WO2015170956A1 - Flacon bocal pharmaceutique à deux ouvertures - Google Patents

Flacon bocal pharmaceutique à deux ouvertures Download PDF

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Publication number
WO2015170956A1
WO2015170956A1 PCT/MX2015/000071 MX2015000071W WO2015170956A1 WO 2015170956 A1 WO2015170956 A1 WO 2015170956A1 MX 2015000071 W MX2015000071 W MX 2015000071W WO 2015170956 A1 WO2015170956 A1 WO 2015170956A1
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WIPO (PCT)
Prior art keywords
vial
further characterized
vial bottle
pharmaceutical
opening
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PCT/MX2015/000071
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English (en)
Spanish (es)
Inventor
Rodolfo VILLALÓN ROJAS
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Individual
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Individual
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    • 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
    • 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
    • B65D1/00—Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material

Definitions

  • This invention relates to a pharmaceutical vial containing two openings, for atomization, of pharmaceutical compositions and bioproducts in humans, which need to be reconstituted or diluted before being used.
  • nasal dosage forms of drug delivery systems include four groups: " ⁇ liquids, which include: nasal instillation catheters, nasal drops, single dose containers, and manually copsible containers (squeezed bottles).
  • measured dose nasal inhalers base their operation on the use of one or more different vehicles or carriers.
  • measured dose nasal inhalers that use pressurized propellant as a vehicle or carrier and nasal spray inhalers based on an aqueous vehicle or carrier.
  • ⁇ a container container that has a unique opening.
  • - a carrier or aqueous vehicle.
  • - a pharmaceutical composition, ie active ingredient and excipients.
  • - a dosing valve that firmly fitted to the single opening, closes the container and administers the doses of its compositions.
  • an actuator which generally although without imitations to this, in action coordinated with the booster valve, administers the doses.
  • this actuator has its own protective cover.
  • Some nasal spray actuators have very sophisticated actuation systems, with insurance to prevent late performance and boxes with operating levers. Notwithstanding this sophistication, its container container, is a pharmaceutical vial made of glass, with a totally conventional external structure that has a unique opening.
  • Veramyst® product in the United States of America or Avamyys2A® in Mexico, Fluticasone Furoato which has such an actuator.
  • Verarnyst® and Avamyys2A® are registered trademarks of the GSK plc corporation and / or its subsidiaries.
  • Nasal sprayers that administer liquid or aqueous compositions, either in solution or suspension generally use pharmaceutical grade vial vials or containers very similar to each other in their general external structure and always have a unique opening.
  • the vial is made of various materials, such as pharmaceutical grade glass in its various classes and colors. There is also the possibility of having various coatings such as silicones or other polymers to improve the insulation and resistance characteristics of these pharmaceutical glass containers. Also, the pharmaceutical grade vial can be manufactured in different pharmaceutical grade polymers. Examples of these polymers are polyethene or PE, polyethiyerephthalate or PET, low density polyethylene and the copolymer of cyclic olefin or cycloolefin, all of them pharmaceutical grade.
  • the current pharmaceutical compositions of intranasa ⁇ administration are basically of two types: pressurized and not pressurized. Pressurized ones use oropelent as a carrier vehicle, which generates a pressurized aerosol. The non-pressurized ones, currently include, but are not limited to, all aqueous compositions and dry powders. Pressurized compositions.
  • compositions for administration by the intranasai route in pressurized aerosol, by using pressurized propellant are generally packaged, but not limited to, in metal alloy cans, capable of withstanding the pressure of the oropelent without problems. Its dosage is carried out with a measured dose valve and its actuator; The dosing valve is firmly secured to the single opening of the metal can.
  • the can assembly, dosing valve and actuator are known in the global pharmaceutical industry as nasal pressurized aerosols, which is a translation of the English "presurized nasal aerosols". In this case, it is pressurized aerosols of measured dose for intranasa ⁇ use.
  • Non-pressurized compositions are:
  • compositions in dry powders which require specific attachments to be administered and liquid compositions or aqueous that use atomizing valves as their base to be administered by means of nasal sprayers.
