CN105848625A

CN105848625A - Beverage cartridge containing pharmaceutical actives

Info

Publication number: CN105848625A
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; Procter and Gamble Co
Priority date: 2013-11-27
Filing date: 2014-11-26
Publication date: 2016-08-10
Anticipated expiration: 2034-11-26
Also published as: AU2014354787A1; AU2014354787B2; CA2929863A1; CN105848625B; WO2015081145A1; RU2016118811A; RU2669392C1; EP3073981A1; MX2016006449A; EP3073981B1; AU2017245390B2; AU2017245390A1

Abstract

A child-resistant cartridge adapted to be used with an automatic brewing machine. The cartridge has a base and a lidding. The base can contain a pharmaceutical active. The lidding can be a multilayer laminate with an outer layer and an inner layer. The cartridge can be made out of tear resistant materials that are sufficient to prevent 70% of children from accessing the contents of three or more cartridges during a Child-Resistant Screening Test.

Description

Comprise the beverage cartridge of pharmaceutically active substance

Technical field

The present invention relates to a kind of beverage cartridge, and more specifically, one is suitable to preparation comprises pharmaceutically active The cylinder of the beverage of material.

Background technology

Currently, exist multiple preparation one cup beverage products such as coffee or tea automatic brewing apparatus in make Cylinder.But, current cylinder is not suitable for being used together with pharmaceutically active substance, because active substance To environmental condition such as humidity and oxygen sensitive, and active substance is degraded in current cylinder.This Outward, Consumer Product Safety Commission (CPSC) requirement, if cylinder comprises some active component such as to acetyl Amino phenols and diphenhydramine, then primary package is Childproof.

Thus it still remains a need a kind of cylinder being suitable to use in automatic brewing apparatus, this cylinder is child-resistant Open, provide again the barrier with environmental condition, to provide the long-time stability of pharmaceutically active substance.

Summary of the invention

A kind of cylinder of the Childproof being adapted to fit in automatic brewing apparatus, including: (a) base portion, its Middle base portion comprises pharmaceutically active substance；(b) capping, wherein capping includes multilayer laminate, this multilamellar Lamilated body includes outer layer and internal layer；Wherein cylinder prevents by being enough to during Childproof filler test The child of 70% makes close to the tear-resistant material of five or the content of more cylinder.

A kind of multilayer laminate capping of the Childproof being applicable to cylinder, including: (a) outer layer；(b) Internal layer；Wherein cover the child by being enough to during Childproof filler test prevent 70% and pass through thorn Chuanfeng's lid makes close to the tear-resistant material of five or the content of more cylinder and wherein capping can quilt Automatically syringe needle or other penetration device of brewing apparatus penetrates.

A kind of cylinder of the Childproof being adapted to fit in automatic brewing apparatus, including: (a) base portion, its Middle base portion comprises pharmaceutically active substance；(b) capping；Wherein cylinder is by being enough in Childproof screening survey Prevent the child of 70% from making close to the tear-resistant material of five or the content of more cylinder during examination.

Accompanying drawing explanation

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 the side sectional view of the beverage cartridge with two compartments；

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.

Detailed description of the invention

Many consumers like drinking hot drink or the cold drink with pharmaceutically active substance.Preparation one cup hot drink Or the facility of cold drink and easy way are the automatic brewing apparatus using and having cylinder.But, current cylinder It is unsuitable for being used together with pharmaceutically active substance due to two reasons.First, current cylinder does not provides To enough barriers of environmental condition to prevent degraded.Secondly, current cylinder is not Childproof. It has been observed that child can open current cylinder in the following manner: utilize they tooth and The finger being then used by them peels capping off with close to content or by utilizing their thumb to capping Apply pressure and pierce through capping.Additionally, once child has understood how to open a cylinder, he just can Open other cylinder rapidly.

The cylinder of the present invention can provide the enough barriers with environmental condition and can be Childproof, institute State environmental condition and include humidity and gas, including oxygen.Bottom and/or the structure of capping and/or material can Long-time stability and/or the Childproof of pharmaceutically active substance are provided.Cylinder can have base portion and capping Structure.In one example, base portion can be multilayer laminate, and it can include polytrifluorochloroethylene (PCTFE), binding agent and there is the polyethylene terephthalate (PETG) of glycol modification agent. In another example, capping can be multilayer laminate structure, its can comprise aluminium foil, binding agent, with And plastics.Base portion and/or capping can be tear-resistant.Although additionally, be Childproof, but Bottom and/or the capping of base portion still can be can be penetrated by the syringe needle of automatic brewing apparatus or penetration device.

This can meet the anti-of U.S.'s gas defence packaging bill (16C.F.R. § 1700.14) according to 1970 The restriction of child.Specifically, cylinder can meet and tests according to Childproof as described herein The restriction of F=3.In another example, cylinder can meet the F=1 according to Childproof test, separately F=2 in one example, in another example F=4, in another example F=5 and at another The restriction of F=6 in individual example.In one example, in the case of not having secondary package, only cylinder is certainly Body meets the restriction of Childproof.

