RU2669392C1 - Cartridge for preparation of beverages, containing active pharmaceutical ingredients - Google Patents

Abstract

FIELD: medicine; pharmaceuticals.

SUBSTANCE: group of inventions relates to the field of preparation of beverages containing active pharmaceutical ingredients. Cartridge with active pharmaceutical ingredients for use in an automatic needle-type beverage preparation machine comprises a base part comprising a first active pharmaceutical ingredient in the form of a powder, and a lid made of a multilayer material including an outer layer and an inner layer. Cartridge is made of a tear-resistant material characterised by a final rate of penetration of water vapour from about 2×10^-5 g per cartridge per day to approximately 2×10^-3 g per cartridge per day. Lid for a cartridge with active pharmaceutical ingredients and a cartridge with such active pharmaceutical ingredients as diphenhydramine and acetaminophen are also disclosed.

EFFECT: group of inventions ensures long-term stability of pharmaceutical ingredients.

14 cl, 7 dwg, 6 tbl, 3 ex

Description

FIELD OF TECHNOLOGY

The present invention relates to a cartridge for the preparation of beverages and, in particular, to a cartridge made for the preparation of beverages containing active pharmaceutical ingredients.

BACKGROUND

Currently, there are a number of cartridges for use in automatic beverage machines that prepare one serving of a drinkable product such as coffee or tea. However, the cartridges currently in use are not suitable for use with active pharmaceutical ingredients, since these active ingredients are sensitive to environmental conditions such as humidity or oxygen content, and the quality of the active ingredients in the cartridges currently in use may be degraded. In addition, as required by the Consumer Product Safety Commission (CPSC), primary packaging must be protected against opening by children if the cartridge contains certain active ingredients, such as acetaminophen and diphenhydramine.

Thus, there remains a need for a cartridge made for use in an automatic machine for preparing drinks, protected against opening by children and providing a barrier against environmental influences in order to ensure long-term stability of the active pharmaceutical ingredients.

SUMMARY OF THE INVENTION

A tamper-resistant cartridge made compatible with an automatic beverage preparation machine, comprising: (a) a main part, the main part containing an active pharmaceutical ingredient; and (b) a lid, wherein the lid comprises a multilayer laminate comprising an outer layer and an inner layer; moreover, the cartridge is made of tear-resistant materials, which prevent 70% of children from accessing the contents of five or more cartridges during the screening test for resistance to opening by children.

A laminate lid, protected from opening by children, made for a cartridge, comprising: (a) an outer layer and (b) an inner layer; wherein the lid is made of tear-resistant materials that prevent 70% of children from accessing the contents of five or more cartridges by punching the lid during a screening test for resistance to opening by children, and the lid is configured to penetrate a needle or other means of penetration automatic machine for making drinks.

An anti-tamper cartridge for children, which may be compatible with an automatic beverage machine, comprising: (a) a main part, the main part containing an active pharmaceutical ingredient; and (b) a cap, wherein the cartridge is made of tear-resistant materials to prevent 70% of children from accessing the contents of five or more cartridges during a screening test for resistance to opening by children.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a three-dimensional exploded view of a beverage cartridge;

FIG. 2 is a sectional side view of the beverage preparation cartridge of FIG. one;

FIG. 3 is a side view in section of the cover of the cartridge for preparing drinks;

FIG. 4A - the cover of the cartridge for the preparation of drinks;

FIG. 4A - the cover of the cartridge for the preparation of drinks;

FIG. 5 is a sectional side view of a beverage preparation cartridge containing two compartments;

FIG. 6 is one example of a sectional side view of a beverage preparation cartridge having two chambers; and

FIG. 7 is one example of a three-dimensional exploded view of a beverage cartridge with a filter.

DETAILED DESCRIPTION OF THE INVENTION

Many consumers like to drink hot or cold drinks that contain active pharmaceutical ingredients. A convenient and easy way to prepare one serving of hot or cold drink is to use an automatic machine for making drinks that contains a cartridge. However, the cartridges currently in use are not suitable for use with active pharmaceutical ingredients for two reasons. First, the currently used cartridge does not provide a sufficient barrier against environmental factors to prevent deterioration. Secondly, the cartridges currently in use are not protected against opening by children. It was noticed that children are able to open the cartridges currently in use with their teeth, and then use the fingers to separate the lid in order to gain access to the contents, or apply pressure to the lid with your thumb to punch the lid. In addition, once a child understands how to open a cartridge, he can quickly open other cartridges.

The cartridges of the present invention can provide a sufficient barrier against environmental conditions, including humidity and gases, including oxygen, and they can be protected against opening by children. The design and / or material (s) of the main body and / or lid may provide long-term stability of the active pharmaceutical ingredients and / or protection against opening by children. The cartridge may comprise a body and a cap structure. In one example, the main part may be a multilayer laminate, which may contain polychlorotrifluoroethylene (PCTFE), glue and glycol-modified polyethylene terephthalate (PETG). In another example, the lid may be a multilayer laminate structure that may contain aluminum foil, glue, and plastic. The body and / or cover may be tear resistant. In addition, the bottom of the main part and / or the lid can still be configured to penetrate the needle or the means of penetration of the automatic machine for making drinks, at the same time they have protection against opening by children.

The cartridge may fulfill the definition of resistance to tampering with children in accordance with the 1970 U.S. Safe Packaging of Toxic Substances (Code of Federal Regulations, section 16, §1700.14). In particular, these cartridges can satisfy the definition of F = 3 in accordance with the Tamper Test described in this document. In another example, the cartridge can satisfy the definition of F = 1 in accordance with the Tamper test, in another example, F = 2, in another example, F = 4, in another example, F = 5, and in another example - F = 6. In one example, the cartridge meets the definition of tamper resistance by children alone, without secondary packaging.