  • compositions that use nasal sprays have to be aqueous or liquid, either in solution or in suspension to be dispensed by their metered dose atomizing valves and also because, they use the current vial vials that have a single opening.
  • the two-opening vial bottles and a single container chamber useful for the atomization of drugs that need to be reconstituted or diluted, prior to their application according to the present invention differ significantly from the device described in U.SA, No. 4,607,671; Said device consists of a single opening vial that requires a second container for the reconstitution process.
  • the device claimed by this US patent, number 4,607,671 is the device itself and not the vial.
  • the reason for the present invention claims ownership exclusively over the two-opening vial with a single container chamber.
  • all possible reconstitution devices are simple vial bottle caps made of resilient, crimped material. by its metal caps, on which this invention makes no claim claims.
  • Figure 1 is a representation of a longitudinal section of the pharmaceutical vial having two openings, where they are: main opening (1); lip of the main opening (2); neck of the main opening (3); body shoulder (4); secondary opening perpendicular to the vertical axis of the vial (5); lip of the secondary opening (6); secondary opening neck (7); body container (8); floor or bottom (9); wall (10); single container chamber (11).
  • Figure 2 is a representation of an average longitudinal section of the pharmaceutical vial having two openings, the main floor-opening vertical axis (11) is illustrated; and the central axis of the secondary opening (12). In this mode, the position at 90 * of the central axis of the secondary opening (5) is shown, relative to the main floor-opening vertical axis.
  • Other structures already numbered and described in Figure 1 respect their numerical order.
  • Figure 3 is a representation of an average longitudinal section of the pharmaceutical vial having two openings, the main floor-opening vertical axis (11) is illustrated; in another embodiment, the secondary opening (51) and its central axis (121) are at an angle less than 46 ° with respect to the main floor-opening vertical axis; the lip of the secondary opening of this modality (61); neck of the secondary opening of this modality (71).
  • Figure 4 is a representation of a longitudinal sectional front view of the pharmaceutical vial having two openings, in this embodiment, both openings have threads, where they are: main opening (1); main opening thread (13); neck of the main opening (3); body shoulder (4); secondary opening (5) perpendicular to the main floor-opening vertical axis (11); secondary opening thread (14); secondary opening neck (7); container of the vial vial body (8); bottom or floor of vial vial (9); and single container chamber (10).
  • Figure 5 is a representation of a longitudinal section of the vial having two openings, in another embodiment whose main opening has a lip, while its secondary opening has a thread, and where they are: main opening (1); lip of the main opening (2); neck of the main opening (3); body shoulder (4); secondary opening (5), perpendicular to the vertical axis of the vial (11); secondary opening thread (14) secondary opening neck (7); central axis of the secondary opening (12); body container (8); floor or bottom (9); and single container chamber (10).
  • Figure 6 illustrates the exterior representation of the vial that has two openings and both openings have a lip. This mode has the cylindrical outer body container (81); and its shoulder of the body has a slightly rounded outer shape (41). The other structures are numbered according to the previous figures.
  • Figure 7 illustrates the exterior representation of the vial that has two openings, of the main opening (1), has a thread (13); the shoulder of the body is slightly rounded (41) and (at secondary opening (5) it has lip (6); this modality has the cylindrical outer body container (81).
  • the other structures are numbered according to the previous figures .
  • Figure 8 illustrates the outer representation of the vial that has two openings and whose outer shape of the body container is composed of two flat side faces and two concave faces (82); the main opening (1) has a lip (2); and the secondary opening (5) also has a lip (6); The outer shape of the shoulder of the body is composed of four well-defined faces (42).
  • Figure 9 is a representation showing three views A) posterior, B) lateral and C) superior, of a vial with two openings.
  • the primary opening (1) has a lip and neck;
  • the secondary opening (5) also has its own lip and neck. It has the shoulder of the body formed by four well-defined faces (42); and its body container (82) has four faces, two of them prismatic sides and concave front and back sides. It is the reverse side that communicates with the secondary opening.
