WO2019211858A1 - Reconstitution and mixing systems - Google Patents
Reconstitution and mixing systems Download PDFInfo
- Publication number
- WO2019211858A1 WO2019211858A1 PCT/IL2019/050500 IL2019050500W WO2019211858A1 WO 2019211858 A1 WO2019211858 A1 WO 2019211858A1 IL 2019050500 W IL2019050500 W IL 2019050500W WO 2019211858 A1 WO2019211858 A1 WO 2019211858A1
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- WIPO (PCT)
- Prior art keywords
- adapter
- additive
- fluid
- water
- coating
- 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
- A61J1/14—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
- A61J1/2048—Connecting 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
-
- 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
- A61J1/1468—Containers characterised by specific material properties
-
- 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
- A61J1/1475—Inlet or outlet ports
-
- 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
- A61J1/2048—Connecting means
- A61J1/2058—Connecting means having multiple connecting ports
-
- 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
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
-
- 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
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
-
- 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/08—Polysaccharides
-
- 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/10—Polypeptides; Proteins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F21/00—Dissolving
- B01F21/20—Dissolving using flow mixing
- B01F21/22—Dissolving using flow mixing using additional holders in conduits, containers or pools for keeping the solid material in place, e.g. supports or receptacles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00495—Surgical glue applicators for two-component glue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/1782—Devices aiding filling of syringes in situ
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
- B01F2101/2202—Mixing compositions or mixers in the medical or veterinary field
Definitions
- the present invention in some embodiments thereof, relates to an adapter and, more particularly, but not exclusively, to an adapter comprising additive coating.
- tissue adhesives are composed of several ingredients that must be kept separately before application.
- a lyophilized drug that needs to be mixed with diluent shortly before injection.
- a tissue adhesive that should be mixed with its curing agent just before applying it.
- Other examples are mixing of two or more ingredients that might react with each other or degrade one another. It is a common practice is to pack these products in separate prefilled containers such as syringes or vials. To allow application, all containers are connected to each other using adapters, which may have an additional mixing tip connected to it.
- an adapter comprising: at least one wall defining a chamber; at least one opening within the wall; a water-soluble additive coating at least a portion of the wall such that fluid flowing from one opening through the chamber dissolves the additive within the chamber.
- the water-soluble additive comprises an adhesiveness property in relation to the wall.
- the water-soluble additive is inert to the fluid.
- the water-soluble additive dissolves homogenously within the fluid.
- the water-soluble additive is selected from the group consisting of: a dye, a pharmaceutical, and a pharmaceutical excipient or any combination thereof.
- the water-soluble additive is a dye.
- the coating further comprises a water-soluble adhesive.
- the coating comprises the water-soluble additive and adhesive at a w/w (weight/weight) ratio of 1: 1 to 1:50.
- the adhesive is selected from the group consisting of: a water-soluble saccharide, a peptide, a protein, a low-molecular weight surfactant, and a water-soluble adhesive polymer.
- the water-soluble adhesive polymer is selected from: a poly-phosphazene, a poly-phosphoester, a poly-oxazoline, a poly-[divinylether-maleic anhydride], a poly-[N(2-hydroxypropyl)methacrylamide], a poly-acrylamide, a poly acrylic acid, a poly-vinyl alcohol, a poly- vinyl pyrrolidone, a poly-ethylene glycol or any combination thereof.
- the water-soluble saccharide is selected from a monosaccharide, an oligosaccharide, and a polysaccharide or any combination thereof.
- the water-soluble adhesive is a monosaccharide.
- the opening is configured to couple to at least one of a vial, a syringe, a compartment, a pipe, a funnel, a beaker, a tube, a pipet, and an adapter.
- the chamber comprises at least two openings and at least one channel between the opening.
- At least a portion of at least one channel is coated by the water-soluble additive.
- the chamber comprises at least two openings and the path of the channel between the openings is longer than the minimal distance between the openings.
- At least a portion of the surface of the wall within the chamber is irregular, textured, and/or comprises irregularities.
- At least a portion of the surface of the channel is irregular, textured, and/or comprises irregularities.
- the irregular surface, textured surface, and/or irregularities comprise at least one of a nanostructure, microstructure, or any combination thereof.
- the water-soluble additive coats at least a portion of the irregular surface, textured surface, and/or irregularities.
- the surface area of at least a portion of the inner surface of the wall inner surface is larger than the surface area of the corresponding outer surface of the portion of the wall in relation to the chamber.
- kits for mixing an additive with fluid comprising: at least one of fluid source and/or a fluid drain; and at least one adapter configured to couple to the fluid source and/or the fluid drain, comprising at least one wall defining a chamber, at least one opening within the wall configured to couple to the fluid source and/or fluid drain; and a water-soluble additive coating at least a portion of the wall such that fluid flowing within the chamber dissolves the additive.
