Single-dose medicine box

Abstract

The invention relates to a single dose cartridge for use with an automatic brewing machine. A cartridge includes a cup, at least one pharmaceutically active ingredient, and a lid that seals the pharmaceutically active ingredient inside the cup and provides a barrier against environmental factors.

Description

Technical Field

[0001] Aspects of the present invention relate to individual dose pods comprising a cup, at least one pharmaceutically active ingredient, and a lid that seals the pharmaceutically active ingredient within the cup and provides a barrier to environmental elements. Background Art

[0002] Single serving pods used with automatic brewing machines provide an easy and convenient way to prepare a single serving of beverage for consumption. This method is particularly suitable for preparing beverages containing pharmaceutical active ingredients, as users of such products generally seek ease of use and convenience. In addition, user-friendly single serving pods encourage users to use products containing pharmaceutical active ingredients that are beneficial to their health and well-being by simplifying the preparation process. Brewing single servings of beverages also avoids waste by preventing the user from preparing more than they need.

[0003] Currently, single-serve cartridges are available, often designed for use with coffee, tea, and other ingredients. Due to the sensitive nature of pharmaceutical active ingredients, these products are not suitable for use with such ingredients. In particular, standard single-serve cartridges fail to protect sensitive pharmaceutical active ingredients from environmental exposure. It is crucial that these products be designed to preserve the quality of the ingredients by preventing exposure to water, oxygen, and other environmental factors. Therefore, sensitive drugs must be packaged in single-serve cartridges with barrier properties to prevent degradation and maintain their efficacy and safety throughout their shelf life.

[0004] Furthermore, many active pharmaceutical ingredients (APIs) are required by law to be packaged in child-resistant packaging, and it is crucial that any single-dose containers used to contain such medications be child-resistant to prevent children from ingesting potentially hazardous substances. Current statistics show that nearly one-third of reported childhood toxic exposures are due to unintentional medication ingestion, and over seventy percent of resulting childhood deaths are caused by accidental exposure to hazardous substances. Therefore, child-resistant packaging has been a significant area of research for the past several decades.

[0005] In light of the above concerns, single-dose kits containing at least one pharmaceutically active ingredient that also provide a barrier to environmental factors would be highly desirable. Summary of the Invention

[0006] Aspects of the present invention relate to a single-dose medicine kit for use with an automatic brewing machine, comprising: a single-serving medicine kit comprising: a cup having a bottom portion and a sidewall portion extending from the bottom portion to a rim surrounding an opening, the space between the bottom portion and the sidewall portion defining an interior space, at least one pharmaceutically active ingredient being provided in the interior space of the cup, and a lid affixed to the rim of the cup to close the opening and secure the at least one pharmaceutically active ingredient within the interior space of the cup; wherein the lid forms a barrier to the passage of liquids and gases, and wherein the lid is a multilayer structure comprising a first layer of biaxially oriented polyethylene terephthalate, a second layer of polyethylene, a third layer of aluminum foil, and a fourth layer of a sealing layer, such as an ionomer layer, a polyethylene layer, or the like, used alone or in combination.

[0007] The present invention further provides at least one pharmaceutically active ingredient that is acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, ibuprofen, pseudoephedrine, guaifenesin, acetylcysteine, chlorpheniramine, cetirizine, levocetirizine, doxylamine succinate, loratadine, doxylamine, or a combination thereof. In one embodiment of the present invention, the at least one pharmaceutically active ingredient is acetaminophen. In another embodiment of the present invention, the at least one pharmaceutically active ingredient is a combination of acetaminophen, phenylephrine, and dextromethorphan. In another embodiment of the present invention, the at least one pharmaceutically active ingredient is a combination of acetaminophen, phenylephrine, and diphenhydramine. In another embodiment of the present invention, the at least one pharmaceutically active ingredient is a combination of guaifenesin and dextromethorphan.

