WO2003077824A1 - Instillateur, sterilisable a haute temperature - Google Patents
Instillateur, sterilisable a haute temperature Download PDFInfo
- Publication number
- WO2003077824A1 WO2003077824A1 PCT/JP2003/003036 JP0303036W WO03077824A1 WO 2003077824 A1 WO2003077824 A1 WO 2003077824A1 JP 0303036 W JP0303036 W JP 0303036W WO 03077824 A1 WO03077824 A1 WO 03077824A1
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- WO
- WIPO (PCT)
- Prior art keywords
- container
- eye drop
- molding
- eyedropper
- liquid injection
- Prior art date
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Classifications
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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
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- 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
- B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
- B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
- B65D51/22—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure
- B65D51/221—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening
- B65D51/222—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening the piercing or cutting means being integral with, or fixedly attached to, the outer closure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/48—Moulds
- B29C49/482—Moulds with means for moulding parts of the parisons in an auxiliary cavity, e.g. moulding a handle
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/26—Component parts, details or accessories; Auxiliary operations
- B29C51/261—Handling means, e.g. transfer means, feeding means
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C57/00—Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor, e.g. collapsible mandrels
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- 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—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, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0207—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features
-
- 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
- B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
- B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/48—Moulds
- B29C2049/4879—Moulds characterised by mould configurations
- B29C2049/4887—Mould halves consisting of an independent neck and main part
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2793/00—Shaping techniques involving a cutting or machining operation
- B29C2793/0045—Perforating
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
- B29C49/428—Joining
- B29C49/42802—Joining a closure or a sealing foil to the article or pincing the opening
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
- B29C49/42808—Filling the article
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
- B29C51/02—Combined thermoforming and manufacture of the preform
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
- B29L2031/7158—Bottles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
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- 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
- B65D2251/00—Details relating to container closures
- B65D2251/0003—Two or more closures
- B65D2251/0006—Upper closure
- B65D2251/0015—Upper closure of the 41-type
-
- 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
- B65D2251/00—Details relating to container closures
- B65D2251/0003—Two or more closures
- B65D2251/0068—Lower closure
- B65D2251/0071—Lower closure of the 17-type
Definitions
- the present invention relates to a medical ophthalmic container (hereinafter, simply referred to as an ophthalmic container) and an eye drop that contain a medical ophthalmic solution so that the ophthalmic solution can be instilled.
- a medical ophthalmic container hereinafter, simply referred to as an ophthalmic container
- an eye drop that contain a medical ophthalmic solution so that the ophthalmic solution can be instilled.
- Examples of the ophthalmic container to be filled with the medical ophthalmic solution include those shown in FIG. 6 or FIG. That is, a so-called three-piece type ophthalmic container, in which the inner cap 11 is attached to the container body 10 formed in a hollow cylindrical shape, and the cap is included, so that the entire eyedropper is formed from three members (FIG. 6). Also, an integrally molded container (Fig. 7), in which the liquid injection cylinder and the container body are integrally formed by professional molding technology, a so-called bottle pack eyedropper is widely used. In this bottle pack ophthalmic container, a predetermined amount of a chemical is filled and sealed at the same time as professional molding or vacuum molding. In particular, in the container shown in FIG.
- a needle-like projection 9 for penetrating a liquid injection hole at the tip of the container body A is integrated with the male screw 5a of the container body A made of a flexible thermoplastic material.
- This is a structure in which the formed cap B is detachably screwed.
- the injection hole 6c is formed in the injection part at the tip of the container body A by the needle-like projection 9 of the cap B by the screwing operation to the tightening side one step deeper than the normal closing position of the cap B.
- the tip portion of the pottlepack eyedropper is formed into a tip shape having an inner plug function.
- a so-called open-bottle pack eye drop container in which the injection hole 6c is formed in advance has been considered. Because eye drops are administered directly to the eye, which is a particularly sensitive organ in the human body, it is strictly required to keep them sterile until instillation. Therefore, the above-mentioned three-piece type eye drop container or the like is manufactured by sterilizing each member with EO gas, electron beam or ⁇ -ray, and then filling it with a drug solution.
- bottle pack ophthalmic containers and open bottle pack ophthalmic containers Since it is integrally molded under heating conditions by a mold method, etc., it becomes possible to fill a chemical solution without particularly requiring sterilization of the container.
- the drug solution needs to be filled in the ophthalmic container in a sterilized state, and therefore, after sterilization by steam sterilization, filtration sterilization using a membrane filter, or the like, Fill aseptically in a sterile room with strict conditions.