- the fluid source and/or fluid drain is at least one of a vial, a syringe, a compartment, a pipe, a funnel, a beaker, a tube, a pipet, and an adapter.
- a method for mixing water-soluble additive with fluid comprising streaming fluid into an adapter through at least one opening; streaming fluid through a chamber of the adapter such that water-soluble additive coating at least a portion of the wall of the chamber dissolves the fluid; and ejecting a homogenous mixture of the fluid and the water-soluble additive through at least one opening of the adapter.
- a method of coating an adapter comprising mixing a water-soluble additive with a solvent, thereby obtaining a coating solution; providing the coating solution, to the adapter; drying the coating solution at 10 to 90°C, thereby coating the adapter.
- the method further comprises mixing an adhesive and the additive.
- a w/w (weight/weight) ratio of the adhesive to the additive ranges from 1 : 1 to 1:50 within the coating solution.
- Fig. 1 is an adapter, in accordance with some embodiments of the present invention
- Figs. 2A, 2B, 2C and 2D are adapters for mixing an additive with fluid, in accordance with some embodiments of the present invention
- Fig. 3 is a kit for mixing an additive with fluid, in accordance with some embodiments of the present invention.
- Fig. 4 is a method for mixing an additive with fluid, in accordance with some embodiments of the present invention.
- an adapter configured to couple with at least one of a fluid source and/or a fluid drain, comprising an inner coat comprising an additive such that fluid entering the adapter is mixed, reconstituted, or dissolved in/with the additive.
- the additive is a water-soluble additive.
- an adapter comprising an inner coat, wherein the coat comprises an adhesive and an additive, wherein the adhesive is bound to a surface of the adapter and the additive is incorporated within the adhesive, wherein the adhesive and the additive are soluble in an aqueous solution, and wherein the w/w (weight/weight) ratio of the additive to the adhesive in the coating ranges from 1: 1 to 1 :50.
- a kit for mixing an additive with fluid comprising an adapter and at least one of a fluid source and/or fluid drain.
- the adapter comprises a chamber and at least one opening within the chamber wall, configured to couple to one or more fluid drain and/or fluid source.
- at least a portion of the chamber wall is coated with an additive such that that fluid flowing between the fluid source and the fluid drain through the chamber interacts with the additive.
- the method comprises streaming fluid into an adapter through one or more opening.
- the method comprises streaming fluid through a chamber of the adapter such that an additive coating at least a portion of the wall of the chamber mixes, reconstitutes and/or dissolves with the fluid.
- the method comprises ejecting the homogenous mixture of the fluid and the additive through at least one opening of the adapter.
- a method of coating an adapter comprising mixing an additive and an adhesive (carrier/encapsulant) at a w/w (weight/weight) ratio ranging from 1: 1 to 1:50 with an aqueous buffer, thereby obtaining an aqueous solution.
- the method comprises providing the aqueous solution to the adapter.
- the method comprises drying the aqueous solution at 10 to 90°C, thereby obtaining the coated adapter.
- the adapter 100 comprises at least one wall 104 defining a chamber 102. In some embodiments, the adapter 100 comprises at least one opening 110/114 within the wall 104. In some embodiments, the adapter 100 comprises an additive 118 coating at least a portion of the wall 104 such that that fluid flowing from one opening 110/114 through the chamber 102 interacts with the additive 118. In some embodiments, the adapter 100 comprises an additive 118 coating at least a portion of the wall 104 such that that fluid flowing from one opening 110/114 to another opening 110/114 through the chamber 102 interacts with the additive 118.
- the wall 104 comprises an inner surface 106 and an outer surface 116.
- the additive 118 coats the inner surface 106.
- the additive 118 is adhered to at least a portion of the wall 104 and/or a portion of the inner surface 106. In some embodiments, the additive 118 is adhered by an adhesive.
- a potential advantage of the additive 118 coating at least a portion of the inner surface 106 is in that fluid flowing through the chamber 102 contacts, dissolves and/or interacts with the additive 118.
- the additive 118 is one or more of a dye, ingredient in a drug, and/or an ingredient for an adhesive, which coats the wall 104 inner surface 106 of a chamber 102 within the adapter 100.
- the additive 118 is a solid or semi-solid.
- the chamber 102 comprises a hollow portion, such as a tube or hollow cylinder.
- the volume of the chamber 102 is l0-80mL. In some embodiments, the volume of the chamber 102 is 20-60mL.
- the chamber 102 wall 104 is rigid, semi-rigid, and/or flexible.
