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
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• • 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
  • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
  • A61J7/0015—Devices specially adapted for taking medicines
  • A61J7/0038—Straws
• • 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
  • 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
  • B01F33/50112—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 of the syringe or cartridge type
• • 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
  • B01F35/71—Feed mechanisms
  • B01F35/713—Feed mechanisms comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
  • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
  • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions

Definitions

• the invention relates to a device for mixing a pharmaceutical, preferably dry and granular, composition, with another, preferably fluid, agent to a preparation, preferably a gel, in accor ance with the preamble of claim 1.
• the major problem forming the basis for the present invention relates to the handling, the storage and the administration of a pharmaceutical composition to be mixed with another agent, that may adversely affect the stability of the composition to form a preparation suited for administration to a living being, especially an animal.
• such preparations e.g. comprising a mixture of a pharmaceutical composition and a consistency forming agent
• a consistency forming agent will have a sho ⁇ storage stability. Therefore, the components comprised in those preparations must be kept isolated from each other until a short time before use, when they are mixed with each other to form the desired preparation.
• the most common prior solution is a syringe of the kind disclosed in the US-A-3 340 873, having a plunger, slidably accommodated in a cylindrical body.
• the two components to be mixed are contained in two different compartments, isolated from each other by a thin diaphragm. Shortly before the preparation is to be used, the diaphragm is ruptured or pierced, so that a communication is established between the two compartments.
• the syringe, with the mixture is then shaken to form a homogenous preparation. After this operation a cap is removed to open a passage and the content is expelled through a needle by depressing the plunger.
• compositions comprising a proton pump inhibitor, such as omeprazole, which degrades during long term storage in the presence of moisture.
• a proton pump inhibitor such as omeprazole
• DK Patent Specification 112 893 filed July 25, 1966 discloses an injection syringe for the injection of a pharmaceutical composition, that can not be stored in solution for a longer period of time without detrimental effects.
• the syringe basically corresponds to a standard syringe, the main difference being that the opening in the needle fitting is sealed by a diaphragm.
• the composition is contained in the syringe in dry form.
• a double ended injection needle is mounted on the needle fitting, one end of the needle piercing the diaphragm. Solvent is aspirated into the syringe through the needle. Then the syringe is shaken and the resulting solution is injected through the needle.
• a drawback with this type of syringe is that the filling operation is rather complex, it requires the mounting of a double-ended injection needle for piercing the diaphragm. Furth ⁇ ermore, after the rupture of the diaphragm, the rnixing chamber will be open to the air, so that care must be taken during the shaking operation to prevent the mixture from leaking out through the needle. Further, because of the .ligh flow resistance of the syringe due to the narrow passages therein, in particular in the needle, it could not be used for viscous, pasty or gel-like preparations. Moreover, this known apparatus is not suited for oral admini ⁇ stration because of the needle. Furthermore, the manufacturing costs for the syringe will be relatively high.
• An object of the invention is to obviate the disadvantages of the prior art by providing a mixing device, in which a pharmaceutical composition may be stored for a longer period of time and to which a desired agent easily and rapidly can be added immediately before the administration of the preparation. After addition of the agent the device also should be capable of being vigorously shaken without leaking. Furthermore, the manufacturing cost for the device of the invention should be relatively low.
• a package or a seal which protects the prefilled chamber against moisture during storage first has to be removed. Then the agent to be mixed with the composition contained in the chamber is supplied, the fluid agent being separated from the chamber by the flexible sealing member. Then the plunger is displaced in opposite direction to the expel direction causing an expansion of the closed chamber defined by the plunger, the side wall portion and the closure, thereby creating a vacuum in the chamber. Initially, the pressure differential over the sealing member will be too low to flex it, but when the plunger continues to be displaced the vacuum in the chamber gradually increases so that the sealing member deforms and looses its contact with the wall, thereby establishing a communication into the chamber. Th agent will then be aspirated into the chamber.
• the device When the required amount of agent has been drawn into the chamber and the flexible sealing member has flexed back to its rest position, the device is shaken until the preparation is ready for administration. Just before the administration is to be carried out, the closure to the chamber is removed and the device is inserted in for example the mouth of a horse. The content of the device is now expelled by depressing the plunger.
• Fig. 1 is an axial section of a first preferred embodiment of the invention.
• Fig. 2 shows the encircled portion in Fig. 1 at a larger scale
• Fig. 3 is a cross- section along the line HI- HI in Fig. 1,
• Fig. 4 is an axial section of a further embodimenL which is slightly modified in relation to that of Figs 1-3,
• Fig. 5 shows the encircled portion of Fig. 4 at a larger scale
• Fig. 6 is a section along the line VI- VI of Fig. 4,
• Fig. 7 shows a part of a slight modification of the embodiment of Fig. 4 at a larger scale
• Fig. 8 is an axial section of still another embodiment of the invention.
• Fig. 9 is a section along the line D -IX of Fig. 8,
• Fig. 10 shows the encircled portion of Fig. 8 at a larger scale
• Fig. 11 discloses a slight modification of the embodiment of Figs 8-10.
• the syringe- like device of the first preferred embodiment of the in- vention comprises a tubular, elongated, cylindrical hollow body 2, which is open at both ends.