- the filling operation is complicated, the work efficiency is reduced, and a large capital investment is required.
- the sterilization operation can be integrated at once and the need for aseptic filling is eliminated. In this case, the expensive capital investment described above can be omitted.
- the container body and the inner stopper are formed of resin of different materials. That is, the container body is formed of a soft resin in order to facilitate the extrusion and discharge of the chemical solution.
- the inner stopper is formed of a relatively hard resin in order to ensure a constant discharge of the chemical solution.
- the inner stopper is dropped into the container body when the heat sterilization is performed after being integrally assembled. Or the assembly is loosened, making it difficult to ensure liquid tightness.
- the container body and the inner plug are formed of a relatively hard material, dimensional accuracy when fitting and assembling the two easily becomes a problem, and again, a problem tends to occur in securing liquid tightness. Was. Further, if the container body is hard, a large force is required for pushing out and discharging the chemical solution, which causes a decrease in operability.
- an object of the present invention is to provide an eye drop container which is easy to manufacture and sterilize, can assure sterility assurance, and has excellent eye drop operability in view of the above-mentioned drawbacks. Disclosure of the invention
- the present inventors have noticed that all the bacteria are killed when heated at 121 ° C for 20 minutes, and as a result of intensive research, they endure this condition and do not melt or deform.
- the present inventors have thought that a desired ophthalmic container may be obtained by integrally molding a resin material, and arrived at the present invention.
- the polyethylene content of the polypropylene-polyethylene random copolymer is preferably from 1 to 10%, more preferably from 3 to 5%.
- a hollow portion that can be gripped by two fingertips is formed in a flexible hollow cylindrical body portion.
- a conical recess with a bottom having a larger inner diameter toward the distal end is formed in a recess, and a liquid injection section is provided at the bottom of the concave.
- the container body and the inner stopper are separately sterilized. Then, they had to assemble them under aseptic conditions and aseptically fill the sterilized drug solution.
- the ophthalmic container of the present invention is integrally molded from a resin material that does not substantially melt and deform when maintained at 121 ° C for 20 minutes and sterilized, the ophthalmic container is filled with a drug solution. It can be sterilized under the conditions of 121 ° C and 20 ⁇ . Therefore, the conventional complicated work process can be reduced to a single sterilization work after the preparation of the eyedropper and the filling of the drug solution, and the manufacturing work process can be simplified. .
- the resin material is polypropylene-polyethylene random copolymer, it has high heat resistance, and not only enables the above-mentioned sterilization treatment, but also a material which is hard but flexible enough to be relatively easily instilled. Therefore, an ophthalmic container in which the container body and the inner plug are integrally formed can be manufactured with good workability, and the ophthalmic operability can be maintained satisfactorily.
- the polyethylene content of the polypropylene-polyethylene random copolymer is 1 to 10%, particularly 3 to 5%, it is possible to achieve a workability and an eye drop workability without deteriorating the heat resistance described above. Resin material.
- the eye drop container has a hollow portion that can be gripped by two fingertips formed in a flexible hollow cylindrical body portion, when administering the drug solution in the container, Since the depression formed in the body is gripped with two fingertips, the gripping position of the fingertip is stabilized.
- a part of the body that is in contact with the fingertip is already recessed, so a part of the cylindrical body is recessed against the elastic restoring force.
- the pressing operation force can be reduced as compared with the case of deforming. Therefore, although it is a simple and inexpensive modification that only forms a hollow part in a hollow cylindrical body, it is easier to hold than conventional eye drop containers, and eye drop operation is performed by reducing the pressing operation force. Since the properties can be improved, the medicinal solution in the container can be accurately and easily administered.
- FIG. 1 is a diagram showing a schematic configuration of an eye drop of the present invention
- FIG. 3 is a front cross-sectional view near the tip of the eye drop container in a state where the cap is screwed into the eye drop container
- FIG. 4 is an overall side view of the eyedropper
- FIG. 5 is a diagram showing a use state at the time of instillation administration.
- FIG. 6 is a view showing an eye dropper having an eyedropper provided with an inner stopper
- FIG. 7 is a side sectional view of an eye drop container configured to be able to penetrate an injection hole
- FIG. 8 is a molding process diagram of the eye drop container by professional molding or vacuum molding
- FIG. It is process explanatory drawing which shows the manufacturing method of eye drops.
