WO2012010564A1

WO2012010564A1 - Medicament cartridges with non-standard dimensions

Info

Publication number: WO2012010564A1
Application number: PCT/EP2011/062278
Authority: WO
Inventors: Christopher Nigel Langley; Joseph Butler; Richard James Vincent Avery
Original assignee: Sanofi-Aventis Deutschland Gmbh
Priority date: 2010-07-19
Filing date: 2011-07-18
Publication date: 2012-01-26

Abstract

A cartridge (120) containing a medicament (125) for use in a drug delivery device (100) has non-standard dimensions to provide a coding system to reduce the risk of a user dispensing the wrong medicament from the drug delivery device (100). The cartridge (120) contains an ampoule (122) having a distal neck portion (131 ) having an outside distal diameter, which includes a ferrule (124) configured to partially enclose a septum (127) that is less than 7.6 mm.

Description

MEDICAMENT CARTRIDGES WITH NON-STANDARD DIMENSIONS Field of the Disclosure

The present disclosure is generally directed to drug delivery devices and reservoirs (i.e. cartridges), particularly reservoirs containing a medicament. More particularly, the present disclosure is generally directed to cartridges having non-standard dimensions that can provide a coding system for drug delivery device components to prevent unwanted cross use. As just one example, such medicament cartridges may comprise an ampoule having a distal neck portion having an outside neck diameter of less than 7.6 mm, including an attached ferrule. Exemplary medical delivery devices include, but are not limited to, syringes, pen-type injection syringes, pumps, inhalers, or other similar injection or infusing devices that require at least one reservoir containing at least one medicament.

Background Medicament reservoirs such as ampoules, cartridges, or vials are generally known. Such reservoirs are especially used for medicaments that may be self administered by a patient. For example, with respect to insulin, a patient suffering from diabetes may require a certain amount of insulin to either be injected via a pen-type injection syringe or infused via a pump. With respect to certain known reusable pen-type drug delivery devices, a patient may load a cartridge containing the insulin into a proximal end of a cartridge holder. After the cartridge has been correctly loaded, the user may then be called upon to select a dose of medicament. Multiple doses may be dosed from the cartridge. Where the drug delivery device comprises a reusable device, once the cartridge is empty, the cartridge holder may be disconnected from the drug delivery device and the empty cartridge may be removed and replaced with a new cartridge. Most suppliers of such cartridges recommend that the user may dispose of the empty cartridges properly. Where the drug delivery device comprises a disposable device, once the cartridge is empty, the user is recommended to dispose of the entire device.

Such known self administration systems requiring the removal and reloading of empty cartridges have certain limitations. For example, in certain generally known systems, a user may simply load a new cartridge into the delivery system without the drug delivery device or without the cartridge having a mechanism of preventing cross use of an incorrect cartridge. That is, the drug delivery device does not have a mechanism for determining whether the medicament contained in the cartridge is indeed the correct type of medicament to be administered by the patient. Alternatively, certain known drug delivery devices do not present a mechanism for determining whether the correct type of medicament within the cartridge should be used with that particular drug delivery system. This potential problem could be exacerbated given that certain elderly patients, such as those suffering from diabetes, may have limited manual dexterity. Identifying an incorrect medicament is quite important, since the administration of a potentially incorrect dose of a medicament such as a-short acting insulin in lieu of a long-insulin could result in injury or even death.

Some drug delivery devices or systems may use a color coding scheme to assist a user or care giver in selecting the correct cartridge to be used with a drug delivery device. However, such color coding schemes pose challenges to certain users, especially those users suffering from poor eyesight or color blindness: a situation that can be quite prevalent in patients suffering from diabetes. Another concern that may arise with such disposable cartridges is that these cartridges are manufactured in essentially standard sizes and manufactured to comply with certain recognized local and international standards, for example ISO Standard 1 1608- 3 2001 . Consequently, such cartridges are typically supplied in standard sized cartridges (e.g. 3 ml cartridges). Therefore, there may be a variety of cartridges supplied by a number of different suppliers and containing a different medicament but they may fit a single drug delivery device. As just one example, a first cartridge containing a first medicament from a first supplier may fit a medical delivery device provided by a second supplier. As such, a user might be able to load and then dispense an incorrect medicament (such as a rapid or basal type of insulin) into a drug delivery device without being aware that the medical delivery device was perhaps neither designed nor intended to be used with such a cartridge.

