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
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
• • 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
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
  • A61J1/035—Blister-type containers
• • 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
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2079—Filtering means
• • 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
  • A61J1/2093—Containers having several compartments for products to be mixed
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D47/00—Closures with filling and discharging, or with discharging, devices
  • B65D47/36—Closures with frangible parts adapted to be pierced, torn or removed, to provide discharge openings
  • B65D47/38—Closures with frangible parts adapted to be pierced, torn or removed, to provide discharge openings with piercing means arranged to act subsequently as a valve to control the opening
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D51/00—Closures not otherwise provided for
  • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
  • B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
  • B65D51/2807—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
  • B65D51/2814—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it
  • B65D51/2821—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a blister, a capsule or like sealed container
• • 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
  • A61J1/065—Rigid ampoules, e.g. glass ampoules
• • 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
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • 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
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2027—Separating means having frangible parts
• • 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
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2079—Filtering means
  • A61J1/2086—Filtering means for fluid filtration

Definitions

• the present invention relates to devices for packaging, preservation and extemporaneous preparation of several active principles, especially at very low dosages and in particular fragile, labile or unstable active ingredients, with a view more particularly to their local or systemic, intravenous administration, intramuscular, subcutaneous or oral mucosa.
• WO2009138644 discloses a device for performing a mixture between an active ingredient, preserved in hermetic and sterile conditions in the interior space of a movable head of said device, movable head provided with a means of rupture, for breaking a membrane waterproof sealing an underlying waterproof tank compartment, containing a liquid solvent of the active ingredient by reference, solvent also sterile.
• the break-in of the membrane by the breaking means of the movable head allows instantaneous extemporaneous dissolution of the active ingredient deposited in said moving head, during the meeting between active ingredient and liquid dissolution.
• This device makes it possible, without any externalization of the contents and in an always tight and sterile atmosphere, to carry out the bringing into contact between the active principle and the solvent, in order to obtain the instantaneous dissolution of the active principle. More particularly, this device allows extemporaneous dissolution under sterile conditions, very low dosages of active principle, typically from less than 1 mg to a few tens of milligrams only, minute dosages that the human hand can not handle without generating loss or alteration or contamination of their dry or liquid elements.
• the document WO2009016309 similarly describes a means for dissolving the active principle that can be administered by the oral mucosa route, in the form of a high-alcohol ethanol aqueous solution, contained in a sealed reservoir, sealed by a perforable membrane. This dissolution is obtained after extemporaneous mixing internal to said device, between active ingredient and solvent.
• the device also allows therapeutic administration of the small volume solution (typically less than 5 ml), by its precise deposition in contact with an oral mucosal area, by means of a cannula forming the upper part of said device.
• the active ingredient is simply deposited during packaging in enclosures constituting each of the two devices, in this case in the documents WO2009138644 and WO2009016309, the walls of the movable head and also the floor constituted by the membrane perforable, which can support said active ingredient, while sealingly sealing the solvent reservoir.
• the walls of the movable head and also the floor constituted by the membrane perforable which can support said active ingredient, while sealingly sealing the solvent reservoir.
• Documents FR2564433, EP1023229, US2002030056 and US6644471 describe other devices of the prior art.
• the object of the present invention is to overcome the above-mentioned drawbacks of existing devices, and in particular those of documents WO2009138644 and WO2009016309, by facilitating their industrialization and their processes for packaging substances, while providing them with additional skills, in particular easier operation. complex component preparations and / or multiple solvents.
• the present invention aims in particular to improve by simplifying the terms and costs of industrial manufacturing of these devices, to better ensure protection, conservation and intrinsic quality in the long term - for at least three years of delay expiry - of several active ingredients introduced in these same devices, active ingredients often extremely fragile and very expensive (sometimes several thousand euros per dose).
• the present invention also aims to provide a simple technical solution that will, without complicating or increasing the manufacturing of devices considered, to prevent any risk of contamination and / or chemical degradation of active ingredients over time, for example in the context a possible content / container interaction, and thus prevent the requirements of studies and controls stemming from the Regulations.
