a cap that is devoid of any apparatus that could be used as an attachment mechanism to a pocket or other article of clothing. Likewise, embodiments of the instant disclosure are directed to an injection device where all outside surfaces of the device are devoid of any means that would allow the injection device to attach to an article of clothing. The method includes providing a user an injection device having a clipless removable cap to discourage or prohibit storing the injection device in a location where the drug is exposed to a temperature higher than a recommended temperature, where maintaining and controlling the temperature below a predetermined maximum temperature will prevent heating the drug above a

predetermined limiting temperature, above which degradation of the drug may occur.

In some embodiments, the injection device is a pen-type injector having a removable cap that does not contain a pocket clip. In other embodiments, the entire outer surface of the injection device is devoid of any mechanism that could be used to attach the injection device to an article of clothing. This would also include the outer surfaces exposed when the cap is not attached to the device, for example, the outer surface of the cartridge holder.

It will be apparent to those skilled in the art, that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention.

BRIEF DESCRIPTION OF THE FIGURES For a better understanding of the present invention, including the various objects and advantages thereof, reference is made to the following description, which is to be taken in conjunction with the accompanying illustrative drawings.

FIG. 1 illustrates an example of a conventional and know pen-type injection device having a removable cap containing a pocket clip; and

FIG. 2 illustrates an exemplary pen-type injection device for delivering drugs to a patient having a clipless cap, according to some embodiments of the present invention.

DETAIFED DESCRIPTION

Fig. 1 illustrates a known conventional pen-type injection device 20 showing a dose setting mechanism 3 connected to a removable cap 21 covering a cartridge holder that can contain a cartridge of medicament. The cap 21 includes a pocket clip 22 to allow a user to attach or hold the injection device 20 inside a pocket or other article of clothing.

In contrast to the known pen-type injection device 20 is one embodiment of the present disclosure illustrated in Figs. 2 and 3 where a pen-type injection device 10 has a dose delivery and setting mechanism 3 and a cap 11 that is removably connected to the dose setting and drive mechanism 3. To discourage and inhibit a user from placing, holding or storing the injection device within or on an article of clothing, cap 11 is purposefully designed and manufactured to not include a clip or any other structural component that would facilitate the attachment to an article of clothing. In this way, the user will be reticent about keeping the injection device 10 attached to clothing where the medicament is subjected to the user's body temperature which will elevated the temperature of the medicament contained in cartridge 9 that is positioned permanently or removably inside cartridge holder 2. Cartridge holder 2 contains an attachment component 7 at the proximal end, shown, for example as threads, that allow a needle assembly 4 to be removable attached. Needle assembly 4 includes needle hub 5 and attached double-ended needle 6 that is configured to pierce a septum in the proximal end of cartridge 9 to establish fluid communication with the medicament in cartridge 9.

Cap 11 can also contain a nib, projection or protuberance 30 that projects radially outward on the outside surface of the cap that will prevent the injection device 10 from rolling on a flat surface, provided that the nib, projection or protuberance does not allow the cap and the attached dose setting mechanism 3 to be connected, attached or secured to an article of clothing. The nib, projection or protuberance 30 will protect the injection device from rolling off a flat surface, such as a table top, and falling, which could damage the injection device. Likewise, a nib, projection or protuberance 31 could optionally be included on an outside surface of the dose delivery mechanism configured to prevent the device from rolling on a flat surface.

The cap or the dose delivery mechanism can also have a portion thereof that is non- circular in shape such that it prevents the cap and/or the injection device from rolling on a flat surface. Fig. 2 shows one possible embodiment where the proximal end of the cap has a portion 32 that is non-circular.

It is to be understood that the embodiments described above and shown in the drawings are to be regarded only as non- limiting examples of the possible designs of the injection cap and such designs may be modified in many ways within the scope of the patent claims.

Claims

1. A pen shaped injection device comprising:

a medicament container containing a medicament;

a dose delivery mechanism connected to the medicament container and configured to allow a user of the injection device to deliver a set dose of medicament from the medicament container to an injection site; and a removable cap that releasably connects to the medicament container or the dose delivery mechanism,

wherein the injection device does not have any structural component that would allow the injection device to be attached or connected to an article of clothing.

2. The injection device of claim 1 where the removable cap does not contain any structural component that would allow the injection device to be attached or connected to an article of clothing.

3. The injection device of claim 1 where the medicament container is a cartridge containing multiple doses of medicament and the dose delivery mechanism is configured to allow the user to set a dose of the medicament for injection.

4. The injection device of claim 3 where the medicament container is permanently connected to the dose delivery mechanism such that the medicament container cannot be removed without damaging the dose delivery mechanism or the medicament container.

5. The injection device of claim 4 where the dose delivery mechanism is

configured to deliver only a single predetermined dose of medicament to an injection site and cannot be reused.

6. The injection device of claim 5 where injection device is an auto-injector, where the user must activate the injection device before triggering a tensioned basing member to release a force to automatically deliver a dose of the medicament.

7. The injection device of claim 1 where an outer surface of the cap comprises a radial protrusion to prevent the device from rolling on a flat surface.

8. The injection device of claim 1 where a portion of the cap or a portion of an outer surface of the dose delivery mechanism is non-circular in shape and configured to prevent the device from rolling on a flat surface.