As such, there is a growing desire from users, health care providers, care givers, regulatory entities, and medical device suppliers to reduce the potential risk of a user loading an incorrect drug type into a drug delivery device. There is also, therefore, a desire to reduce the risk of dispensing an incorrect medicament (or the wrong concentration of the medicament) from such a drug delivery device.

There is, therefore, a general need to physically dedicate or mechanically code a cartridge to its drug type and design an injection device that accepts or works with the dedication or coded features provided on or with the cartridge so as to prevent unwanted cartridge cross use. Similarly, there is also a general need for a dedicated cartridge that allows the medical delivery device to be used with an authorized cartridge containing a specific medicament while also preventing undesired cartridge cross use. There is also a general need to provide a dedicated cartridge that is difficult to tamper with so that the cartridge may not be compromised in that the cartridge can be used with an unauthorized drug or drug delivery device. Because such cartridges may be difficult to tamper with, they may also reduce the risk of counterfeiting: i.e. making it more difficult for counterfeiters to provide unregulated counterfeit medicament carrying products.

These and other advantages and features will become evident from the following more detailed description of the invention.

Problem to be solved The problem to be solved by the present invention is to provide a medicament cartridge, a system of cartridges and a drug delivery system where the safety of the user is increased. SUMMARY

According to an exemplary arrangement, a cartridge is provided having "non-standard" dimensions (i.e. non-ISO standard), where the cartridge is intended for use with a matched reservoir or cartridge holder of a drug delivery device. A system of such non- standard cartridges may allow for a coding system that distinguishes cartridges containing the same medicament at different concentration levels and/or cartridges containing different medicaments. A matching cartridge holder may accept only the non-standard cartridge. A standard cartridge may be comprised of an ampoule. The ampoule may comprise a proximal end. The ampoule may comprise distal end. The distal end may have a neck portion. The neck portion may define an opening where a medicament, such as insulin, can be dispensed through a needle cannula. The distal neck portion may contain a pierceable septum. The septum may be fixed to the ampoule by a ferrule that is typically crimp fitted to the neck portion. The cartridge may also contain a bung, stopper, or piston that is slidably positioned inside the ampoule, in particular the proximal end of the ampoule. The bung may form a seal to contain the medicament within the ampoule. Typically, the ampoule is formed from glass, but the present disclosure may work with plastics or any like materials. A "standard cartridge" is known to those skilled in the art of drug delivery devices to be one that comports with the dimensions set by International Standard ISO 1 1608-3:2000A. For a cartridge nominally holding 3 ml, the ISO standard specifies the following standard dimensions:

L (total length) 63.90 + 0.30

NL (length of distal neck) 6.30 max. D (distal diameter) 8.0 max.

The 8 mm maximum dimension shown above for the distal diameter of the cartridge is measured as a cross-section of the distal end of the cartridge and includes the thickness of the ferrule. Thus, this dimension D is a function of the wall thickness of the ampoule, the thickness of ferrule, and the size of the distal opening of the ampoule. Manufacturing tolerances of + 0.20 mm are industry normal. In order to use such a standard cartridge to administer medicament by injection, the drug delivery device typically has a cartridge holder with an internal diameter of 8.2 mm or greater to ensure the standard cartridge will fit into the cartridge holder portion of the injection device.

One aspect relates to a medicament cartridge comprising an ampoule. The ampoule may have a proximal portion. The ampoule may have a total length L. The ampoule may have a distal neck portion. The distal neck portion may have a length NL. The distal neck portion may have a body length (L - NL). A ferrule, partially enclosing a septum, may be permanently or releasably fixed to the distal neck portion. A

medicament may be sealed inside the ampoule, in particular by a piston or stopper. The piston may be is slidably positioned within the proximal portion of the ampoule. An outside distal diameter D, measured in same manner as defined by the ISO standards (i.e. the cross-section of the distal end of the cartridge including the ferrule) may be less than 7.6 mm.

Although the total length L of such a cartridge could be equal to the ISO standard set forth above, the cartridge would still be considered "non-standard" because the distal diameter is less than what is specified by the ISO standard. Varying diameter as well as length would ensure that a standard cartridge would not fit into a drug delivery device intended for the "non-standard" cartridge, but also that the "non-standard" cartridge would not fit into a device intended for a standard cartridge.

