WO2012010564A1 - Cartouches de médicament ayant des dimensions non-standard - Google Patents

Cartouches de médicament ayant des dimensions non-standard Download PDF

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Publication number
WO2012010564A1
WO2012010564A1 PCT/EP2011/062278 EP2011062278W WO2012010564A1 WO 2012010564 A1 WO2012010564 A1 WO 2012010564A1 EP 2011062278 W EP2011062278 W EP 2011062278W WO 2012010564 A1 WO2012010564 A1 WO 2012010564A1
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WO
WIPO (PCT)
Prior art keywords
cartridge
medicament
distal
drug delivery
cartridges
Prior art date
Application number
PCT/EP2011/062278
Other languages
English (en)
Inventor
Christopher Nigel Langley
Joseph Butler
Richard James Vincent Avery
Original Assignee
Sanofi-Aventis Deutschland Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi-Aventis Deutschland Gmbh filed Critical Sanofi-Aventis Deutschland Gmbh
Publication of WO2012010564A1 publication Critical patent/WO2012010564A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/40—General identification or selection means by shape or form, e.g. by using shape recognition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/2474—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6045—General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe

Definitions

  • 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.
  • 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.
  • the drug delivery device comprises a reusable device
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a first cartridge containing a first medicament from a first supplier may fit a medical delivery device provided by a second supplier.
  • 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.
  • 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.
  • a cartridge 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.
  • 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:
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • the distal neck portion LN may be greater than or less than 6.3 mm.
  • 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.
  • 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.
  • the second concentration of medicament is not equal to the first concentration.
  • the medicament in the first cartridge may be different than the medicament in the second cartridge.
  • 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.
  • 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.
  • 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.
  • 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.
  • variations in total length could be coded or match to different drug concentrations of the same medicament or to different medicaments.
  • all the total lengths L of the cartridges in the system are greater than 64.5 mm.
  • 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.
  • 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.
  • 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.
  • the cartridge holder may be configured to only accept one of the first cartridge and the second cartridge in the cartridge system.
  • 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.
  • 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.
  • mechanical coding features to the non-standard cartridges of the present disclosure, for example, coded labels or ring/bands/collars attached to the ampoule.
  • a medicament cartridge 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.
  • 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
  • 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.
  • a system of cartridges 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.
  • 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.
  • a system of cartridges comprising at least two cartridges.
  • 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.
  • a system of cartridges comprising at least two cartridges.
  • 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.
  • a drug delivery system 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.
  • a drug delivery 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.
  • Figure 1 illustrates an exemplary pen-type drug delivery device
  • Figure 2 illustrates an exemplary drug cartridge
  • 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.
  • FIG. 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
  • 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.
  • the cartridge holder 104 and the dose setting mechanism 102 are removably coupled together. In a disposable device, they are permanently coupled together.
  • the dose setting mechanism 102 comprises a spindle 109, such as a threaded spindle that rotates when a dose is injected.
  • a double ended needle assembly (not shown) is attached to a distal end 108 of the cartridge holder 104.
  • 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.
  • 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.
  • 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
  • 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 .
  • 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.
  • 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.
  • the user 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.
  • 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.
  • each cartridge 120 could have a different distal diameter that is coded or matched to a different medicament 125 or concentration of medicament 125.
  • the table below illustrates a possible cartridge system.
  • 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.
  • one such system could be comprised of the following non-standard cartridges 120.
  • 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.
  • a drug or medicament contained within a reservoir might fit into an incorrect device.
  • 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.
  • a plurality of drugs can be prevented from fitting into an incorrect device.
  • the coded reservoir for one drug 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.
  • 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.
  • one such system could be comprised of the following nonstandard cartridges 120.
  • 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.
  • one such system could be comprised of the following non-standard cartridges 120:
  • 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.
  • the presently proposed non-standard cartridge schemes may apply to other drugs.
  • the coding system may apply to various drug delivery devices.
  • the cartridge system of the present disclosure results in a number of advantages.
  • 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.
  • the coding may be designed to block all incorrect reservoirs or cartridges from being inserted into an incorrect cartridge holder.
  • the coding may be designed to block reservoirs of a given type, but not all types of reservoirs.
  • 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.
  • 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
  • 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; ⁇ 29- ⁇ -( ⁇ - carboxyheptadecanoyl)-des(B30) human insulin and ⁇ 29- ⁇ -( ⁇ - carboxy
  • 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:
  • 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.
  • 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
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une cartouche (120) contenant un médicament (125) pour utilisation dans un dispositif de distribution de médicament (100) qui a des dimensions non-standard pour produire un système de codage pour réduire le risque qu'un utilisateur distribue un médicament erroné depuis le dispositif de distribution de médicament (100). La cartouche (120) contient une ampoule (122) ayant une partie de col distal (131) ayant un diamètre distal extérieur, qui comprend une férule (124) configurée pour contenir partiellement un septum (127) qui fait moins de 7,6 mm.
PCT/EP2011/062278 2010-07-19 2011-07-18 Cartouches de médicament ayant des dimensions non-standard WO2012010564A1 (fr)

