WO2003017914A1 - Cartouche pour insuline liquide - Google Patents

Cartouche pour insuline liquide Download PDF

Info

Publication number
WO2003017914A1
WO2003017914A1 PCT/DK2002/000553 DK0200553W WO03017914A1 WO 2003017914 A1 WO2003017914 A1 WO 2003017914A1 DK 0200553 W DK0200553 W DK 0200553W WO 03017914 A1 WO03017914 A1 WO 03017914A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
insulin
glass
zone
piston
Prior art date
Application number
PCT/DK2002/000553
Other languages
English (en)
Inventor
Lars Thougaard Kristensen
Steffen Hansen
Lars Peter Klitmose
Original Assignee
Novo Nordisk A/S
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 Novo Nordisk A/S filed Critical Novo Nordisk A/S
Priority to KR10-2004-7002694A priority Critical patent/KR20040029015A/ko
Priority to DE60205390T priority patent/DE60205390T2/de
Priority to AT02758183T priority patent/ATE300933T1/de
Priority to JP2003522437A priority patent/JP2005507682A/ja
Priority to IL15990102A priority patent/IL159901A0/xx
Priority to EP02758183A priority patent/EP1424984B1/fr
Priority to CA002457943A priority patent/CA2457943A1/fr
Priority to PL02367865A priority patent/PL367865A1/xx
Priority to AU2002325201A priority patent/AU2002325201B2/en
Publication of WO2003017914A1 publication Critical patent/WO2003017914A1/fr
Priority to ZA2004/00344A priority patent/ZA200400344B/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—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
    • A61J1/05—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