Cylinder is applicable to automaton, the automatic brewing apparatus of such as one cup.Some in these machines can have Having penetration device or syringe needle, this penetration device or syringe needle can penetrate capping and then provide by capping The flowing of the water (typically hot water) in hole, simultaneously the second penetration device or syringe needle squeeze through the bottom of base portion with Receive the outflow of beverage and assign it in cup or container.Although base portion and capping layer are anti-youngsters Virgin unlatching, but in some instances, they can be penetrated by the penetration device of brewing apparatus or syringe needle.? In another example, Childproof and/or barrier characteristics do not hinder the normal operating of automatic brewing apparatus.

As used herein, " active substance " or " pharmaceutically active substance " includes can be used in suckling Animal especially people treats and/or prevent disease and/or the complete of general health and healthy and helpful effect is provided Portion's compound and compositions.The non-limiting example of concrete useful active substance includes OTC (over-the-counter) (OTC) active substance and the active substance of prescription, vitamin, mineral after active substance, sales counter Matter, the material of plant origin, energy excitation material, probiotic bacteria, fiber, prebiotics and they Combination.

As used herein, " Childproof " refers to be designed or be configured to make child reasonably Open or obtain the material addition difficult wherein comprised of poisonous or harmful amount in time, and for correctly The most difficult cylinder or other packaging for the adult used, but do not refer to that this type of children all can not be Reasonably open or obtain the packaging of poisonous or harmful amount in the time.

As used herein, " dissolving " refers to gradually become solution.

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

As used herein, " permanently engaging " refers to that wherein the first element is fixed to the second element, In the case of making the one or both in destroying these elements the most at least in part, these elements are usual The configuration that can not be separated from each other.

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

As used herein, " being releasably engaged " refers to that wherein the first element is fixed to the second element, Make the first element and the second element can not damage or minimally damage the first element and second yuan Separate configuration in the case of part.

As used herein, " tear-resistant " refer to experience the stress of reasonable level and/or deformation and not The notable loss of experience integrity.Stress and/or deformation can be applied by multi-motion, including but do not limit In biting at cylinder, tractive, shell, stab, push away and/or disclose.In one example, in these motions Any one can be carried out by child, and tear-resistant refers to when standing the power that can be applied by child, material The stress of reasonable level and/or deformation can be experienced and do not suffer from the notable loss of integrity.Show at one In example, child is six years old or less, in another example five years old or less, in another example Four years old or less, in another example three years old or less, in another example two years old or less, And in another example 18 months or less.In one example, although cylinder is tear-resistant, But still with the syringe needle of automatic brewing apparatus or penetration device, it can be pierced through.

As used herein, term " processes " (treat or treating) and includes preventing, alleviates, changes Kind, suppression or alleviate one or more of mammal (especially people and such as adult) and be good for Health state.The non-limiting example of health status can include respiratory passage diseases.

As used herein, article " " and " a kind of " are understood to claimed Or one or more materials described, such as, " a kind of active substance " or " compartment ".

Fig. 1 illustrates that the exploded view of cylinder 1 and Fig. 2 illustrate the side sectional view of cylinder 1.Cylinder 1 includes base Portion 10 and capping 20.Base portion 10 includes opening 11 and faces out the edge 13 in portion.Base portion 10 can have There are cup, cylinder, bowl or the shape of inverted truncated cone.Base portion 10 can include component 12, Component 12 can include active substance and/or excipient.In one example, this component can be powder.Base The bottom 15 in portion 10 can be pierced device during use or syringe needle penetrates.

With reference to Fig. 2, the inner surface 26 of capping 20 can be permanently joined to base portion at sealing 25 The edge 13 of 10.Capping can be bonded to base portion by any suitable method.In one example, envelope Lid has the coating of thermal activation, so that it is attached to the edge of base portion when exposed to heat.At another In individual example, capping can use supersonic frequency to be attached, and in another example, capping can use Sensing heating attachment.Alternatively, capping available contact adhesive attachment.

Capping 20 can be the lamilated body of the Childproof with outer layer 21 and internal layer 22.Outer layer 21 Childproof can be provided and can be tear-resistant, simultaneously still can be by the syringe needle of automatic brewing apparatus Or other penetration device penetrates.In one example, outer layer 21 can comprise reinforcing lines 24, and it can provide Other Childproof.Reinforce lines 24 and can form mesh sheet in whole capping 20, and In one example, being intended to the position pierced through by syringe needle or penetration device in capping, mesh sheet can be open 's.In one example, reinforce in the lamilated body that lines can embed Childproof.Show at another In example, reinforce lines below outer layer.In another example, reinforcing lines can be below internal layer. In another example, reinforcing lines can be between outer layer and internal layer.In another example, reinforce Lines can embed in outer layer and/or internal layer.Reinforce lines to be made up, including Buddhist nun of any suitable material Dragon, polypropylene, glass fibre and combinations thereof.

Internal layer 22 can reduce the amount of the gas (including oxygen) entering cylinder 1.Internal layer 22 can be by any Suitably material is made, and in one example, internal layer 22 can be made up of aluminium foil.Internal layer 22 can For opaque, this can provide other Childproof.In another example, internal layer 22 is also Ink can be included.In one example, outer layer 21 and internal layer 22 are permanently engaged by binding agent.

Capping both can be Childproof, can provide again the enough barriers with gas and humidity, simultaneously Still can be penetrated by the syringe needle of automatic brewing apparatus or other penetration device.In one example, cover as layer Fit.Lamilated body can have any number of layer.In one example, lamilated body has at least two Layer, at least three layer in another example, at least four layer in another example, and separately At least five layer in one example.In another example, capping can be only one layer.Show at one In example, one or more layers of capping can be opaque, and in another example, capping One or more layers can be transparent.