• the lower end in Fig. 1 is the outlet end 4.
• a plunger 6 is inserted through the open upper end 10.
• a flange portion or a finger grip portion 13 extends substantially per ⁇ pendicular to the longitudinal direction of the hollow body 2 around the upper end thereof.
• the outlet end 4 is closed by a removable lid 12, which has a groove 14, having a diameter corresponding to that of the side wall 8 of the hollow body 2.
• the groove 14 is constructed with a depth to provide an airtight seal with the lower end 4 of the cylindrical body into the interior of the hollow body 2.
• the lid 12 has a radially extending lug 16 to facilitate the removal of the lid 12 when the preparation is to be expelled.
• the plunger 6 is comprised by two parts 18, 20.
• a support means 18 in the form of a flat web, which extends diametrically, perpendicularly to the axis of the hollow body 2 and a sealing member 20 in the shape of a thin, flexible disc, which when unloaded is sized to sealingly contact the inner wall 8 of the hollow body 2, thereby isolating the spaces on each side of the sealing member 20 from each other.
• the disc 20 is at the centre provided with a peg 22, having a compressible bulged end portion 24, while the web 18 has a centre aperture 26 having a diameter less than that of the bulge portion 24.
• the shank 28 of the peg 22 is adapted to the thickness of the web 18, so that the peg 22 may be snapped into the aperture 26, so that the disc 20 will lie close to the web 18.
• a rod 30 is made integral with the plunger 6. Its external diameter is somewhat smaller than the internal diameter of the hollow body 2, so that the rod 30 is slidably guided therein.
• the rod 30 is tubular, and its annular end portion 32 is made in one piece with the web 18. The end face ⁇ f said portion 32 flushes with the end face (the lower face in Fig. 1) of the web 18.
• a radially extending finger grip 23 is provided at the open end 40 of the rod 30 .
• the flexible disc 20 is made of a resilient material and will deflect, when subjected to a sufficiently large force and return to its original position upon the removal of said force.
• a closed chamber 38 is defined by the lid 12 or other seal, the flexible disc 20 and the inner wall 8 of the hollow body, the volume of said chamber being variable due to the axially displaceable plunger 6.
• the unloaded disc 20 rests against the web 18 and the annular end portion of the rod 30.
• the edge portion 34 of the disc 20 is prevented from flexing upwards by the web 18 and the annular end portion 32.
• the edge portion 34 is allowed to flex downwardly. If this occurs the edge portion 34 will loose its sealing contact with the inner wall 8 of the hollow body 2, thereby opening a communication at the wall 8 between the upper and lower sides of the flexible disc 20.
• the disc 20 thus functions as a non-return valve.
• any method for fixing the resilient disc 20 to the rod 30 may be used.
• a keyhole connection could be used.
• a keyhold aperture is then provided at the bottom end of the rod 30 and, the peg 22 of the sealing disc 20 then being introduced through the wider opening of the keyhole and then being pushed into the narrower slit of the keyhole.
• the flexible disc 20 may be provided with a shank portion at the center thereof which portion then is introduced in an aperture provided at the lower end of the rod 30. The end of shank is then heatened to a softening temperature and thereupon flattened to form a rivet joint- like connection.
• the rod 30 is tubular and has an open bottom and, which normally is sealed by the flexible disc 20.
• the interior 36 of the rod 30 and the disc 20 form a filling compartment for the agent to be mixed with a composition contained in the chamber.
• composition for the device is described in WO/SE94/25070.
• the pharmaceutical composition is constituted by beads of an active substance, such as enteric coating layered omeprazole pellets mixed with a gelforming agent such as xanthan gum, guar gum, locust bean gum. tragacanth, modified cellulose derivates or similar, to which mixture of dry components a fluid agent such as for instance water later is added for forming a viscous gel.
• a gelforming agent such as xanthan gum, guar gum, locust bean gum.
• tragacanth modified cellulose derivates or similar, to which mixture of dry components a fluid agent such as for instance water later is added for forming a viscous gel.
• a fluid agent such as for instance water later is added for forming a viscous gel.
• a suitable dosage of a dry mixture of enteric coating layered omeprazole pellets and a gelforming agent is filled into the chamber 38.
• a buffering or pH-adjusting agent such as citric acid may optionally be added to prevent premature dissolution of the enteric coated beads when water later is added to the composition.
• This operation could be carried out in two ways, either the plunger 6 is placed in a suitable position in the hollow body 2 with the lid 12 removed, the filling then taking place through the lower end 4, or the lid 12 is applied on the lower end 4 with the plunger 6 removed, the filling then taking place via the upper opening 10.
• the quantity or the volume of the mixture is optional within certain limits, since the volume of the chamber 38 is variable because of the axially displaceable plunger 6.
• the hollow rod 30 in an advantageous manner serves as a metering device for the agent to be added to the chamber 38. It is transparent and preferably provided with gradation lines, so that the agent to be added precisely could be measured with the device. Superfluous agent may be poured off from the rod 30 before the rod 30 has been displaced to open a communication into the chamber 38.
• a very precise measuring of the agent to be added can be made without the need of any additional means than the syringe itself.
• the content in the chamber must be protected against penetrating moisture, which else would accumulate in the gelfo ⁇ riing agent to sooner or later cause degradation of the omeprazole during long-term storage. Therefore, after the filling operation, the device is enclosed in a moisture tight envelope, preferably having a moisture barrier made of aluminium, but other materials fulfilling the same purpose are of course also conceivable.
• a siccative preferably in a small bag, is enclosed in the envelope as a further protection against moisture.