Definitions

  • the invention relates to ampoules or cartridges for insulin delivery systems.
  • Such cartridges are commonly shaped as a glass tube being at one end closed by a piston, which may be pressed into the tube to expel the content of the tube at the other end of the tube.
  • This other end is formed as a bottleneck, the outer end of which may be pierced by an injection needle or a catheter through which the content is expelled.
  • Glass cartridges as described in the preamble of claim 1 are widely known for various medicament delivery systems. They are especially used for insulin delivery systems, and are usually supplied pre-filled with either 1 ,5 ml of insulin or 3,0 ml of insulin.
  • a 1 ,5 ml cartridge usually has an inside diameter around 6,85 mm and a 3,0 ml cartridge usually has an inside diameter around 9,25 mm.
  • These known cartridges are pre-filled with insulin having a concentration on 100 International Units (IU) pr. ml.
  • a 1 ,5 ml cartridge therefore contains 150 IU and a 3,0 ml cartridge contains 300 IU.
  • the typical diabetes patient will require a certain amount of insulin either injected or infused into their body every day. Some patients need as much as 100 IU per day, in which case the 3,0 ml cartridge is recommended.
  • the patient loads the cartridge into either an injection system or a pump system and injects or infuses the insulin into their body at a prescribed rate, either through an injection needle or through a catheter inserted into their body. Once the cartridge is empty it is disposed of and a new cartridge is loaded into the delivery system.
  • Glass is the most preferred material for cartridges containing insulin, since glass are both chemically and biologically inert so that insulin can be stored within the glass cartridge with- out reactions occurring between the liquid insulin and the glass material. Glass has the additional advantage that it can be thermally sterilized. Glass cartridges are produced from long glass tubes, which are cut up into smaller tubes, one end of which is melted so that a small opening remains. The opposite open end of the tubes is provided with a movable piston, which are usually manufactured from rubber or plastic. Cartridges made from glass however has the disadvantage that the inside diameter is variable due to the manufacturing process. The inside diameter of glass cartridges, varies by 0,1 mm at an average inside diameter of about 10 mm. However, finer tolerances are available by pre sorting the glass cartridges or by tightened monitoring of the glass process. The following table shows the tolerances typically available today:
  • the dose accuracy of an insulin delivery system is the subject of the ISO standard 11608-1.
  • This standard prescribes that a dose in the range 0 to 20 IU most have an accuracy of +/- 1 IU, i.e. a nominal dose of 20 IU most contain between 19 to 21 IU.
  • the ISO standard allows a tolerance of doses smaller than 20 IU to be within +/- 1 IU, while the tolerances of a dose exceeding 20 IU most be within +/- 5 %. The most difficult part of the standard to meet is therefore typically the demand for accuracy on +/- 1 IU for a dose of 20 IU.
  • a large diameter combined with a large tolerance provides large variations in the cross section area of the glass cartridge, which will result in large tolerances in the volume delivered by the insulin delivery system. This is however not a major problem when the insulin has a concentration on only 100 IU per ml.
  • V H ⁇ - R 2
  • One IU of liquid U200 insulin has the volume of 0,005 ml, the front wall of the piston in e.g. a cartridge having a nominal inside diameter of 9,25 mm most therefore be displaced by 0,074 mm in order to expel one IU.
  • the volume expelled within these tolerances can be calculated using the following formula:
  • V(IU) CS • D ⁇ IC
  • V(IU) Volume expressed in IU
  • the following table show the expelled volume measured in International Units for a cartridge having a nominal diameter of 9,25 mm and tolerances of +/- 0,06 mm, i.e. an inside diameter between 9,19 mm and 9,31 mm, equaling a cross section area of the volumen of the cartridge between 66,33 mm 2 and 68,08 mm 2 , when the cartridge is used in an insulin delivery system which can move the piston forward with a tolerance of +/- 0,055 mm.
  • the forward movement hence being in the range 1 ,433 mm to 1 ,543 mm.
  • the mechanical insulin delivery systems available today all have quit a large imprecision due to the mechanical system.
  • the leading injection devices has a displacement accuracy around +/- 0,083, meaning that the front wall of the piston can only be moved forward within tolerances of approximately +/- 0,083 mm.
  • the maximum allowable inner diameter of the cartridge must, according to the table shown in figure 1 , be smaller than a nominal 7,5 mm cartridge in order to meet the demands set up in the ISO 11608-1 standard.
  • Cartridges having an inside diameter larger than 7,5 mm all needs a displacement accuracy smaller than +/- 0,083 mm in order to meet the ISO standard. They are therefore not suitable for use in ordinary insulin pen systems.
  • Insulin pumps for pump treatment of diabetes usually have a more precise mechanism than mechanical injection devices due to the presence of a motor mechanism, which is also the case for motor driven injection devices. It is however not necessary with a precise mechanism in insulin pumps due to the presence of a continuous insulin delivery profile.
  • cartridges containing liquid U200 insulin and having a diameter from the lower tolerance limit of a nominal 7,5 mm cartridge i.e. 7,45 mm to the upper tolerance limit of a nominal 9,25 mm cartridge i.e. 9,31 can be used both in pumps and in precision injection devices having tolerances within +/- 0,055 mm to +/- 0,083 mm, without dispensing from the requirements of ISO 11608-1.
  • a glass cartridge having an inside diameter between 7,45 and 9,31 mm will, when filled with a liquid U200 insulin, be able to fulfil the ISO 11608-1 standard when the cartridge is being used in a precision insulin delivery system having a displacement accuracy of the mechanism advancing the piston within the range from 0,055 mm to 0,083 mm.
  • Glass cartridges with an inside diameter in the claimed range can therefore be used both in insulin pump systems and in insulin injection systems.
  • the cartridge can be made very slim and with very narrow tolerances, leaving maximum tolerances for the imprecision of the insulin delivery system.
  • a glass cartridge having a nominal inside diameter of 7,5 mm needs a length of the stroke zone of approximately 34 mm in order to contain a volume of approximately 1 ,5 ml.
  • the total amount of International Unit is 300 IU, which for most patient will be sufficient for three days of treatment.
  • the pump is usually connected to the body of the user through a catheter. Due to inflammation of the skin at the site where the catheter is inserted, it is normally recommended to change the catheter and the site approximately every third day. A cartridge containing insulin for minimum three days are therefore to be preferred.
  • the overall length of such a car- tridge will be approximately 52 mm.
  • a glass cartridge having a nominal inside diameter of 9,25 mm needs a length of the stroke zone of approximately 23 mm in order to contain a volume of approximately 1 ,5 ml, resulting in an overall length of approximately 44 mm.
  • Figure 1 Shows a table of the displacement accuracy for different cartridge designs
  • FIG. 2 Shows a glass cartridge including needle penetration according to the invention.
  • the figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out.
  • the same reference numerals are used for identical or corresponding parts.
  • FIG. 1 A table of the displacement accuracy for different cartridge designs is shown in figure 1.
  • the displacement accuracy of an insulin delivery system using a cartridge having a nominal diameter of 9,25 mm must be 0,084 mm when the cartridge contains a liquid U100 insulin.
  • distal end of the cartridge 1 is meant to refer to the end carrying the conduit 7 through which the insulin is expelled, whereas the term “proximal end” is meant to refer to the opposite end carrying the piston 9.
  • a cartridge 1 comprising a cylindrical wall 2 is disclosed in figure 2.
  • the cylindrical wall 2 is at the distal end 10 of the cartridge terminated in a neck part ending in a circumferential flange 3 against which a piercable and flexible membrane 4 is held sealingly by a metal cap 5.
  • the metal cap 5 At a central part of the membrane 4 the metal cap 5 has an opening 6 through which the membrane 4 is exposed.
  • a hollow conduit 7, such as an injection needle or a catheter can be stuck through the membrane 4 to communicate with the inner space of the cartridge 1 in which the liquid insulin is stored between the membrane 4 and a front wall 8 of a piston 9 which fits into the cartridge 1.
  • the piston 9 is usually made from a suitable rubber material, such that it is tightly sealed against the inside of the cylindrical wall 2.
  • the inside diameter of the glass cartridge is indicated with D in figure 1.
  • the cartridge 1 is divided into three different zones.
  • the first zone is the connecting zone C, which extends from the distal end 10 of the cartridge 1 to the shoulder 12. Due to the re- quizd diameter of the cylindrical wall 2 of the cartridge 1 on the part of the cylindrical wall 2 lying between the distal end 10 of the cartridge 1 and the shoulder 12, the piston 9 cannot be moved beyond the shoulder 12 and into the neck part area of the cartridge 1. The insulin contained in the neck part of the cartridge 1 can therefore not be pressed out of the cartridge, and will hence be disposed of when the cartridge 1 is discarded.
  • the second zone is the stroke zone S, which extends from the shoulder 12 to the front wall 8 of the piston 9. Only the insulin contained in the stroke zone can be utilized for injection or infusion.
  • the third zone is the piston zone P, which extends from the proximal end 11 of the cartridge 1 to the front wall 8 of the piston 9. This piston zone P holds the piston 9 and is therefore not available for the insulin contained in the cartridge 1.