The cartridge can be made for use in an automatic machine, such as an automatic machine for preparing one serving of a drink. Some of these machines may contain a penetrating agent or a needle capable of passing through the lid and then allowing a stream of water, often hot water, to pass through the opening in the lid, while the second penetrating means or needle is pushed through the bottom of the main body, taking the exit flow of the beverage and dosing it in a glass or container. In some examples, even if the layers of the main body and the lid are protected against opening by children, a penetration agent or needle of a beverage machine may penetrate through them. In another example, the hallmarks of protection against opening by children and / or a barrier do not interfere with the normal operation of the automatic beverage machine.

As used herein, an “active ingredient” or “active pharmaceutical ingredient” encompasses all compounds and compositions that can be used to treat and / or prevent a disease, and / or to provide benefits for the general health and well-being of a mammal, in particular a human . Non-limiting examples of particularly useful active ingredients include over-the-counter factory-prepared active ingredients (OTC), over-the-counter active ingredients sold by the pharmacist, and over-the-counter active ingredients, vitamins, minerals, herbal products, energy-giving products, probiotics, fiber, prebiotics, and combinations thereof.

As used herein, “tamper-proof” means a cartridge or other packaging designed or constructed so that opening or receiving a toxic or harmful amount of the substance contained therein is a significant difficulty for young children within a reasonable period of time, and at the same time proper use was not difficult for normal adults, but does not mean packaging that all such children cannot open or from which they cannot get toxic or harmful amount of content within a reasonable period of time.

As used herein, “dissolve” refers to a transition to a solution.

As used herein, “decay” refers to breaking up into smaller parts.

As used herein, “inseparably connected” refers to configurations in which the first element is securely attached to the second element so that these elements cannot usually be separated from each other without at least partially breaking one or both of the elements.

As used herein, “primary packaging” refers to a packaging component that is or may be in direct contact with the dosage form.

As used herein, “detachably connected” refers to configurations in which the first element is securely attached to the second element so that the first element and the second element can be separated without damage or with minimal damage to the first and second element.

As used herein, “tear resistance” means capable of withstanding a reasonable level of stress and / or deformation without significant loss of integrity. Stress and / or deformation can be applied through a number of movements, including, without limitation, biting, stretching, peeling, piercing, punching and / or piercing the cartridge. In one example, any of these movements can be performed by a child, while “tear resistant” refers to a material that can be subjected to a reasonable level of stress and / or deformation without significant loss of integrity when exposed to forces that the child may make . In one example, a child is six years old or less, in another example five years or less, in another example four years or less, in another example three years or less, in another example two years or less and in another example, 18 months or less. In one example, even if the cartridge is tear resistant, a needle or penetration means of an automatic beverage machine can still pierce it.

As used herein, “treating,” or “treating” encompasses the prevention, alleviation, reduction of intensity, retardation or mitigation of one or more health problems in a mammal, in particular in humans, and, in one example, in an adult. Non-limiting examples of health problems may include respiratory diseases.

In the framework of the present description, "one of" should be understood so that the singular form means one or more of the claimed or described materials, for example, "active ingredient" or "separation".

In FIG. 1 is an exploded view of the cartridge 1, and FIG. 2 is a cross-sectional side view of cartridge 1. Cartridge 1 comprises a main body 10 and a cover 20. The main body 10 comprises an opening 11 and an outwardly facing rim 13. The main body 10 may be in the form of a cup, cylinder, cup, or reverse truncated cone. The main part 10 may contain component 12, which may contain the active ingredient and / or inert filler. In one example, this component may be a powder. The bottom 15 of the main part 10 may be configured to penetrate the penetration means or needles during use.

As shown in FIG. 2, the inner surface 26 of the cover 20 can be inseparably connected to the rim 13 of the main part 10 by a seal 25. The lid can be connected to the main part in any suitable way. In one example, the lid has a coating that is activated when heated, which causes it to adhere to the rim of the main body when exposed to heat. In another example, the cover may be attached using ultrasonic frequency, and in yet another example, the cover may be attached using induction heating. Alternatively, the cover may be attached using contact adhesive.

The cover 20 may be a laminate protected from being opened by children, with an outer layer 21 and an inner layer 22. The outer layer 21 can provide protection against opening by children and can be tear resistant and, at the same time, adapted to penetrate a needle or other penetration means of an automatic machine for preparing beverages. In one example, the outer layer 21 may contain reinforced threads 24, capable of providing additional protection against opening by children. Reinforced threads 24 may form a net on the lid 20 and, in one example, this net may be open in a position that is intended to pierce the lid with a needle or penetration. In one example, reinforced yarns can be embedded in a laminate that is protected against opening by children. In another example, the reinforced yarn is under the outer layer. In another example, the reinforced yarn may be under the inner layer. In yet another example, the reinforced yarns may be between the outer layer and the inner layer. In another example, reinforced yarns may be embedded in the outer layer and / or in the inner layer. Reinforced threads can be made of any suitable material, including nylon, polypropylene, fiberglass, and combinations thereof.

The inner layer 22 can reduce the amount of gases, including oxygen, entering the cartridge 1. The inner layer 22 can be made of any suitable material and, in one example, the inner layer 22 can be made of aluminum foil. The inner layer 22 may be opaque, which may provide additional protection against opening by children. In another example, the inner layer 22 may also contain paint. In one example, the outer layer 21 and the inner layer 22 are inextricably connected by glue.