• the device When to be used, the device is taken out from the moisture tight package or the seal on top of the tubular rod 30 is removed. A suitable quantity of water to be added to the mixture within the chamber 38 is then filled into the tubular compartment of the rod 30 up to a desired level (marked by a gradation line or level mark). The plunger 6 is then displaced upwardly, thus creating a vacuum in the chamber 38. After a sufficient displacement, the vacuum will be so strong therein, that the flexible disc 20 will flex downwards, the circumferential edge 34 of the flexible disc 20 loosing its sealing contact with the inner wall 8, so that a communication is established from the compartment 36 into the chamber 38, so that the water in the compartment 36 of the rod 30 will be aspirated into the chamber 38.
• the disc 20 When the water has been transferred thereto, the disc 20 will flex back to its rest position and the device is then shaken until a viscous gel containing the omeprazole pellets has been formed. During the shaking operation, the mixture is prevented by the flexible disc 20 to leak into the compartment 36.
• the mixture could be stored in the device for a short period of time before administration. Just before administration the lid 12 is removed and the device is placed, where the preparation is to be administered. The preparation is then expelled by depressing the rod 30.
• the rod 30 has such an axial length, that when fully depressed, all of the preparation is expelled from the device.
• the flexible disc 20 has an even surface to expel the composition completely, thereby avoiding the risk for any residues, pellets or gel, being left in openings or slits, which could happen with a slitted disc.
• a tear-off or a rupturable seal could be provided to seal the chamber 38.
• Fig. 4 demonstrates a slight modification of the embodiment of Figs 1-3.
• the tubular rod 30a has two opposed longitudinal slits 42, which extend from the bottom portion of the rod 30a up to about half the height of the rod 30a, thereby providing a communication between the interior 36a of the rod 30a and the upper side of the disc 20a.
• the bottom portion comprises an aperture 26a in the centre, which functions in a similar way as the aperture 26 in the embodiment of Fig. 1.
• the bottom portion of the rod 30 is circular and provides a support for the middle portion of the flexible disc 20a.
• the sealing member 20'a is integral with the rod 30'a and consists of an annular flexible ring, see Fig. 7.
• the advantage of this embodiment is that it only requires a single operation in the manufacture of the rod 30'a and the sealing member 20'a.
• the upper part of the rod 30b is tubular, while the lower part 46 thereof has a section in the shape of a cross, as clearly could be seen in Fig. 9.
• the lower part consists of two longitudinally extending, pe ⁇ endicular wall portions 48, 50, which extend from the bottom portion of the rod 30b up to about half the height of the rod 30b.
• the cross-shaped portion 46 includes a first part having a constant section to provide sufficient stiffness and guidance against the inner wall 8.
• the following part 56 tapers downwards towards the bottom portion, which in turn comprises an annular rim 60 to support the flexible disc 20b and prevent it from being flexed upwardly.
• the bottom portion also includes an aperture 62, into which the bulge 24b of the flexible disc 20b is snapped (cf. Fig. 10).
• FIG. 11 A modification of the Figs. 8-10 embodiment is shown in Fig. 11.
• the flexible sealing member 34'b is integral with the rod 30b. which has a radially protruding annular rim 60', which is prolonged by a thinner flexible annular edge 34'b in sealing contact with the inner wall 8 of the hollow body 2.
• the water to be added is introduced as before through the open end 40 of the rod 30b but in opposition to the previously described embodiments the water will not be contained in a lower tubular portion of the rod. but will rise along the cross-shaped portion up to a desired level.
• the cross-shaped portion could be provided with coloured lines to indicate the volume levels.
• the rod must not be transparent but can be made in an appropriate colour.
• a fluid agent preferably water
• water is filled into the upper end 40 of the rod 30, which water then flows through the opening provided in the rod and subsequently reaches the upper side of the flexible sealing member.
• the sealing member prevents the water from reaching the chamber 38.
• the rod will then be displaced backwards, thereby creating a vacuum in the chamber 38.
• the combined action of the weight of the water and the vacuum will flex the sealing member downwards, so that water will be aspirated into the chamber 38.
• said member will flex back to its original rest position and seal off the chamber 38.
• the sealing member is a separate constructional detail, it offers a great freedom in the choice of material.
• the material in the sealing mem er can be chosen to have optimal sealing and elastic properties, w hue the material in the rod can be chosen to provide sufficient stiffness and support for the sealing member. If the rod and the sealing member are made integral, the choice of material must be a compromise between required stiffness of the rod and needed flexibility and elasticity of the sealing member. However, this latter solution offers advantages as regards manufacturing costs.
• all the elements can be made of polymeric materials, such as for instance polyethylene, polypropylene, polyester, elastomer, polycarbonate, rubber or silicone, and manufactured by conventional and cheap methods, such as injection moulding. Moreover, all the details have a simple construction and are easy to assemble. Consequently, the devices can be produced at a low cost
• the lid 12 is provided with an radially protruding lug 16, which extends around a part of the circumference of the lid 12 and forms a grip portion for facilitating the removal of said element
• the grip portion may have any suitable configuration. For example, it could be oval, or it could be constituted by a protruding flange extending over the whole circumference of the lid.
• the devices are in particular suited for oral administration to an animal, especially a horse, in particular of an aqueous gel containing a formulation of a proton pump inhibitor e.g. omeprazole or a similar composition.
• a proton pump inhibitor e.g. omeprazole or a similar composition.
• the use of the device is not restricted to this field, since it can be used for rnixing various kinds of pharmaceutical compositions with other agents, and for oral, rectal or any other suitable administration to many different kinds of living beings, including humans.
• compositions in the sense of this application does not solely mean a drug, also other kinds of beneficial agents, for instance essential nut ⁇ rients are intended to be included by this expression.