- FIG. 1 is a diagram showing a schematic configuration of the eye drop of the present invention
- FIG. 2 is a view showing a state near the tip of the eye drop container in a state where the cap and the eye drop container are separated
- FIG. FIG. 4 is a view showing an integrated state
- FIG. 4 is an overall side view of the eyedropper
- FIG. 5 is a view showing a state at the time of instillation.
- the eyedropper A has a circular bottom portion 1 that curves inward, a hollow cylindrical body portion 2 connected to the periphery of the bottom portion 1, and a cylindrical neck portion 3 that is continuous with a shoulder portion 2a of the body portion 2.
- Resin materials that do not melt or deform when sterilized by maintaining at 121 ° C for 20 minutes which is a constituent material of this ophthalmic container A, include polypropylene-polyethylene random copolymer, polypropylene, etc.
- the entire eyedropper A is configured to be elastically deformable.
- M I material properties
- preferred M I being 0.2-2.5, more preferably 0.3-1.5.
- polypropylene-polyethylene random copolymer a random polymer of propylene containing 1 to 10%, particularly 3 to 5% of ethylene can be applied, and the moldability is sufficient, and the sterilization conditions described above are sufficient. It is suitable for the production of ophthalmic containers because it can withstand enough.
- polypropylene When polypropylene is applied, it can withstand the above sterilization conditions sufficiently, but it may be difficult to mold depending on the shape of the ophthalmic container, so it is suitable for molding ophthalmic containers having a simple shape.
- the injection tube portion 6 of the eyedropper container A is formed with a conical bottomed recess 6b having a larger inner diameter toward the injection port 6a side (the distal end side).
- a small-diameter liquid injection hole 6c is formed in the liquid injection section formed at the bottom of the concave portion 6.
- the depth of the recess 6b is in the range of 2 to 7 m: n, preferably in the range of 5 to 7 mm, and most preferably 6 mm, and the diameter (mouth diameter) of the liquid injection port 6a. Adjust in the range of f2 »1 ⁇ 1 to £ 4111 ⁇ 1 according to the liquid property of the chemical solution.
- the diameter of the injection port 6a In order to make the volume of one drop constant (adjusted within the range of 25 to 5 O pL per one drop according to the purpose), in the case of liquid with high surface tension, the diameter of the injection port 6a should be changed. In the case of a liquid property having a small surface tension, the diameter of the injection port 6a is increased.
- the injection hole 6c is formed using a suspicious needle having a range of f0.1 mm to f0.8 mm.
- the diameter of this needle is preferably as small as possible, and most preferably about f 0.2 mm. However, if it is too small, it will be technically difficult. In practice, use a needle in the range of f 0.4 mm to f 0 .6 mm.
- the eye drops can be applied along with the pressing operation by the finger of the body 2.
- the amount of droplets extruded from the container A can be controlled to a set amount.
- the body 2 of the eyedropper A is provided with a recess 7 that can be gripped by two fingertips. It is composed of a pair of flat or almost flat holding surfaces 7a formed in two places in the circumferential direction of the part 2 and formed in each of the parts facing each other across the container axis X.
- the cap B is formed with a first sealing convex portion 15 which is screwed into the male screw 5 a of the eye dropping container A to be fitted into the recess 6 b of the eye dropping container A and sealed.
- the protrusion amount of the first sealing projection 15 is about 0.6 to 1.0 mm.
- the cap B can be screwed and integrated with the eyedrop container A satisfactorily.
- the material of the cap B is a polypropylene-polyethylene random copolymer.
- the manufacturing method of the eye drop of the present application will be described in the order of manufacturing the eye drop container and integrating the eye drop container with the cap.
- FIG. 8 (a) a pair of main molding dies 21 each having a first cavity 20 for molding a portion ranging from the annular step portion 4 to the bottom portion 1 of the eyedropper A. And a second cavity 2 for forming the screw cylinder 5 and the injection cylinder 6 of the eyedropper A.
- the extruder head 24 disposed on the upper part of the pair of dies 23 vertically moves through the space between the two dies 21 and 23.
- a parison 25 of a predetermined length which is an elongated hollow tubular semi-molten thermoplastic material.
- the main molding die 21 is closed and actuated, and the molding surface 2 of the main molding die 21 is formed by blowing compressed air or vacuum. Form while expanding parison 25 along 1a. In this state, a predetermined amount of liquid (drug) is filled from the drug supply pipe 26 as shown in FIG. 8 (b).
- the sub-molding mold 23 is closed and actuated, and the sub-molding mold 23 is actuated by the compressed air / air blowing action or the vacuum action.