[0008] The present invention further provides a single-dose kit having a child resistant performance exceeding 70% as determined by the Child Resistant Test. In a preferred embodiment of the present invention, the single-dose kit has a child resistant performance of 100% as determined by the Child Resistant Test. Specifically, the single-dose kit has a child resistant performance of at least 70% as determined by the Child Resistant Test, more specifically, has a child resistant performance of at least 70% or greater as determined by the Child Resistant Test, for example, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or 100% as determined by the Child Resistant Test.

[0009] The present invention provides a lid for a single-dose kit having appropriate moisture and / or oxygen barrier properties for the stability of a particular API (i.e., wherein the API substantially maintains its physical and / or chemical stability and / or activity during storage). In some embodiments, the present invention further provides a lid for a single-dose kit having a water vapor transmission rate of less than 0.001 g H2O / 100 in² / 24 hours. In some embodiments, the present invention further provides a lid for a single-dose kit having an oxygen transmission rate of less than 0.005 cc / 100 in² / 24 hours. A single-dose medicine kit for use with an automatic brewing machine is provided, comprising: a single-dose medicine kit comprising: a cup having a bottom portion and a sidewall portion extending from the bottom portion to a rim surrounding an opening, the space between the bottom portion and the sidewall portion defining an interior space, at least one pharmaceutically active ingredient being provided in the interior space of the cup, and a lid attached to the rim of the cup to close the opening and secure the at least one pharmaceutically active ingredient within the interior space of the cup; wherein the lid forms a barrier to the passage of liquids and / or gases, and wherein the lid is a multilayer structure comprising a first layer of biaxially oriented polyethylene terephthalate, a second layer of polyethylene, a third layer of aluminum foil, and a fourth layer of a sealing layer. Specifically, the at least one pharmaceutically active ingredient is acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, ibuprofen, pseudoephedrine, guaifenesin, acetylcysteine, chlorpheniramine, cetirizine, levocetirizine, doxylamine succinate, loratadine, doxylamine, or a combination thereof. In some embodiments, at least one pharmaceutically active ingredient is acetaminophen. In some embodiments, at least one pharmaceutically active ingredient is a combination of acetaminophen, phenylephrine, and dextromethorphan. In some embodiments, at least one pharmaceutically active ingredient is a combination of acetaminophen, phenylephrine, and diphenhydramine. In some embodiments, at least one pharmaceutically active ingredient is a combination of guaifenesin and dextromethorphan. Specifically, the single-dose kit has a childproof performance exceeding 70% as determined by childproof testing. More specifically, the single-dose kit has a childproof performance reaching 100% as determined by childproof testing. In some embodiments, the sealing layer is an ionomer layer, a polyethylene layer, a polyethylene-based ionomer layer, or a combination thereof. Specifically, the lid forms a barrier to the passage of liquids and gases, particularly water and oxygen. Specifically, the lid has a water vapor transmission rate of less than 0.001 g H2O / 100 in² / 24 hours and / or an oxygen transmission rate of less than 0.005 cc / 100 in² / 24 hours. In some embodiments, the cover has a water vapor transmission rate of less than 0.001 g H2O / 100 in² / 24 hours and an oxygen transmission rate of less than 0.005 cc / 100 in² / 24 hours.Specifically, the lid is connected to the edge of the cup by heat sealing, thereby closing the opening and securing at least one pharmaceutically active ingredient within the interior space of the cup. In a specific embodiment, a single-dose medicine box for use with an automatic brewing machine is provided, comprising: a single-dose medicine box comprising: a cup having a bottom portion and a sidewall portion extending from the bottom portion to a rim surrounding the opening, the space between the bottom portion and the sidewall portion defining an interior space, at least one pharmaceutically active ingredient being provided in the interior space of the cup, and a lid attached to the edge of the cup, thereby closing the opening and securing at least one pharmaceutically active ingredient within the interior space of the cup; wherein the lid forms a barrier to the passage of liquid and / or gas, and wherein the lid is a multi-layer structure, including a first layer of A biaxially oriented polyethylene terephthalate layer, a second layer being a polyethylene layer, a third layer being an aluminum foil layer, and a fourth layer being a sealant layer, wherein the at least one pharmaceutically active ingredient is selected from the group consisting of acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, ibuprofen, pseudoephedrine, guaifenesin, acetylcysteine, chlorpheniramine, cetirizine, levocetirizine, doxylamine succinate, loratadine, doxylamine, or a combination thereof; wherein the sealant layer is an ionomer layer, a polyethylene layer, a polyethylene-based ionomer layer, or a combination thereof; and wherein the single-dose container has a child resistance performance exceeding 70% as determined by a child resistance test. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 shows a perspective view of a single-serving kit of the present invention;