Landscapes

• Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Pharmacology & Pharmacy (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Package Specialized In Special Use (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Priority Applications (11)

Applications Claiming Priority (2)

Publications (1)

Family

ID=20398172

Family Applications (1)

Country Status (21)

Cited By (5)

Families Citing this family (2)

Citations (2)

• 1995
  • 1995-05-03 SE SE9501631A patent/SE504683C2/sv not_active IP Right Cessation
• 1996
  • 1996-04-05 TW TW085103956A patent/TW341520B/zh active
  • 1996-04-22 ZA ZA963190A patent/ZA963190B/xx unknown
  • 1996-04-23 HU HU9801947A patent/HUP9801947A3/hu unknown
  • 1996-04-23 KR KR1019970707794A patent/KR19990008268A/ko not_active Application Discontinuation
  • 1996-04-23 CA CA002218739A patent/CA2218739A1/en not_active Abandoned
  • 1996-04-23 PL PL96323157A patent/PL323157A1/xx unknown
  • 1996-04-23 JP JP8533227A patent/JPH11504245A/ja active Pending
  • 1996-04-23 WO PCT/SE1996/000527 patent/WO1996034681A1/en not_active Application Discontinuation
  • 1996-04-23 AU AU55203/96A patent/AU700156B2/en not_active Ceased
  • 1996-04-23 NZ NZ306603A patent/NZ306603A/en unknown
  • 1996-04-23 EP EP96912371A patent/EP0827419A1/en not_active Withdrawn
  • 1996-04-23 BR BR9608271A patent/BR9608271A/pt unknown
  • 1996-04-23 EE EE9700265A patent/EE9700265A/xx unknown
  • 1996-04-23 SK SK1428-97A patent/SK142897A3/sk unknown
  • 1996-04-23 TR TR97/01288T patent/TR199701288T1/xx unknown
  • 1996-04-23 CZ CZ973456A patent/CZ345697A3/cs unknown
  • 1996-04-23 CN CN96193658A patent/CN1183057A/zh active Pending
  • 1996-05-02 AR AR33638396A patent/AR001841A1/es unknown
• 1997
  • 1997-10-20 IS IS4595A patent/IS4595A/is unknown
  • 1997-10-31 NO NO975019A patent/NO975019L/no not_active Application Discontinuation

Patent Citations (2)

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