• the present invention proposes in particular to entrust the separating membrane, located between the dry compartment and the fluid compartment, with dual competence: while remaining a perforable intercompartmental waterproofing membrane, it now has a capacity of a container of multiple active ingredients, both assembled within it but also perfectly separated from each other.
• the present invention therefore relates to a device for packaging, preservation and extemporaneous preparation of several active ingredients, comprising a reservoir, comprising at least one compartment intended to contain at least one volume of liquid, said reservoir having a neck defining an opening of the reservoir, a head movable relative to said reservoir between a first storage position in which said head is in a distal position by relative to the body and a second preparation position in which said head is in a position proximal to the body, means for sealing the neck of said tank, and means for breaking said sealing means, said sealing means being formed by a sealed blister containing at least two active ingredients, said blister having at least two compartments separated by longitudinal and / or transverse partitions and / or superimposed, each compartment containing an active ingredient, said blister being fixed on the neck of said reservoir for the sealingly closing, such that after opening said blister by said breaking means, said active ingredients come into contact with the liquid and dissolve therein.
• At least one active ingredient is in solid form.
• At least one active ingredient is in the form of powder, lyoc, lyophilisate, tablet or gel.
• At least one active ingredient is in liquid form.
• said blister comprises an outer wall facing outwardly of the reservoir and an inner wall facing towards the inside of the reservoir.
• said blister comprises a radially outer peripheral flange fixed on a radial edge of said tank.
• said fixing is carried out by hot sealing or high frequency polymerization or mechanical stress-tight crimping processes with flexible joints under a ring formed or retracted or crimped.
• said blister is previously manufactured, filled with said active ingredients and sealed, before being sealingly attached to said reservoir.
• a seal is interposed between the head and the reservoir to ensure sealing after opening the blister by the breaking means.
• said liquid contained in the reservoir is a solvent or a hydro-alcoholic solution.
• the volume of said liquid contained in the reservoir is less than 5 ml.
• said reservoir comprises a filling opening opposite to said neck of the reservoir, said filling opening being, after filling said reservoir with said liquid, sealingly sealed by a stopper, advantageously secured to a gripping pallet.
• said head comprises a filter and a sampling membrane, an internal component, preferably in the form of a hollow cylinder, being inserted into said head to define said sampling chamber in the volume delimited in said internal component between said filter and said sampling membrane.
• the dimensions of said internal component are adjustable to define sampling chambers of varying shapes and volumes.
• said movable head comprises a cannula whose dispensing orifice is closed by an end plug containing solid or liquid active principles, held in said end cap by a separation membrane, said active ingredients being released into said cannula by breaking said separation membrane, advantageously by a complete screwing of said end cap to said dispensing orifice of said cannula.
• said movable head comprises a cannula whose dispensing orifice is closed by an end plug containing at least one solid or liquid active principle, held in said end cap by a separation membrane, said cannula also containing at least one solid or liquid active principle, said active ingredients being mixed in said cannula by breaking said separation membrane, advantageously by a complete screwing of said end cap onto said dispensing orifice of said cannula.
• FIG. 1 is a perspective view of the device according to a first advantageous embodiment of the invention
• FIG. 2 is a diagrammatic sectional view of the device of FIG. 1, before use,
• FIGS. 3 and 4 show schematic views of two variants of the invention
• FIGS. 5 to 7 show diagrammatic views from above of three other variants of the invention.
• FIG. 8 is a schematic sectional view of a second advantageous embodiment of the invention.
• a device 10 comprising a reservoir 12 which can be in any material avoiding evaporation through the wall and able to prevent the action of light or air on the contents.
• the material constituting the reservoir 12 does not release unwanted constituent substances in contact with the solvent it contains, in particular an aqueous solvent.
• This reservoir comprises a neck defining a dispensing opening through which the contents of said reservoir can be dispensed.
