CN105848625B

CN105848625B - Beverage cartridge comprising pharmaceutically active substance

Info

Publication number: CN105848625B
Application number: CN201480064906.8A
Authority: CN
Inventors: K·F·特朗布利
Original assignee: Procter and Gamble Ltd
Current assignee: Procter and Gamble Ltd
Priority date: 2013-11-27
Filing date: 2014-11-26
Publication date: 2019-07-09
Anticipated expiration: 2034-11-26
Also published as: CA2929863A1; AU2014354787A1; MX2016006449A; RU2016118811A; AU2017245390B2; AU2014354787B2; AU2017245390A1; EP3073981A1; RU2669392C1; WO2015081145A1; EP3073981B1; CN105848625A

Abstract

The invention discloses a kind of suitable for the cylinder for the Childproof being used together with automatic brewing apparatus.Cylinder has base portion and capping.Base portion may include pharmaceutically active substance.Capping can be the multilayer laminate with outer layer and internal layer.Cylinder can be by being enough to prevent 70% children to be made during Childproof screening test close to the tear-resistant material of the content of three or more.

Description

Beverage cartridge comprising pharmaceutically active substance

Technical field

The present invention relates to a kind of beverage cartridges, and more specifically, a kind of beverage suitable for preparing comprising pharmaceutically active substance Cylinder.

Background technique

Currently, there are a variety of cylinders used in the automatic brewing apparatus of preparation one cup beverage products such as coffee or tea.So And current cylinder is not suitable for being used together with pharmaceutically active substance, because active material is to environmental condition such as humidity and oxygen Sensitivity, and active material is degraded in current cylinder.In addition, Consumer Product Safety Commission (CPSC) requires, if cylinder includes Certain active constituents such as paracetamol and diphenhydramine, then primary package is Childproof.

Be suitable for the cylinder used in automatic brewing apparatus therefore, there is still a need for a kind of, this tin be both Childproof and For the barrier with environmental condition, to provide the long-time stability of pharmaceutically active substance.

Summary of the invention

A kind of cylinder for the Childproof being adapted to fit in automatic brewing apparatus, comprising: (a) base portion, wherein base portion include Pharmaceutically active substance；(b) it covers, wherein capping includes multilayer laminate, which includes outer layer and internal layer；Wherein Cylinder is by being enough to prevent 70% children close to the resistance to of the content of five or more cylinders during Childproof screening test Tearing material is made.

A kind of multilayer laminate capping of the Childproof suitable for cylinder, comprising: (a) outer layer；(b) internal layer；Wherein Capping is by being enough to prevent 70% children from covering by piercing through close to five or more during Childproof screening test The tear-resistant material of the content of cylinder is made and wherein covers and can be penetrated by the syringe needle of automatic brewing apparatus or other penetration devices.

A kind of cylinder for the Childproof being adapted to fit in automatic brewing apparatus, comprising: (a) base portion, wherein base portion include Pharmaceutically active substance；(b) it covers；Wherein cylinder prevents 70% children from approaching by being enough during Childproof screening test The tear-resistant material of the content of five or more cylinders is made.

Detailed description of the invention

Fig. 1 is the three-dimensional, exploded view of beverage cartridge；

Fig. 2 is the side sectional view of the beverage cartridge of Fig. 1；

Fig. 3 is the side sectional view of the capping for beverage cartridge；

Fig. 4 A is the capping for beverage cartridge；

Fig. 4 B is the capping for beverage cartridge；

Fig. 5 is that there are two the side sectional views of the beverage cartridge of compartment for tool；

Fig. 6 is the example of the side sectional view of the beverage cartridge with two chambers；And

Fig. 7 is the exemplary three dimensional exploded view of the beverage cartridge with filter.

Specific embodiment

Many consumers like drinking hot drink or cold drink with pharmaceutically active substance.Prepare one cup hot drink or cold drink just Sharp and easy way is using the automatic brewing apparatus with cylinder.However, current cylinder is unsuitable for due to two and medicine Active substances are used together.Firstly, current cylinder does not provide enough barriers to environmental condition to prevent from degrading.Secondly, working as Preceding cylinder is not Childproof.It has been observed that children can open in the following manner current cylinder: utilizing theirs Tooth and then using their finger peel off capping with approach content or by using they thumb to capping apply Pressure covers to pierce through.As soon as once he can quickly open other cylinder in addition, children have understood how to open a cylinder.

Cylinder of the invention can provide and enough barriers of environmental condition and can be for Childproof, the environmental condition Including humidity and gas, including oxygen.The structure and/or material of bottom and/or capping can provide the long-term of pharmaceutically active substance Stability and/or Childproof.Cylinder can have base portion and closure construction.In one example, base portion can be multiple-layer laminated Body may include polytrifluorochloroethylene (PCTFE), adhesive and the polyethylene terephthalate with glycol modification agent (PETG).In another example, capping can be multilayer laminate structure, may include aluminium foil, adhesive and plastics.Base Portion and/or capping can be tear-resistant.Although the bottom of base portion and/or capping still may be used in addition, being Childproof To be that can be penetrated by the syringe needle of automatic brewing apparatus or penetration device.

This tin can meet the Childproof according to U.S.'s gas defence packaging bill (16C.F.R. § 1700.14) in 1970 Restriction.Specifically, cylinder can meet the restriction of the F=3 according to Childproof as described herein test.In another example In, cylinder can meet according to Childproof test F=1, in another example F=2, in another example F=4, F=5 and the restriction of F=6 in another example in another example.In one example, in the feelings of not secondary package Under condition, only cylinder itself meets the restriction of Childproof.