The lid can both have protection against opening by children and provide a sufficient barrier against gases and humidity, at the same time it will still be made with the possibility of penetration of a needle or other means of penetration of an automatic machine for making drinks. In one example, the lid is a laminate. This laminate may contain any number of layers. In one example, this laminate contains at least two layers, in another example at least three layers, in another example at least four layers, and in another example at least five layers. In another example, the cap may be only one layer. In one example, one or more layers of the lid may be opaque, and in another example, one or more layers of the lid may be transparent.

In FIG. 3 shows one example of a cross-sectional side view of a cover 30 of a beverage cartridge. The cover 30 may comprise an outer layer 32, a second layer 33, a third layer 34 and an inner layer 35. In one example, the outer layer 32 may comprise polyethylene terephthalate (PET), the second layer 33 may comprise oriented polyamide (OPA), and the third layer 34 may comprise aluminum, and the inner layer 35 may contain polyethylene vinyl acetate (PE-EVA). In another example, the inner layer 35 may comprise linear low density polyethylene (LLDPE). In one example, each layer is attached to the adjacent layer with glue. In another example, the paint is between the outer layer and the second layer. In another example, the ink is printed on the outer layer. In yet another example, the inner layer is partially or fully coated with a hot-melt coating.

In FIG. 4A and 4B show examples of covers with weakened zones. The weakened zone may be in an area intended for punching with a needle or other means of penetration of an automatic beverage machine. This weakened area of the lid may provide protection against opening by children and, at the same time, allow the penetration of a needle or means of penetration through the lid. The weakened zone may partially or completely pass through one or more layers of the laminate cover. In one example, the weakened zone is on the outer layer of the lid. In another example, the weakened zone is not located on the outer layer of the lid, as the child can see this weakened zone and gain access or pierce and separate this weakened zone from the edge. In one example, the weakened zone does not penetrate the inner layer. In another example, the weakened zone penetrates or partially penetrates only into the outer layer. In one example, the weakened area may be quite small, so it is difficult for a child to use it to access the contents of the cartridge. In one example, the weakened area has a size of from about 1 mm to about 12 mm at its widest point, in another example, from about 2 mm to about 10 mm, and in another example, from about 3 mm to about 8 mm.

In FIG. 4A shows one example of a cover 40 with a weakened area, orifice 42. This orifice may be of any suitable shape. Non-limiting examples of shapes may include round, square, rhomboid, rectangular, triangular, star-shaped, cruciform, oval, and combinations thereof.

In FIG. 4B shows one example of a cover 45 with a weakened area, a notch portion 47. Section 47 with notches can have any of the above forms, as well as the form of "x", hatching, many points and their combinations.

In FIG. 5 shows one example of a cross-sectional side view of a beverage preparation cartridge 5 containing more than one compartment. For some components, it would be advantageous to separate some of the ingredients until immediately before they are consumed. In one example, the active ingredients and / or inert excipients are incompatible, and their separation prolongs the stability of these components. In another example, the components are in different states, for example, one of the components is a solid, and the other is a liquid. In yet another example, one compartment contains a component with an active ingredient, and another compartment contains a component with a flavor, which can make delivery of the flavor more reliable, in particular if the flavor is a liquid.

In FIG. 5, the beverage preparation cartridge 5 comprises a first compartment 51 containing a first component 53 and a second compartment 52 containing a second component 54. The first compartment 51 and the second compartment 52 are separated by a spacer 55.

The separator may be made of any suitable material. In one example, the separator partially or completely dissolves or partially or completely disintegrates when exposed to hot or cold water. In another example, the separator may be a mesh or woven material that separates the components when they are solids, but when the components dissolve in water, the solution can move through this mesh or woven material. In yet another example, the separator may be punctured by a needle or penetration means of an automatic beverage machine. If the separator is broken, water and the second component can flow from the second compartment to the first compartment.

A beverage cartridge may contain multiple compartments. In one example, a beverage cartridge may contain at least two compartments, in another example at least three compartments, and in another example, at least four compartments. The compartments can be located in any direction, including horizontally - across the cartridge, vertically - from the bottom of the main part to the cover, diagonally or in a combination of directions.

In FIG. 6 shows one example of a side view in section of a cartridge 6 for preparing drinks with multiple cameras. The cartridge 6 contains a first chamber 61 containing a first component 63 and a second chamber 62 containing a second component 64. The cameras not only can hold the components separately until immediately before use, but they can also allow the user to choose which active ingredients he wants to receive in the drink.

In one example, an automatic beverage machine may include an upper needle 66 that punches the lid 65 approximately in the center and does not pierce the first chamber 61 or the second chamber 62. At the same time, the lower needle 67 pierces the bottom 68 of the main body 69 and the chamber 63. Lower needle 67 it doesn’t break through the middle of the main part 69, but instead it breaks through a section offset from the center. Thus, when the cartridge 6 is positioned in a specific orientation in the beverage machine, one chamber may be disturbed, while the other chamber remains intact. In one example, chambers may be made of brittle material and / or they may be pre-fitted with notches, so that when the lower needle pierces the chamber, the chamber will split or completely collapse into two or more parts. Non-limiting examples of brittle materials may include starch-based films, water-soluble modified cellulose films, such as hydroxyethyl cellulose, ethyl vinyl acetate films, and combinations thereof. When the preparation of the beverage begins, water flows from the upper needle and flows around the intact chamber, while it is combined with the components of the destroyed chamber and ensures the preparation of the beverage with the required components.

For example, the first chamber may contain an active ingredient for the treatment of pain and pain, such as acetaminophen or ibuprofen, and the second chamber may contain an active ingredient for the treatment of cough, such as dextromethorphan. If the consumer does not have a cough, he can install the cartridge in an automatic machine for making drinks so that the lower needle penetrates only into the chamber containing the active ingredients for the treatment of pain and pain. However, if the consumer wants to use both active ingredients, he can prepare a drink with two ingredients with a penetration of both chambers.

