Classifications

• • 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
  • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P5/00—Drugs for disorders of the endocrine system
  • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
  • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
  • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
  • B01F33/25—Mixers with loose mixing elements, e.g. loose balls in a receptacle
  • B01F33/251—Mixers with loose mixing elements, e.g. loose balls in a receptacle using balls as loose mixing element
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
  • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
  • B01F33/50—Movable or transportable mixing devices or plants
  • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
  • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
  • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
  • B01F35/30—Driving arrangements; Transmissions; Couplings; Brakes
  • B01F35/32—Driving arrangements
  • B01F35/32005—Type of drive
  • B01F35/3202—Hand driven
  • B01F35/32021—Shaking by hand a portable receptacle or stirrer for mixing
• • 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
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
  • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
  • B01F35/30—Driving arrangements; Transmissions; Couplings; Brakes
  • B01F35/32—Driving arrangements
  • B01F35/32005—Type of drive
  • B01F35/3202—Hand driven

Definitions

• the present invention relates to a device for the administration of a medicament suspension, particularly a device holding a medicament container filled with a medicament suspension and including two mixing elements of a predetermined size and density for mixing of medicaments that includes suspended particulates.
• Medicaments are usually filled in containers, which also contain a gas space above the suspension.
• the suspended particulate in the medicament suspension frequently settles down to form a deposit.
• the patient uses a combination of the rolling of the container between the palms and by turning the container upside down.
• the former procedure mainly loosens deposit from the walls whereas the latter mainly ensures proper mixing along the length of the cartridges.
• the suspension can be homogenized by shaking the suspension and all this mobility is essentially due to the presence of the gas space in the container.
• lubricant dispersions and paints which are filled into spray cans
• the lubricants are easily dispersible substances such as molybdenum sulfide and graphite which can easily be converted into a sprayable form by a few shaking movements.
• EP 235.691 discloses a medica- ment container, such as an injection ampoule or cartridge, for multiple administration of a medicament suspension.
• the container is filled with medicament so as to be free of gas bubbles, and includes at least one inert mixing element of suitable size whose density is different from that of the suspension.
• the mixing element acts to homogenize the medicament suspension as the container is shaken.
• the material of which all the mixing element is made are the same for instance, as mentioned in example 2, two glass beads are used for homogenization of the medicament suspension.
• the object of the present invention is to overcome the before-mentioned disadvantages and provide for several advantages for the resuspension of the particulates that are initially deposited at a side-or end-wall of a cartridge. It is yet another object of the present invention to ensure that one of the mixing beads is never buried within the deposited particulate.
• Yet still another object of the present invention is to improve the efficiency of the current mixing procedure.
• the present invention provides for a container for storage and administration of a medicament suspension which container has two mixing elements which differ with respect to their density such that one element has a density significantly above the background liquid density and above the fully mixed suspension density and the other element has a density significantly below the background liquid density and below the fully mixed suspension density.
• mixing elements are the preferred number any number can be used as long as at least two of the mixing elements differ with respect to their density as explained.
• the term "medicament” or “drug” is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow nee- die in a controlled manner, such as a liquid, solution, gel or fine suspension.
• a delivery means such as a hollow nee- die in a controlled manner, such as a liquid, solution, gel or fine suspension.
• Representative drugs includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
• subcutaneous injection is meant to encompass any method of transcutaneous delivery to a subject.
• “Inert” as used in the present application is taken to mean that a mixing element neither in- teracts chemically nor physically in an interfering manner with the medicament preparation. Thus, neither a chemical change nor a physical impairment such as adsorption or abrasion may occur to a significant extent.
• “Supension” is taken to mean a background liquid in which particulate matter is suspended. Further the term “injection needle” defines a piercing member adapted to penetrate the skin of a subject for the purpose of delivering or removing a liquid.
• Fig. 1 illustrates a situation where the cartridge/container have rested for a long time and particulates with a density above the background liquid have settled at the distal end near the outlet port.
• Fig. 2 illustrates a situation where the cartridge/container has rested for a long time and particulates with a density below the background liquid have settled at the proximal end near the plunger.
• Fig. 3 shows the rolling motion of the cartridge during the resuspension procedure.
• Fig. 4 shows the upside-down turning motion of the cartridge during the resuspension procedure.