• Such a reservoir is advantageously thick monobloc plastic or glass, preferably opacified, pharmaceutical grade, with high mechanical strength, any section, for example square, oval, rectangular, triangular or round.
• This device 10 comprises a head 14, secured in a mobile manner at least in translation relative to the reservoir 12.
• This head 14 is movable between a first storage position in which said head 14 is distal to the reservoir 12 and a second preparation position in which said head 14 is proximal to the reservoir 12.
• the reservoir 12 comprises at least one compartment intended to contain a very small volume of at least one pharmaceutical solvent 22, such as saline for an application in injectable form, or an aqueous-alcoholic solution to allow the administration of the active ingredients dissolving in contact with the oral mucosa.
• a pharmaceutical solvent 22 such as saline for an application in injectable form, or an aqueous-alcoholic solution to allow the administration of the active ingredients dissolving in contact with the oral mucosa.
• the volume of solvent in a compartment is a volume of less than 5 ml, very preferably less than 1 ml.
• the neck of the reservoir 12 is closed in a sealed manner.
• this sealing of the reservoir neck is carried out by a blister-shaped membrane having an internal volume for receiving substances, hereinafter called blister 100, comprising at least two compartments intended for each contain a dose of at least one active ingredient in solid form, for example in the form of lyophilisate, powder, tablet or specific polymeric gel, or in liquid form.
• the active ingredient is in powder form or freeze-dried.
• the dose of active principle in such a blister is preferably a dose less than 50 mg, preferably less than 10 mg, or even less than 5 mg.
• the device according to the invention is suitable for variable dosages according to the type of active principles considered, their specific routes of administration and the number of components and different compartments of the device. It is particularly suitable for administering very low dosages of active ingredients, but can be used for larger dosages.
• Active ingredient means a substance or combination of substances capable of producing a demonstrated pharmacological activity on sets of tissues or receptors, extra or intracellular, in order to reduce, prevent or correct an acute or chronic or epidemic disease or a particular degeneration.
• the blister 100 comprises a radially outer peripheral flange 1 10 adapted to be sealingly attached to the edge of the neck of the reservoir 12. If the filling of the reservoir 12 is through said neck, the blister 100 will be fixed after filling. Alternatively, if the filling of the reservoir 12 is done by another filling passage, for example by a filling opening provided in the reservoir, placed in any section of said reservoir, for example its basal portion, the filling can be advantageously after prior fixing of the blister 100 on the neck of the tank.
• the fixing of said blister 100 for sealing the neck of the reservoir 12 may, for example, be carried out by heat sealing or high frequency polymerization methods, or any other methods customary in these applications, or by the use of other compatible and adapted methods, such as mechanical stress sealing (ring formed or retractile or crimped).
• Figures 3 and 4 illustrate two variants of fixing the blister 100 on the reservoir 12, with the cavity of the blister facing respectively inwardly (Figure 3) or outwardly ( Figure 4) of the reservoir 12, after fixing.
• Figure 2 shows the variant of Figure 3, but it is understood that this is an example of non-limiting embodiment.
• This blister 100 has an outer wall 101 and an inner wall 102. The outer wall 101 is thus turned towards the outside of the reservoir 12 and the inner wall 102 is turned towards the inside of the reservoir 12. These two outer and inner walls 101 , 102 are preferably parallel to one another, and substantially perpendicular to the longitudinal central axis of the reservoir 12.
• FIG. 3 shows a blister with two compartments 105a and 105b separated by a longitudinal partition 120, that is to say a partition which extends in the width direction parallel to the upper and lower walls 101 and 102 of the blister 100
• Figure 4 has three compartments 105a, 105b and 105c separated by two longitudinal partitions 120 and 130.
• Figure 6 describes four compartments 105a, 105b, 105c and 105d separated by three transverse partitions 120 ', 130' and 140 ', that is to say walls extending in the direction of the height perpendicular to the upper and lower walls 101 and 102 of the blister 100.
• Figure 7 depicts a complex structure with a star-shaped partition 120 ", seen from above, which defines five compartments, four compartments 105a, 105b, 105c and 105d outside the partition 120 ", and a compartment 105e inside this partition 120.