[0011] Figure 2 An exploded view showing a single-serving kit of the present invention; and

[0012] Figure 3 A cross-sectional view of the layers of the lid of the present invention is shown. Detailed Description of the Invention

[0013] Aspects of the present invention relate to a single-serving medicine container comprising a cup, at least one pharmaceutically active ingredient, and a lid. The single-serving medicine container can be used with an automatic brewing machine to brew a single serving of a beverage containing the pharmaceutically active ingredient. The single-serving medicine container serves as a primary packaging for the pharmaceutically active ingredient.

[0014] Figure 1 and Figure 2 A single-serving kit 100 is generally depicted. Specifically, Figure 1 A perspective view of a single-serving pill box 100 is shown, and Figure 2An exploded view of a single-serve medicine container 100 is shown. The single-serve medicine container 100 includes a cup 110 and a lid 120. The cup 110 has a bottom portion 150 and a sidewall portion 160 extending upward from the bottom portion 150 to a rim 130 surrounding an opening 170. The opening 170 leads to an interior space 140 defined by the sidewall portion 160 and the bottom portion 150 of the cup 110. The lid 120 can be attached to the rim 130 of the cup 110 to form a permanent, child-resistant, and barrier-resistant seal. The pharmaceutically active ingredient 200 can be stored in the interior space 140 of the cup 110 and sealed by the lid 120. The lid 120 provides an impermeable barrier to the environment, including but not limited to water and oxygen. In use, the single-serve medicine container 100 can be placed in an automatic brewing machine for preparation.

[0015] During a brewing cycle, the lid 120, bottom portion 150, and / or sidewall portion 160 may be pierced or otherwise penetrated by the automatic brewing machine so that liquid (e.g., water) may enter the cup 110 to mix with the pharmaceutically active ingredient 200 and the prepared beverage may be released from the cup 110.

[0016] Non-limiting examples of materials that can be incorporated into the laminate of the cup 110 and / or lid 120 include polystyrene, ethylene vinyl alcohol, polyethylene, biaxially oriented polyethylene terephthalate, polyethylene vinyl acetate, high-density polyethylene, cyclic olefin copolymer, biaxially oriented polyamide, ionomer, polychlorotrifluoroethylene, polypropylene, polyester, amorphous polyethylene terephthalate, polyvinyl chloride, polyethylene, aluminum foil, polyethylene terephthalate glycol, polyethylene terephthalate, oriented polyamide, low-density polyethylene, polyvinylidene chloride, or any combination thereof. The cup 110 and / or lid 120 can be a multilayer structure. Each layer of the laminate of the cup 110 or lid 120 can be adhered to an adjacent layer by an adhesive.

[0017] In a preferred embodiment, cup 110, including bottom portion 150 and sidewall portion 160, can be a multilayer structure made of any suitable material that provides the desired barrier properties. In one embodiment, cup 110 includes at least a polystyrene outer layer, an ethylene vinyl alcohol (EVOH) middle layer, and a polyethylene inner layer. In a preferred embodiment, the cup is made of a high-impact polystyrene (HIPS) inner layer, a polyvinylidene chloride middle layer, and a polyethylene outer layer. In this embodiment, HIPS can serve as the base layer, the polyvinylidene chloride can serve as a barrier layer to provide barrier properties to the cup to maintain the stability of the active pharmaceutical ingredient 200, and the polyethylene layer can serve as a contact layer and / or sealing layer. Additional adhesive layers can be provided between the layers as desired. The total thickness of the multilayer structure of the cup is between about 500 microns and about 1500 microns. In a preferred embodiment, the thickness of the multilayer structure of the cup is about 1100 microns.