In another example, the chamber may contain various flavors, which allows the user to select a flavor for the drink.

In another example, the upper needle can pierce both chambers. The lower needle pierces only one chamber, and liquid from the upper needle can flow into both chambers, while the drink can only leak out of the chamber pierced by the lower needle. Thus, the consumer can prepare a drink with the required components.

The cartridge may contain any suitable number of cameras. In one example, a cartridge may contain at least two cameras, in another example, at least three cameras, and in another example, at least four cameras. In one example, a cartridge may comprise a single chamber, which may enable a user to prepare a beverage using only a component located outside the chamber, or using both components.

In another example, cameras can be used to separate incompatible components.

In FIG. 7 illustrates one example of a cartridge 7 with a main body 70, a lid 71 and a filter 72. The filter 72 contains a component 73. The filter can be used in the preparation of a beverage such as coffee or tea. Water will seep through the filter and extract the essence of the components, and solid particles will be retained by the filter. In one example, the active ingredients and / or other inert excipients may dissolve in water as it passes through the filter. In one example, a filter cartridge can be used to make coffee or tea containing the active ingredients.

In one example, the cartridge does not contain a filter.

In another example, at least one of the ingredients is packaged in a separate container and added by the consumer or the person preparing the beverage for the consumer, before or after preparation of the beverage by an automatic beverage preparation machine. In one example, the ingredient may be a flavor, and in another example, the ingredient may contain one or more active ingredients. In one example, a separate container may be a sachet. In one example, a separate container may contain liquid. In another example, a separate container may contain a solid, the solid may be a powder, colored sugar, capsule, tablet, or combinations thereof. In another example, the consumer uses an automatic beverage preparation system to punch the top of the cartridge, but before preparing the beverage, the consumer reopens the machine and adds the separately packaged ingredient to the cartridge through the hole made by the automatic beverage machine, then closes the machine and prepares the beverage.

The main part can be made of any suitable material (s) providing the required barrier properties and protection against opening by children, as well as the fact that a needle or a means of penetration of an automatic machine for preparing drinks can still penetrate through it. Non-limiting examples of materials that can be included in the main body laminate material may include high density polyethylene (HDPE), cyclic olefin copolymers (COC), biaxially oriented polyamide (OPA), polypropylene (PP), polyester (PET), amorphous polyethylene terephthalate (APET ), polyvinyl chloride (PVC), polyethylene (PE), aluminum foil, and combinations thereof. In another example, the laminate may contain a polyvinylidene chloride coating, and in yet another example, the laminate may contain ethyl vinyl alcohol (EVOH). In one example, the main part may be transparent, and in another example, the main part may be opaque.

In one example, the main part may be a laminate made of polychlorotrifluoroethylene (PCTFE), optional glue, and polyethylene terephthalate glycol (PETG). In one example, PETG may have a thickness of from about 25 microns to about 1.5 mm, in another example, from about 50 microns to about 1 mm, in another example, from about 100 microns to about 500 microns, and in another an example is from about 200 microns to about 300 microns. In another example, PCTFE may have a thickness of from about 10 microns to about 250 microns, in another example, from about 25 microns to about 150 microns, in yet another example, from about 30 microns to about 100 microns, and in yet another example, from about 40 microns to about 75 microns.

In one example, the main part may be a laminate with an inner layer and an outer layer. In one example, the inner layer may be EVOH or other material that is difficult for the child to pierce or tear. The inner layer and the outer layer of the main part can be detachably connected. When a child tries to open the container, for example, by punching, tearing or biting, the inner layer can be separated from the outer layer. This separation may delay the child, which may give the parent or carer more time to intervene and prevent the child from accessing the cartridges. This separation can also make the child feel as if he is approaching the opening of the package, while in fact the separation of these two layers does not contribute to gaining access to the component, since the child cannot overcome the inner and / or outer layer.

In one example, the maximum thickness of the material of the main part may be greater than the maximum thickness of the currently used barrier materials for pharmaceutical products, for example, in the area of the cavities of a blister pack, since the cartridge has a larger geometric dimension than a typical shell for pharmaceutical products. The use of the material of the main part with a larger initial thickness provides sufficient thickness when forming the main part of the cartridge, since the material is more stretched towards the bottom of the main part of the cartridge.

Children can remove the cover currently in use by combining biting and scratching. Therefore, the cap may be tear resistant. In one example, the lid is a multilayer laminate. Non-limiting examples of materials that may be included in the cover laminate material may include aluminum foil, PCTFE, EVOH, HDPE, OPA, COC, PP, PET, APET, PVC, PE, and combinations thereof.

In the case of a laminate, both in the lid layer and in the main body, the laminate layers can be bonded with an adhesive layer, which may contain a polyolefin material, such as low density polyethylene (LDPE).

In one example, a laminate may comprise an outer layer, a second layer and an inner layer. The outer layer may be PET, the second layer may be a foil, and the inner layer may be LLDPE.

In one example, the outer layer, or PET layer, may have a thickness of from about 5 microns to about 40 microns, in another example, from about 10 microns to about 35 microns, in another example, from about 15 microns to about 30 microns, and in yet another example, from about 20 microns to about 25 microns. In one example, the outer layer, or PET layer, may have a thickness of more than about 8 microns, in another example, more than about 11 microns, in another example, more than about 16 microns, in another example, more than about 20 microns, and in another example, more than about 22 microns.