A further aspect of the present disclosure can therefore include a distal diameter D of less than 7.6 mm in combination with a total length L greater than 64.5 mm. According to one embodiment, the distal neck portion LN is greater than 6.3 mm in length. The body length may remain the same as a standard cartridge, so the total length may increase.

According to one embodiment,, the cartridge has a distal diameter D of less than 7.6 mm. Additionally, the distal neck portion LN may be less than 6.3 mm. The total length L may remain the same as a standard cartridge so the body length may increase. According to one embodiment, a distal diameter D is less than 7.6 mm. Additionally, the total length L may be greater than or less than 64.5 mm. Additionally or

alternatively, the distal neck portion LN may be greater than or less than 6.3 mm.

Manufacturing or simply providing a drug delivery device, either disposable or refillable, that has a cartridge holder with an internal diameter less than 7.6 mm will accept cartridges of the present disclosure (i.e. "non-standard"), but will not accept a

"standard" 3 ml cartridge as defined by ISO. This exclusion of standard cartridges may provide a way to prevent or reduce the potential risk of a user loading an incorrect drug type into a drug delivery device. Likewise, this may prevent undesired cartridge cross use.

A further aspect relates to a system of cartridges. The system may be defined as two or more cartridges. In particular the system may comprise a first cartridge as described above. The system may comprise a second cartridge as described above. The first cartridge may contain a first medicament or a first concentration of medicament. The second cartridge may contain a second medicament or a second concentration of medicament. The outside distal diameter of the first cartridge may be less than 7.6 mm. The outside distal diameter of the second cartridge may be smaller than the outside distal diameter of the first cartridge. The first and second cartridges in the system may each comprise an ampoule having a proximal portion, a total length L, and a distal neck portion that includes a ferrule partially enclosing a septum and that is fixed to the ampoule as describe above. The distal diameter D of the first cartridge may be less than 7.6 mm and the distal diameter of the second cartridge may be smaller than D. Preferably, the second concentration of medicament is not equal to the first concentration. Additionally or alternatively, the medicament in the first cartridge may be different than the medicament in the second cartridge. Of course, the system could include a number of cartridges, where each cartridge may have a different neck diameter all of them being less than 7.6 mm. In such a system, different medicaments can be coded or matched to different distal diameters. According to an embodiment, the system further comprises a third cartridge. The third cartridge may comprise an ampoule having a proximal portion. The third cartridge may comprise a total length. The third cartridge may comprise a distal neck portion. The distal neck portion may have a ferrule partially enclosing a septum and fixed to the ampoule. The third cartridge may comprise an outside distal diameter that is defined by the cross-section of the distal neck portion including the ferrule as described above. The outside distal diameter of the third cartridge may e smaller than the outside distal diameter of the second cartridge.

A further aspect relates to a system of cartridges. The system may comprise at least two cartridges. In particular the system may comprise a first cartridge as described above. The first cartridge may comprise a first medicament or a first concentration of medicament. The system may comprise a second cartridge as described above. The second cartridge may comprise a second medicament or a second concentration of medicament. The second concentration of medicament may not be equal to the first concentration. Additionally or alternatively, the medicament in the first cartridge may be different than the medicament in the second cartridge. The distal diameter of the first and second cartridges in the system may be the same. The distal diameter of the first and second cartridges may be less than 7.6 mm. In this system, the total length L of the first and second cartridges in the system may be different. In such a case, variations in total length could be coded or match to different drug concentrations of the same medicament or to different medicaments. Preferably, all the total lengths L of the cartridges in the system are greater than 64.5 mm. In yet another aspect, the distal diameter D of all the cartridges in the system could be less than 7.6 mm. The distal neck portion length NL of each cartridge may be different, preferably greater than 6.3 mm. Again, medicament type or concentration could be matched to the various distal diameters and/or neck portion lengths. Improper cartridge use can be avoided by providing drug delivery devices with cartridge holders that only accept one or more cartridges having varying neck lengths. This may be accomplished by varying the internal dimensions at the distal end of the cartridge holders. A further aspect relates to a drug delivery system. The drug delivery system may comprise a drug delivery device, e.g. a pen-type device such as a pen-type injector. The drug delivery device may comprise a dose setting mechanism. The drug delivery system may comprise a cartridge holder. The cartridge holder may be permanently or removably coupled to the dose setting mechanism. The drug delivery system may comprise a system of at least two cartridges. The system of cartridges may comprise a first cartridge. The first cartridge may contain a first medicament. The system of cartridges may comprise a second cartridge. The second cartridge may contain a second medicament. The first and second cartridges may each comprise an ampoule. The ampoule may have a proximal portion. The ampoule may have a total length. The ampoule may have a distal neck portion. The distal neck portion may have a ferrule partially enclosing a septum and fixed to the ampoule. An outside distal diameter of the cartridges may be defined by the cross-section of the distal neck portion including the ferrule. The outside distal diameter of the first cartridge may be less than 7.6 mm. The outside distal diameter of the second cartridge may be smaller than the outside distal diameter of the first cartridge. The cartridge holder will only accept a cartridge in the cartridge system. In particular, the cartridge holder may be configured to only accept one of the first cartridge and the second cartridge in the cartridge system.