Fig. 3 is the example of the side sectional view of the capping 30 for beverage cartridge.Outside capping 30 can include Layer 32, the second layer 33, third layer 34 and internal layer 35.In one example, outer layer 32 can wrap Containing polyethylene terephthalate (PET), the second layer 33 can comprise oriented polyamide (OPA), third layer 34 can comprise aluminum, and internal layer 35 can comprise polyethylene vinylacetate (PE-EVA).At another In example, internal layer 35 can comprise linear low density polyethylene (LLDPE).In one example, each Layer utilizes binding agent to be attached to adjacent layer.In another example, ink be in outer layer and the second layer it Between.In another example, ink print is on outer layer.In another example, heat seal coating portion Divide or internal layer is completely covered.

Fig. 4 A and 4B is the example of the capping with atenuator region.The region weakened can be at being intended to by In the region that the syringe needle of automatic brewing apparatus or other penetration device pierce through.This region weakened can allow envelope Lid is Childproof, still allows for capping simultaneously and is penetrated by syringe needle or penetration device.The region weakened Can partially or completely extend through one or more layers of lamilated body capping.In one example, weaken Region be on the outer layer of capping.In another example, the region of reduction is not at outside capping On layer, because child may see the region of reduction and obtain close at the edges of regions weakened Or pick up and peel off.In one example, the region of reduction does not penetrates through internal layer.In another example In, the region of reduction only penetrates or partial penetration outer layer.In one example, the region of reduction can be Sufficiently small, in order to child is difficult with its content close to cylinder.In one example, reduction Region is about 1mm to about 12mm at its widest point, is about 2mm to about in another example 10mm, and in another example, it is about 3mm to about 8mm.

Fig. 4 A is the region with reduction, i.e. the example of the capping 40 in hole 42.Any conjunction of this Kong Kewei Suitable shape.The non-limiting example of shape can include circle, square, rhombus, rectangle, triangle Shape, star, cross, ellipse and combinations thereof.

Fig. 4 B is the region with reduction, i.e. the example of the capping 45 of knurled portion 47.Knurled portion 47 can be any one in shape listed above, and " x ", intersect hachure, Duo Gedian and Combinations thereof.

Fig. 5 is the example of the side sectional view of the beverage cartridge 5 with more than one compartment.For some Component, by some compositions separately until they will be consumed can be favourable.An example In, active substance and/or excipient are incompatible and they separately extend stablizing of these components Property.In another example, described component is in different conditions, such as a kind of component be solid and Another kind of component is liquid.In another example, a compartment comprises the component of active material And another compartment comprises the component with flavoring agent, this can allow more sane flavor delivery, Especially when flavoring agent is liquid.

In Figure 5, beverage cartridge 5 has the first compartment 51 comprising the first component 53 and comprises second Second compartment 52 of component 54.First compartment 51 and the second compartment 52 are by separator 55 separately.

Separator can be any suitable material.In one example, when being exposed to hot water or cold water Time, separation sections or be completely dissolved or partially or completely decompose.In another example, separate Thing can be when component is solid by separate for component mesh material or weaving material, but when component is molten During Xie Yushui, solution may pass through mesh material or weaving material.In another example, available from Automatically syringe needle or the penetration device of brewing apparatus pierces through separator.When separator is pierced, water and second group Divide and can flow to the first compartment from the second compartment.

Beverage cartridge can have multiple compartment.In one example, beverage cartridge can have at least two every Room, at least three compartment in another example, and at least four compartment in another example. Compartment can extend in any direction, including level across cylinder, from base bottom vertically to capping, edge Diagonal or combinations thereof.

Fig. 6 is the example of the side sectional view of the beverage cartridge 6 with multiple chamber.Cylinder 6 has and comprises First chamber 61 and second chamber 62 comprising second component 64 of the first component 63.Chamber not only may be used Keep component separately until will use, and they can allow user to select in its beverage Want which kind of active substance.

In one example, automatic brewing apparatus can have top syringe needle 66, and its approximation is central spine Chuanfeng Cover 65 and do not pierce through the first chamber 61 or the second chamber 62.Meanwhile, lower needle 67 pierces through base portion The bottom 68 of 69 and chamber 63.Lower needle 67 does not pierce through the centre of base portion 67, on the contrary its eccentric thorn Wear.Therefore, by arranging that cylinder 6 has specific orientation in brewing apparatus, a chamber can be broken Bad, another chamber keeps complete simultaneously.In one example, chamber can be made up also of friable material And/or person can indentation in advance, in order to when bottom needle pierces chamber, chamber cracks or fractures into completely Two or more parts.The non-limiting example of friable material can include that starch basement membrane, water solublity change Property cellulose membrane such as hydroxyethyl cellulose, ethyl vinyl acetate film and combinations thereof.When Brewed when starting, water will flow out top syringe needle and flow around complete chamber, simultaneously and rupture chamber The component mixing of room and preparation have the beverage of expectation component.

Such as, the first chamber can comprise the active substance treating pain, such as acetaminophen Or ibuprofen, and the second chamber can comprise the active substance for treating cough, and the rightest U.S. husky Fragrant.If consumer does not cough, then cylinder can be positioned in automatic brewing apparatus by she so that passes through Bottom syringe needle only penetrates the chamber with the active substance for pain.But, if consumer wants Two kinds of active substances, then she can be brewed twice, pierce through two chambers.