Landscapes

  • 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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • External Artificial Organs (AREA)

Abstract

Cette invention se rapporte à une cartouche en verre qui peut être utilisée à la fois dans un système de pompe à insuline et dans un système d'injection d'insuline. Cette cartouche en verre contient de l'insuline U200. Pour obtenir une précision appropriée des doses distribuées par ce système, il faut que le diamètre intérieur de la cartouche soit compris entre 7,45 et 9,32 mm.
PCT/DK2002/000553 2001-08-31 2002-08-23 Cartouche pour insuline liquide WO2003017914A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
KR10-2004-7002694A KR20040029015A (ko) 2001-08-31 2002-08-23 액체 인슐린용 카트리지
DE60205390T DE60205390T2 (de) 2001-08-31 2002-08-23 Eine patrone für flüssiges insulin
AT02758183T ATE300933T1 (de) 2001-08-31 2002-08-23 Eine patrone für flüssiges insulin
JP2003522437A JP2005507682A (ja) 2001-08-31 2002-08-23 液状インシュリン用カートリッジ
IL15990102A IL159901A0 (en) 2001-08-31 2002-08-23 A cartridge for liquid insulin
EP02758183A EP1424984B1 (fr) 2001-08-31 2002-08-23 Cartouche pour insuline liquide
CA002457943A CA2457943A1 (fr) 2001-08-31 2002-08-23 Cartouche pour insuline liquide
PL02367865A PL367865A1 (en) 2001-08-31 2002-08-23 A cartridge for liquid insulin
AU2002325201A AU2002325201B2 (en) 2001-08-31 2002-08-23 A cartridge for liquid insulin
ZA2004/00344A ZA200400344B (en) 2001-08-31 2004-01-16 A cartidge for liquid insulin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200101282 2001-08-31
DKPA200101282 2001-08-31

Publications (1)

Publication Number Publication Date
WO2003017914A1 true WO2003017914A1 (fr) 2003-03-06

Family

ID=8160689

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2002/000553 WO2003017914A1 (fr) 2001-08-31 2002-08-23 Cartouche pour insuline liquide

Country Status (15)