- the wall 104 comprises one or more opening 110/114. In some embodiments, the wall 104 comprises one or more openings 110/114 positioned on opposing sides of the chamber 102. In some embodiments, and as described in greater detail elsewhere herein, the opening 110/114 is configured to couple to one or more of a fluid source and/or fluid drain. In some embodiments, the opening 110/114 comprises a coupling mechanism couplable to one or more of a fluid source and/or fluid drain.
- one or more opening 110/114 of the adapter 100 is coupled to one or more fluid source and/or fluid drain through a connector, e.g., a pipe.
- the coupling mechanism is one or more of a needle 108 and a luer lock 112.
- a needle 108 coupled to the adapter 100 penetrates a fluid source such that the chamber 102 is in fluid communication with the fluid source through the needle 108.
- the coupling mechanism between an opening 110/114 and one or more of the fluid source and the fluid drain comprises a lock and key configuration (e.g., an opening 110/104 comprises a threaded portion which is compatible with a raised portion of the fluid source and/or fluid drain), a screw-on mechanism, a pressure lock, a sealed lock, or any combination thereof.
- a lock and key configuration e.g., an opening 110/104 comprises a threaded portion which is compatible with a raised portion of the fluid source and/or fluid drain
- a screw-on mechanism e.g., a screw-on mechanism, a pressure lock, a sealed lock, or any combination thereof.
- more than one opening 110/114 is couplable to more than one fluid source. In some embodiments, more than one opening 110/114 is couplable to more than one fluid drain. [0053] A potential advantage of the adapter 100 comprising more than one opening 110/114 couplable to more than one fluid source is in that a plurality of ingredients can be kept separate before entering the chamber 102.
- the chamber 102 comprise one or more channels 120 between a plurality of openings 110/114.
- at least a portion of the channel wall 218 is coated by the additive 118.
- an adhesive adheres between the channel wall 218 and the additive 118.
- at least a portion of the inner surface 106 defines channel 120.
- a potential advantage of the chamber 102 comprising at least one channel 120 is in that the fluid flowing within the chamber 102 interacts with the surfaces of the channel wall 218 and/or the inner surface 106 chamber 102 thereby having more interaction with the additive-coated surfaces than a chamber 102 without any channels 120.
- the surface area of at least a portion of the wall 104 inner surface 106 is larger than the surface area of the corresponding outer surface of the portion of the wall 104.
- at least a portion of the inner surface 106 and/or channel 120 is irregular, textured, and/or comprises irregularities.
- the irregular surface, textured surface, and/or irregularities comprise one or more of a nanostructure, microstructure, or any combination thereof.
- the additive 118 coats at least a portion of the irregular surface, textured surface, and/or irregularities.
- a potential advantage of at least a portion of the inner surface 106 and/or channel 120 comprising an irregular surface, textured surface, and/or irregularities at least partially coated by an additive 118 is in that fluid flowing through the chamber 102 interacts with a larger surface area of the coat of additive 118 than a fluid flowing through a chamber comprising no irregular surface, textured surface, and/or irregularities coated by an additive 118.
- the one or more channels 120 guide the flow of fluid within the chamber 102.
- the one or more channels 120 guide the flow of fluid from one opening 110/114 to another opening 110/114 and/or back into the same opening 110/114.
- the channel 202 splits into a plurality of separate channels 204/206, each being configured to direct fluid from an opening 216 through a plurality of separate openings 210/208, respectively.
- fluid is streamed into the chamber 202 through one or more openings 210/208 and streamed out of the chamber 202 through an additional opening, e.g., opening 216.
- the chamber 214 comprises a plurality of channels 214 configured to direct a fluid from one opening 224 to another opening 222 and/or from one opening 224 to the same opening 224.
- the chamber 226 is a solid comprising a plurality of pores 228, coated by an additive 118, through which the one or more opening 232/230 is in fluid communication with the pores 228.
- the path of the channel 234 is longer than the minimal distance between the one or more openings 244/246 through which the fluid is streamed.
- the adapter 100/250/260/270/280 is coupled to a mixing tip 238.
- the mixing tip 238 is coupled between a plurality of fluid sources 240 and the adapter 100/250/260/270/280.
- a mixture flows from the mixing tip 238 into the adapter 100/250/260/270/280.
- at least a portion of the inner surface 242 of the mixing tip 238 is coat by the additive 118.
- kits 300 which is a kit for mixing an additive with fluid, in accordance with some embodiments of the present invention.
- the kit 300 comprises at least one adapter 100/250/260/270/280/304 configured to couple with at least one or more of a fluid source 306 and/or a fluid drain 302.
- the kit 300 comprises at least one of a fluid source 306 and/or a fluid drain 302.
- the fluid source 306 is one or more of a vial, a syringe, a compartment, a pipe, a funnel, a beaker, a tube, a pipet, and an adapter.
- the fluid drain 302 is one or more of a vial, a syringe, a compartment, a pipe, a funnel, a beaker, a tube, a pipet, and an adapter.