In another example, chamber can comprise different flavoring agents, thus allows user to select it The taste of beverage.

In another example, top syringe needle can be pierced two chambers.Lower needle only pierces through a chamber Room and from flowable to two chambers of liquid of top syringe needle, but beverage will only be able to from quilt The chamber that lower needle pierces through flows out.Therefore, the beverage with expectation component can be prepared by consumer.

Cylinder can have any suitable number of chamber.In one example, cylinder can have at least two chamber Room, at least three chamber in another example, and at least four chamber in another example. In one example, cylinder can have single chamber, and it can allow consumer's preparation only to have exterior thereto The beverage of component or preparation there is the beverage of two kinds of components.

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

Fig. 7 is the example of the cylinder 7 with base portion 70, capping 71 and filter 72.Filter 72 comprise component 73.When infusion beverage such as coffee or tea time can use filter.Water is by permeation filtration Device the elite of extraction components, solid particle will remain in filter.In one example, water is worked as During through filter, in active substance and/or other excipient solubilized to water.In one example, The brewed coffee comprising active substance of the cylinder with filter or tea can be used.

In one example, cylinder does not comprise filter.

In another example, at least one is component packaged in autonomous container and by consumer or be Consumer prepares the people of beverage and added before or after by automatic brewing apparatus beverage brewed.At one In example, this composition can be flavoring agent, and in another example, this composition can comprise one or Various active material.In one example, autonomous container can be pouch.In one example, independent Container can comprise liquid.In another example, autonomous container can comprise solid, and wherein solid can be Powder, sugar grain, capsule, tablet or combinations thereof.In another example, consumer uses Automatically brewing system pierces through the top of cylinder, but before beverage brewed, consumer reopens machine And the composition of independent packaging is added in the hole prepared by automatic brewing apparatus in cylinder, then by machine weight New closedown beverage brewed.

Base portion can be made up of any suitable material, and described material provides desired barrier and child-resistant Openability and still can being penetrated by the syringe needle of automatic brewing apparatus or penetration device.Can be coupled to the lamination of base portion The non-limiting example of the material in material can include high density polyethylene (HDPE) (HDPE), cyclic olefin copolymerization Thing (COC), Biaxially orientated polyamide (OPA), polypropylene (PP), polyester (PET), amorphous poly-to benzene Dioctyl phthalate second diester (APET), polrvinyl chloride (PVC), polyethylene (PE), aluminium foil and their group Close.In another example, lamilated body can include poly-inclined vinylidene chloride coating, and at another In individual example, lamilated body can include ethyl vinyl alcohol (EVOH).In one example, base portion can be Bright, in another example, base portion can be opaque.

In one example, base portion can be by polytrifluorochloroethylene (PCTFE), optional binding agent, with And the lamilated body that the polyethylene terephthalate (PETG) of glycol modification is made.In one example, It is thick to about 1.5mm that PETG can be about 25 μm, is about 50 μm to about in another example 1mm, in another example, about 100 μm are to about 500 μm, and are about in another example 200 μm are to about 300 μm.In another example, PCTFE can be about 10 μm to about 250 μm, In another example, about 25 μm are to about 150 μm, are about 30 μm to about in another example 100 μm, and in another example, it is about 40 μm to about 75 μm.

In one example, base portion can be the lamilated body with internal layer and outer layer.In one example, Internal layer can be EVOH, or child is difficult to the another kind of material that pierces through or tear.The internal layer of base portion is with outer Layer can be releasably engaged.When child attempts to open container, such as by piercing through, tear or Biting, internal layer can separate with outer layer.This child separately can be made to slow down, this can give father and mother or treatment Person interferes and stops child close to cylinder the more time.This separately also can make child feel they Open and in packaging, achieve progress, and in fact be not conducive to obtaining component by the layering of the two layer It is close, because child can not break internal layer and/or outer layer.

In one example, the maximum gauge of base material can be more than current pharmaceutical product barrier material The maximum gauge in (chamber in such as blister card), because cylinder has more than typical pharmaceutical product shell Size.When forming the base portion of cylinder, use the base material with bigger initial thickness to provide and fill The thickness of foot, the bigger degree because this material is stretched towards the bottom of cylinder base portion.

Current capping can be utilized the combination biting and plugging to remove by child.Therefore, capping can be Tear-resistant.In one example, cover as multilayer laminate.Can be coupled to the laminate of capping In the non-limiting example of material can include aluminium foil, PCTFE, EVOH, HDPE, OPA, COC, PP, PET, APET, PVC, PE and combinations thereof.

For the lamilated body in capping layer and base portion, the layer of lamilated body can be attached by adhesive phase Even, adhesive phase can comprise polyolefine material, such as Low Density Polyethylene (LDPE).

In one example, lamilated body can have outer layer, the second layer and internal layer.Outer layer can be PET, the second layer can be paper tinsel, and internal layer can be LLDPE.

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

In another example, the second layer or layers of foil can be about 3 μm to about 30 μm, show at another In example, about 8 μm are to about 25 μ m-thick, and are about 15 μm in another example to about 22 μm Thick.In another example, the second layer or layers of foil can be greater than about 5 μ m-thick, big in another example In about 8 μ m-thick, greater than about 12 μ m-thick in another example, in another example greater than about 15 μ m-thick, and greater than about 17 μ m-thick in another example.