Cylinder is applicable to automaton, the automatic brewing apparatus of such as one cup.Some in these machines have penetration device or Syringe needle, the penetration device or syringe needle, which can penetrate, to be covered and then provides the stream of the water (usually hot water) by the hole in capping It is dynamic, while the second penetration device or syringe needle squeeze through the bottom of base portion to receive the outflow of beverage and assign it to cup or container In.Although base portion and capping layer are Childproofs, in some instances, they can be by the penetration device or needle of brewing apparatus Head penetrates.In another example, Childproof and/or barrier characteristics do not interfere the normal operating of automatic brewing apparatus.

As used herein, " active material " or " pharmaceutically active substance " includes that can be used in mammal especially people The whole compounds and composition for the treatment of and/or prevention disease and/or offer general health and healthy and beneficial effect.Specifically have The non-limiting example of active material includes the work of active material and prescription after over the counter (OTC) active material, sales counter Property substance, vitamin, minerals, the substance of plant origin, energy excitation substance, probiotics, fiber, prebiotics and they Combination.

As used herein, " Childproof " refer to be designed or be configured to make child open within reasonable time or Obtain the substance addition difficult wherein included of toxic or harmful amount, and cylinder not difficult for proper use of adult or Other packagings, but not refer to that all such children cannot open or obtain within reasonable time the packet of toxic or harmful amount Dress.

As used herein, " dissolution ", which refers to, gradually becomes solution.

As used herein, " decomposition ", which refers to, is broken into fraction.

As used herein, " permanently engage " refers to that wherein first element is fixed to second element, so that not at least These elements usually can not configuration separated from each other in the case where partly destroying one or both of these elements.

As used herein, " primary package " refer to or the package member that can directly be contacted with dosage form.

As used herein, it " is releasably engaged " and refers to that wherein first element is fixed to second element, so that first element With second element can be separated in the case where not damaging or minimally damaging first element and second element configuration.

As used herein, " tear-resistant " be refer to experience reasonable level stress and/or deformation and do not suffer from integrality Significant loss.Stress and/or deformation can be applied by multi-motion, including but not limited to bite, pull at cylinder, shelling, stabbing, It pushes away and/or discloses.In one example, any of these movements can be carried out by children, and tear-resistant be referred to be subjected to can When the power applied by children, material can undergo reasonable level stress and/or deformation and do not suffer from the significant loss of integrality. In one example, children are six years old or smaller, in another example five years old or smaller, in another example four years old or more It is small, three years old or smaller in another example, two years old or smaller in another example, and 18 months in another example Or it is smaller.In one example, although cylinder be it is tear-resistant, still can be used automatic brewing apparatus syringe needle or penetration device by it It pierces through.

As used herein, term " processing " (treat or treating) includes prevention, alleviates, improves, inhibits or mitigate One or more health status of mammal (especially people and such as adult).The non-limiting example of health status can Including respiratory passage diseases.

As used herein, "one" and "an" of article be understood to claimed or description one kind or Multiple material, for example, " a kind of active material " or " compartment ".

Fig. 1 shows the exploded view of cylinder 1 and Fig. 2 shows the side sectional views of cylinder 1.Cylinder 1 includes base portion 10 and capping 20.Base Portion 10 includes the edge 13 of opening 11 and facing external.Base portion 10 can have cup, cylinder, bowl or inverted truncated cone Shape.Base portion 10 may include component 12, and component 12 may include active material and/or excipient.In one example, the component It can be powder.The bottom 15 of base portion 10 can be pierced device during use or syringe needle penetrates.

With reference to Fig. 2, the edge 13 of base portion 10 can be permanently joined at sealing 25 by covering 20 inner surface 26.Envelope Lid can be bonded to base portion by any suitable method.In one example, capping have thermal activation coating, thus make its The edge of base portion is attached to when being exposed to heat.In another example, it covers and supersonic frequency attachment can be used, and at another In example, covers and induction heating attachment can be used.Alternatively, capping can be attached with contact adhesive.

Capping 20 can be the lamilate of the Childproof with outer layer 21 and internal layer 22.Outer layer 21 can provide child-resistant and open Opening property and can be to be tear-resistant, while still can be penetrated by the syringe needle of automatic brewing apparatus or other penetration devices.In an example In, outer layer 21 may include reinforcing lines 24, can provide other Childproof.Reinforcing lines 24 can be in entire capping 20 Upper formation mesh sheet, and in one example, at the position that capping is intended to be pierced through by syringe needle or penetration device, mesh sheet can be opening 's.In one example, it reinforces in the lamilate of the embeddable Childproof of lines.In another example, lines are reinforced to exist Below outer layer.In another example, reinforcing lines can be below internal layer.In another example, reinforcing lines can be in outer layer Between internal layer.In another example, it reinforces in the embeddable outer layer of lines and/or internal layer.Reinforcing lines can be by any suitable Material be made, including nylon, polypropylene, glass fibre and their combination.

Internal layer 22 can reduce the amount into the gas (including oxygen) of cylinder 1.Internal layer 22 can be made of any suitable material, And in one example, internal layer 22 can be made of aluminium foil.Internal layer 22 can be to be opaque, this can provide other child-resistant and opens Qi Xing.In another example, internal layer 22 may also include ink.In one example, outer layer 21 and internal layer 22 pass through adhesive forever Engage to long property.