- the adapter 100 is used for reconstitution, e.g., by mixing the content of a vial or a syringe with a diluent.
- the fluid source 306 supplies fluid to and/or from the adapter 100/250/260/270/280/304.
- the fluid drain 302 supplies fluid to and/or from the adapter 100/250/260/270/280/304.
- the kit 300 comprises a mixing tip 238.
- the adapter 100/250/260/270/280/304 and/or mixing tip 238 is smaller than the fluid source and/or fluid drain.
- the mixing tip 238 and/or the adapter 100/250/260/270/280/304 is coated with the additive 118 and/or an additional ingredient.
- a potential advantage of the mixing tip 238 and/or the adapter 100/250/260/270/280/304 comprising the additive 118 and/or an additional ingredient is in that specific amounts of the additive 118 and/or an additional ingredient are used to mix with a fluid flowing from the fluid source 306 and/or fluid drain 302, which enables higher accuracy than manually adding the additive 118 and/or an additional ingredient.
- the kit 300 comprises a fluid reservoir which supplies fluid for one or more of the fluid drain 302 and/or the fluid source 306.
- the kit 300 comprises one or more connector 308/310 configured to couple between the adapter 100/250/260/270/280/304 and one or more of fluid source 306 and/or fluid drain 302.
- the connector 308/310 is a pipe, tube, channel, or the like.
- the adapter 100/250/260/270/280/304 is in fluid communication with one or more of the fluid source 306 and/or the fluid drain 302 through the connector 308/310.
- Fig. 4 is a method for mixing an additive with fluid in accordance with some embodiments of the present invention.
- the method comprises streaming fluid into an adapter 100/250/260/270/280/304 through one or more opening.
- the method comprises streaming fluid through a chamber of the adapter such that an additive coating at least a portion of the wall of the chamber mixes, dissolves, and/or reconstitutes with the fluid.
- the method comprises ejecting a homogenous mixture of the fluid and the additive through a second opening of the adapter.
- the adapter 100/250/260/270/280/304 comprises the additive 118, e.g., a dried drug or dye.
- the fluid source 306 is a vial containing a fluid, e.g., a fluid diluent and is coupled to the adapter 100/250/260/270/280/304.
- the fluid drain 302 is a syringe and is coupled to the adapter 100/250/304. In some embodiments, the fluid drain 302 is used to remove fluid pressure from the adapter 100/250/260/270/280/304.
- removing fluid pressure from the adapter 100/250/260/270/280/304 ejects the fluid from the fluid source 306 and into the adapter 100/250/260/270/280/304 (step 402).
- the fluid streaming into the adapter 100/250/260/270/280/304 is mixed with the additive 118, e.g., a dried drug (step 404).
- the additive 118 is reconstituted and/or dissolved within the fluid.
- the fluid drain 302 applies negative pressure to the adapter 100/250/260/270/280/304 such that the mixture of fluid and additive 118, e.g., reconstituted drug and/or dyed fluid, flows from the adapter 100/250/260/270/280/304 into the fluid drain 302.
- the mixture of fluid and additive 118 e.g., reconstituted drug and/or dyed fluid
- the fluid source 306 comprises a dried diluent.
- a fluid is streamed into the fluid source 306 through the adapter 100/250/260/270/280/304, which reconstitutes the dried diluent into a fluid diluent.
- the fluid for reconstituting the dried diluent is ejected from the fluid drain 302 into the adapter 100/250/260/270/280/304.
- the coating comprises a water-soluble additive.
- water-soluble means sufficiently soluble in an aqueous solution, such as water or a solution based primarily on water (e.g. a buffer, or a salt solution).
- a water-soluble additive has adhesive properties to the adapter. In some embodiments, a water-soluble additive has adhesive properties to a wall of the adapter. In some embodiments, a water-soluble additive is bound to the wall. In some embodiments, a water-soluble additive forms non-covalent bonds with the wall. In some embodiments, a water-soluble additive forms van der Waals bonds with the wall. In some embodiments, a water-soluble additive forms p-p stacking interactions with the wall.
- non-covalent bonds encompasses ligand-receptor interactions, hydrogen bonding, dipole-dipole interactions and van der Waals bonds or any combination thereof.
- non-covalent bond formation between the adhesive and the surface of the adapter provides adhesive properties to the coating.
- the coating further comprises a water-soluble adhesive which is bound to the wall.
- a water-soluble adhesive forms non- covalent bonds with the wall.
- a water-soluble adhesive forms hydrogen bonds with the wall.
- the coating comprises a water-soluble adhesive and a water-soluble additive.
- the coating comprises an adhesive which encapsulates an additive.
- an additive is absorbed to an adhesive.