In another example, internal layer or LLDPE layer can be about 10 μm to about 40 μ m-thick, separately In one example, about 15 μm are to about 35 μ m-thick, are about 20 μm to about in another example 30 μ m-thick, and in another example, it is about 22 μm to about 27 μ m-thick.In another example In, internal layer or LLDPE layer can be greater than about 8 μ m-thick, greater than about 13 μ m-thick in another example, Greater than about 18 μ m-thick in another example, greater than about 20 μ m-thick in another example, at another Greater than about 22 μ m-thick in individual example, and greater than about 24 μ m-thick in another example.

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

Cylinder can be that pharmaceutically active substance provides long-time stability.In one example, the medicine in cylinder is lived The shelf life that property material has is at least about 1 year, in another example at least about 18 months, In another example at least about 2 years, and in another example at least about 2.5 years.Such as this paper institute With, " shelf life " refers to a period of time, estimates to be maintained at approval at Chinese medicine product during this period of time Shelf life within, precursor conditions be under conditions of it limits in containers labels store.Structure Build the shelf life test residing for condition, specifically measure and can use, be applicable to consumption or for sale Minimum essential requirement can be by government or set by regulatory authorities and can be disclosed 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 February 6th, 2003 announces version.

In one example, pharmaceutically active substance is at least about the 90% of label, continues at least 1 Year, in another example at least about 1.5 years, in another example at least about 2 years, and separately In one example at least about 3 years.In another example, pharmaceutically active substance be label at least about 95%, continue at least 1 year or at least about 1.5 years or at least about 2 years.Cylinder can be by keeping Pharmaceutically active substance greater than about 80% or label the most at least about 1 year or at least about 1.5 years or Long-time stability were provided at least 2 years.

Cylinder can be in secondary package.In one example, secondary package can be the carton of standard, It comprises about 1 to about 12 cylinder, and about 3 to about 6 cylinders in another example.At another In example, secondary package can be Childproof.In one example, secondary package can be conducive to The overall Childproof of cylinder.In another example, secondary package can be F=1 Childproof Packaging, F=2 Childproof packaging in another example, and in another example, F=3 prevents Child is packed.In another example, each cylinder is individually wrapped in secondary package.At another In individual example, secondary package can provide other barrier properties to extend the stability of component with help.

In one example, cylinder can be used together and may be adapted to be assemblied in bubble automatically with automatic brewing apparatus In machine processed.In another example, cylinder can use in the case of not having automatic brewing apparatus.

In one example, cylinder is disposable, it means that can incite somebody to action after limited access times Cylinder is disposed or abandons.In one example, cylinder can use five times or the most secondary, in another example Three times or the most secondary, in another example twice or the most secondary, and in another example, cylinder is only Use once.In another example, cylinder is recycling and available comprises active substance and/or figuration The component of agent refills.

Component can include one or more active substances and/or one or more excipient.Component can be at Any suitable form, includes but not limited to powder, liquid, gel or tablet.Excipient non- Limitative examples can include flavoring agent, sweeting agent, disintegrating agent, filler, pigment, lubricant, fluidizer Agent, adsorbent, preservative, sensory agent and combinations thereof.In one example, component is The powder dissolved when water is through cylinder.In another example, component is can be dilute when water is through cylinder The concentrated liquid released.In another example, component is only partly solubilized or extracts to prepare beverage.

Cylinder can comprise one or more active substances.In one example, the beverage of active substance is comprised Can be by adult and 12 years old and above children market.In another example, comprise the drink of active substance Material can be intended to by children market, generally under the monitoring of adult.

Active substance can treat multiple symptom, includes but not limited to be caused by flu, influenza or allergy Symptom.The non-limiting example of active substance can include Decongestant, expectorant, antihistaminic, Cough medicine, analgesic and combinations thereof.

In one example, cylinder can provide many symptoms of flu and/or flu-like symptom alleviate and can be intended to For night.During single brew cycle, cylinder can deliver about 650mg acetaminophen, about 30mg dextromethorphan HBr, about 10mg phenylephrine, the False path of about 30 to about 60mg Alkali and/or about 12.5mg doxylamine succinate.

In some instances, deliver how many active substances and be not necessarily mean that this comprises this amount Active substance.Cylinder may comprise ratio and be delivered to the more active substance of user, because in some examples In, and not all active substance will be transferred to beverage from cylinder.Additionally, according to statutory regulation such as USP, the delivering amount of active substance can be within the 10% of special topic discussion amount.

In another example, if this can help to alleviate insomnia and/or your difficulty falling asleep once in a while Words can help to reduce the time fallen asleep.Cylinder can provide about 50mg diphenhydramine HCl or about 25mg how western Draw quick succinate.

In another example, this cylinder can help user to treat allergic symptom.This cylinder can deliver about 25mg to about 50mg diphenhydramine HCl, about 10mg loratadine, about 650mg to about 1000mg Acetaminophen, about 7.5mg deoxygenate adrenal gland to about 12.5mg doxylamine and/or about 10mg Element.