According to an embodiment, the drug delivery system comprises a reusable drug delivery system. According to an embodiment, the drug delivery system comprises a non-reusable drug delivery system.

The drug delivery device and the non-standard cartridges described herein can be considered a drug delivery system. Such a drug delivery system can be reusable, meaning the cartridge can be replaced when empty, or the system can be non- reusable (disposable), meaning the cartridge cannot be replaced and the entire system is thrown away when the cartridge is empty. In any of the arrangements described above, it is possible to add mechanical coding features to the non-standard cartridges of the present disclosure, for example, coded labels or ring/bands/collars attached to the ampoule.

According to a preferred embodiment, a medicament cartridge is provided comprising, an ampoule having a proximal portion and a distal neck portion, a ferrule partially enclosing a septum, the ferrule being fixed to the distal neck portion and a medicament sealed inside the ampoule. An outside distal diameter of the cartridge is defined by the cross-section of the distal neck portion including the ferrule and is less than 7.6 mm. According to a preferred embodiment, a medicament cartridge is provided comprising, an ampoule having a proximal portion, a total length, and a distal neck portion, a ferrule partially enclosing a septum and fixed to the distal neck portion and a

medicament sealed inside the ampoule by a stopper that is slidably positioned within the proximal portion of the ampoule. An outside distal diameter is defined by the cross- section of the distal neck portion including the ferrule and is less than 7.6 mm.

According to a preferred embodiment, a system of cartridges is provided, the system comprising at least a previously described first cartridge and at least a previously described second cartridge. The first cartridge contains a first medicament and the second cartridge contains a second medicament. The outside distal diameter of the second cartridge is smaller than the outside distal diameter of the first cartridge. The total length of the first cartridge is different from the total length of the second cartridge. According to a preferred embodiment, a system of cartridges comprising at least two cartridges is provided. A first cartridge contains a first medicament and a second cartridge containing a second medicament. The first and second cartridges each comprise an ampoule having a proximal portion, a total length, and a distal neck portion having a ferrule partially enclosing a septum and fixed to the ampoule, and an outside distal diameter that is defined by the cross-section of the distal neck portion including the ferrule. The outside distal diameter of the first cartridge is less than 7.6 mm and the outside distal diameter of the second cartridge is smaller than the outside distal diameter of the first cartridge.

According to a preferred embodiment, a system of cartridges comprising at least two cartridges is provided. A first cartridge contains a first medicament and a second cartridge contains a second medicament. The first and second cartridges each comprise an ampoule having a proximal portion, a total length, and a distal neck portion having a ferrule partially enclosing a septum and fixed to the ampoule, and an outside distal diameter that is defined by the cross-section of the distal neck portion including the ferrule. The outside distal diameter of the first cartridge is less than 7.6 mm and the outside distal diameter of the second cartridge is smaller than the outside distal diameter of the first cartridge. The total length of the first cartridge is different than the total length of the second cartridge.