In another example, the second layer, or foil layer, may have a thickness of from about 3 microns to about 30 microns, in yet another example, from about 8 microns to about 25 microns, and in yet another example, from about 15 microns to about 22 microns . In another example, the second layer, or foil layer, may have a thickness greater than about 5 microns, in another example greater than about 8 microns, in yet another example greater than about 12 microns, in yet another example greater than about 15 microns, and in another example, exceeding approximately 17 microns.

In another example, the inner layer, or LLDPE layer, may have a thickness of from about 10 microns to about 40 microns, in another example, from about 15 microns to about 35 microns, in another example, from about 20 microns to about 30 microns, and in yet another example, from about 22 microns to about 27 microns. In another example, the inner layer or LLDPE layer may have a thickness greater than about 8 microns, in yet another example greater than about 13 microns, in yet another example

- greater than about 18 microns, in yet another example greater than about 20 microns, in yet another example greater than about 22 microns, and in yet another example greater than about 24 microns.

The body, cap and / or cartridge may provide an effective barrier. In one example, the body, cap, and / or cartridge may have a final water vapor permeation rate of from about 2 × 10 ⁻⁵ g / cartridge / day to about 2 × 10 ⁻³ g / cartridge / day; in another example, from from about 1 × 10 ^-4 g / cartridge / day to about 6 × 10 ^-4 g / cartridge / day, and in another example, from about 2 × 10 ^-4 g / cartridge / day to about 3 × 10 ^-4 g / cartridge / day as defined by the United States Pharmacopeia (USP) Standard 671 (August 1, 2013). Method 1 was followed in the case of unit dose containers and unit dose containers for capsules and tablets.

The cartridge may provide long-term stability of the active pharmaceutical ingredients. In one example, the active pharmaceutical ingredient in a cartridge has a shelf life of 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 at least 2.5 years. As used herein, “shelf life” refers to the period of time during which the finished dosage form is expected to meet approved quality standards during storage, provided that it is stored under the conditions indicated on the container label. The conditions under which the shelf life test, specific measurements and minimum requirements for usability, suitability for use or sale can be set by government or regulatory authorities and published in guidance documents such as the United States Pharmacopeia (USP) or the Agreed Tripartite Guidelines of the International Conference on Harmonization (ICH), entitled “Stability Testing of New Drug Substances and Products Q1A (R2), Step 4”, published on February 6, 2003.

In one example, the amount of active pharmaceutical ingredient is at least about 90% of what is indicated on the label for at least 1 year, in another example for at least about 1.5 years, in another example, for over at least about 2 years, and in yet another example, for at least about 3 years. In another example, the amount of active pharmaceutical ingredient is at least about 95% of what is indicated on the label for at least 1 year, in the alternative for at least about 1.5 years, in the alternative for at least about 2 years. The cartridge can provide long-term stability by storing more than about 80% of the amount of the active pharmaceutical ingredient indicated on the label for at least about 1 year, alternatively for at least about 1.5 years, alternatively for at least about 2 years.

Cartridges may be in secondary packaging. In one example, the secondary packaging may be a standard carton containing from about 1 cartridge to about 12 cartridges, and in another example, from about 3 cartridges to about 6 cartridges. In another example, the secondary packaging may have protection against opening by children. In one example, the secondary packaging may contribute to the overall resistance of the cartridge to opening by children. In another example, the secondary packaging may be a tamper-resistant packaging with F = 1, in another example, a tamper-resistant packaging with F = 2, and in yet another example, a tamper-resistant packaging with F = 3. In another example, each cartridge is individually packaged in a secondary packaging. In another example, the secondary packaging may provide additional barrier properties that contribute to the extension of the stability of the components.

In one example, the cartridge can be used with an automatic machine for making drinks, and it can be made compatible with an automatic machine for making drinks. In another example, the cartridge may be used without an automatic beverage machine.

In one example, the cartridges are disposable, which means that the cartridge can be removed or discarded after a limited number of uses. In one example, the cartridge can be used five times or less, in another example, three times or less, in another example, two times or less, and in another example, the cartridge is used only once. In another example, the cartridge can be reused and refilled with a component containing the active ingredient and / or an inert filler.

The component may contain one or more active ingredients and / or one or more inert fillers. The component may be in any suitable form, including but not limited to the form of a powder, liquid, gel, or tablet. Non-limiting examples of inert fillers may include flavors, sweeteners, disintegrants, fillers, colorants, lubricants, lubricants, sorbents, preservatives, sensory-perceptible substances, and combinations thereof. In one example, the component is a powder that dissolves in water as it passes through a cartridge. In another example, the component is a concentrated liquid that can be diluted with water passing through the cartridge. In yet another example, the component is only partially dissolved or recovered during preparation of the beverage.

The cartridge may contain one or more active ingredients. In one example, a beverage containing active ingredients can be consumed by adults and children aged 12 or more. In another example, a beverage containing active ingredients may be intended for use by children, often under the supervision of an adult.

The active ingredients can be used to treat a variety of symptoms, including but not limited to symptoms of the common cold, flu, or allergies. Non-limiting examples of active ingredients may include decongestants, expectorants, antihistamines, antitussives, painkillers, and combinations thereof.

In one example, the cartridge may provide relief of several symptoms of the common cold and / or flu, and may be intended for use at night. During one beverage preparation cycle, the cartridge may release approximately 650 mg of acetaminophen, approximately 30 mg of dextromethorphan hydrobromide, approximately 10 mg of phenylephrine, approximately 30 mg to approximately 60 mg of pseudoephedrine and / or approximately 12.5 mg of doxylamine succinate.