  • Figure 10 is a representation of the vial of two openings and other components separately from a first nasal spray mode.
  • the two-opening vial has a lip in both openings and a cylindrical outer body container (15), in the main opening (1) the following are integrated: the metered dose atomizing valve (17), its actuator ( 18) and plug (19); In the secondary opening (5), they are integrated: a cap for a vial made of resilient material (20) and its metal bushing (21) for crimping.
  • Figure 11 is a representation of the vial of two openings and other components separately from a second embodiment of nasal spray.
  • the pharmaceutical vial of two openings whose container of the body has an outer shape composed of concave front and back faces and two prismatic side faces (16), this two-opening vial has lip in both openings .
  • the route of intranasal administration of drugs offers two great therapeutic possibilities: the first possibility is to be a direct route for local, topical or in situ treatments, whose target organs are the irrtranasal mucous membranes and rhinosinusates, using minimal doses for it.
  • the second possibility is to be an access route for systymic drugs, with target tissues and organs, very different from the nasal mucosa or nasal cavity.
  • a topical treatment is one that is applied to the skin or mucous membranes to achieve a therapeutic effect.” In this case, the application of the drug is directly on the nasal mucosa.
  • the objective of the present invention is to provide the pharmaceutical industry with a vial containing two openings, which not only packages and administers pharmaceutical compositions that use the intranasal route, but also has the ability to reconstitute or dilute , pharmaceutical compositions and bioproducts inside, maintaining the integrity of both the atomizer and the pharmaceutical composition itself, ensuring the integrity of the container-content system.
  • These reconstitution or dilution capabilities generate real possibilities of creating new and very diverse pharmaceutical and bioproduct compositions.
  • the present invention as a vial of pharmaceutical quality and bioproducts maintains the existence of an essentially piano floor or bottom (9), as well as a well-defined shoulder of the body (4), (41 ⁇ and (42).
  • the shoulder of the body is also a well defined part in the pharmaceutical vial and bioproduct motif of the present invention, it is a transition structure that joins the body container with the main opening. Its exterior shape can be varied, starting from the perfect flat, rounded, as well as the integrated by several flat, convex or concave faces and combinations thereof.
  • Each of the two openings of the present invention have their own neck, that is to say in this vial, the neck of the main opening (3) and the neck of the secondary opening (7).
  • each of the two openings of the present invention has its own outer distal edge, which allows incorporating attachments for closure, closure and passage, as well as for administration in measured doses .
  • This outer distal edge has two options: - is a lip (2) and (6).
  • the lip allows to its opening in question, the crimping or coupling of additional elements such as: a metered dose atomizing valve, or a vial vial cap, firmly crimped with its metal cap.
  • additional elements such as: a metered dose atomizing valve, or a vial vial cap, firmly crimped with its metal cap.
  • the lip is a regular exterior prominence, of perfect central outer shape, located in the distal part, of one or both openings of the vial of the present invention, is easily distinguishable, at the end of the neck of its corresponding opening.
  • One embodiment of the present invention is that it has, has its two lip openings ( Figures 1, 2 and 3).
  • each of the two openings has a thread, instead of having a lip ( Figure 4).
  • Another modality has one of the two threaded openings, while another opening has a lip ( Figure 5).
  • the thread (13) and (14) is also an outer prominence around the opening, but now its shape is ia of a single helical thread and not of perfect cylindrical.
  • this thread in the openings of the present invention allows him to fix other elements by screwing, such as, the metered dose atomizing valves and threaded metal caps, which when screwed by turning Threads of the vial of the present invention close their openings in the pharmaceutical plant.
  • the incorporation of a second useful and practical opening does not modify at all the single container chamber of the conventional vial. That is, the present invention It maintains the existence of a single container chamber (10) and at no time, for any reason, or under any procedure, more than one container chamber is generated inside the present vial containing two openings.
  • the single container chamber is the entire interior space within the wall of the two-opening vial which is the subject of the present invention.