Capping may be either Childproof, and can provide enough barriers with gas and humidity, while still can be by certainly The syringe needle or other penetration devices of dynamic brewing apparatus penetrate.In one example, it covers as lamilate.Lamilate can have any number Layer.In one example, lamilate is at least two layers, in another example at least three layers, in another example In at least four layers, and at least five layers in another example.In another example, capping can be only one layer.? In one example, one or more layers of capping can be opaque, and in another example, the one or more of capping Layer can be transparent.

Fig. 3 is the example of the side sectional view of the capping 30 for beverage cartridge.Capping 30 may include outer layer 32, the second layer 33, third layer 34 and internal layer 35.In one example, outer layer 32 may include polyethylene terephthalate (PET), second Layer 33 may include oriented polyamide (OPA), and third layer 34 may include aluminium, and internal layer 35 may include polyethylene vinylacetate (PE-EVA).In another example, internal layer 35 may include linear low density polyethylene (LLDPE).In one example, each Layer is attached to adjacent layer using adhesive.In another example, ink is between outer layer and the second layer.In another example In, ink print is on outer layer.In another example, heat seal coating partly or completely all standing internal layer.

Fig. 4 A and 4B are the examples with the capping of atenuator region.The region of reduction can be at being intended to by automatic brewing apparatus In the region that syringe needle or other penetration devices pierce through.It is Childproof that the region of this reduction, which allows capping, while still Allow to cover and be penetrated by syringe needle or penetration device.The region of reduction can partially or completely extend through one or more of lamilate capping A layer.In one example, the region of reduction is on the outer layer of capping.In another example, the region of reduction is not at On the outer layer of capping, because children may can be appreciated that the region of reduction and be approached or picked up at the edges of regions of reduction And it removes.In one example, the region of reduction does not penetrate internal layer.In another example, the region of reduction only penetrates or portion Divide and penetrates outer layer.In one example, the region of reduction can be to be sufficiently small, so that children are difficult with its content close to cylinder Object.In one example, the region of reduction is about 1mm to about 12mm at its widest point, be in another example about 2mm extremely About 10mm, and be in another example about 3mm to about 8mm.

Fig. 4 A is the region with reduction, the i.e. example of the capping 40 in hole 42.The hole can be any suitable shape.Shape Non-limiting example may include circle, square, diamond shape, rectangle, triangle, star, cross, ellipse and they Combination.

Fig. 4 B is the region with reduction, the i.e. example of the capping 45 of knurled portion 47.Knurled portion 47 can be for above-listed Any of shape out, and " x ", intersecting hachure, Duo Gedian and their combination.

Fig. 5 is the example of the side sectional view of the beverage cartridge 5 with more than one compartment.It, will be some for some components It can be advantageous that ingredient, which separates until they will be consumed,.In one example, active material and/or excipient are not Stability compatible and that they are separately extended to these components.In another example, the component is in different conditions, Such as a kind of group be divided into solid and another group is divided into liquid.In another example, a compartment includes active object The component of matter and another compartment include the component with flavoring agent, this allows more steady flavor delivery, especially When flavoring agent is liquid.

In Fig. 5, beverage cartridge 5 have the first compartment 51 comprising the first component 53 and second comprising the second component 54 every Room 52.First compartment 51 and second compartment 52 are separated by separator 55.

Separator can be any suitable material.In one example, when being exposed to hot water or cold water, separation sections Or it is completely dissolved or partially or completely decomposes.In another example, separator can be when group is divided into solid by component point The mesh material or weaving material opened, but when component is dissolved in water, solution may pass through mesh material or weaving material.Another In one example, syringe needle or penetration device puncture separator from automatic brewing apparatus can be used.When separator is pierced, water and Two components can flow to first compartment from second compartment.

Beverage cartridge can have multiple compartments.In one example, beverage cartridge can have at least two compartments, show at another At least three compartments in example, and at least four compartment in another example.Compartment can extend in any direction, including water It is flat across cylinder, from base bottom vertically to capping, diagonally or their combination.

Fig. 6 is the example of the side sectional view of the beverage cartridge 6 with multiple chambers.Cylinder 6, which has, includes the first component 63 First chamber 61 and second chamber 62 comprising the second component 64.Chamber can not only keep component to separate until that will use it Before, and they allow which kind of active material user's selection wants in its beverage.

In one example, automatic brewing apparatus can have a top syringe needle 66, approximate to pierce through capping 65 and not at center Pierce through first chamber 61 or second chamber 62.Meanwhile lower needle 67 pierces through bottom 68 and the chamber 63 of base portion 69.Lower needle 67 do not pierce through the centre of base portion 67, its opposite eccentric puncture.Therefore, there is specific orientation in brewing apparatus by arrangement cylinder 6, One chamber can be destroyed, while another chamber keeps complete.In one example, chamber can be made simultaneously of friable material And/or person can preparatory indentation, so as to when lower needle pierce through chamber when, chamber cracks or fractures into two or more portions completely Point.The non-limiting example of friable material may include starch basement membrane, water-soluble modified cellulose membrane such as hydroxyethyl cellulose, second Base vinylacetate film and their combination.When brewed beginning, water will flow out top syringe needle and around complete chamber Flowing, while being mixed with the component of rupture chamber and preparing the beverage with desired component.