In some examples, the release amount of the active ingredient does not necessarily mean that the cartridge contains this amount of active ingredient. The cartridge probably contains more active ingredient than is available to the user, as in some examples not all of the active ingredient will be transferred from the cartridge to the beverage. In addition, in accordance with regulations such as the USP, the amount of active ingredient released may be within 10% of the amount indicated in the pharmacopoeial articles.

In another example, a cartridge can help relieve occasional insomnia and / or can help reduce the time to fall asleep if there are difficulties with falling asleep. The cartridge may produce approximately 50 mg of diphenhydramine hydrochloride or approximately 25 mg of doxylamine succinate.

In another example, a cartridge may help treat allergy symptoms in a user. The cartridge may produce from about 25 mg to about 50 mg of diphenhydramine hydrochloride, about 10 mg of loratadine, from about 650 mg to about 1000 mg of acetaminophen, from about 7.5 mg to about 12.5 mg of doxylamine and / or about 10 mg of phenylephrine.

In another example, cartridges can be sold in combination with other products, in particular with products containing over-the-counter active ingredients, or vitamins, and / or minerals. In one example, the cartridge may contain active ingredients intended to alleviate the symptoms of the common cold and / or flu at night, and this cartridge may be packaged or otherwise sold in combination with active ingredients designed to alleviate the symptoms of the common cold and / or flu. daytime, such as acetaminophen, dextromethorphan, and phenylephrine. In another example, the cartridge may contain vitamins, for example, tea containing vitamins, and it may be packaged or otherwise sold in combination with over-the-counter active ingredients, for example, active ingredients containing agents for relieving cold symptoms and / or flu during the day and / or night. Over-the-counter active ingredients can be in any dosage form, including but not limited to form, liquid, solid dosage forms, such as liquid capsules or tablets, or a cartridge form.

An automatic beverage machine can dose the entire dose of the active ingredient defined in the pharmacopeia article. Thus, the active ingredient can quickly dissolve or can be extracted with water when it is prepared. In one example, the cartridge may contain a dose of the active ingredient in excess of that indicated in the pharmacopoeial articles in order to ensure that the correct dose is present in the consumer cup. The drink can be provided in any volume. In one example, the beverage is provided in a volume of from about 100 ml to about 500 ml, in another example, from about 125 ml to about 250 ml, in another example, from about 130 ml to about 250 ml, and in yet another example, from about 150 ml to about 200 ml. In one example, a beverage is provided in a volume of approximately 6 fluid ounces (177.41 ml), and in another example, a beverage is provided in a volume of approximately 8 fluid ounces (236.59 ml).

In one example, after each use, an automatic beverage machine may be washed with water or otherwise cleaned to remove residual active ingredients and / or inert fillers. For example, a beverage preparation cycle may be conducted by a consumer without a cartridge in a machine. In one example, an automatic beverage machine can be cleaned with water. In another example, an automatic beverage machine can be cleaned with a detergent, such as a detergent containing vinegar. Some consumers also wish to clean their beverage machine before preparing a drink.

In one example, the cartridge may be tamper-resistant by children, and may be given a rating called the F value. The F value refers to the number of standard doses that are considered unsatisfactory to gain access to. The number following “F” refers to the number of unit doses that can cause serious harm to health or lead to serious illness, per child weighing 25 pounds (11.4 kg).

The Tamper Test is a standardized test and can be found in C.F.R., Section 16, §1700, “Regulation on the Safe Packaging of Toxic Substances”. In one example, a childproof package is a package with F = 1, in another example, a package with F = 2, in another example, a package with F = 3, in another example, a package with F = 4 , and in another example, packaging with F = 5.

In one example, in a child resistance test, approximately 80% or more of the children cannot access the contents of 5 cartridges or less, in another example, approximately 70% or more of the children cannot access the contents of 5 cartridges or less, in in one example, approximately 60% or more of the children cannot access the contents of 5 cartridges or less. In another example, in a test for resistance to opening by children, approximately 80% or more of the children cannot access the contents of 4 cartridges or less, in another example, approximately 70% or more of the children cannot access the contents of 4 cartridges or less, in in one example, approximately 60% or more of the children cannot access the contents of 4 cartridges or less. In another example, in a test for resistance to opening by children, approximately 80% or more of the children cannot access the contents of 3 cartridges or less, in another example, approximately 70% or more of the children cannot access the contents of 3 cartridges or less, in in one example, approximately 60% or more of the children cannot access the contents of 3 cartridges or less. In another example, in a test for resistance to opening by children, approximately 80% or more of the children cannot access the contents of 2 cartridges or less, in another example, approximately 70% or more of the children cannot access the contents of 2 cartridges or less, in in one example, approximately 60% or more of the children cannot access the contents of 2 cartridges or less.

Test methods

Child Tamper Test

A test for resistance to tampering by children can be carried out in accordance with the Code of Federal Regulations, section 16, paragraph 1700.

Screening test for resistance to tampering with children

The screening test for resistance to opening by children can be carried out as follows.

The age of children participating in the screening test for resistance to opening by children is 42-51 months. An approximately equal number of boys and girls are chosen.

The test result is determined to be unsatisfactory if any child has access to the contents of the cartridge. In the case of the following experiment, the test result was deemed unsatisfactory if any child had access to the contents of three or more cartridges for the full 10 minutes of the test. As used herein, “access” means that the active ingredients have been recovered or could be recovered in whole or in part. In the case of a cartridge, the active ingredient can be removed if any amount of the active ingredient can spill out of the cartridge if turned over. If the cartridge or packaging is damaged and the contents were not removed, but could have been removed, this is also considered access.