According to a preferred embodiment, a system of cartridges comprising at least two cartridges is provided. A first cartridge contains a first medicament and a second cartridge contains a second medicament. The first and second cartridges each comprise an ampoule having a proximal portion, a total length, and a distal neck portion having a ferrule partially enclosing a septum and fixed to the ampoule, and an outside distal diameter that is defined by the cross-section of the distal neck portion including the ferrule. The outside distal diameter of the first cartridge is less than 7.6 mm and the outside distal diameter of the second cartridge is smaller than the outside distal diameter of the first cartridge. The distal neck portion of each cartridge in the system has a different length. According to a preferred embodiment, a drug delivery system is provided comprising a drug delivery device comprising a dose setting mechanism, a cartridge holder coupled to the dose setting mechanism and the previously described system of the first cartridge and the second cartridge. The cartridge holder is configured to only accept one of the first cartridge and the second cartridge in the cartridge system.

According to a preferred embodiment, a drug delivery system is provided, the system comprising a drug delivery device comprising a dose setting mechanism and a cartridge holder removably coupled to the dose setting mechanism and a system of at least two cartridges comprising a first cartridge containing a first medicament and a second cartridge containing a second medicament. The first and second cartridges each comprise an ampoule having a proximal portion, a total length, and a distal neck portion having a ferule partially enclosing a septum and fixed to the ampoule, and an outside distal diameter that is defined by the cross-section of the distal neck portion including the ferrule. The outside distal diameter of the first cartridge is less than 7.6 mm and the outside distal diameter of the second cartridge is smaller than the outside distal diameter of the first cartridge. The cartridge holder will only accept a cartridge in the cartridge system.

These as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying figures. The scope of the invention is defined by the content of the claims. The invention is not limited to specific embodiments but comprises any combination of elements of different embodiments. Moreover, the invention comprises any combination of claims and any combination of features disclosed by the claims.

BRIEF DESCRIPTION OF THE FIGURES Exemplary embodiments are described herein with reference to the figures, in which: Figure 1 illustrates an exemplary pen-type drug delivery device;

Figure 2 illustrates an exemplary drug cartridge; and

Figure 3 is a cross-sectional view of a standard 3 ml cartridge not fitting into a cartridge holder configured to accept only non-standard cartridges.

DETAILED DESCRIPTION

Figure 1 illustrates a drug delivery device 100 in the form of a pen-type syringe. This drug delivery device 100 comprises a dose setting mechanism 102, a cartridge holder

104, and a removable cap 106. A proximal end 105 of the cartridge holder 104 and a distal end 103 of the dose setting mechanism 102 are removably secured together.

The pen-type syringe may comprise a re-usable or a disposable pen-type syringe.

Where the syringe comprises a reusable device, the cartridge holder 104 and the dose setting mechanism 102 are removably coupled together. In a disposable device, they are permanently coupled together. In Figure 1 , the dose setting mechanism 102 comprises a spindle 109, such as a threaded spindle that rotates when a dose is injected. To inject a previously set dose, a double ended needle assembly (not shown) is attached to a distal end 108 of the cartridge holder 104. Preferably, the distal end 108 of the holder 104 comprises a thread 121 (or other suitable connecting mechanism such as a snap lock, snap fit, form fit, or bayonet lock mechanism) so that the needle assembly may be removably attached to the distal end 108 of the holder 102. When the drug delivery device 100 is not in use, the removable cap 106 can be releasably retained over the cartridge holder 104. An inner cartridge cavity 1 1 1 defined by the cartridge holder 104 is dimensioned and configured to securely receive and retain a non-standard cartridge 120 of the present disclosure. Figure 2 illustrates a partial cross-sectional view of the non-standard cartridge 120 that may be used with the drug delivery device 100 illustrated in Figure 1 . The cartridge 120 includes an ampoule 122 extending from a distal end 130 to a proximal end 132. The distal end 130 is defined by a neck portion 131 having an inwardly converging shoulder 133.

At the distal end 130, the cartridge 120 includes an outside distal diameter D and an annular bead 135. This bead 135 extends circumferentially thereabout at the extreme distal end of shoulder 133. A pierceable seal or septum 127 is securely mounted across the open distal end of the ampoule 122. The seal 127 may be held in place by a metallic sleeve or ferrule 124. This ferrule 124 may be crimped around the

circumferential bead at the distal end of the neck 131. A medicament 125 is pre-filled into the cartridge 120 and is retained within the cartridge 120, in part, by the pierceable seal 127, the ferrule 124, and a piston 128. The piston 128 is in sliding fluid-tight engagement with the inner tubular wall of the ampoule 122. Axially directed forces acting upon the piston 128 during dose injection or dose administration urges the medication 125 from the cartridge 120 through the double ended needle (not shown) mounted onto the distal end 108 of the cartridge holder 104 and into the injection site. Such axial forces may be provided by the spindle 109.