Country Link
EP (1) EP1424984B1 (fr)
JP (1) JP2005507682A (fr)
KR (1) KR20040029015A (fr)
CN (1) CN1264493C (fr)
AT (1) ATE300933T1 (fr)
AU (1) AU2002325201B2 (fr)
CA (1) CA2457943A1 (fr)
DE (1) DE60205390T2 (fr)
DK (1) DK1424984T3 (fr)
ES (1) ES2247366T3 (fr)
IL (1) IL159901A0 (fr)
PL (1) PL367865A1 (fr)
RU (1) RU2299723C2 (fr)
WO (1) WO2003017914A1 (fr)
ZA (1) ZA200400344B (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008055689A1 (fr) * 2006-11-10 2008-05-15 Roche Diagnostics Gmbh Récipient destiné à recevoir des liquides médicaux
WO2016150900A3 (fr) * 2015-03-23 2016-10-27 Sanofi-Aventis Deutschland Gmbh Dispositif d'injection
US10780215B2 (en) 2013-03-15 2020-09-22 Tandem Diabetes Care, Inc. Device and method for setting therapeutic parameters for an infusion device

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4585439A (en) * 1983-09-07 1986-04-29 Disetronic Ag. Portable infusion unit
US4850966A (en) * 1986-02-26 1989-07-25 Hoechst Aktiengesellschaft Device for the administration of medicament suspensions
EP0745369A2 (fr) * 1995-06-02 1996-12-04 Eli Lilly And Company Conteneurs pour médicaments liquides
WO2000071191A2 (fr) * 1999-04-30 2000-11-30 Eli Lilly And Company Ensemble cartouche pour suspensions medicamenteuses

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK503386D0 (da) * 1986-10-20 1986-10-20 Novo Industri As Peptidpraeparater
US5334162A (en) * 1993-03-15 1994-08-02 Eli Lilly And Company Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
ZA941881B (en) * 1993-04-02 1995-09-18 Lilly Co Eli Manifold medication injection apparatus and method
US6146361A (en) * 1996-09-26 2000-11-14 Becton Dickinson And Company Medication delivery pen having a 31 gauge needle
WO1999044754A1 (fr) * 1998-03-06 1999-09-10 Novo Nordisk A/S Systeme de revetement a frottement reduit

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4585439A (en) * 1983-09-07 1986-04-29 Disetronic Ag. Portable infusion unit
US4850966A (en) * 1986-02-26 1989-07-25 Hoechst Aktiengesellschaft Device for the administration of medicament suspensions
US4850966B1 (en) * 1986-02-26 1994-09-06 Hoechst Ag Device for the administration of medicament suspensions
EP0745369A2 (fr) * 1995-06-02 1996-12-04 Eli Lilly And Company Conteneurs pour médicaments liquides
WO2000071191A2 (fr) * 1999-04-30 2000-11-30 Eli Lilly And Company Ensemble cartouche pour suspensions medicamenteuses

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008055689A1 (fr) * 2006-11-10 2008-05-15 Roche Diagnostics Gmbh Récipient destiné à recevoir des liquides médicaux
US10780215B2 (en) 2013-03-15 2020-09-22 Tandem Diabetes Care, Inc. Device and method for setting therapeutic parameters for an infusion device
EP2968743B1 (fr) * 2013-03-15 2021-04-07 Tandem Diabetes Care, Inc. Dispositif et procédé pour régler des paramètres thérapeutiques pour un dispositif de perfusion
WO2016150900A3 (fr) * 2015-03-23 2016-10-27 Sanofi-Aventis Deutschland Gmbh Dispositif d'injection
US10773027B2 (en) 2015-03-23 2020-09-15 Sanofi-Aventis Deutschland Gmbh Injection Device

Also Published As

Publication number Publication date
DK1424984T3 (da) 2005-11-14
DE60205390D1 (de) 2005-09-08
EP1424984B1 (fr) 2005-08-03
EP1424984A1 (fr) 2004-06-09
AU2002325201B2 (en) 2007-11-01
CN1547459A (zh) 2004-11-17
ES2247366T3 (es) 2006-03-01
KR20040029015A (ko) 2004-04-03
ATE300933T1 (de) 2005-08-15
JP2005507682A (ja) 2005-03-24
ZA200400344B (en) 2005-03-30
IL159901A0 (en) 2004-06-20
CA2457943A1 (fr) 2003-03-06
PL367865A1 (en) 2005-03-07
CN1264493C (zh) 2006-07-19
RU2299723C2 (ru) 2007-05-27
RU2004109579A (ru) 2005-03-20
DE60205390T2 (de) 2006-04-20

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