- the parison 25 is molded along the molding surface while expanding, and the filled liquid is sealed (enclosed) at the same time as molding. Then, the work is completed in the step of FIG. 8 (d).
- a metal convex forming die 30 for forming the conical concave portion 6b with the bottom and the liquid injection hole 6c are formed.
- the metal needle-shaped mold 31 to be formed is used.
- the convex molding die 30 includes a conical molding protrusion 30 B for molding a conical concave portion 6 b with a bottom at the tip of the mounting shaft 30 A, and an outer periphery of the liquid injection cylinder portion 6 of the eyedrop container A.
- the surface is formed by forming a bowl-shaped (bell-shaped) molding surface 30 C for molding the surface, and the needle-shaped molding die 31 is provided with a small-diameter note at the tip of the mounting shaft 31 A. It is formed by forming needle-shaped protrusions 31B forming liquid holes.
- a part of the liquid injection tube 6 which is the tip of the eyedropper A is heated with a hot air or halogen lamp, a laser beam or the like. Is heated to room temperature or 70 ° C. to 150 ° C. by the first heating means C.
- the heating temperature depends on the material and shape of the eye dropper A, but a temperature at which the tip of the eyedropper A is slightly softened is preferable. If the thermoplastic material of the eyedropper A is a soft resin material such as polyethylene, the tip will buckle if not heated, so at least the part to be molded by the convex mold 30 must be formed before molding.
- the bowl-shaped molding surface 30 C of the convex molding die 30 paris at the time of blow molding protruding from the outer peripheral surface of the liquid injection cylinder 6 of the eyedropper A can be removed.
- the temperature of the convex mold 30 itself is controlled in the range of room temperature to 150 ° C. in accordance with the shape and thickness of the liquid injection tube 6 of the eyedropper A to be molded.
- the heating temperature should be as low as possible, taking into account the cooling and solidification of the tip of the injection cylinder 6.
- the convex mold 30 can be easily replaced according to the liquid property of the liquid to be filled.
- the needle-shaped molding die 31 is placed at the center of the bottom of the concave portion 6b formed in the liquid injection tube portion 6 of the eyedropper A.
- a small-diameter liquid injection hole is formed that can be pressed from the direction of the container axis X to control the amount of liquid droplets ejected from the ophthalmic container A to a set amount in accordance with the pressing operation by the fingertip of the body 2.
- the heating temperature is at least the temperature at which the resin of the container material melts at least the needle-like projections 31B of the needle-shaped mold 31 and is in the range of 130 ° C to 180 ° C. It is preferred to heat to.
- the needle-shaped mold 31 is heated by a second heating means D such as high-frequency induction heating, a halogen lamp, or hot air.
- the mounting shaft 31 A which is the base of the needle-shaped mold 31, is a water heater.
- -It is configured to cool with a cooling means E such as a jacket and compressed air.
- the needle-shaped mold 31 is cooled to a predetermined temperature, the needle-shaped mold 31 is moved along the container axis X direction from the liquid injection cylinder 6 of the eye drop container A formed into a predetermined shape. And pull it out.
- the needle-shaped mold 31 may be subjected to surface treatment such as plating, fluororesin coating, or special plating to improve the resin releasability and mold releasability. It is desirable that the surface treatment be able to withstand high temperatures and not easily peel off.
- surface treatment such as plating, fluororesin coating, or special plating to improve the resin releasability and mold releasability. It is desirable that the surface treatment be able to withstand high temperatures and not easily peel off.
- the container body A can be obtained.
- the cap B used in the present application is obtained by molding in advance the predetermined shape described above. Now, after the manufacture of the container body A has been completed as described above, at the time of initial mounting in which the cap is first mounted on the container body A, the thermoplastic material of the container body A reduces its plasticity. The cap B is screwed to the container main body A in a state where the container B has a certain degree of plasticity so that the outer shape of the container main body A does not collapse even if the cap B is screwed.
- the first sealing projection 15 is brought into close contact with the recess 6b, and the airtight state is established. Guaranteed.
- the extrusion stress if the extrusion stress is 2 ON or more, the user will feel a strong resistance to the fingertip during the eye drop operation, so it is preferable to set the extrusion stress to 15 N or less.
- the extrusion stress when an ophthalmic container having the same resin material as described above and having no hollow portion withstanding similar sterilization conditions was formed, the extrusion stress was about 35.3 N (3.64 kgf), and the present invention was improved. The product was found to be extremely excellent in eye drop operability.