A portion of the cartridge holder 104 defining the cartridge holder cavity 1 1 1 is of substantially uniform diameter. This inner diameter is preferably slightly greater than the outer diameter OD at the proximal end 132 of the cartridge 120. The interior of the cartridge holder 104 includes an inwardly-extending annual portion or stop that is dimensioned to prevent the cartridge 120 from moving within the cartridge holder 104. In this manner, when the cartridge 120 is loaded into the cavity 1 1 1 of the cartridge holder 104 and the cartridge holder 104 is then connected to the dose setting member 102, the cartridge 120 will be securely held within the cartridge cavity 1 1 1 . More particularly, the neck portion 131 of the cartridge 120 is inserted from a proximal to a distal direction into the open proximal end 105 of the cartridge holder 104 with the neck portion 131 eventually passing entirely into a tapered down distal portion of cavity 1 1 1 of the holder 104. With the holder 104 removably coupled to the dose setting

mechanism 102, the proximal end 132 of the cartridge 120 will typically abut a stop provided by the dose setting member 102.

A number of doses of the medicament 125 may be dispensed from the cartridge 120. It will be understood that the cartridge 120 may contain a type of medicament 125 that must be administered often, such as one or more times a day. One such medicament 125 is insulin. The dose setting mechanism 102 comprises a dose setter 1 17 (see Figure 1 ) at the proximal end 107 of the drug delivery device 100. In one preferred arrangement, the dose setter 1 17 may extend along the entire length of the dose setting mechanism 102. The dose setter 1 17 may be rotated by a user to set a dose.

To administer a dose that may be set by rotating the dose setter 1 17, the user attaches the needle assembly comprising the double ended needle on the distal end 108 of the cartridge holder 104. In this manner, the needle assembly pierces the seal 127 of the cartridge 120 and is, therefore, in liquid communication with the medicament 125. The user pushes on the dose setter 1 17 to inject the set dose. The same dose setting and dose administration procedure is followed until the medicament 125 in the cartridge 120 is expended and then a new cartridge must be loaded in the device 100. To exchange an empty cartridge 120, the user is called upon to remove the cartridge holder 104 from the dose setting mechanism 102.

A coding system comprising the non-standard cartridges 120 of the present disclosure for use with a drug delivery system, such as drug delivery device 100, is provided. In an example of the present disclosure, a system of cartridges 120 are manufactured where the distal diameter D is less than 7.6 mm, which is less than the standard ISO distal diameter of 8 mm maximum with a manufacturing tolerance of + 0.20 mm. As such, each cartridge 120 could have a different distal diameter that is coded or matched to a different medicament 125 or concentration of medicament 125. For example, the table below illustrates a possible cartridge system. Non-Standard Cartridge Nominal Distal Diameter D (mm) Lower Tolerance Diameter (mm) Upper Tolerance Diameter (mm)

Drug 1 7.15 6.95 7.35

Drug 2 6.5 6.3 6.7

Drug 3 5.85 5.65 6.05

Yet another possible system would include a collection of non-standard cartridges 120 all having the same distal diameter that is less than 7.6 mm and having varying total lengths L that are coded or matched to different medicament 125 or the same medicament125 at different concentrations. For example, one such system could be comprised of the following non-standard cartridges 120.

Non-Standard Cartridge Distal Diameter D (mm) Total Length L (mm)

Drug A (10% concentration) 7.15 63.9

Drug A (25% concentration) 7.15 64.5

Drug A (50% concentration) 7.15 65.1

In alternative embodiments, the present disclosure can include a distal diameter D of less than 7.6 mm in combination with a total length L greater than or less than 64.5 mm, or a distal neck portion LN greater than or less than 6.3 mm. In a system where coding is provided in only one dimension, a drug or medicament contained within a reservoir might fit into an incorrect device. For example, a reservoir with a large distal diameter D would not fit into a device intended for a smaller diameter, but a small diameter would fit into a device intended for a larger diameter. However, if a system is coded by more than one dimension, a plurality of drugs can be prevented from fitting into an incorrect device. In order to prevent assembly of a reservoir containing a drug into an incorrect device, the coded reservoir for one drug must be smaller in one dimension and larger in another than corresponding features for other drugs. In other words, the coded reservoir must cover an area that is not completely covered by the area of any other reservoirs that might be used for different medicaments.