In another example, cylinder can be combined sale with other products, especially comprises OTC (over-the-counter) activity Material or vitamin and/or the product of mineral.In one example, this cylinder can comprise and is intended to for feeling The active substance emitted and/or alleviate at night of flu-like symptom and cylinder can be intended to for flu and/or influenza In the daytime the active substance (such as acetaminophen, dextromethorphan and the deoxidation kidney that alleviate of symptom Upper parathyrine) combine packaging or sell.In another example, cylinder can comprise vitamin, such as, comprise The tea of vitamin, and it can such as comprise flu and/or flu-like symptom with OTC (over-the-counter) active substance In the daytime and/or the active substance that alleviates night combines packaging or sells.OTC (over-the-counter) active substance can be any Dosage form, includes but not limited to liquid, solid dosage forms such as liquid capsule or tablet or cassette dosage form.

Automatically brewing apparatus can distribute the active substance of whole dosage, as measured by monograph. Therefore, when brewed, active substance is rapidly dissolvable maybe can be extracted in water.An example In, cylinder can comprise the active substance discussing dosage more than special topic, in order to guarantees have in the cup of consumer Correct dosage.Beverage can be any volume.In one example, beverage is about 100mL to about 500mL, is about 125mL to about 250mL in another example, is about in another example 130mL is to about 250mL, and is about 150mL to about 200mL in another example.At one In 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 water can be rinsed or with other Mode cleans to remove active substance and/or the excipient of remnants.Such as, can there is no cylinder in the machine In the case of carry out brew cycle by consumer.In one example, automatic brewing apparatus available water is clear Clean.In another example, available cleaning agent, the cleaning agent cleaning such as comprising vinegar is the most brewed Machine.Some consumers may also want to clean brewing apparatus before beverage brewed.

In one example, cylinder can be Childproof and can be given and be referred to as commenting of F value Level.F value refers to the quantity of unit dose, and the unit dose close to described quantity is considered test crash. " F " numeral below refers to that child based on 25 pounds (11.4kg) may produce serious personal injury Or the quantity of the unit dose of serious disease.

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

In one example, about 80% or more child in Childproof test is non-accessible Content in 5 cylinders or less cylinder, in another example, about 70% or more child can not connect Content in nearly 5 cylinders or less cylinder, in another example, about 60% or more child is not Can be close to the content in 5 cylinders or less cylinder.In another example, Childproof is tested In about 80% or more non-accessible 4 cylinders of child or content in less cylinder, at another In example, the content in about 70% or more non-accessible 4 cylinders of child or less cylinder, separately Content in one example, in about 60% or more non-accessible 4 cylinders of child or less cylinder. About 80% or more child non-accessible 3 in another example, in Childproof test Content in individual cylinder or less cylinder, in another example, about 70% or more child can not connect Content in nearly 3 cylinders or less cylinder, in another example, about 60% or more child is not Can be close to the content in 3 cylinders or less cylinder.In another example, Childproof is tested In about 80% or more non-accessible 2 cylinders of child or content in less cylinder, at another In example, the content in about 70% or more non-accessible 2 cylinders of child or less cylinder, separately Content in one example, in about 60% or more non-accessible 2 cylinders of child or less cylinder.

Method of testing

Childproof is tested

Can be according to Code of Federal Regulations the 16th: the 1700th part carries out child-resistant Open test.

Childproof filler test

Can be carried out as follows Childproof filler test:

For Childproof filler test, child is between the 42-51 monthly age.With approaches uniformity Quantity selects boy and girl.

Test crash is defined as obtaining the close any child to cylinder content.For following experiment, If any child in whole 10 minutes periods of test close to the content of three or more cylinders, that Test crash.As used herein, and " it is right to obtain ... close " refer to that active substance is taken Go out or can be removed wholly or in part.For cylinder, if be inverted the active substance of former any quantity at cylinder Can spill outside cylinder, then active substance can be removed.If cylinder or packaging is destroyed and content not It is removed but can be removed, then this is still considered as close.

Once two children of test.Accompanying two children to test zone and makes them take a seat, in order to Physical barriers is not had between child and tester.Tester will talk so that they loosen with child. Do not give child in contest or the sensation of match, do not award to them, and do not tell them this test is Play or test interesting.For starting test, tester should give the identical cylinder of child and saying and " please taste Examination helps me to open this ".If after test has begun to, child refuses to participate in, then tester Child should be comforted and softly encourage child to attempt.If child continues refusal, then tester should Require that cylinder is placed on his/her by child above-knee until another child terminates.Not should by this to child from knot Remove in Guo, unless the child of refusal upsets the participation of another child.

Each child will be given and within 5 minutes, open his/her cylinder.Tester should make the talk with child Littleization, as long as they continue to attempt to open their cylinder.Tester should be with language form or profit Child is stoped by facial expression.If child becomes dejected or bored and ceases attempt to open his/her Cylinder, then tester should comfort child and softly encourage child to keep punching.Should allow child certainly By moving to be devoted to their cylinder, if tester it can be seen that two children (such as they can To stand, to be sitting on floor or to fiercely attack or to prize packaging).Child should be allowed about opening cylinder each other Talk and them should be allowed to look at each other and attempt opening packaging.If child opens his/her cylinder, survey Examination person should say " thank you " and the cylinder opened is taken away from child and gives child another be not switched on Cylinder.