- an additive is dispersed in an adhesive.
- an adhesive and an additive are bound via non-covalent bonds.
- an adhesive and an additive are bound via hydrogen bonds.
- an adhesive and an additive are bound via electrostatic bonds.
- an adhesive and an additive are bound via van der Waals bonds.
- the coating is in a solid form. In some embodiments, the coating is a dry solid. In some embodiments, the dry solid consists less than 10% water. In some embodiments, the water content of the dry solid is less than 5 %w/w. In some embodiments, the water content of the dry solid is less than 2 %w/w. In some embodiments, the water content of the dry solid is less than 1 %w/w.
- the coating forms a film on a wall of the adapter. In some embodiments, the coating forms a stable layer on the wall of the adapter. In some embodiments, the coating is bound to the wall.
- the coating covers the wall of the adapter. In some embodiments, the coating is a partial coating, covering at least a part of the wall. [0081] In some embodiments, the coating forms a uniform layer on the wall. In some embodiments, the coating forms a layer with differential thickness. In either embodiment, the thickness of a coating layer is not limited.
- the w/w ratio of an additive to an adhesive in the coating ranges from 1: 1 to 1:50. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1 : 1 to 1:3. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1:3 to 1:5. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1 :5 to 1 :8. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1 :8 to 1: 10. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1: 10 to 1 : 15.
- the w/w ratio of an additive to an adhesive in the coating ranges from 1 : 15 to 1:20. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1:20 to 1:30. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1:30 to 1:40. In some embodiments, the w/w ratio of an additive to an adhesive in the coating ranges from 1:40 to 1:50.
- the coating is soluble in the fluid. In some embodiments, the coating dissolves homogenously within the fluid. In some embodiments, after contacting the coating with the fluid, the coating releases an additive. In some embodiments, after dissolving the coating, a solution comprising an additive is formed. In some embodiments, the solution is a homogenous additive solution. In some embodiments, the solution is a homogenous solution comprising an adhesive and an additive is formed. In some embodiments, the solution is an aqueous solution.
- the coating does not undergo a chemical reaction upon contacting with the fluid. In some embodiments, the coating does not undergo a chemical reaction upon dissolution. In some embodiments, the coating does not undergo a chemical reaction with an aqueous solution. In some embodiments, the coating does not undergo a chemical reaction with the compartment of the vial. In some embodiments, a solution comprising the coating does not undergo a chemical reaction with the compartment of the vial. In some embodiments, an aqueous solution comprising the coating does not undergo a chemical reaction with the compartment of the vial. In some embodiments, the coating does not have a therapeutic activity. In some embodiments, the coating does not affect a therapeutic activity of an active ingredient.
- the coating further comprises an additional ingredient selected from the group consisting of: a tackifier, a crosslinking agent, and a binder or any combination thereof.
- a tackifier may be used to increase a stickiness of the surface of the adhesive.
- Such agents may be useful for combining the compound of the invention with carriers to yield a coating composition.
- Such compositions may aid to maintain contact between the compound of the invention or a composition containing thereof, and a weed.
- Non-limiting examples of adherents include but are not limited to: a lecithin, formononetin, alkali formononetinate, hesperetin, polyvinyl acetate, a cephalin, Mineral Oil, Arabino-galactan, Glycerol, Triethylene glycol, Vinyl Acetate, Polystyrene, and Polyvinyl.
- Non-limiting examples of crosslinking agents include but are not limited to: an isocyanate compound, a melamine compound, a poly(meth)acrylate compound, an epoxy compound, and the like.
- Binders may be used to impart cohesiveness of the coating.
- Non-limiting examples of binders include but are not limited to: hydroxy propyl methyl cellulose, hydroxy propyl cellulose, hydroxy ethyl cellulose, ethyl cellulose, cellulose derivatives, maize starch, polyvinylpyrrolidone 25 alone or in combination with polyethylene glycols and the like. Binders may be used in the range of about 5% to about 30% by weight of total composition.
- the coating is a multilayer coating.
- the multilayer coating comprises a first layer bound to the wall of the adapter, and a second layer.
- the second layer is a top layer.
- the second layer is bound to the first layer.
- the second layer is devoid of an additive.
- the second layer is a protective layer.
- the second layer prevents the first layer from degradation, such as abrasion or bleaching.
- the second layer comprises an adhesive, as described hereinbelow.
- the second layer further comprises an additional ingredient selected from the group consisting of: a tackifier, a crosslinking agent, and a binder or any combination thereof.
- a water-soluble adhesive is selected from the group consisting of: a water-soluble saccharide, a peptide, a protein, a low-molecular weight surfactant, and a water-soluble adhesive polymer or any combination thereof.
- the adhesive is soluble in the fluid. In some embodiments, the adhesive dissolves homogenously within the fluid.