For example, first chamber may include the active material to treat pain, such as paracetamol or brufen, and And second chamber may include the active material for treating cough, such as dextromethorphan.If consumer does not cough, she Cylinder can be located in automatic brewing apparatus, so that only penetrating the chamber with the active material for pain by bottom syringe needle. However, if consumer want two kinds of active materials, she can it is brewed twice, pierce through two chambers.

In another example, chamber may include different flavoring agent, so that user be allowed to select the taste of its beverage.

In another example, top syringe needle can pierce two chambers.Lower needle only pierces through a chamber and comes from The liquid of top syringe needle is flowable into two chambers, but beverage will only be able to flow from the chamber pierced through by lower needle Out.Therefore, consumer can prepare the beverage with desired component.

Cylinder can have any suitable number of chamber.In one example, cylinder can have at least two chambers, at another At least three chamber in example, and at least four chamber in another example.In one example, cylinder can have single chamber Room, allowing consumer's preparation, only there are two types of the beverages of component for the beverage of the component with exterior thereto or preparation tool.

In another example, chamber can be used for separately incompatible component.

Fig. 7 is the example of the cylinder 7 with base portion 70, capping 71 and filter 72.Filter 72 includes component 73.When Filter can be used in infusion beverage such as coffee or tea time.For water by the essence of percolating filter and extraction components, solid particle will It keeps in the filter.In one example, when water passes through filter, active material and/or other excipient be can dissolve In water.In one example, the brewed coffee or tea comprising active material of cylinder with filter can be used.

In one example, cylinder does not include filter.

In another example, at least one is component packaged prepares in autonomous container and by consumer or for consumer The people of beverage adds before or after through automatic brewing apparatus beverage brewed.In one example, which can be flavoring agent, And in another example, which may include one or more active materials.In one example, autonomous container can be small Bag.In one example, autonomous container may include liquid.In another example, autonomous container may include solid, wherein solid It can be powder, sugared grain, capsule, tablet or their combination.In another example, consumer is pierced using automatic brewing system Wear the top of cylinder, but before beverage brewed, consumer reopen machine and the hole that is prepared by automatic brewing apparatus to The ingredient of independent packaging is added in cylinder, and machine is then re-closing off simultaneously beverage brewed.

Base portion can be made of any suitable material, the material provide desired barrier property and Childproof and It can still be penetrated by the syringe needle of automatic brewing apparatus or penetration device.The non-limiting of the material that can be coupled in the laminate of base portion is shown Example may include high density polyethylene (HDPE) (HDPE), cyclic olefin copolymer (COC), Biaxially orientated polyamide (OPA), polypropylene (PP), polyester (PET), amorphous polyethylene terephthalate (APET), polyvinyl chloride (PVC), polyethylene (PE), aluminium foil, And their combination.In another example, lamilate may include gathering inclined vinylidene chloride coating, and show at another In example, lamilate may include ethyl vinyl alcohol (EVOH).In one example, base portion can be transparent, in another example, Base portion can be opaque.

In one example, base portion can be for by polytrifluorochloroethylene (PCTFE), optional adhesive and glycol modification Polyethylene terephthalate (PETG) made of lamilate.In one example, PETG can be about 25 μm to about 1.5mm Thickness is about 50 μm in another example to about 1mm, is in another example about 100 μm to about 500 μm, and another It is about 200 μm to about 300 μm in a example.In another example, PCTFE can be about 10 μm to about 250 μm, show at another It is about 25 μm to about 150 μm in example, is in another example about 30 μm to about 100 μm, and be in another example about 40 μm to about 75 μm.

In one example, base portion can be the lamilate with internal layer and outer layer.In one example, internal layer can be EVOH or children are difficult to another material for piercing through or tearing.The internal layer and outer layer of base portion can be releasably engaged.Work as children It when attempting to open container, such as by puncture, tearing or bites, internal layer can be separated with outer layer.It is this separately children to be made to subtract Slowly, this can give parent or tender more times to interfere and prevent children close to cylinder.It is this separately also children to be made to feel Feel that they achieve progress on opening packaging, and the two layer of layering in fact do not help to obtain the close of component, Because children cannot break internal layer and/or outer layer.

In one example, the maximum gauge of base material can be greater than current pharmaceutical product barrier material (such as blister card On chamber) maximum gauge because cylinder have greater than typical pharmaceutical product shell size.When forming the base portion of cylinder, make Sufficient thickness is provided with the base material with bigger initial thickness, because the bottom of the material towards cylinder base portion is stretched Bigger degree.

Current capping can be removed by children using the combination for biting and plugging.Therefore, capping can be tear-resistant.? In one example, cover as multilayer laminate.The non-limiting example for the material that can be coupled in the laminate of capping can wrap Include aluminium foil, PCTFE, EVOH, HDPE, OPA, COC, PP, PET, APET, PVC, PE and their combination.

For the lamilate and both base portions in capping layer, the layer of lamilate can be attached by adhesive phase, adhesive phase It may include polyolefine material, such as low density polyethylene (LDPE) (LDPE).

In one example, lamilate can have outer layer, the second layer and internal layer.Outer layer can be PET, and the second layer can be Foil, and internal layer can be LLDPE.