[0018] During brewing in a standard automatic brewing machine, the cup 110 may be exposed to extremely hot liquid; therefore, the cup 110 should maintain its shape and securely retain the pharmaceutically active ingredient 200 within the interior space 140 for the duration of the brewing process. Furthermore, the automatic brewing machine can pierce the bottom portion 150 of the cup 110 to allow liquid to pass through the cup 110 and into the user's container for drinking. Therefore, the cup's structure and materials strike a balance between frangibility and shatterproofness, meaning it can break without significant deformation when subjected to pressure. This allows the bottom portion 150 of the cup 110 to be easily and reliably pierced by any standard automatic brewing machine while preventing broken pieces of the cup from entering the prepared beverage. The beverage prepared for drinking can be of any volume. In certain embodiments, the prepared beverage can be approximately 5 fluid ounces, approximately 8 fluid ounces, or approximately 10 fluid ounces. In a preferred embodiment, the prepared beverage is approximately 8 fluid ounces.

[0019] The pharmaceutical active ingredient 200 provided within the interior space 140 of the cup 110 can be any compound or composition that can be used to treat and / or prevent disease and / or provide overall health and wellness benefits to the user. Non-limiting examples of pharmaceutical active ingredients include over-the-counter actives, behind-the-counter actives, prescription actives, vitamins, minerals, plant-derived materials, energy-boosting materials, probiotics, sports drinks, health drinks, dietary supplements, functional drinks, coffee, coffee with milk, tea, tea with milk, fiber, prebiotics, decongestants, anti-inflammatory drugs, cough suppressants, expectorants, antihistamines, antitussives, analgesics, or any combination thereof.

[0020] The active pharmaceutical ingredient 200 can be acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, ibuprofen, pseudoephedrine, guaifenesin, acetylcysteine, chlorpheniramine, cetirizine, levocetirizine, doxylamine succinate, loratadine, doxylamine, or any combination thereof. The present invention can be used with any active pharmaceutical ingredient, any combination of active pharmaceutical ingredients, or a combination of an active pharmaceutical ingredient and one or more excipients. The active pharmaceutical ingredient 200 can be in any suitable form, including but not limited to a powder, liquid, gel, or tablet.

[0021] In a preferred embodiment, the pharmaceutical active ingredient may be a combination of acetaminophen, phenylephrine, and dextromethorphan. In another preferred embodiment, the pharmaceutical active ingredient may be a combination of acetaminophen, phenylephrine, and diphenhydramine. In another preferred embodiment, the pharmaceutical active ingredient may be acetaminophen.

[0022] In certain embodiments, one or more pharmaceutically active ingredients may be present in an amount between about 1 mg and about 2,000 mg. In embodiments where pharmaceutically active ingredient 200 includes acetaminophen, it is present in an amount between about 300 mg and about 1,000 mg. In a preferred embodiment, acetaminophen is present in an amount of about 650 mg. In another preferred embodiment, acetaminophen is present in an amount of about 500 mg. In embodiments where pharmaceutically active ingredient 200 includes phenylephrine, it is present in an amount between about 5 mg and about 30 mg. In a preferred embodiment, phenylephrine is present in an amount of about 10 mg. In embodiments where pharmaceutically active ingredient 200 includes dextromethorphan, it is present in an amount between about 5 mg and about 30 mg. In a preferred embodiment, dextromethorphan is present in an amount of about 20 mg. In embodiments where the pharmaceutically active ingredient comprises diphenhydramine, it is present in an amount between about 5 mg and about 50 mg. In a preferred embodiment, diphenhydramine is present in an amount of about 25 mg.