- the injection cylinder 6 of the blow-molded or vacuum-molded container body A has a conical bottomed bottom 6 b whose inner diameter increases toward the injection port 6 a, and a body 2.
- an ophthalmic container having a small-diameter liquid injection hole 6 c capable of controlling the amount of liquid droplets extruded from the container body A to a set amount in accordance with the pressing operation of the fingertip of the present invention has been described,
- the present invention is not limited to such an eye dropping container, and as shown in FIG. 6, is made of a flexible thermoplastic material which is filled and sealed with a predetermined amount of a chemical solution at the same time as professional molding or vacuum molding.
- a cap B integrally formed with a needle-like projection 9 for forming a liquid injection hole at the end of the container main body A is detachably screwed to the male screw 5a of the container main body A of the container main body A. Needle-like projection of cap B by screwing into the tightening side one step deeper than the normal closing position of cap B 9 Infusion section of the distal end of the container body A is arranged to form a filling hole 6 c to.
- the eyedropper having the depression is described.
- the present invention is not limited to this shape, and may be applied to an eyedropper having no depression.
- the shape is not limited to a cylindrical shape, and may be an elliptical shape.
- Various forms can be adopted, and are appropriately set based on a resin material, a use, and the like to be used.
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Mechanical Engineering (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Manufacturing & Machinery (AREA)
- Ceramic Engineering (AREA)
- Ophthalmology & Optometry (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002477418A CA2477418A1 (en) | 2002-03-18 | 2003-03-13 | High-temperature-sterilizable instillator |
KR1020047012514A KR101014638B1 (ko) | 2002-03-18 | 2003-03-13 | 고온 멸균이 가능한 점안 용기 |
EP03710348A EP1486192A4 (en) | 2002-03-18 | 2003-03-13 | HIGH-TEMPERATURE-STERILIZABLE INSTILLER |
US10/508,289 US20050159715A1 (en) | 2002-03-18 | 2003-03-13 | High-temperature-sterilizable instillator |
AU2003221379A AU2003221379A1 (en) | 2002-03-18 | 2003-03-13 | High-temperature-sterilizable instillator |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002074205 | 2002-03-18 | ||
JP2002-074205 | 2002-03-18 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003077824A1 true WO2003077824A1 (fr) | 2003-09-25 |
Family
ID=28035288
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2003/003036 WO2003077824A1 (fr) | 2002-03-18 | 2003-03-13 | Instillateur, sterilisable a haute temperature |
Country Status (8)
Country | Link |
---|---|
US (1) | US20050159715A1 (ja) |
EP (1) | EP1486192A4 (ja) |
KR (1) | KR101014638B1 (ja) |
CN (1) | CN100475175C (ja) |
AU (1) | AU2003221379A1 (ja) |
CA (1) | CA2477418A1 (ja) |
TW (1) | TWI287980B (ja) |
WO (1) | WO2003077824A1 (ja) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7178703B2 (en) * | 2004-11-23 | 2007-02-20 | Allergan, Inc. | Autoclaveable small-volume dropper bottle |
US20080039807A1 (en) * | 2006-08-08 | 2008-02-14 | Jerrold Scott Pine | Ophthalmic Drug Dispensing Tip |
AU2007330356B2 (en) * | 2006-12-07 | 2013-05-02 | Sun Pharma Advanced Research Company Ltd | Metered drop bottle for dispensing microliter amounts of a liquid in the form of a drop |
US20140350492A1 (en) * | 2013-05-26 | 2014-11-27 | Ever Rojas Escalante | Eyedrop dispenser |
CN105233397A (zh) * | 2015-10-14 | 2016-01-13 | 广东三蓝药业股份有限公司 | 一种新型滴眼剂瓶 |
USD826068S1 (en) * | 2016-11-13 | 2018-08-21 | Eyad Aboabdo | Dispensing bottle kit |