In one example, outer layer or pet layer can be about 5 μm to about 40 μ m-thicks, be in another example about 10 μm extremely About 35 μ m-thicks are about 15 μm in another example to about 30 μ m-thicks, and are in another example about 20 μm to about 25 μm It is thick.In another example, outer layer or pet layer can be greater than about 8 μm, greater than about 11 μm in another example, show at another Greater than about 16 μm in example, greater than about 20 μm in another example, and it is greater than about 22 μm in another example.

In another example, the second layer or layers of foil can be about 3 μm to about 30 μm, be in another example about 8 μm extremely About 25 μ m-thicks, and be in another example about 15 μm to about 22 μ m-thicks.In another example, the second layer or layers of foil can be big In about 5 μ m-thicks, greater than about 8 μ m-thicks in another example, greater than about 12 μ m-thicks in another example, in another example Greater than about 15 μ m-thicks, and it is greater than about 17 μ m-thicks in another example.

In another example, internal layer or LLDPE layers can be about 10 μm to about 40 μ m-thicks, in another example be about 15 It is in another example about 20 μm to about 30 μ m-thicks, and be in another example about 22 μm to about μm to about 35 μ m-thicks 27 μ m-thicks.In another example, internal layer or LLDPE layers can be greater than about 8 μ m-thicks, in another example greater than about 13 μ m-thicks, It is greater than about 18 μ m-thicks in another example, in another example greater than about 20 μ m-thicks, in another example greater than about 22 μ M is thick, and is greater than about 24 μ m-thicks in another example.

Base portion, capping, and/or cylinder can provide effective barrier.In one example, base portion, capping, and/or cylinder The final moisture transmission that can have is about 2 × 10^-5To about 2 × 10^-3G//day, be about 1 × 10 in another example^-4Extremely About 6 × 10^-4G//day, and be in another example about 2 × 10^-4To about 3 × 10^-4G//day, such as pass through United States Pharmacopeial (USP)<671>(on August 1st, 2013) is measured.It follows for Single-Unit The method 1 of the program of Containers and Unit-Dose Containers for Capsules and Tablets.

Cylinder can provide long-time stability for pharmaceutically active substance.In one example, the pharmaceutically active substance in cylinder has Shelf life be at least about 1 year, at least about 18 months in another example, at least about 2 years in another example, and At least about 2.5 years in another example.As used herein, " shelf life " refers to a period of time, the drug in this period Product is estimated to be maintained within the shelf life of approval, and precursor conditions are that it is stored up under conditions of limiting in containers labels It deposits.The locating condition of building shelf life test, specific measurement and it is available, suitable for consuming or minimum essential requirement for sale It can disclose by government or set by regulatory authorities and in directive document, such as United States Pharmacopeial (USP) or ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A (R2), step 4, on 2 6th, 2003 announcement versions.

In one example, pharmaceutically active substance is at least about the 90% of label, continues at least 1 year, shows at another At least about 1.5 years in example, at least about 2 years in another example, and at least about 3 years in another example.At another In example, pharmaceutically active substance is at least about the 95% of label, continues at least 1 year or at least about 1.5 years or at least about 2 Year.Cylinder can by keep pharmaceutically active substance be greater than about 80% or label continue at least about 1 year or at least about 1.5 years or At least long-time stability are provided over 2 years.

Cylinder can be in secondary package.In one example, secondary package can be standard cardboard case, it includes about 1 to About 12 cylinders, and about 3 to about 6 cylinders in another example.In another example, secondary package can be Childproof 's.In one example, secondary package can be conducive to the overall Childproof of cylinder.In another example, secondary package It can be packed for F=1 Childproof, F=2 Childproof is packed in another example, and F=in another example 3 Childproofs packaging.In another example, each cylinder is individually wrapped in secondary package.In another example, secondary Packaging can provide other barrier properties to help to extend the stability of component.

In one example, cylinder can be used together with automatic brewing apparatus and may be adapted to be assemblied in automatic brewing apparatus.? In another example, cylinder can use in the case where not automatic brewing apparatus.

In one example, cylinder is disposable, it means that cylinder can be disposed or be lost after limited access times It abandons.In one example, cylinder can be used five times or less times, in another example three times or less secondary, in another example In it is twice or less secondary, and in another example cylinder be used only it is primary.In another example, cylinder is recycling and can It is refilled with the component comprising active material and/or excipient.

Component may include one or more active materials and/or one or more excipient.Component can be at any suitable Form, including but not limited to powder, liquid, gel or tablet.The non-limiting example of excipient may include flavoring agent, sweet tea Taste agent, disintegrating agent, filler, pigment, lubricant, glidant, adsorbent, preservative, sensory agent and their combination.One In a example, group is divided into the powder dissolved when water passes through cylinder.In another example, group be divided into when water pass through cylinder when can be dilute The concentrated liquid released.In another example, component is only partly solubilized or is extracted to prepare beverage.

Cylinder may include one or more active materials.In one example, the beverage comprising active material can by adult and 12 years old or more children markets.In another example, the beverage comprising active material can be intended to usually be existed by children market Under adult monitoring.

Active material can treat a variety of symptoms, including but not limited to the symptom as caused by flu, influenza or allergy.Activity The non-limiting example of substance may include decongestant, expectorant, antihistamine, antitussive, antalgesic and their group It closes.