• a star-shaped partition 120 " seen from above, which defines five compartments, four compartments 105a, 105b, 105c and 105d outside the partition 120 ", and a compartment 105e inside this partition 120.
• any number of compartments, and partitions of any shape desirable are possible, and the examples shown are not therefore limiting.
• the deposits of active principle (s) can thus be made within said blister, in all known forms (powder, lyoc, granule, grain, semi-solid gel, etc.). Very low dose powders can for example be very precisely deposited without losses in these same blisters, by robotic systems designed for this purpose.
• said blister could even include in its available internal spaces, a compartment of liquid.
• the packaging / filling of the blister can take place in two successive stages, for example first that of the dry compartment (powder, lyoc.) Sealed in a first operation, then the liquid compartment, filled and sealed during a second stage.
• the head 14 comprises in its upper part at least one sampling chamber 32 provided with a filter or filter membrane 40, which avoids any particulate contamination of the active ingredient dissolved during sampling, ensuring mechanical filtration of the solution before this sampling.
• the device may also include several sampling chambers.
• the sampling chamber 32 is preferably of a suitable size. Its length is advantageously greater than or equal to that of a sampling needle, typically between about 8 and 40 mm, so that at the end of the stroke a needle can never damage the filter 40 and also that the end of the sampling needle introduced, remains more constantly located in the very heart of the liquid to be taken.
• the filter 40 preferably has a mesh size of between 5 and 500 microns.
• the device 10 of Figures 1 and 2 also comprises rupture means 18 of the blister 100 so that the active ingredients come into contact with the solvent 22 and dissolve therein.
• the breaking means 18 are means for cutting the walls 101 and 102 of the blister 100, for example perforating means.
• the reservoir 12 and the head 14 are equipped with displacement means 30, 34 for translational movement of said head 14 from the distal position to the proximal position.
• the translational displacement means comprise, for example, a set of screws 30 or a bayonet device allowing the rotation to be maintained, preferably entirely traversed over a quarter of a rotation only, and carried by the reservoir 12. more particularly by the neck of this reservoir, and a thread 34 of conjugate profile of the screw thread of the container carried by the head 14 so as to cooperate by screwing.
• the container is also provided with safety locking means so as to prevent any involuntary displacement, in translation, of the head 14 relative to the reservoir 12.
• the locking means advantageously comprise a removable ring 36 interposed between the head 14 in position distal and the reservoir 12.
• This ring 36 may have a C-shaped profile or be a continuous tear-off continuous band, which is mounted elastically on the thread 30 carried by the reservoir 12, prohibiting the translational movement of the head 14 by compared to this reservoir 12.
• the head 14 is provided with a flexible sampling membrane 38 and waterproof, protective and perforable to allow sampling.
• This sampling membrane 38 is intended to be perforated for removal of the contents of the device 10 by sterile syringe and needle.
• this sampling membrane 38 which may be in sterile medical latex gum or in polymer, is fixed on the head and protected by a protective cap 42 held, for example via a fastener 45 by screwing or clipping or crimping, on the head 14.
• This cap 42 may comprise a central axial opening closed by a removable safety tab 44, protecting the sterility of said sampling membrane 38.
• the practitioner wishes to administer the drug composition, it suffices to remove the ring 36 by simply pulling and screwing the head 14. There then occurs a displacement in translation of said head which causes the breaking means 18 to open the walls 101 and 102 from blister which ensured the tight closure of the reservoir 12 and the separation between the solvent 22 and the active ingredients, allowing the active ingredients to dissolve in the solvent. For better dissolution, it is best to shake the solution for a few seconds.
• the removal of the safety tab 44 makes it possible to access the sampling membrane 38 through the axial central opening of the cap 42.
• the cap 42 can also be removable from the head 14, for example unscrewable. The user only has to punch the sampling membrane 38 with a sterile mini syringe and a needle to collect the contents of the device.