At the end of 5 minutes sections, tester should require that child puts down their cylinder and then should Show and how to open cylinder.By carry out how machine (K75Platinum Edition is brewed Machine) in use cylinder displaying carry out this displaying.During showing the time period, should not be allowed to child Continue to attempt to open their cylinder.Tester should say " seeing that I uses this to pack ".Once tester Obtaining whole concerns of child, tester should hold demonstration packaging about two feet from child and with just Constant velocity opens packaging, just as tester will use content.Should not have and excessive open fortune Dynamic.Tester should not discuss or describe how to open packaging.After opening packaging, tester should be to Child's display packing.

Then, attempt opening their cylinder to second five-minute period section of child.Tester passes through Say the time period that " you attempt opening your cylinder now " starts five minutes.If two children Their tooth is not used to attempt opening their cylinder first 5 minutes period, then test Person just should start before second 5 minutes section or say that " you can make the most immediately With your tooth, if you think ".This is that tester should be done only about using tooth One statement.Test should continue another five minutes or open until two children their packaging, Whichever first arrives.

Embodiment 1

Embodiment 1 illustrates the result from Childproof filler test.Follow as previously discussed for The program of Childproof filler test.Test uses Swiss Miss(in October, 2013 Within 25th, buy on Keurig.com, lot number 6696PL120, January 17 2015 effect duration Day).Table 1 below illustrates and opens how many cylinders and open each time spent.Table 2 describes How each cylinder opened is approached.

Table 1

* give child and there is lasting second the five minute testing time section of cylinder reinforcing top.Use and utilize fiber reinforced bag Dress band reinforces top.Band is attached to Swiss MissCapping on and use hot plate to be brought into by bar One step is bonded to capping.

Table 2

Utilize Swiss MissChildproof filler test there is 65% pass through Rate.If child opens two or less cylinder, then container passes through.For comprising drug products, For the beverage products of the product especially comprising acetaminophen or diphenhydramine, this is to connect The Childproof level being subject to.Nearly all child close to content employs their tooth and comes Pierce through capping.Therefore, in order to prepare the cylinder of Childproof, have and can not pierce through by biting or tear The capping split is probably important.One child pierces through paper tinsel by applying stable pressure with his thumb Packaging is opened in capping.Therefore, if capping not readily passes through extruding and is opened, then it also can quilt It is prepared as Childproof.

Additionally what is interesting is notice child watch show and be apprised of can use they tooth it After, more child obtains the close of the content to cylinder.If it addition, child can open one Cylinder, then he or she usually opens very quickly on remaining cylinder.Therefore, so that cylinder is Childproof, it may be necessary to make cylinder tear-resistant.

Although the cylinder reinforced with packaging strip is not Childproof, but it takes child really The longer time is close to these content.Therefore, if heat seal is higher, then can improve The Childproof characteristic of packaging.

Although receive have reinforce top cylinder two children can close to content, but they are not Can bring close to content by biting or otherwise piercing through reinforcing strip.On the contrary, they can lead to Cross stripping will reinforce band withCapping is separately.Therefore, if packaging strip is more firmly attached to Capping, such as in laminate structure, then can realize enough Childproof levels.

Embodiment 2

Embodiment 2 illustrates the result from the second Childproof filler test, and this test utilizes and it is believed that It is better than in embodiment 1 the lamilated body closure construction of those tested.Follow as previously discussed for preventing The program of child filler test.This embodiment uses base portion same as in Example 1；But envelope Lid has different laminate structure.Lamilated body has outer layer, the second layer and internal layer.Outer layer is 12 μm PET, the second layer is 9 μm paper tinsels, and internal layer is 25 μm LLDPE.Outer layer utilizes binding agent It is connected to the second layer and the second layer utilizes binding agent to be connected to internal layer.Cylinder is filled with(batch Number #401158801G).Table 3 below illustrates and opens how many cylinders and open each time spent. Table 4 describes each child institute opening three or more cylinders during Childproof filler test Method.Age group is as follows: the A=42-44 month is big, and the B=45-48 month is big, and the C=49-51 month Greatly.

Table 3

* child finds the mode of the product of the product close to the method used for preparing the prototype sample for test.According to Letter, normal manufacture would not allow for the success of this mean of access.

Table 4

This Childproof filler test using the lamilated body capping of embodiment 2 counts #12 child in There is the percent of pass of 75%, and will there is the percent of pass of 80% if his eliminating.If child opens Three or less cylinder, then container passes through.For comprising drug products, especially comprise acetyl For the beverage products of the product of amino phenols or diphenhydramine, 75% is unacceptable Childproof Property level (80% is minimum acceptable level).Nearly all child close to content employs him Tooth or finger pierce through capping.Therefore, in order to prepare the cylinder of Childproof, having can not The capping pierced through by biting or tear is probably important.

Embodiment 3

Embodiment 3 illustrates the result from the 3rd Childproof filler test, and this test utilizes and it is believed that It is better than in embodiment 1 and embodiment 2 the new wrapper component material of those tested.Follow as with The upper described program for Childproof filler test.Test uses base same as in Example 1 Portion；But capping has different laminate structure.Lamilated body has outer layer, the second layer and interior Layer.Outer layer is 23 μm PET, and the second layer is 18 μm paper tinsels, and internal layer is 25 μm LLDPE.Outward Layer utilizes binding agent to be connected to the second layer and the second layer utilizes binding agent to be connected to internal layer.Cylinder is filled with(lot number #401158801G).Table 5 below illustrates and opens how many cylinders and open each The time spent.Table 6 describes opens three or more cylinders during Childproof filler test The method used by each child.Age group is as follows: the A=42-44 month is big, and the B=45-48 month is big, and The C=49-51 month is big.