  • This interior space includes, of course, the spaces within the necks of each of the openings and of course within the entire interior of the container and shoulder of the body.
  • the single container chamber communicates with each other to both openings of the vial of the present invention.
  • the body container begins where the shoulder of the body ends to the essentially piano floor or bottom. It can have perfect cylindrical exterior shape; oval; cubic, trapezoid, with flat, convex or concave faces and combinations thereof.
  • the wall of the container of the body in its outer part is the most common site in the industry, for the pharmaceutical labeling of the vial vials motive of the present invention.
  • its measurement parameter is its outer perimeter. This is measured on the outside of the body container, immediately below or above the secondary opening. If there are differences between both measures, the official data will be the major measure between the two.
  • the vial of motif of the present invention measures in its outer perimeter of the body container of 50 to 130 millimeters.
  • the main opening (1) is physically located in the shoulder of the body, in a completely opposite position to the floor or bottom that is essentially flat of the vial vial motive of the present invention. This physical position of the main opening totally opposite to the flat floor or floor, creates the existence of a vertical axis floor-main opening (11).
  • the main opening of the vial of two openings has several functions:
  • the measurement parameter of the main opening is its outer diameter.
  • the outer diameter of the main opening is measured, from the outside of its lip or, where appropriate, from the outside of its thread.
  • the outer diameter of the main opening of the pharmaceutical pharmaceutical vial of the present invention measures from 12 to 21 millimeters.
  • the measuring parameter of this lip will be its height.
  • the height of the lip of the main opening is measured from its outer part, from the distal part of the opening, to where this uniform edge ends to join its respective neck.
  • the height of the lip of the main opening is measured on the outside of the lip, following the direction of the main floor-opening vertical axis, in the present invention it measures from 3 to 6 millimeters.
  • the main opening always has its own neck, which is referred to in the present invention as the neck of the main opening (3).
  • This neck of the main opening is cylindrical and its measurement parameters are two:
  • the outer diameter of the neck of the main opening can be measured at any point of the neck, where there is no interference from the lip or the thread, since being a cylindrical structure its measurement is uniform.
  • the outer diameter of the neck of the main opening measures 8 to 17 millimeters.
  • the length of the neck of the main opening may not be uniform, since in certain modalities of a vial with two irregularly shaped shoulder openings, or by optional presence of the thread, the length measurement of the neck of the main opening would not always be the same, so when there is more than one length measurement of the neck of the main opening, its official measurement will be the largest of these, from the shoulder of the body to the lip without including the latter, or up to the limit of the main opening, despite the presence of the thread.
  • the neck length of the main opening measures from 3 to 20 millimeters.
  • the secondary opening (5) of the vial subject of the present invention is located on the wall of the body container (8), with its central axis of the secondary opening (12) in a transverse position of 30 ° to 90 ° degrees to the main vertical axis of the main cover (11), (figures 2 and 3).
  • the measurement parameter of the secondary opening is also its outer diameter.
  • the outer diameter of the secondary opening is measured from the outside of its Sage or, where appropriate, from the outside of its thread.
  • the outer diameter of the secondary opening of the pharmaceutical vial vial of the present invention measures from 12 to 21 millimeters.
  • the measurement parameter of this lip will be its height.
  • the height of the lip of the secondary opening is measured from its outer part, from the distal part of its opening, to where this uniform edge ends to join the body container.
  • the height of the lip of the secondary opening is measured on the outside of the lip, following the direction of the central axis of the secondary opening, in the present invention it measures from 3 to 6 millimeters.
  • the secondary opening always has a propk> neck, which is referred to in the present invention as a neck of the secondary opening (7).
  • This pendulum of the secondary opening is cylindrical and its measurement parameters are two:
  • the outer diameter of the neck of the main opening can be measured at any point of the same, since in the case of a cylindrical structure its measurement is uniform.
  • the outer diameter of the secondary opening collet measures 8 to 17 millimeters.