WO2018206386A1 (en) * | 2017-05-06 | 2018-11-15 | Novaliq Gmbh | Drop dispenser |
CA184963S (en) | 2017-07-13 | 2019-06-12 | Chubby Gorilla Inc | Bottle |
CN108464928A (zh) * | 2018-05-09 | 2018-08-31 | 赵金巧 | 一次性预冲式泪冲器 |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6055005A (ja) * | 1983-09-07 | 1985-03-29 | Showa Denko Kk | 耐放射線性成形品 |
JPS60125628A (ja) * | 1983-12-13 | 1985-07-04 | Mitsui Toatsu Chem Inc | 透明性に優れたブロ−成形容器 |
WO2000003736A1 (en) * | 1998-07-14 | 2000-01-27 | Alcon Laboratories, Inc. | Prostaglandin product |
JP2000202002A (ja) * | 1998-11-13 | 2000-07-25 | Tosoh Corp | 医療用耐熱容器 |
WO2001012124A1 (fr) * | 1999-08-17 | 2001-02-22 | Santen Pharmaceutical Co., Ltd. | Conteneur a instillation ouverte et procede de fabrication dudit conteneur |
WO2001012125A1 (fr) * | 1999-08-17 | 2001-02-22 | Santen Pharmaceutical Co., Ltd. | Element encastre formant un conteneur d'instillation |
WO2001028885A1 (en) * | 1999-10-18 | 2001-04-26 | Novartis Ag | Package for a pharmaceutical product and method of manufacturing and sterilizing the package |
JP2001120639A (ja) | 1999-08-17 | 2001-05-08 | Santen Pharmaceut Co Ltd | 開口点眼容器及びそれの製造方法 |
JP2001181344A (ja) * | 1999-12-27 | 2001-07-03 | Sumitomo Chem Co Ltd | プロピレン重合体樹脂および容器 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5425480A (en) * | 1992-12-17 | 1995-06-20 | Ryder International Corporation | Dose dispenser having a molded plastic housing with a cavity and a metallic foil wall covering the cavity |
SI1352837T1 (sl) * | 1999-05-28 | 2006-08-31 | Novartis Ag | Postopek za izdelovanje sterilizirane stisljive embalaze za farmacevtski proizvod |
-
2003
- 2003-03-13 KR KR1020047012514A patent/KR101014638B1/ko active IP Right Grant
- 2003-03-13 CN CNB038062518A patent/CN100475175C/zh not_active Expired - Fee Related
- 2003-03-13 EP EP03710348A patent/EP1486192A4/en not_active Withdrawn
- 2003-03-13 US US10/508,289 patent/US20050159715A1/en not_active Abandoned
- 2003-03-13 CA CA002477418A patent/CA2477418A1/en not_active Abandoned
- 2003-03-13 WO PCT/JP2003/003036 patent/WO2003077824A1/ja active Application Filing
- 2003-03-13 AU AU2003221379A patent/AU2003221379A1/en not_active Abandoned
- 2003-03-14 TW TW092105679A patent/TWI287980B/zh not_active IP Right Cessation
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6055005A (ja) * | 1983-09-07 | 1985-03-29 | Showa Denko Kk | 耐放射線性成形品 |
JPS60125628A (ja) * | 1983-12-13 | 1985-07-04 | Mitsui Toatsu Chem Inc | 透明性に優れたブロ−成形容器 |
WO2000003736A1 (en) * | 1998-07-14 | 2000-01-27 | Alcon Laboratories, Inc. | Prostaglandin product |
JP2000202002A (ja) * | 1998-11-13 | 2000-07-25 | Tosoh Corp | 医療用耐熱容器 |
WO2001012124A1 (fr) * | 1999-08-17 | 2001-02-22 | Santen Pharmaceutical Co., Ltd. | Conteneur a instillation ouverte et procede de fabrication dudit conteneur |
WO2001012125A1 (fr) * | 1999-08-17 | 2001-02-22 | Santen Pharmaceutical Co., Ltd. | Element encastre formant un conteneur d'instillation |
JP2001120639A (ja) | 1999-08-17 | 2001-05-08 | Santen Pharmaceut Co Ltd | 開口点眼容器及びそれの製造方法 |
WO2001028885A1 (en) * | 1999-10-18 | 2001-04-26 | Novartis Ag | Package for a pharmaceutical product and method of manufacturing and sterilizing the package |
JP2001181344A (ja) * | 1999-12-27 | 2001-07-03 | Sumitomo Chem Co Ltd | プロピレン重合体樹脂および容器 |
Also Published As
Publication number | Publication date |
---|---|
KR20040093056A (ko) | 2004-11-04 |
EP1486192A1 (en) | 2004-12-15 |
CN100475175C (zh) | 2009-04-08 |
TW200304805A (en) | 2003-10-16 |
US20050159715A1 (en) | 2005-07-21 |
CA2477418A1 (en) | 2003-09-25 |
KR101014638B1 (ko) | 2011-02-16 |
EP1486192A4 (en) | 2010-07-14 |
AU2003221379A1 (en) | 2003-09-29 |
TWI287980B (en) | 2007-10-11 |
CN1642511A (zh) | 2005-07-20 |
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