• Fig. 5 illustrates that the cartridge has been stored on the side for some time with the deposited material having a larger density than the liquid.
• Fig. 6 illustrates upside down turning procedure of the cartridge having two mixing beads according to the present invention.
• Fig. 7 illustrates a proper dimensioning of the beads for achieving a suitable passing position in the cartridge.
• proximal end in the appended figures is meant to refer to the end of the filled cartridge carrying the plunger whereas the term “distal end” is meant to refer to the opposite end of the filled cartridge carrying the outlet port to which an injection needle is coupled in use.
• the mixing element preferably has a spherical shape but it is to be understood to a person skilled in the art that the shape of the mixing element is not to be limited to being a sphere.
• the container 1 has a movable plunger 2 at the proximal end and is filled with a medicament suspension so as to be bubble free and contains one or more spherical mixing element 5, 6.
• the container 1 is provided with an outlet port 4 typically covered by a rubber membrane which can be penetrated by the injection needle.
• Figure 1 shows a situation where the cartridge 1 has rested for a long time and the particulate 3 has settled with a density above the density of the background liquid and with the first mixing element 5 buried in the particulate 3.
• the second mixing element 6 is outside the region of the particulate 3.
• the reason for the second mixing element 6 being outside the region of the particulate 3 is because the density of the second mixing element 6 is smaller than the density of the background liquid. Buoyancy therefore ensures that the second mixing element 6 that is lighter is available for the mixing procedure.
• buoyancy ensures that the first mixing element 5 which is heavier is outside the region of the suspension and is available for the mixing procedure.
• Figures 1 and 2 therefore are illustrative of the fact that one of the two mixing elements is never buried within the deposited particulate and is always available for mixing.
• FIGS 3 to 7 demonstrate the improved efficiency of the mixing procedure because of the presence of two mixing elements having different densities.
• Figure 3 shows the rolling motion of the cartridge during the re-suspension procedure.
• the mixing elements 5, 6 play a minor role in the re-suspension procedure during rolling, the presence of these two elements approximately doubles the efficiency of the elements, compared to having one element.
• the light mixing element 6 will be on the upward facing side of the cartridge whereas the heavy mixing element 5 will be at the downwards facing side and consequently mixing is achieved in a double acting way.
• the deposit material may stick to the surface and if, by chance, the cartridge is turned so that the deposit material 7 is placed on the upper side of the cartridge, the heavy mixing element 5 is actually outside the deposit material 7 during the re-suspension procedure.
• adding the second mixing element increases the likelihood of said elements passing through the deposit.
• FIG 7 Another situation is as shown in Figure 7, which improves the mixing process because of the interaction between the mixing elements.
• the cartridge is shown in the upside down position and the heavy mixing element 5 will move downwards along the lower side of the wall whereas the low density mixing element 6 will move upwards along the upper side of the wall.
• the velocity of the two beads 5, 6 may be adjusted as desired. For example, if the light mixing element travels with half the velocity of the heavy mixing element 5, the two elements will meet at 1/3 and 2/3 cartridge length respectively during a full upside down turn of the cartridge as shown in this figure.
• the lighter mixing element 6 may be introduced as a hollow glass sphere. Alternatively, a low-density material like plastic material may be used. Said material should be inert with respect to the medicament suspension.
• the dimension of said lighter element is determined from the properties of the existing high-density element 5 such that the velocity of the light mixing element 6 is a fraction of the velocity of the high mixing element 5. This velocity is a function of the element and liquid densities, liquid viscosity and element size.
• the density of the suspension is not likely to vary very much and consequently, the range of the required low density elements/beads depends mainly on the range of viscosities. Estimates of suitable element size and density results from relatively simple calculations.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Engineering & Computer Science (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Vascular Medicine (AREA)
• Hematology (AREA)
• Diabetes (AREA)
• Heart & Thoracic Surgery (AREA)
• Anesthesiology (AREA)
• Medicinal Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• General Chemical & Material Sciences (AREA)
• Organic Chemistry (AREA)
• Endocrinology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Pharmacology & Pharmacy (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Medicinal Preparation (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Priority Applications (1)

Applications Claiming Priority (3)

Publications (1)

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Family Applications (1)

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• 2006
  • 2006-04-28 EP EP06754922A patent/EP1890747A1/de not_active Withdrawn
  • 2006-04-28 CN CNB2006800150801A patent/CN100571802C/zh not_active Expired - Fee Related
  • 2006-04-28 WO PCT/EP2006/061922 patent/WO2006117340A1/en not_active Ceased
  • 2006-04-28 US US11/912,349 patent/US20080161756A1/en not_active Abandoned
  • 2006-04-28 JP JP2008509420A patent/JP2008539838A/ja not_active Withdrawn

Non-Patent Citations (1)

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