  • the length of the neck of the secondary opening may not be uniform, since in certain modalities of a vial with two openings the cylindrical shape of the container of the body with a concave or irregular outer shape, or thread, the measure of the length of the secondary opening cave would not always be the same. In this way, when there is more than one length measurement of the neck of the secondary opening, its official measurement will be the greater of these, from the container of the body to the lip without including the latter, or to the limit of the secondary opening , despite the presence of thread.
  • the length of the main opening hole measures from 3 to 20 millimeters.
  • the secondary opening incorporated into the pharmaceutical vial has several functions, since it is not only capable of allowing the entry of pharmaceutical compositions and solid, semi-solid bioproducts, in gei, but also adapts with the closing and passage means, to enter a pharmaceutically acceptable reconstituting agent to the single container chamber, to reconstitute or dilute said pharmaceutical or bioproduct compositions before being administered.
  • this secondary opening allows its entry into the single container chamber, as well as its dilution before being administrable.
  • the existence of the secondary opening allows a second access to collect an additional attachment, for example a needle syringe.
  • the secondary opening allows the reconstituting agent or diluent to be introduced into the single container chamber, where it will come into contact with the pharmaceutical composition packaged therein.
  • the secondary opening has its own elements of the corresponding closure and passage means screwed, screwed.
  • the elements of the closure and passage means for the process of reconstitution or dilution of the ingredients of the pharmaceutical compositions are of two types; the combination of a vial bottle cap made of resilient material (20), with a metal bushing (21) or a metal cap for crimping or screwing in the secondary opening; and the combination of a shut-off valve "luer" type, for use with a syringe without a needle, with its metal cap or metal cap for crimping or screwed into the secondary opening.
  • the present invention employs as a means of closure and passage, the combination of a vial vial cap, made of resilient material and its metal cap or metal cap, crimped or screwed into the secondary opening, to perform reconstitution or dilution of the pharmaceutical compositions.
  • the body of the two-opening vial has structures similar to those of the single-opening vial, that is, a body with an essentially piano and well-defined floor or bottom, shoulder of the body with a well-defined exterior shape, which joins the container of the body with the neck of the main opening.
  • the container of the body (8), (81 ⁇ and (82), of the vial viai of the present invention begins where the shoulder of the body ends, to the floor or flat bottom. have a very diverse exterior shape that goes from (to a perfect cylindrical shape and the ovaf, passing through the shape formed by conical, concave or concave faces and any combination thereof.
  • tota ⁇ aitura measures 35 to 66 millimeters. This total height is measured, following the vertical axis of the main floor-opening, from the floor or bottom, to the distal limit of the main opening.
  • the pharmaceutical vial that has two openings that are the subject of the present invention can be manufactured using the following materials always with pharmaceutical quality: glass, polytethiene, low density polyethylene, polyether phosphate, polypropylene , polyvinyl chloride or pvc, the cyclic olefin or cycloolefin copolymer, as well as any other material known in the state of the art.
  • the pharmaceutical grade materials very useful in the manufacture of the vial vials motive of the present invention can be clear or transparent, as well as amber coffer in its very different shades.
  • the vial bottles that have two motive openings of the present invention, adapt to the techniques and machinery known in the state of the art.
  • the expert in the field will recognize that the entry of pharmaceutical compositions and solid, semi-solid, gel or liquid bioproducts, into the interior of the vial vials motive of the present invention, is carried out with the techniques, areas, conditions and machinery, common in the state of the art.
  • the vial bottles, which have two openings that are the subject of the present invention are adapted as metered dose dispensers, with the incorporation of a metered dose atomizing valve (17), with its actuator (18) and cap (19) (figures 10 and 11), to atomize the pharmaceutical or bioproduct composition, after being reconstituted or diluted.
  • the vial bottles that have two motif openings of the present invention also comprise: a vial stopper (20), made of resilient material crimped by its metal cap (21) (figures 10 and 11), or screwed with a metal cap threaded to (at secondary opening; and a pharmaceutical or bioproduct composition in solid, semi-solid, gel or liquid state, which needs to be reconstituted or digested to be administrated and then atomized.