- the adhesive does not undergo a chemical reaction upon contacting with the fluid. In some embodiments, the adhesive does not undergo a chemical reaction upon dissolution. In some embodiments, the adhesive does not undergo a chemical reaction with an aqueous solution. In some embodiments, the adhesive does not undergo a chemical reaction with the compartment of the vial. In some embodiments, a solution comprising the adhesive does not undergo a chemical reaction with the compartment of the vial. In some embodiments, an aqueous solution comprising the adhesive does not undergo a chemical reaction with the compartment of the vial. In some embodiments, the adhesive does not have a therapeutic activity. In some embodiments, the adhesive does not affect a therapeutic activity of an active ingredient.
- the adhesive has adhesiveness to the surface of the adapter. In some embodiments, the adhesive facilitates bonding of the additive to the surface of the adapter. In some embodiments, the adhesive facilitates adhering of the additive to the surface of the adapter. In some embodiments, the adhesive forms non-covalent bonds with the wall of the adapter and with an additive. In some embodiments, the adhesive has at least one functional group selected from: an aromatic ring, an alkyl chain, a charged residue, a hydrogen bond donor or acceptor. In some embodiments, the adhesive is an amphiphilic substance containing a hydrophobic segment and a hydrophilic segment.
- the adhesive is a water-soluble adhesive polymer.
- adhesive polymer used herein means a polymer, which exhibits adhesion to a surface.
- Non-limiting examples of water soluble adhesive polymers include but are not limited to: poly-phosphazene, poly-phosphoester, poly-oxazoline, a poly-[divinylether- maleic anhydride], poly-[N(2-hydroxypropyl)methacrylamide], poly-acrylamide, poly acrylic acid, poly-vinyl alcohol, poly- vinyl pyrrolidone, poly-ethylene glycol or any combination thereof.
- Non-limiting examples of low-molecular weight surfactants include but are not limited to: Polysorbate 80, sodium dodecyl sulfate, sunflower lecithin, egg lecithin, egg phosphatidylglycerol, soy lecithin, hydrogenated soy lecithin, and sphingomyelin.
- the adhesive is a saccharide.
- saccharide is referred to any water-soluble, optionally substituted mono-, di-, oligo-, or polysaccharide.
- Non-limiting examples of water-soluble saccharides include but are not limited to: monosaccharide (e.g. fructose, glucose, galactose), a disaccharide (e.g. sucrose), an oligosaccharide (e.g. raffinose, maltotriose), a polysaccharide (e.g. cellulose acetate, gum arabic, gum ghatti, dextran, pullulan, amylopectin), and a substituted sugar (e.g. aminoglycoside) .
- monosaccharide e.g. fructose, glucose, galactose
- a disaccharide e.g. sucrose
- an oligosaccharide e.g. raffinose, maltotriose
- a polysaccharide e.g. cellulose acetate, gum arabic, gum ghatti, dextran, pullulan, amylopect
- the adhesive is a monosaccharide. In some embodiments, the adhesive is a disaccharide. In some embodiments, the adhesive is an oligosaccharide.
- a water-soluble additive is selected from a dye, a pharmaceutical, and a pharmaceutical excipient or any combination thereof.
- the additive is soluble in the fluid. In some embodiments, the additive dissolves homogenously within the fluid. In some embodiments, the additive dissolves homogenously in an aqueous solution.
- the additive does not undergo a chemical reaction upon contacting with the fluid. In some embodiments, the additive does not undergo a chemical reaction upon dissolution. In some embodiments, the additive does not undergo a chemical reaction with an aqueous solution. In some embodiments, the additive does not undergo a chemical reaction with the compartment of the vial. In some embodiments, a solution comprising the additive does not undergo a chemical reaction with the compartment of the vial. In some embodiments, an aqueous solution comprising the additive does not undergo a chemical reaction with the compartment of the vial. In some embodiments, the additive does not have a therapeutic activity. In some embodiments, the additive does not affect a therapeutic activity of an active ingredient.
- Non-limiting examples of dyes include but are not limited to: anionic dyes (e.g. Alizarine Pure Blue B, Acid red 88), cationic dyes (e.g. methine dyes, anthraquinone dyes, azo dyes), and neutral dyes (e.g. Neutral Orange RL, Neutral Red GRL, Neutral Gray 2BL).
- anionic dyes e.g. Alizarine Pure Blue B, Acid red 88
- cationic dyes e.g. methine dyes, anthraquinone dyes, azo dyes
- neutral dyes e.g. Neutral Orange RL, Neutral Red GRL, Neutral Gray 2BL.
- a dye further comprises a pharmaceutically acceptable salt.
- Non-limiting examples of pharmaceutical excipients include but are not limited to: fillers, plasticizers, flavors, preservatives, and sorbents.