In one example, more symptoms that cylinder can provide flu and/or flu symptom, which mitigate and can be intended for night, to be made With.During single brew cycle, cylinder can deliver about 650mg paracetamol, about 30mg dextromethorphan HBr, about 10mg and go Oxygen adrenaline, about 30 to about 60mg pseudoephedrine, and/or about 12.5mg doxylamine succinate.

In some instances, deliver that how many active material are not necessarily mean that this tin includes the active material of this amount. Cylinder may be comprising than being delivered to the more active materials of user, because in some instances, and not all active material will be from Cylinder is transferred to beverage.In addition, according to statutory regulation such as USP, the delivering amount of active material can thematic discussion amount 10% it It is interior.

In another example, this tin can help to mitigate insomnia once in a while and/or can help if your difficulty falling asleep Reduce the time fallen asleep.Cylinder can provide about 50mg diphenhydramine HCl or about 25mg doxylamine succinate.

In another example, which can help user to treat allergic symptom.The cylinder can deliver about 25mg to about 50mg Diphenhydramine HCl, about 10mg Loratadine, about 650mg are more to about 1000mg paracetamol, about 7.5mg to about 12.5mg Hila is quick, and/or about 10mg neo-synephrine.

In another example, cylinder can be sold in conjunction with other products, especially comprising over the counter active material or dimension life The product of element and/or minerals.In one example, this tin may include being intended for catching a cold and/or night of flu symptom subtracts Light active material and cylinder can be intended for catching a cold and/or the active material of flu symptom mitigated in the daytime is (such as to second Acylamino- phenol, dextromethorphan and neo-synephrine) it combines packaging or sells.In another example, cylinder may include dimension life Element, such as the tea comprising vitamin, and it can be with over the counter active material, such as the day comprising flu and/or flu symptom Between and/or night mitigate active material combine packaging or sell.Over the counter active material can be any dosage form, including but unlimited In liquid, solid dosage forms such as iquid capsule or tablet or cassette dosage form.

Automatic brewing apparatus can distribute the active material of entire dosage, as measured by disquisition.Therefore, brewed When, active material is rapidly dissolvable or can be extracted in water.In one example, cylinder may include discussing dosage more than special topic Active material has correct dosage in the cup to ensure consumer.Beverage can be any volume.In one example, it drinks Material is about 100mL to about 500mL, is in another example about 125mL to about 250mL, is in another example about 130mL It to about 250mL, and is in another example about 150mL to about 200mL.In one example, beverage is about 6 ounce fluid ounces (177.41mL), and in another example, beverage is about 8 ounce fluid ounces (236.59mL).

In one example, after every use, automatic brewing apparatus can be rinsed with water or clean in other ways with Remove remaining active material and/or excipient.For example, can in the machine without cylinder in the case where carried out by consumer it is brewed Period.In one example, automatic brewing apparatus can be cleaned with water.In another example, detergent can be used, such as includes vinegar Detergent cleans automatic brewing apparatus.Some consumers may also want to clean brewing apparatus before beverage brewed.

In one example, cylinder can for Childproof and the grading of referred to as F value can be given.F value refers to list The quantity of position dosage, the unit dose close to the quantity are considered as test crash." F " subsequent number refers to based on 25 pounds There may be serious personal injury or the quantity of the unit dose of serious disease by the children of (11.4kg).

Childproof test is a standard testing and is found in 1700 gas defence of 16C.F.R. § packaging.Show at one In example, Childproof is packaged as F=1 packaging, is in another example F=2 packaging, is in another example F=3 packet Dress is in another example F=4 packaging, and packs in another example for F=5.

In one example, non-accessible 5 cylinders of about 80% or more children or more in Childproof test Content in few cylinder, in another example, the content in non-accessible 5 cylinders of about 70% or more children or less cylinder Object, in another example, the content in non-accessible 5 cylinders of about 60% or more children or less cylinder.At another In example, Childproof test in non-accessible 4 cylinders of about 80% or more children or less cylinder in content, In another example, the content in non-accessible 4 cylinders of about 70% or more children or less cylinder, in another example In, the content in non-accessible 4 cylinders of about 60% or more children or less cylinder.In another example, child-resistant is opened The content in non-accessible 3 cylinders of about 80% or more children or less cylinder in the test of opening property, in another example, Content in non-accessible 3 cylinders of about 70% or more children or less cylinder, in another example, about 60% or more Non-accessible 3 cylinders of children or less cylinder in content.In another example, the pact in Childproof test Content in non-accessible 2 cylinders of 80% or more children or less cylinder, in another example, about 70% or more Content in non-accessible 2 cylinders of children or less cylinder, in another example, about 60% or more children are non-accessible Content in 2 cylinders or less cylinder.

Test method

Childproof test

Can be the 16th according to Code of Federal Regulations: the 1700th part carries out Childproof test.

Childproof screening test

It can carry out as follows Childproof screening test:

For Childproof screening test, children are between the 42-51 monthly age.Boy is selected with the quantity of approaches uniformity And girl.

Test crash is defined as obtaining close any children to cylinder content.For following experiment, if any youngster Child during entire 10 minutes of test close to the content of three or more, then test crash.As used herein, " acquisition pair ... close " refers to that active material has been taken out or can be removed completely or partially.For cylinder, if The active material that cylinder is inverted former any quantity can spill outside cylinder, then active material can be removed.If cylinder or packaging are destroyed simultaneously And content is not removed but can be removed, then this be still considered as it is close.