[0023] The limiting examples of excipient comprises flavoring agent, filler, disintegrant, glidant, lubricant, antioxidant, sweetener, pigment, preservative, lubricant, sorbent or its any combination.Suitable flavoring agent can comprise for example peppermint, menthol, peppermint, wintergreen, sweet mint, spearmint, vanillin, caramel, chocolate, coffee, cinnamon, cloves, citrus, lemon, green tea, white tea, chamomile, sour orange (lime), orange, grape, cherry, strawberry, fruit punch (fruit punch), honey, honey lemon, other fruit flavors or its any combination.Suitable filler can comprise for example maltodextrin, silicon dioxide, sodium citrate, tricalcium phosphate, anhydrous citric acid, sodium citrate, various levels of microcrystalline cellulose (for example Avicel PH101, Avicel PH102 and Avicel PH200), corn starch or its any combination. Suitable disintegrants can include, for example, sodium starch glycolate [Explotab], cross-linked polyvinyl pyrrolidone, corn starch, gum arabic, cross-linked sodium carboxymethyl cellulose [Ac-di-sol], sodium carboxymethyl cellulose, magnesium aluminum silicate (veegum), alginates, or any combination thereof. Suitable glidants can include, for example, talc, corn starch, stearic acid, calcium stearate, polyethylene glycol, silicon dioxide, sodium stearyl fumarate, magnesium stearate, vegetable oil and mineral oil, or any combination thereof. Suitable lubricants can include, for example, magnesium stearate, stearic acid and pharmaceutically acceptable alkali metal salts thereof, calcium stearate, sodium stearate, Cab-O-Sil, Syloid, sodium lauryl sulfate, sodium chloride, magnesium lauryl sulfate, talc, or any combination thereof. Suitable antioxidants can include, for example, alpha-tocopherol, beta-tocopherol, gamma-tocopherol, delta-tocopherol, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), ascorbic acid, fumaric acid, malic acid, ascorbyl palmitate, propyl gallate, sodium ascorbate, sodium metabisulfite, or any combination thereof. Suitable sweeteners can include, for example, acesulfame K, aspartame, sucrose, or any combination thereof. Suitable pigments can include, for example, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40.

[0024] In a preferred embodiment, the lid 120 can be a multi-layer structure made of any suitable material that provides the desired barrier properties while being childproof. Preferably, the lid 120 includes at least a polyester layer, an adhesive layer, a primer layer, an aluminum foil layer, and a polyethylene CoEx heat seal coating layer. The lid 120 can be securely and permanently sealed to the rim 130 of the cup, and the pharmaceutically active ingredient 200 is sealed in the interior space 140 of the cup 110. The lid forms an airtight, moisture-proof, barrier-protective, and childproof seal between the lid 120 and the cup 110, protecting the pharmaceutically active ingredient 200.

[0025] The lid's multi-layer construction provides the moisture and child-resistant ratings required for pharmaceutical products – higher standards than those required by manufacturers of single-serve containers for tea, coffee or other similar beverages.

[0026] Figure 3 A cross-sectional view of the various layers of the lid 120 of the present invention is shown. The first layer is a biaxially oriented polyethylene terephthalate (BoPET) layer. First layer 121 is a polyester film made from polyethylene terephthalate stretched in two different directions to enhance mechanical orientation. First layer 121 provides various properties to the present invention, including, but not limited to, high tensile strength, durability, barrier properties, and clarity. In preferred embodiments, first layer 121 is clear, transparent, or translucent.

[0027] Furthermore, the thickness of the first layer 121 of the lid 120 is between about 9 microns and about 30 microns. Preferably, the thickness of the first layer 121 is about 19.1 microns. The thickness of the first layer 121 increases the strength of the lid 120 and further supports the child-resistant function of the lid 120. Typically, the thickness of the BoPET layer used in similar products is much smaller; however, such similar products are not child-resistant and therefore cannot be used with pharmaceutical ingredients.

[0028] In a preferred embodiment, the cover 120 includes a second layer 122, which is an adhesive. In one embodiment, the adhesive can be an ionomer layer. The second layer 122 of the cover 120 has a thickness of about 3 microns to about 10 microns. In a preferred embodiment, the second layer 122 has a thickness of about 7.6 microns.