- the additive has adhesiveness to the surface of the adapter. In some embodiments, the additive forms van der Waals bonds with the wall. In some embodiments, the additive forms p-p stacking interactions with the wall. In some embodiments, the additive is absorbed to the wall.
- the additive has at least one functional group selected from: an aromatic ring, an alkyl chain, and a charged residue.
- the additive is a neutral compound comprising a hydrogen donor or acceptor.
- the additive comprises an aromatic ring.
- the additive is a charged compound.
- the additive is an amphiphilic substance containing a hydrophobic segment (e.g. an aromatic ring) and a hydrophilic segment (e.g. a charged group).
- the additive is absorbed to the adhesive. In some embodiments, the additive is bound to the adhesive via non-covalent bonds. In some embodiments, the additive is incorporated within the adhesive. In some embodiments, the additive is incorporated within the coating layer. In some embodiments, the additive is bound to the outer surface of the coating layer.
- the additive is a dye. In some embodiments, the additive is selected from an anionic and a cationic dye.
- a method of coating an adapter comprises mixing an additive with a solvent, thereby obtaining a coating solution comprising the additive.
- the coating solution further comprises an adhesive.
- the method comprises mixing the additive and the adhesive with a solvent, thereby obtaining a coating solution comprising the additive and the adhesive.
- the coating solution further comprises a constituent.
- the constituent is selected from the group consisting of: a surfactant, a tackifier, a crosslinking agent, a wetting agent, and a binder or any combination thereof.
- the constituent mentioned herein may be used in the amounts suitable for such purposes, for example the wetting agent and the emulsifier in a concentration of 0.5 to 30 w/w%, the thickeners in a concentration of 0.1 to 30 w/w%.
- Non-limiting examples of solvents that can be used to prepare the coating solution include those that will dissolve solid components of the coating, that are compatible with the coating and the adapter, and can ensure uniform coverage of the surface of the adapter.
- Potential solvents include, but are not limited to, the following: water, ethanol, methanol, ethylene glycol, or any combination thereof.
- the coating solution is an aqueous solution.
- the solution is a buffered solution with an acidic pH (e.g. 0-6).
- the solution has a basic pH (e.g. 8-14).
- the solution has a pH in the range of 6 to 8.
- the coating solution is an aqueous alcoholic solution.
- the coating solution is a dispersion.
- the coating solution is an emulsion.
- the method comprises mixing an additive and an adhesive at a w/w (weight/weight) ratio ranging from 1: 1 to 1:50 with a solvent, thereby obtaining a coating solution comprising the additive and the adhesive.
- the coating is applied to the adapter by a method selected from: spin coating, spray coating, spray and spin coating, curtain coating, flow coating, dip coating, injection molding, casting, roll coating, wire coating, chemical vapor deposition, physical vapor deposition and any of the methods used in preparing overlays.
- the application method selected will depend upon, among other things, chemical properties of materials composing the coating, the thickness of the desired coating, the geometry of the surface to which the coating is applied, and the viscosity of the coating.
- the method optionally comprises cleaning at least a portion of the adapter surface prior to applying any coatings thereto. This can be done for the purposes of cleaning and/or promoting adhesion of the coating. Effective treatment techniques are known to those skilled in the art.
- the coating is applied to the adapter by dip coating.
- the method comprises contacting the adapter with the coating solution.
- the method comprises contacting at least a part of the adapter with the coating solution.
- the adapter is placed into a container containing the coating solution.
- the method comprises:
- the method further comprises applying a vacuum after contacting the coating solution or the molten coating with the adapter, to remove air from the coating.
- air removal is performed in order to obtain a uniform coating.
- air removal is performed in order to facilitate penetration of the coating solution into the smallest parts of the adaptor.
- the method comprises drying the coating solution at 10 to 90°C, thereby obtaining a coated adapter.
- drying is performed by convection drying, such as by applying a hot gas stream to a coated surface.
- drying is performed by cold drying, such as by applying a de-humidified gas stream to the surface.
- drying is performed by infrared (IR) drying. In some embodiments, drying is performed by microwave drying. In some embodiments, the method further comprises reacting one or more components of the coating (e.g. by photo-crosslinking). Generally, the drying method and exact drying conditions selected will depend upon, among other things, chemical and physical properties of materials composing the coating, and chemical and physical properties of the adaptor (e.g. thermal stability).
- the method further comprises vacuum drying of the coating solution. In some embodiments, the method comprises a partial drying of the coating.
- a container comprising the coating solution and the adapter is provided to conditions suitable for drying, such as a temperature ranging from 10 to 90°C. In some embodiments, conditions suitable for drying further comprise applying a vacuum.
- one opening of the adapter is closed by a plug to obtain a chamber for holding the coating solution.