  • a vial stopper (20) made of resilient material crimped by its metal cap (21) (figures 10 and 11), or screwed with a metal cap threaded to (at secondary opening; and a pharmaceutical or bioproduct composition in solid, semi-solid, gel or liquid state, which needs to be reconstituted or digested to be administrated and then atomized.
  • the present invention snaps, collects or screws tightly in its main opening, metered dose atomizing valves, which comprise valves of wide range of doses, although without any limitation in this, administer 50 to 140 microliters per actuation and have measures comprised of 13 at 21 mm.
  • metered dose atomizing valves which comprise valves of wide range of doses, although without any limitation in this, administer 50 to 140 microliters per actuation and have measures comprised of 13 at 21 mm.
  • Their actuators and the caps for these actuators correspond in size to their respective atomizing valves.
  • the two-way vial flask of the present invention is very own and adapts with the machinery and routine tools, for placement and crimping or coupling or screwed on, atomizing valves that are firmly fixed to the main opening. Once the valve is fixed, it can receive its actuator and plug; also with machinery and routine tools, the actuators are fixed to them, guiding the bases of the actuators on the pistils of the valves. The caps of the actuators are placed at the end of this stage on the pistils of their respective actuators.
  • the two-way vial which is the subject of the present invention is very own and is adapted with routine machinery and tools, for placing the caps made of resilient material in the secondary opening. Once the plug made of resilient material is placed, also with machinery and routine tools, this plug is crimped or screwed to the secondary opening by metal bushings or by threaded metal caps.
  • the present invention is very own and adapts to firmly hook the lip, or screw the thread of the secondary opening, vial caps made of resilient material placed in it, using metal caps or threaded metal caps.
  • the caps for vial and metal caps or threaded metal caps correspond to measures ranging from 13 to 20 mm.
  • the vial vial cap made of resilient material, placed and crimped or screwed with its metal cap or threaded metal cap, to the secondary opening of the present invention comprises one of butyl, chlorobutyl, bromobutyl, Isoprene, rubber, silicone, cyclobutyl / isoprene or butyl / polytetrafiuoroethiene, as well as four other material described in the prior art.
  • the vial of pharmaceutical use of two openings is totally suitable and proper to: enter its single container chamber, reconstitute or dilute and atomize, pharmaceutical compositions and solid, semi-solid, gel and liquid bioproducts that require the reconstitution of its ingredients , before being administered. Also to close their openings with their respective attachments, after entering the composition into the single container chamber.
  • Said compositions include one or more active principles in solid, semi-solid and gel, or liquid physical state, to be reconstituted or diluted before being administered.
  • the innovation of the present invention allows this novel bottle via its main opening to have a metered dose atomizer valve firmly crimped, coupled or screwed, thus closing it by integrating its respective actuator and cap, while its secondary opening, it can have, at the same time, the elements of the closing and passage means, which consists of the combination of a vial vial cap made of pharmaceutically acceptable resilient material and metal alloy cap or a threaded metal cap that locks it or screws it tightly.
  • compositions so packaged, reconstituted or diluted before being administered.
  • pharmaceutical or bioproduct compositions that comprise active ingredients of low pharmaceutical stability and that require refrigeration during their useful life, it is important to note that the reconstituted or diluted pharmaceutical compositions administered in the vial vials of the present invention are totally compatible with refrigeration, since none of the elements of the vial of the present invention are opposed to it.
  • compositions that need to be reconstituted or diluted before being used include one or more active ingredients as well as other different ingredients and / or pharmaceutically acceptable excipients.
  • active ingredients include one or more active ingredients as well as other different ingredients and / or pharmaceutically acceptable excipients.
  • other ingredients other than the active ingredients may include solubilizing, tonicity, suspending, pH regulating, gelling, absorption enhancers, preservatives, antioxidants, humectants and surfactants widely described in the international pharmacopoeia.