Children participated in the test, two at a time. These two children were escorted to the test site and seated so that there was no physical barrier between the children and the tester. The tester should talk with the children so that they feel at ease. Children are not given the impression of participating in a competition or rivalry, they are not offered a reward, and they are not told that the challenge is a game, or that it is fun. To begin the test, the tester should give the children the same cartridges and say, “Please try opening them for me.” If the child refuses to participate after the test has begun, the tester should convince and gently encourage the child to try. If the child continues to refuse, the tester should ask the child to hold the cartridge on his lap until the other child completes the test. This pair of children should not be excluded from the results if the child who refuses does not interrupt the participation of another child.

Each child is given 5 minutes to open the cartridge. The tester should minimize conversations with children while they continue to try to open the packaging. The tester should not discourage children with words or facial expressions. If the child looks disappointed or bored and stops trying to open the cartridge, the tester should convince and gently encourage the child to continue trying. Children should be given freedom of movement to operate the cartridges, provided that the tester can observe both children (for example, they can stand, sit on the floor, or hit or open the packaging). Children should be allowed to talk to each other about opening the cartridges, and they should be allowed to observe each other's attempts to open the packages. If the child opened the cartridge, the tester should say: “Thank you,” take the child’s open cartridge and give the child another unopened cartridge.

At the end of the 5-minute period, the tester should ask the children to put the cartridges aside, and then they should demonstrate how to open the cartridge. This demonstration should be done by demonstrating how to use the cartridge in a machine, namely a Keurig® K75 Platinum Edition beverage machine. Children should not be allowed to continue trying to open their cartridges during the demo period. The tester should say, “See how I use this package.” Once the tester has attracted the full attention of the children, the tester should keep the demo pack approximately two feet away from the children and open the pack at normal speed, as if the tester was about to use the contents. There should not be any exaggerated opening movements. The tester should not discuss or describe how to open the package. After opening the package, the tester should show the package to children.

The children are then given a second five minute period of time to attempt to open the cartridges. The tester begins this five-minute period with the words: “Now try opening your packages.” If both children did not use their teeth when trying to open the packaging within the first 5 minutes, immediately before or shortly after the start of the second 5-minute period, the tester should say: “If you want, you can use your teeth.” This is the only statement about tooth use that a tester should make. The test should be continued for the next five minutes or until both children open the packages, whichever comes first.

Example 1

Example 1 shows the results of a screening test for resistance to opening by children. The procedures of this screening test for resistance to opening by children were performed as described above. The test used Swiss Miss K-Cups® (purchased on Keurig.com on October 25, 2013, lot number 6696 PL120, expiration date was January 17, 2015). Table 1 below shows how many cartridges were opened and how long it took to open each one. Table 2 describes how access to the contents of each of the open cartridges was obtained.

A screening test for resistance to tearing up children using Swiss Miss K-Cups® was characterized by a success rate of 65%. The container was considered successful if the child opened two or less cartridges. This level is not an acceptable level of protection against opening by children for drinking products containing pharmaceutical products, in particular products containing acetaminophen or diphenhydramine. Almost all children who gained access to the contents punched the lid with their teeth. Thus, to create a cartridge that is protected against opening by children, it is important to have a cover that cannot be broken or torn by biting. One child opened the package by applying constant pressure with his thumb in order to break through the foil lid. Thus, the lid can also be made resistant to opening by children if it cannot be opened by pressure.

It is also interesting to note that after the children saw the demonstration and they were told that they could use their teeth, a much larger number of children got access to the contents of the cartridge. Also, if a child could open one cartridge, he or she usually could / could very quickly open the rest of the cartridges. Therefore, in order to make the cartridge resistant to opening by children, it may be necessary to make the cartridge resistant to tearing.

Although cartridges reinforced with packing tape did not have protection against opening by children, access to the contents of these cartridges took children a longer time. Thus, if the thermal bonding was more durable, then the packaging properties associated with being protected from being opened by children could be improved.

Although the two children who received cartridges with reinforced tops were able to access the contents, they could not access by biting or otherwise punching the reinforced tape. Instead, they were able to separate the reinforced tape from the K-Cup® lid by peeling. Therefore, if the packaging tape was more securely glued to the lid, for example, was part of the laminate structure, an adequate level of protection against opening by children could be achieved.

Example 2

Example 2 shows the results of the second screening test for resistance to opening by children using a laminate cover design, which is supposed to be superior to the designs tested in example 1. The procedures for this screening of testing for resistance to opening by children were performed as described above. In this example, the same main part was used as in example 1, however, the lid had a different laminate construction. The laminate contained an outer layer, a second layer and an inner layer. The outer layer was 12 μm PET, the second layer was 9 μm foil, and the inner layer was 25 μm LLDPE. The outer layer was glued to the second layer, and the second layer was glued to the inner layer. Cartridges were filled with Ovaltine® (lot number 401158801G). Table 3 below shows how many cartridges were opened and how long it took to open each one. Table 4 describes the method that each child used to open three or more cartridges during the screening test for resistance to opening by children. Age groups were as follows: A = 42-44 months, B = 45-48 months, and C = 49-51 months.

This screening test for resistance to opening by children using a laminate cover from Example 2 was characterized by a successful completion rate of 75%, taking into account child No. 12, and a successful completion rate of 80% if excluded. The container was considered successful if the child opened three or less cartridges. 75% is not an acceptable level of protection against opening by children (the minimum acceptable level is 80%) for drinking products containing pharmaceutical products, in particular products containing acetaminophen or diphenhydramine. Almost all children who gained access to the contents punched the lid with their teeth or fingers. Thus, to create a cartridge that is protected against opening by children, it is important to have a cover that cannot be broken or torn by biting.