Once two children of test.Two children are accompanied to test zone and take a seat them, so as in children and survey There is no physical barriers between examination person.Tester will talk with children so that they loosen.Not to children in contest or the sense of match Feel, do not awarded to them, and does not tell that their tests are that game or test are interesting.To start to test, tester should be given The identical cylinder of children and say " please attempt that me is helped to open this ".If children refuse to participate in after test has begun, that Tester should comfort children and softly children be encouraged to attempt.If children continue to refuse, tester should be required It is above-knee until another children terminates that cylinder is placed on his/her by child.This should not remove children from result, unless refusal Children upset the participation of another children.

Each children will be given 5 minutes to open his/her cylinder.Tester should make to minimize with the talk of children, as long as They continue to attempt to open their cylinder.Tester should not prevent children with language form or using facial expression.If Children become dejected or bored and cease attempt to open his/her cylinder, then tester should comfort children and softly rouse Children are encouraged to keep punching.Children should be allowed to move freely the cylinder to be dedicated to them, as long as two children can be seen i.e. in tester It can (such as they can stand, be sitting on floor or fiercely attack or agitate packaging).Children should be allowed to talk to each other about cylinder is opened And them should be allowed to look to attempt to open packaging each other.If children open his/her cylinder, tester should say " thank you " simultaneously And open cylinder is taken away from children and gives children's cylinder that another is not switched on.

At the end of 5 minutes section, tester should require children to put down their cylinder and then should show how to beat Open cylinder.By carry out how machine (K75Platinum Edition brewing apparatus) in using the displaying of cylinder come into This displaying of row.During showing the period, children should not be allowed to continue to attempt to open their cylinder.Tester, which should say, " sees me Use this packaging ".Once tester obtains whole concerns of children, tester should hold demonstration packaging from about two English of children Ruler and with normal speed open pack, just as tester will use content.There should not be excessive open movement.It surveys Examination person should not discuss or describe how to open packaging.After opening packaging, tester should be to children's display packing.

Then, attempt to open their cylinder to second five-minute period section of children.Tester by says " it is present you Attempt to open your cylinder " start five minutes periods.If two children first during 5 minutes without using him Tooth attempt to open their cylinder, then tester should be just before starting second 5 minutes section or at it Say " your tooth can be used in you, if you think " immediately later.This is that tester should be about using tooth institute The unique statement done.Test should continue another five minutes or until two children open their packaging, whichever It arrives first.

Embodiment 1

Embodiment 1 shows the result from Childproof screening test.It follows as previously discussed for Childproof The program of screening test.Test uses Swiss Miss(on October 25th, 2013 is bought on Keurig.com, Lot number 6696PL120, January 17 2015 validity period).Following table 1, which is shown, to be opened how many cylinder and opens what each spent Time.Table 2 describes how open each cylinder is approached.

Table 1

* giving children, there is the cylinder for reinforcing top to continue second five minute testing time section.It is fiber reinforced using utilizing Packaging strip reinforce top.Band is attached to Swiss MissCapping on and using hot plate item is brought into One step is bonded to capping.

Table 2

Utilize Swiss MissChildproof screening test have 65% percent of pass.If youngster Child opens two or less cylinders, then container passes through.For comprising drug products, especially including paracetamol or benzene For the beverage products of the product of extra large Lamine, this is that unacceptable Childproof is horizontal.It is nearly all close to content Children used their tooth pierce through capping.Therefore, in order to prepare the cylinder of Childproof, having can not be by biting It pierces through or the capping of tearing may be important.One children by with his thumb apply stable pressure pierce through foil capping come Open packaging.Therefore, if capping not readily passes through extruding and is opened, it can also be prepared to Childproof.

In addition what is interesting is noticing after children watch and show and be apprised of the tooth that they can be used, more Children obtain to the close of the content of cylinder.In addition, he or she usually can be very if children can open a cylinder Quickly open remaining cylinder.Therefore, in order to enable cylinder is Childproof, it may be necessary to so that cylinder is tear-resistant.

Although not being Childproof with the cylinder that packaging strip is reinforced, it takes children's longer time really Carry out the content close to these.Therefore, if heat seal is stronger, the Childproof characteristic of packaging can be improved.

Although receiving has two children of the cylinder for reinforcing top can be close to content, they cannot be by biting Or it pierces through reinforcing strip in other ways and brings close to content.On the contrary, they can by stripping by reinforcing strip band with Capping separates.Therefore, if packaging strip is more firmly attached to capping, such as in laminate structure, then foot can be realized Enough Childproofs are horizontal.

Embodiment 2

Embodiment 2 shows from the second Childproof screening test as a result, the test is using it is believed that better than embodiment 1 The middle lamilate closure construction those of tested.Follow the program for being used for Childproof screening test as previously discussed.It should Embodiment uses base portion same as Example 1；However capping has different laminate structures.Lamilate has outer layer, the Two layers and internal layer.Outer layer is 12 μm of PET, and the second layer is 9 μm of foils, and internal layer is 25 μm of LLDPE.Outer layer utilizes bonding Agent is connected to the second layer and the second layer is connected to internal layer using adhesive.Cylinder is filled with(lot number # 401158801G).Following table 3, which is shown, to be opened how many cylinder and opens each time spent.Table 4 is described to be opened in child-resistant Method used in each children of three or more is opened during opening screening test.Age group is as follows: the A=42-44 month is big, The B=45-48 month is big, and the C=49-51 month is big.