  • the vial via the motive of the present invention is very own and is adapted to the entry of solid, semi-solid or gel, or liquid pharmaceutical compositions that need to be reconstituted or diluted before administrable, as well as the closure of their main opening with its atomizing valve with actuator and cap and when closing its secondary opening with the elements of the closing and passage means, in sterile areas, with normal atmosphere conditions, without the use of non-oxidizing or nitrogen enriched atmosphere, Argon, or any other non-oxidizing inert or noble element or gas. Under conditions of normal working atmosphere, in one area the entry of the composition into the single container chamber and the closure of the openings of the sterile vial is carried out with the sequence that includes:
  • the corresponding pharmaceutical or bioproduct composition is introduced in solid, semi-solid, gel, or liquid state, to its single container chamber:
  • the vial of the present invention passes into its final packaging and is incorporated into it: the sterile pharmaceutically acceptable liquid reconstituent or diluent, packaged in its own vial containing a single opening and which is closed by a vial vial cap made of resilient material, crimped with a metal cap; Also added in this final carton, a syringe with needle both sterile and an instruction manual.
  • the vial of the present invention spends its entire shelf life packed in this way.
  • the present invention is understood as the solution or suspension required by the pharmaceutical compositions, which, due to their initial solid, semi-solid or gel physical state, always require it, before they can be administered by means of metered dose sprays.
  • Dilution is understood in the present invention, to the depletion of the concentration, required by the pharmaceutical and bioproduct compositions, which, due to their initial liquid physical state, so they need, before they can be administered by means of measured dose sprays,
  • the vial of the present invention is adapted to reconstitute and dilute the pharmaceutical and bioproduct compositions entered in its single container chamber and when its two openings were already closed with its atomizing valve with actuator and cap and the closing and passage means, first , when a pharmaceutically acceptable reconstituent or diluent is introduced through the secondary opening, which is the specific part of the vial, of the present invention, adapted for this purpose.
  • the pharmaceutically acceptable reconstituting agent or diluent is taken out of its own container in the amount necessary for that purpose.
  • the safety seal of the metal cap or metal cap is removed, on the cap for vial vial stuck or screwed into the secondary opening of the vial of the present invention and introduces the reconstituting agent or diluent contained in the syringe, in the amount necessary to the single container chamber.
  • the pharmaceutical or bioproduct composition within the single container chamber has contact with the reconstituting agent or diluent.
  • the vial of the present invention with its contents, is vigorously shaken manually to achieve adequate reconstitution or dilution of the pharmaceutical or bioproduct composition, so that from this point the composition is administrable and its atomization is possible.
  • any pharmaceutically acceptable agent is understood as capable of achieving the necessary solution or suspension, so that solid, semi-solid or gel pharmaceutical or bioproduct compositions can be administered by measured dose sprays.
  • any pharmaceutically acceptable agent is understood as capable of achieving a reduction in the necessary concentration, so that the pharmaceutical or bioproduct compositions in the initial liquid state reach their final and complete aqueous phase, for that can be administered in a better way, atomized in measured doses.
  • the metered dose atomizing valve used by the atomizers that are incorporated into the vial vials that are the subject of the present invention, consists of an attachment that operates correctly until the pharmaceutical composition is properly reconstituted or diluted.
  • pharmaceutically acceptable reconstituting agents or diluents include sterile injectable water and optionally include other excipients, such as:
  • the pharmaceutical vial and btoproducts motive of the present invention spends its entire shelf life in its final carton.
  • This vial then allows the reconstitution or dilution of the pharmaceutical or bioproduct composition that has been in its single container chamber in a solid, semi-solid, gel or liquid state, so that it is first admirable and then atomized manually.