Example 3

Example 3 shows the results of a screening test for resistance to autopsy by children. In the test, new packaging component materials were used that are expected to be superior to the materials tested in Example 1 and Example 2. The procedures for this screening test for resistance to tearing by children were performed as described above. The test used the same main part as in example 1, however, the cover was characterized by a different laminate construction. The laminate contained an outer layer, a second layer and an inner layer. The outer layer was 23 μm PET, the second layer was 18 μm foil, and the inner layer was 25 μm LLDPE. The outer layer was glued to the second layer, and the second layer was glued to the inner layer. Cartridges were filled with Ovaltine® (lot number 401158801G). Table 5 below shows how many cartridges were opened and how long it took to open each one. Table 6 describes the method that each child used to open three or more cartridges during the screening test for resistance to opening by children. Age groups were as follows: A = 42-44 months, B = 45-48 months, and C = 49-51 months.

This screening test for resistance to opening by children using a laminate lid from Example 3 was characterized by a success rate of 90%. The container was considered successful if the child opened three or less cartridges. 90% is an acceptable level of protection against opening by children (the minimum acceptable level is 80%) for drinking products containing pharmaceutical products, in particular products containing acetaminophen or diphenhydramine.

The dimensions and values disclosed herein are not to be understood as being strictly limited to the indicated exact numerical values. On the contrary, unless otherwise indicated, each such size should be implied both as a specified value and as a functionally equivalent range covering a given value. For example, a dimension indicated as “40 mm” should be understood as “approximately 40 mm”.

Each document referred to in the present description, including any cross-reference or related patent or application, as well as any patent application or patent with respect to which this application claims priority or advantage, is hereby incorporated by reference in its entirety, with the exception of clearly stated exceptions or other restrictions. The citation of any document is not an assumption that it is a prototype of any disclosed or claimed invention, or that it, itself, or in combination with another source or sources, provides explanations, assumptions or discloses any of these inventions. Also, in the event that any meaning or definition of a term in this document contradicts any meaning or definition of the same term in the document incorporated by reference, the meaning or definition assigned to such a term in this document should be paramount.

Although specific embodiments of the invention have been illustrated and described, it will be apparent to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. Thus, the appended claims are intended to cover all such changes and modifications that are within the scope of this invention.

Claims (14)

1. Cartridge with active pharmaceutical ingredients for use in an automatic needle-type machine for preparing drinks, comprising a body containing a first active pharmaceutical ingredient in powder form and a lid made of a multilayer material comprising an outer layer and an inner layer, the cartridge being made of sustainable tensile material, characterized endpoint WVTR of about 2 × 10 ^-5 g per cartridge per day to zoom in no 2 × 10 ^-3 g per day in the cartridge. 2. The cartridge according to claim 1, wherein the outer layer of the lid material is made of polyethylene terephthalate (PET), and the inner layer of the lid material is made of linear low density polyethylene (LLDPE). 3. The cartridge according to claim 1, wherein the outer layer of the lid material is made of polychlorotrifluoroethylene (PCTFE) and the inner layer of the lid material is made of glycol-modified polyethylene terephthalate (PETG). 4. The cartridge according to claim 1, the main part of which further comprises an inert filler in the form of a powder. 5. The cartridge according to claim 1, in which the main part is divided by a partition into the first and second compartments, wherein said first active pharmaceutical ingredient is located in the first compartment, and the second active pharmaceutical ingredient is placed in the second compartment. 6. The cartridge according to claim 5, in which the partition is made in the form of a grid. 7. The cartridge of claim 5, wherein the first and second active pharmaceutical ingredients are incompatible. 8. The cartridge according to claim 1, in the main part of which the first and second chambers are placed, the first active pharmaceutical ingredient is placed in the first chamber, and the second active pharmaceutical ingredient is placed in the second chamber, the first active pharmaceutical ingredient and the second active pharmaceutical ingredient providing reducing the severity of different symptoms, while the cartridge is made so that during one cycle of preparation of the drink the lower needle of the automatic machine for making drinks penetrates only to the first chamber or only to the second chamber. 9. The cartridge according to claim 8, in which the first and second chambers are made of brittle material. 10. The lid of the cartridge with active pharmaceutical ingredients, intended for use in an automatic needle-type machine for making drinks, made of a multilayer material comprising a first outer layer and a second layer, while the lid material is tear resistant and is characterized by a finite rate of penetration of water vapor from about 2 × 10 ^-5 g per cartridge per day to about 2 × 10 ^-3 g per cartridge per day, and the cap is configured to penetrate needles or other penetration means of an automatic machine for preparing drinks due to the weakened zone. 11. The cover of claim 10, wherein the second layer is made of aluminum foil. 12. The cap of claim 10, wherein the first outer layer is made of polychlorotrifluoroethylene (PCTFE) or polyethylene terephthalate (PET). 13. The cover according to claim 10, characterized in that it further comprises a third inner layer adjacent to the second layer made of linear low density polyethylene (LLDPE) or glycol-modified polyethylene terephthalate (PETG). 14. Cartridge with active pharmaceutical ingredients for use in an automatic needle-type machine for preparing drinks, containing a bulk containing an active pharmaceutical ingredient in the form of a powder, and a lid, wherein the cartridge is made of tear-resistant material characterized by a finite rate of water vapor penetration from about 2 × 10 ^-5 g per cartridge per day to about 2 × 10 ^-3 g per day in a cartridge, and as the active pharmaceutical ingredient kartri J comprises diphenhydramine and is adapted to release during the beverage preparation cycle about 50 mg diphenhydramine and acetaminophen comprises or is adapted to release during the beverage preparation cycle about 650 mg acetaminophen.

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