- the coating solution is provided via a second opening to the chamber, thereby contacting the adapter with the coating solution.
- the adapter holding the coating solution is provided to conditions suitable for drying as described herein.
- the method further comprises applying a second layer.
- an intermediate layer is applied to attach the first layer to the second layer.
- range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
- each of the words“comprise” “include” and“have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.
- each of the words“comprise” “include” and“have”, and forms thereof are not necessarily limited to members in a list with which the words may be associated.
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Abstract
Description
Claims
Priority Applications (8)
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CA3099368A CA3099368A1 (en) | 2018-05-04 | 2019-05-05 | Reconstitution and mixing systems |
CN201980044523.7A CN112437678A (en) | 2018-05-04 | 2019-05-05 | Reconstitution and mixing system |
JP2021510583A JP2021522055A (en) | 2018-05-04 | 2019-05-05 | Reconstruction and mixing system |
BR112020022415-4A BR112020022415A2 (en) | 2018-05-04 | 2019-05-05 | reconstitution and mixing systems |
EP19796236.8A EP3796958A4 (en) | 2018-05-04 | 2019-05-05 | Reconstitution and mixing systems |
US17/052,924 US20210228443A1 (en) | 2018-05-04 | 2019-05-05 | Reconstitution and mixing systems |
AU2019263126A AU2019263126A1 (en) | 2018-05-04 | 2019-05-05 | Reconstitution and mixing systems |
KR1020207034132A KR20210008002A (en) | 2018-05-04 | 2019-05-05 | Reconstruction and mixing systems |
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US201862666776P | 2018-05-04 | 2018-05-04 | |
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EP (1) | EP3796958A4 (en) |
JP (1) | JP2021522055A (en) |
KR (1) | KR20210008002A (en) |
CN (1) | CN112437678A (en) |
AU (1) | AU2019263126A1 (en) |
BR (1) | BR112020022415A2 (en) |
CA (1) | CA3099368A1 (en) |
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JP6488232B2 (en) * | 2012-07-03 | 2019-03-20 | エスアイオーツー・メディカル・プロダクツ・インコーポレイテッド | Drug package SiOx barrier and coating process |
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2019
- 2019-05-05 US US17/052,924 patent/US20210228443A1/en not_active Abandoned
- 2019-05-05 CA CA3099368A patent/CA3099368A1/en active Pending
- 2019-05-05 JP JP2021510583A patent/JP2021522055A/en active Pending
- 2019-05-05 CN CN201980044523.7A patent/CN112437678A/en active Pending
- 2019-05-05 BR BR112020022415-4A patent/BR112020022415A2/en not_active Application Discontinuation
- 2019-05-05 KR KR1020207034132A patent/KR20210008002A/en not_active Application Discontinuation
- 2019-05-05 WO PCT/IL2019/050500 patent/WO2019211858A1/en unknown
- 2019-05-05 AU AU2019263126A patent/AU2019263126A1/en active Pending
- 2019-05-05 EP EP19796236.8A patent/EP3796958A4/en not_active Withdrawn
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WO2007067623A2 (en) * | 2005-12-06 | 2007-06-14 | Tyco Healthcare Group Lp | Biocompatible tissue sealants and adhesives |
WO2010139666A1 (en) * | 2009-06-02 | 2010-12-09 | Sanofi-Aventis Deutschland Gmbh | Delivery of two or more medicaments through a single dose selection and dispense interface |
WO2010139669A1 (en) * | 2009-06-02 | 2010-12-09 | Sanofi-Aventis Deutschland Gmbh | Medicated module with premix medicament |
WO2010139670A1 (en) * | 2009-06-02 | 2010-12-09 | Sanofi-Aventis Deutschland Gmbh | Medicated module for a drug delivery device |
EP2550043B1 (en) * | 2010-03-25 | 2017-10-11 | Sanofi-Aventis Deutschland GmbH | Medicated module with user selection |
WO2012115022A1 (en) * | 2011-02-21 | 2012-08-30 | 三井化学株式会社 | Device and kit for mixing three components |
WO2016061548A1 (en) * | 2014-10-18 | 2016-04-21 | Abbvie Inc. | Wearable automatic injection system and apparatus |
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Also Published As
Publication number | Publication date |
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AU2019263126A1 (en) | 2020-12-03 |
CN112437678A (en) | 2021-03-02 |
JP2021522055A (en) | 2021-08-30 |
KR20210008002A (en) | 2021-01-20 |
EP3796958A4 (en) | 2022-01-26 |
CA3099368A1 (en) | 2019-11-07 |
EP3796958A1 (en) | 2021-03-31 |
US20210228443A1 (en) | 2021-07-29 |
BR112020022415A2 (en) | 2021-03-09 |
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