For example, another possible system would include a collection of non-standard cartridges 120 all having the same distal diameter that is less than 7.6 mm and having varying lengths of the distal neck portion NL, each of which is coded or matched to different medicament 125 or the same medicament 125 at different concentrations. The body length may remain the same as a standard cartridge, so the total length varies. For example, one such system could be comprised of the following nonstandard cartridges 120.

Non-Standard Cartridge Distal Diameter D (mm) Length of Distal Neck Portion NL(mm)

Drug A (10% concentration) 7.15 6.3

Drug A (25% concentration) 7.15 6.8

Drug A (50% concentration) 7.15 7.3

Drug B (10% concentration) 5.85 6.3

Drug B (25% concentration) 5.85 6.8

Drug B (50% concentration) 5.85 7.3

In another example, one drug or medicament 125 might have a reservoir or cartridge 120 with a small distal diameter D and a small distal neck portion LN, while another drug 125 might have a larger distal diameter D and a larger distal neck portion LN but the same total length L. For example, one such system could be comprised of the following non-standard cartridges 120:

Non-Standard Cartridge Distal Diameter D (mm) Length of Distal Neck Portion NL(mm) Total Length L (mm)

Drug A 7.4 6.3 64.5

Drug B 7.0 5.8 64.5 Drug C 6.6 5.3 64.5

Because the cartridge holder 104 is manufactured to fit the non-standard distal diameters D for each cartridge system, an attempt to insert or use a standard cartridge will fail as illustrated in Fig. 3. The cartridge 120' shown in Fig. 3 is a standard 3 ml cartridge having the dimensions specified by the ISO standard mentioned earlier. As such, the distal diameter D is nominally 7.8 + 0.20 mm (or 8 mm max.). Cartridge holder 104 is sized to fit the non-standard cartridges 120 of the present disclosure, which have distal diameters D less than 7.6 mm. As illustrated, it is not possible to accidentally use a standard cartridge 120' in place of the non-standard cartridge.

Although aimed primarily at the insulin market, the presently proposed non-standard cartridge schemes may apply to other drugs. Likewise, the coding system may apply to various drug delivery devices.

The cartridge system of the present disclosure results in a number of advantages. For example, the system may help a user to ensure that a given drug delivery device component is only attached to a drug delivery device component for which it is intended. The system may also result in a low cost coding mechanism since the manufacture of cartridges with varying distal diameters and matching holders does not require a large number of parts and can be manufactured in a cost effective manner. Moreover, there are quite a large number of different possible dimensions of the distal diameter, total length, and distal neck portion that can be used. Consequently, with the proposed non-standard cartridge schemes, a large number of medicaments can be distinguished from one another.

In given embodiments, the coding may be designed to block all incorrect reservoirs or cartridges from being inserted into an incorrect cartridge holder. In alternative embodiments, the coding may be designed to block reservoirs of a given type, but not all types of reservoirs. For example, in an embodiment, the coding may block only reservoirs not intended for the housing and that comprise dangerous drugs. For instance, a short-acting drug could be fitted into a device intended for long-acting drugs, but not vice versa. As another example, a low concentration drug could be fitted into a device intended for high concentration drugs, but not vice versa. Exemplary embodiments of the present disclosure have been described. However, as those of skill in the art will recognize certain changes or modifications to such arrangements may be made. Those skilled in the art will understand, however, that further changes, modifications, revisions and/or additions may be made to the presently disclosed arrangements without departing from the true scope and spirit of the present invention, which is defined by the claims.

The term "drug" or "medicament", 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 proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is 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, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.

Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin;

Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val 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 derivates are for example B29-N-myristoyl-des(B30) human insulin; 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-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; Β29-Ν-(ω- carboxyheptadecanoyl)-des(B30) human insulin and Β29-Ν-(ω- carboxyhepta-"decanoyl) human insulin. Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly- Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe- lle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following list of compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

des Pro36 [Asp28] Exendin-4(1 -39),

des Pro36 [lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39), des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39); or des Pro36 [Asp28] Exendin-4(1 -39),

des Pro36 [lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1 -39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6- NH2,

H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39)-Lys6-NH2, des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1 -39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6- NH2,

H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1 -39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 - 39)-NH2,

des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1 -39)- (Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 - 39)-(Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative.

Hormones are 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.

A polysaccharide is for example 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, e.g. a poly-sulphated form of the above-mentioned

polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, 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 described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of

Pharmaceutical Technology. Pharmaceutically acceptable solvates are for example hydrates.

Reference numerals

100 drug delivery device

102 dose setting mechanism

103 distal end of dose setting mechanism

104 cartridge holder

105 proximal end of cartridge holder

106 cap

107 proximal end of device

108 distal end of cartridge holder

109 spindle

11 1 cavity

117 dose setter

120 non-standard cartridge

120' standard cartridge

121 thread

122 ampoule

124 ferrule

125 medicament

127 seal

128 piston

130 distal end

131 neck portion

132 proximal end

133 shoulder

135 bead

Claims

1. A medicament cartridge (120) comprising,

an ampoule (122) having a proximal portion and a distal neck portion (131);

a ferrule (124) partially enclosing a septum (127), the ferrule (124) being fixed to the distal neck portion (131); and

a medicament (125) sealed inside the ampoule (122)

wherein an outside distal diameter of the cartridge (120) is defined by the cross-section of the distal neck portion (131) including the ferrule (124) and is less than 7.6 mm.

2. The cartridge (120) of claim 1 , wherein the outside distal diameter of the cartridge (120) is less than the outside distal diameter of a cartridge according to standard ISO 1 1608-3 2001.

3. The cartridge (120) of claim 1 or claim 2,

having a total length, wherein the total length is greater than 64.5 mm.

4. The cartridge (120) of any of the previous claims,

wherein the distal neck portion (131) is greater than 6.3 mm in length.

5. The cartridge (120) of any of the previous claims,

wherein the distal neck portion (131) is less than 6.3 mm in length.

6. The cartridge (120) according to any of the previous claims,

wherein the ampoule (122) comprises glass.

7. The cartridge (120) according to any of the previous claims, further comprising a mechanical coding feature, wherein the mechanical coding feature comprises a coded label, ring, band and / or collar attached to the cartridge (120).

8. A system of cartridges (120) comprising at least a first cartridge (120) according to any of the previous claims and at least a second cartridge (120) according to any of the previous claims,

wherein the first cartridge (120) contains a first medicament (125) and the second cartridge (120) contains a second medicament (125), and wherein the outside distal diameter of the second cartridge (120) is smaller than the outside distal diameter of the first cartridge (120), or wherein the total length of the first cartridge (120) is different from the total length of the second cartridge (120).

9. The system of claim 8,

wherein the second medicament (125) is different from the first medicament (125).

10. The system of claim 8 or claim 9,

wherein the first medicament (125) is a different concentration than the second medicament (125).

1 1. The system according to any of claims 8 to 10,

wherein the distal neck portion (131) of the first and the second cartridges (120) in the system has a different length.

12. The system according to any of claims 8 to 11 ,

wherein the length of the neck portion (131) of the first and the second cartridges (120) in the system is greater than 6.3 mm.

13. The system according to any of claims 8 to 12,

further comprising a third cartridge (120) according to any of claims 1 to 6, wherein the outside distal diameter of the third cartridge (120) is smaller than the outside distal diameter of the second cartridge (120).

14. A drug delivery system comprising

a drug delivery device (100) comprising a dose setting mechanism (102), a cartridge holder (104) coupled to the dose setting mechanism (102) and the system of the first cartridge (120) and the second cartridge (120) according to any of claims 8 to 13,

wherein the cartridge holder (104) is configured to only accept one of the first cartridge (120) and the second cartridge (120) in the cartridge system.

15. The drug delivery system of claim 14,

wherein the drug delivery system is reusable.

16. The drug delivery system of claim 14,

wherein the drug delivery system is non-reusable.