Table 5

Table 6

This Childproof filler test utilizing the lamilated body of embodiment 3 to cover has 90% Percent of pass.If child opens three or less cylinder, then container passes through.Produce for comprising medicine Product, for the beverage products of the product especially comprising acetaminophen or diphenhydramine, 90% is Acceptable Childproof level (80% is minimum acceptable level).

It is to be appreciated that dimension disclosed herein and value are not intended to be strictly limited to cited perfect number Value.On the contrary, except as otherwise noted, the most each such dimension be intended to indicate that described value and around The scope that this value is functionally equivalent.Such as, the dimension being disclosed as " 40mm " is intended to indicate that " about 40mm”。

Unless expressly excluded or limited, each document cited herein, bag Include any cross reference or Patents or application and the application it to be claimed priority or its useful effect Any patent application of fruit or patent, be incorporated by reference in its entirety herein the most accordingly.Any document Quote not is to its existing as disclosed herein or claimed any invention Technology, or its individually or with any combination of other list of references any, or with reference to, propose, Advise or disclose accreditation of this type of invention any.Additionally, when any implication or fixed of term in the present invention When justice and any implication of same term in the file that is incorporated by reference or definition contradiction, it should clothes From the implication or the definition that give this term in the present invention.

Although illustrate and described specific embodiments of the present invention, but for this area It is readily apparent that can do in the case of without departing substantially from spirit and scope of the present invention for technical staff Go out multiple other to change and modification.Therefore, it is intended in claims contain belong to the present invention In the range of all these changes and modification.

Claims

1. be suitable to a cylinder for the Childproof being used together with automatic brewing apparatus, including:

A. base portion, wherein said base portion comprises pharmaceutically active substance；With

B. cover, wherein said capping include multilayer laminate, described multilayer laminate include outer layer and Internal layer；

Wherein said cylinder prevents the child of 70% close by being enough to during Childproof filler test The tear-resistant material of the content of three or more cylinders is made.

The cylinder of Childproof the most according to claim 1, wherein said base portion for comprise PET and The multilayer laminate of LLDPE.

The cylinder of Childproof the most according to claim 1, wherein said cylinder includes about 2 × 10^-5Extremely About 2 × 10^-3Final moisture transmission.

The cylinder of Childproof the most according to claim 1, also includes excipient and wherein said tax Shape agent and described pharmaceutically active substance are powder.

The cylinder of Childproof the most according to claim 1, also includes excipient and wherein said tax Shape agent and described pharmaceutically active substance are concentrated liquid.

The cylinder of Childproof the most according to claim 1, wherein said base portion also includes the first compartment With the second compartment, described first compartment comprises described pharmaceutically active substance, described second compartment bag Separator is passed through containing the second pharmaceutically active substance, wherein said first compartment and described second compartment Separately.

The cylinder of Childproof the most according to claim 6, wherein said separator is mesh sheet.

The cylinder of Childproof the most according to claim 6, wherein said pharmaceutically active substance and described Second pharmaceutically active substance is incompatible.

The cylinder of Childproof the most according to claim 1, wherein said base portion also includes the first chamber With the second chamber, described first chamber comprises described pharmaceutically active substance, described second chamber bag Containing the second pharmaceutically active substance, wherein said pharmaceutically active substance and described second pharmaceutical actives Matter is suitable to treat different symptoms, and wherein said cylinder is only adapted to during a brew cycle Described first chamber or described second chamber are penetrated by the lower needle of automatic brewing apparatus.

The cylinder of Childproof the most according to claim 6, wherein said first chamber and described Two chambers are made up of friable material.

The multilayer laminate capping of 11. 1 kinds of Childproofs being applicable to cylinder, including:

A. outer layer；With

B. the second layer；

Wherein said capping prevents the child of 70% from leading to by being enough to during Childproof filler test Cross and pierce through described capping and make also close to the tear-resistant material of the content of three or more cylinders And wherein said capping can be penetrated by the syringe needle of automatic brewing apparatus or other penetration device.

The capping of 12. Childproofs according to claim 11, wherein said capping also includes reinforcing Lines.

The capping of 13. Childproofs according to claim 11, the wherein said second layer comprises aluminum Paper tinsel.

The capping of 14. Childproofs according to claim 11, wherein said outer layer comprises poly-to benzene Dioctyl phthalate second diester.

The capping of 15. Childproofs according to claim 11, in wherein said capping also includes Layer.

The capping of 16. Childproofs according to claim 11, wherein said capping also includes weakening Region.

The capping of 17. Childproofs according to claim 11, wherein said capping includes about 2 × 10^-5To about 2 × 10^-3Final moisture transmission.

The cylinder of 18. 1 kinds of Childproofs being adapted to fit in automatic brewing apparatus, including:

B. cover；

The cylinder of 19. Childproofs according to claim 18, wherein said cylinder contains pharmaceutical actives Matter, described pharmaceutically active substance comprises diphenhydramine, and wherein said cylinder can be in brew cycle Period delivers the diphenhydramine of about 50mg.

The cylinder of 20. Childproofs according to claim 18, wherein said pharmaceutically active substance comprises Second v acylamino-phenol and wherein said cylinder can be delivered the right of about 650mg during brew cycle Acetyl aminophenol.