Table 3

The mode of the product of the product of the close method for being used to prepare the prototype sample for test of * children discovery. It is believed that normal manufacture would not allow for this mean of access success.

Table 4

#12 children are counted in 75% using this Childproof screening test that the lamilate of embodiment 2 covers Percent of pass, and if he is excluded with 80% percent of pass.If children open three or less cylinders, container Pass through.For comprising drug products, for the beverage products of the product especially comprising paracetamol or diphenhydramine, 75% is that unacceptable Childproof is horizontal (80% is minimum acceptable level).Nearly all youngster close to content Child has used their tooth or finger to pierce through capping.Therefore, in order to prepare the cylinder of Childproof, having can not be by gnawing The capping for stinging puncture or tearing may be important.

Embodiment 3

Embodiment 3 shows from third Childproof screening test as a result, the test is using it is believed that better than embodiment 1 With the new wrapper component material those of tested in embodiment 2.It follows and is surveyed as previously discussed for Childproof screening The program of examination.Test uses base portion same as Example 1；However capping has different laminate structures.Lamilate has Outer layer, the second layer and internal layer.Outer layer is 23 μm of PET, and the second layer is 18 μm of foils, and internal layer is 25 μm of LLDPE.Outer layer The second layer is connected to using adhesive and the second layer is connected to internal layer using adhesive.Cylinder is filled with(lot number # 401158801G).Following table 5, which is shown, to be opened how many cylinder and opens each time spent.Table 6 is described to be opened in child-resistant Method used in each children of three or more is opened during opening screening test.Age group is as follows: the A=42-44 month is big, The B=45-48 month is big, and the C=49-51 month is big.

Table 5

Table 6

There is 90% percent of pass using this Childproof screening test that the lamilate of embodiment 3 covers.Such as Fruit children open three or less cylinders, then container passes through.For comprising drug products, especially including paracetamol Or for the beverage products of the product of diphenhydramine, 90% is acceptable Childproof level, and (80% is minimum connect By level).

It is to be appreciated that dimension disclosed herein and value, which are not intended to, is strictly limited to cited exact numerical.On the contrary, unless Otherwise indicated, otherwise each such dimension is intended to indicate that described value and the range functionally equivalent around the value.For example, public It opens and is intended to indicate that " about 40mm " for the dimension of " 40mm ".

It is limited unless expressly excluded or in other ways, each document cited herein, including any intersection Reference or related patents or application and the application is claimed priority to it or any patent application or patent of its advantages, It is incorporated by reference and is incorporated herein accordingly.The reference of any document is not to it as disclosed herein or by right The prior art of any invention of claim protection or its individually or any combination with any other bibliography, or With reference to, propose, suggest or disclose the approval of any such invention.In addition, when the present invention in term any meaning or definition with In file incorporated by reference any meaning of same term or define contradiction when, should obey in the present invention assign should The meaning or definition of term.

Although specific embodiments of the present invention have had been illustrated and described, those skilled in the art are come It says it is readily apparent that a number of other changes and modification can be made without departing substantially from spirit and scope of the present invention.Cause This, is intended to all these changes and the modification covered in appended claims and belonged in the scope of the invention.

Claims

1. a kind of suitable for the cylinder for the Childproof being used together with automatic brewing apparatus, comprising:

A. base portion, wherein the base portion includes pharmaceutically active substance；With

B. cover, wherein it is described capping include multilayer laminate, the multilayer laminate include PET outer layer, the foil second layer and LLDPE internal layer；

Wherein the cylinder prevents 90% children close to the content of more than three cylinder during Childproof screening test；

Wherein the outer layer is at least 23 μ m-thicks, and the second layer is at least 18 μ m-thicks, and wherein the internal layer is at least 25 μ M is thick, and the layer is bonded together using LDPE；And

Wherein the capping does not include mesh sheet stiffener, and

Wherein the capping includes atenuator region, and from 3mm to 8mm, the atenuator region does not exist the widest point of the atenuator region It can be penetrated on the outer layer of the capping and by the syringe needle of automatic brewing apparatus or other penetration devices.

2. the cylinder of Childproof according to claim 1, wherein the cylinder includes 2 × 10^-5To 2 × 10^-3G//day Final moisture transmission.

It further include excipient and the wherein excipient and described 3. the cylinder of Childproof according to claim 1 Pharmaceutically active substance is powder.

It further include excipient and the wherein excipient and described 4. the cylinder of Childproof according to claim 1 Pharmaceutically active substance is concentrated liquid.

5. the cylinder of Childproof according to claim 1, wherein the base portion further includes first compartment and second compartment, The first compartment includes the pharmaceutically active substance, and the second compartment includes the second pharmaceutically active substance, wherein described the One compartment and the second compartment are separated by separator.

6. the cylinder of Childproof according to claim 5, wherein the separator is mesh sheet.

7. the cylinder of Childproof according to claim 5, wherein the pharmaceutically active substance and second drug are living Property substance is incompatible.

8. the cylinder of Childproof according to claim 1, wherein the pharmaceutically active substance includes paracetamol And wherein the cylinder can deliver the paracetamol of 650mg during brew cycle.

9. the cylinder of Childproof according to claim 1, wherein the cylinder contains pharmaceutically active substance, the drug is living Property substance include diphenhydramine and optionally paracetamol, and wherein the cylinder can deliver during brew cycle The diphenhydramine of 50mg.