• the sterile needle carried by a suitable syringe allows the immediate administration of the reconstituted solution, whatever the route of administration, intra-ophthalmic, intravenous, intramuscular, subcutaneous, intra-articular, intra-cavitary.
• the active ingredient is dissolved in the solvent just before its administration, which prevents any premature degradation.
• a required dose of active ingredient is administered in a precise and controlled manner.
• a gripping pallet 46 advantageously disposed in the lower part of the reservoir 12, can also be provided.
• This gripping pallet 46 allows good gripping bidigitale gripper, despite the small size of the container to allow the user to maneuver the head 14 in rotation.
• This pallet 46 can also form an extension of a sealing plug of a filling opening which would be provided in the base of the tank 12.
• the pallet 46 also provides an advantage of handling after rotation of the head relative to the reservoir and after removal of the safety tab 44, namely that of allowing easy removal of the content with a device adapted to this manipulation.
• the head 14 may comprise on its outer peripheral surface facilitated gripping means 50, such as support fins.
• the active ingredients are dissolved extemporaneously and simultaneously with the encounter with the liquid solution delivered by this rupture; they are thus ideally assembled for their best dissolution in a single time, since put in contact with the liquid expressed during the rupture at the same point of the blister assembly,
• the invention responds in the most appropriate manner to the recommendations of the Health authorities, anxious to prevent prolonged exchanges and migrations by contact between active principle (s) and the walls of the container; indeed, thanks to the invention, the therapeutic solution being shaped at the only moment of its medical use, it will not be in contact for more than a few seconds with the parietal materials of the container before being extracted, for administration, a delay without really measurable consequences, -
• the blister guarantees optimal protection of the active ingredients considered, since through the widespread use for decades of these composite structures, for example of the metalloplastic type, is used an extremely common means in the industries pharmaceutical companies and their subcontractors, which has been extensively evaluated as being perfectly adapted to most pharmaceutical active ingredients and to their specific peculiarities, for their better conservation over time, under various formulations,
• the invention considerably simplifies the industrial manufacturing process, since it makes it possible to perform a double operation by the same means, namely to close off the solvent reservoir and at the same time to collect and protect the active ingredients in the best stability conditions. required over several years, while placing them in the best possible arrangements for their dissolution, ie at the proximal contact of the solvent liquid,
• the invention also makes it possible, in an extremely advantageous and economical manner with respect to the prior art, to implement production programs that are distinct over time, namely the packaging of the sealed blister pack containing the active ingredients, the filling of the reservoir of solvent, and the closure of the reservoir by the same blister, without any constraint of simultaneity for operations also demanding, always performed in atmosphere and sterile conditions.
• the invention therefore greatly simplifies the packaging of the active ingredients concerned, especially if it is very low dosages and guarantees their pharmaceutical quality maintained over time.
• the device of FIGS. 1 and 2 adapted to the extemporaneous preparation of injectable sterile solutions, comprises an internal component 200 which can be placed in contact with the walls of the sampling chamber 32, which will thus be modified in size, and particularly in section, height and volume.
• This internal component 200 preferably made in the form of a hollow cylinder, can be introduced into said sampling chamber 32 to provide several functions:
• the internal volume of said cylinder as containing an additional active ingredient, which would be deposited therein in any suitable form; it is understood here that the body of said cylinder 200 may be made of a perfectly inert material and thereby free from any chemical remanence, for example glass or metal, so that the active ingredient that would be deposited therein in contact will not feel any alterations,
• the invention makes it possible to obtain a liquid column internal to said sampling chamber, such that, being located on a suitable height, said fluid column always remains sufficiently narrow in width or in section so that the end of the aspirating needle which has been introduced through the pierceable sterile membrane 38, remains in the presence of a sufficient quantity of liquid to be sucked, so that during a conventional sampling in a vertical position, the sampling needle goes stay more constantly in contact with the solution it takes without sucking air.
• this cylinder advantageously combines with the use of the blister described above, but that the cylinder could also be implemented independently of said blister.