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US36546010P 2010-07-19 2010-07-19
US61/365,460 2010-07-19
EP10174995 2010-09-02
EP10174995.0 2010-09-02

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108294943A (zh) * 2017-01-12 2018-07-20 江苏大红鹰恒顺药业有限公司 一种新型多功能无菌塑料安瓿瓶
USD907193S1 (en) 2018-02-21 2021-01-05 Eli Lilly And Company Secured medication transfer set
WO2022066834A1 (fr) * 2020-09-25 2022-03-31 Becton, Dickinson And Company Élément de rondelle pour cartouche et dispositif d'injection médical le comprenant
US11730678B2 (en) 2016-08-22 2023-08-22 Eli Lilly And Company Secured medication transfer system

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4886495A (en) * 1987-07-08 1989-12-12 Duoject Medical Systems Inc. Vial-based prefilled syringe system for one or two component medicaments
US5435076A (en) * 1992-04-21 1995-07-25 Pharmacia Aktiebolag Injection device
US5716338A (en) * 1993-10-20 1998-02-10 Pharmacia & Upjohn Aktiebolag Dual-chamber type injection cartridge with bypass connection
US20050171476A1 (en) * 2002-05-24 2005-08-04 Judson Jared A. Medication injecting apparatus with fluid container piston-engaging drive member having internal hollow for accommodating drive member shifting mechanism
US20060052747A1 (en) * 2001-11-22 2006-03-09 Terumo Kabushiki Kaisha Two-chamber pre-filled syringe
US20090131864A1 (en) * 2004-10-25 2009-05-21 Ewald Pickhard Method and devices for lyophilizing, reconstituting, and administering a reconstituted agent

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4886495A (en) * 1987-07-08 1989-12-12 Duoject Medical Systems Inc. Vial-based prefilled syringe system for one or two component medicaments
US5435076A (en) * 1992-04-21 1995-07-25 Pharmacia Aktiebolag Injection device
US5716338A (en) * 1993-10-20 1998-02-10 Pharmacia & Upjohn Aktiebolag Dual-chamber type injection cartridge with bypass connection
US20060052747A1 (en) * 2001-11-22 2006-03-09 Terumo Kabushiki Kaisha Two-chamber pre-filled syringe
US20050171476A1 (en) * 2002-05-24 2005-08-04 Judson Jared A. Medication injecting apparatus with fluid container piston-engaging drive member having internal hollow for accommodating drive member shifting mechanism
US20090131864A1 (en) * 2004-10-25 2009-05-21 Ewald Pickhard Method and devices for lyophilizing, reconstituting, and administering a reconstituted agent

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Remington's Pharmaceutical Sciences", 1985, MARK PUBLISHING COMPANY
JORGE E GARCIA, ARTHUR BRANDWOOD: "Incompatibility of insulin pens and cartridges", vol. 351, no. 9105, 14 March 1998 (1998-03-14), pages 832 - 833, XP002621160, Retrieved from the Internet <URL:http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673605789637.pdf> [retrieved on 20101119], DOI: 10.1016/S0140-6736(05)78963-7 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11730678B2 (en) 2016-08-22 2023-08-22 Eli Lilly And Company Secured medication transfer system
CN108294943A (zh) * 2017-01-12 2018-07-20 江苏大红鹰恒顺药业有限公司 一种新型多功能无菌塑料安瓿瓶
USD907193S1 (en) 2018-02-21 2021-01-05 Eli Lilly And Company Secured medication transfer set
USD990659S1 (en) 2018-02-21 2023-06-27 Eli Lilly And Company Needle hub
USD997341S1 (en) 2018-02-21 2023-08-29 Eli Lilly And Company Secured medication transfer set
WO2022066834A1 (fr) * 2020-09-25 2022-03-31 Becton, Dickinson And Company Élément de rondelle pour cartouche et dispositif d'injection médical le comprenant

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