  • the method for reconstitution or dilution and atomization with the vial vial of the present invention, of pharmaceutical compositions and of solid, semi-solid, gel or liquid bioproducts, which thus k> require before being administrable is further characterized because it comprises: first, providing the vial vial motive of the present invention with all its attachments and content, provided in the final carton; fill with the sterile needle syringe both and provided in the final carton, with the necessary amount of the pharmaceutically acceptable reconstituting agent or diluent and also provided in the final carton; then, remove the safety seal from the casquiiio or metal cover crimped or screwed to its secondary opening; then introduce the reconstituting agent or diluent inside, to that it comes into direct contact with the pharmaceutical or bioproduct composition in (a single container chamber; subsequently, shake the vial with all its attachments and vigorously containing, to obtain with this, a pharmaceutical or bioproduct composition, which is from this point administrate, inside the single container chamber, and finally, manually
  • the pharmaceutical and bioproduct compositions which were solid, semi-solid, gel or liquid, are administrable from this point and their Atomization is now possible.
  • the vial vial motive of the present invention is adapted with the metered dose atomizing valve in coordination with its actuator, as well as with the manipulation of the user for the atomization, of the pharmaceutical compositions and of already administrable bioproducts, that is to say after these They were reconstituted or diluted.
  • the atomization can be carried out at any time, holding the vial vial motive of the present invention, with all its attachments hooked, coupled or screwed and its pharmaceutical or bioproduct composition already administered inside the container chamber unique, as follows:
  • the atomization is carried out directly with the manipulation of the user, atomizing measured doses of 50 to 140 micro-meters for each action, manageable intranasally.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne des flacons bocaux destinés à un usage pharmaceutique et pour des bioproduits, ces flacons bocaux possédant deux ouvertures. Ces deux ouvertures permettent le conditionnement ainsi que la reconstitution ou la dilution et l'administration en doses mesurées, de compositions pharmaceutiques et de bioproduits, pouvant être administrés par voie intranasale, lesquelles compositions pharmaceutiques ou lesquels bioproduits nécessitent la reconstitution ou la dilution de leurs ingrédients avant leur utilisation. Cette invention part de la structure globale des flacons bocaux à usage pharmaceutique à ouverture unique, avec une seconde ouverture comme élément novateur. De cette manière, le flacon bocal à usage pharmaceutique et pour des bioproduits qui possède deux ouvertures peut comporter, dans son ouverture principale, une valve de pulvérisation de doses mesurées avec son actionneur, qui administre les compositions pharmaceutiques et de bioproduits en doses mesurées et, en même temps, des éléments ajoutés qui sont pris dans des rainures ou enroulés dans sa seconde ouverture et qui permettent la reconstitution ou la dilution de ladite composition pharmaceutique ou de bioproduit, contenue à l'intérieur de ce récipient, avant son utilisation.
PCT/MX2015/000071 2014-05-06 2015-05-04 Flacon bocal pharmaceutique à deux ouvertures Ceased WO2015170956A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
MX2014005427A MX2014005427A (es) 2014-05-06 2014-05-06 Frasco vial farmaceutico con dos aberturas.
MXMX/A/2014/005427 2014-05-06

Publications (1)

Publication Number Publication Date
WO2015170956A1 true WO2015170956A1 (fr) 2015-11-12

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Application Number Title Priority Date Filing Date
PCT/MX2015/000071 Ceased WO2015170956A1 (fr) 2014-05-06 2015-05-04 Flacon bocal pharmaceutique à deux ouvertures

Country Status (2)

Country Link
MX (1) MX2014005427A (fr)
WO (1) WO2015170956A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3156383A (en) * 1962-04-05 1964-11-10 Maison Ind Tecnico Chimiche Ne Expansible single use dispensing container
US3938520A (en) * 1974-06-10 1976-02-17 Abbott Laboratories Transfer unit having a dual channel transfer member
US4113129A (en) * 1978-01-05 1978-09-12 Respiratory Care, Inc. Container for sterile liquids

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3156383A (en) * 1962-04-05 1964-11-10 Maison Ind Tecnico Chimiche Ne Expansible single use dispensing container
US3938520A (en) * 1974-06-10 1976-02-17 Abbott Laboratories Transfer unit having a dual channel transfer member
US4113129A (en) * 1978-01-05 1978-09-12 Respiratory Care, Inc. Container for sterile liquids

Also Published As

Publication number Publication date
MX2014005427A (es) 2015-11-05

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