• such a cylinder can be used very advantageously in a device as described in WO 2009/138644.
• blister 100 has been explained above with reference to FIGS. 1 and 2 for a device of the type of that described in document WO2009138644.
• this blister could also be used on other types of devices, for example of the type described in WO2009016309, as illustrated schematically in FIG. 8.
• the device 10 comprises a reservoir 12, typically made of plastic or glass, containing a small volume of a hydroalcoholic solution 23.
• the reservoir is sealed by a blister structure 100 containing several active ingredients.
• the structure and function of the blister 100 may be identical or similar to those described above with reference to the first embodiment, and shown in FIGS. 3 to 7.
• This blister provides an exclusive service by allowing extemporaneous mixing of labile active principles with an aqueous-alcoholic solution to allow instantaneous therapeutic systemic administration, by this oral mucosal route.
• the neck of the tank 12 may comprise a screw thread 30 on which can for example screw a thread 34 in a movable head 14.
• a safety band 36 is advantageously provided to prevent any unwanted movement of the head 14 relative to the reservoir 12.
• This moving head 14 comprises a cannula 141 defining a tube with air intake 142.
• the dispensing orifice of the cannula 141 may be closed by an end plug 143.
• This end cap 143 may also contain at least two active ingredients, they are in solid or liquid form, retained in said end cap by a suitable separating membrane. These active principles are likely to be released into the free space of the cannula 141 by breaking said separation membrane, which can be achieved for example by a complete screwing of said end cap 143 on the dispensing orifice of the cannula 141.
• the plug may comprise at least one active ingredient and said cannula 141 may also contain at least one active ingredient.
• the active ingredients can also be mixed in the cannula, in particular by complete screwing of said end cap. In the example of FIG.
• the fluid filling of the reservoir 12 is carried out not by the neck of the reservoir closed by the blister 100, but by a filler opening 121 provided at the base of said reservoir, and therefore opposed to said neck.
• said tank is closed by a leakproof cap 400, which can be secured to the gripping pallet 46, sealing cap which is advantageously permanently sealed after the same filling.
• a seal 300 may be disposed within the portion of the head 14 which receives the thread 34, to ensure the sealing of the device after perforation, when the screwing of the head 14 abuts on the upper edge of the reservoir neck 12. The compression of this seal 300 between the two sections of the head 14 and the tank 12 ensures the realization of a complete and sufficient sealing given the short time of use of the product when it was formed.
• the device in a device of the first embodiment of FIGS. 1 and 2, namely a device of the type described in the document WO2009138644 for injectable solutions, the device will preferably contain an amount of active ingredient and a liquid dissolution volume that is slightly greater than at useful therapeutic dosages, so as not to risk a product defect, whether it is related to a residual internal confinement loss to the device or to a handling error during the sampling.

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• Health & Medical Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Physics & Mathematics (AREA)
• Fluid Mechanics (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Package Specialized In Special Use (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
• Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)

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• 2010
  • 2010-11-30 FR FR1059883A patent/FR2967894B1/fr not_active Expired - Fee Related
• 2011
  • 2011-11-28 EP EP11808670.1A patent/EP2645982B1/de not_active Not-in-force
  • 2011-11-28 US US13/990,228 patent/US9394090B2/en not_active Expired - Fee Related
  • 2011-11-28 WO PCT/FR2011/052795 patent/WO2012072934A1/fr not_active Ceased
  • 2011-11-28 ES ES11808670.1T patent/ES2541404T3/es active Active
  • 2011-11-28 DK DK11808670.1T patent/DK2645982T3/en active
  • 2011-11-28 PL PL11808670T patent/PL2645982T3/pl unknown
  • 2011-11-28 CA CA2819305A patent/CA2819305C/en not_active Expired - Fee Related
  • 2011-11-28 RU RU2013129918/12A patent/RU2567227C2/ru not_active IP Right Cessation
• 2016
  • 2016-04-14 US US15/098,959 patent/US9918901B2/en not_active Expired - Fee Related

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