[0029] In a preferred embodiment, the cover 120 includes a third layer 123, which is a primer. The thickness of the third layer 123 of the cover 120 is about 3 microns to 15 microns. In a preferred embodiment, the thickness of the third layer 123 is about 6.8 microns.

[0030] In a preferred embodiment, lid 120 includes a fourth layer 124, which is aluminum foil. Fourth layer 124 has a thickness of about 20 microns to about 45 microns. Preferably, fourth layer 124 has a thickness of about 37 microns. Fourth layer 124 enables lid 120 to block the passage of liquids and gases, including water and oxygen. Specifically, the molecular structure of aluminum foil forms a strong barrier, which is ideal for use with pharmaceutical ingredients, which are sensitive to environmental factors.

[0031] Fourth layer 124 (which may be referred to as a sealant) eliminates exposure to liquids and gases, thereby extending the shelf life of the present invention and maintaining the quality and efficacy of the pharmaceutically active ingredient 200 within cup 110. Furthermore, fourth layer 124 is both durable and strong, yet lightweight and malleable; therefore, it is ideal for packaging products of various shapes and sizes without sacrificing barrier properties. The sealant can be an ionomer layer, or comprised of a polymer material selected from low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), very low-density polyethylene (VLDPE), medium-density polyethylene (MDPE), high-density polyethylene (HDPE), or blends of these polymers with or without ionomers, and a heat-seal coating. In some embodiments, the sealant can be an ionomer layer, a polyethylene layer, a polyethylene-based ionomer layer, or a combination thereof.

[0032] In a preferred embodiment, the lid 120 includes a fifth layer 125, which is a polyethylene CoEx heat seal coating layer. The thickness of the fifth layer 125 is about 15 microns to about 40 microns. In a preferred embodiment, the thickness of the fifth layer 125 is about 30 microns.

[0033] like Figure 3 As shown, the first layer 121 may be the outermost layer on the outer side of the cover 120. The second layer 122 may be disposed between the first layer 121 and the third layer 123. The third layer 123 may be disposed between the second layer 122 and the fourth layer 124. The fourth layer 124 may be disposed between the third layer 123 and the fifth layer 125. The fifth layer 125 may be the innermost layer on the inner side of the cover 120.

[0034] The total thickness of the cover 120 can be between about 100 microns and about 150 microns. In a preferred embodiment, the total thickness of the cover 120 is about 130 microns.

[0035] The lid 120 has excellent oxygen and moisture barrier properties, which are ideal for the pharmaceutically active ingredient 200 that may be used in the single-dose kit 100. The water vapor transmission rate of the lid 120 may be less than 0.001 g H2O / 100 in 2 / 24 hours. The water vapor transmission rate of the cover 120 is tested at a temperature of 100°F and a relative humidity of 90%. In addition, the oxygen transmission rate of the cover 120 can be less than 0.005cc / 100in 2 / 24 hours.

[0036] The lid 120 can be attached to the rim to seal the interior space by any suitable method, such as by heat sealing, crimping, adhesives (food-safe approved by the U.S. Food and Drug Administration ("FDA")), etc. In one embodiment, the lid has a heat-activated coating that adheres to the base rim when exposed to heat. In another embodiment, ultrasonic frequencies can be used to attach the lid, and in another embodiment, induction heating can be used to attach the lid. Alternatively, the lid can be attached using a contact adhesive.

[0037] Furthermore, the lid 120 provides child-resistant and tear-resistant packaging for the single-serving medication container 100. Tear-resistant refers to the ability of a material to withstand a reasonable degree of stress and / or deformation when subjected to forces applied by an individual without significant loss of integrity. It is crucial that the lid 120 be child-resistant to prevent children from accessing and potentially ingesting hazardous materials, such as the active pharmaceutical ingredient 200 that may be contained within the cup 110 of the present invention.

[0038] According to 16. CFR 1700 anti-toxic packaging has been subjected to standardized child-resistant (Child-Resistant) testing. Test failure is defined as any child opening the package or contacting the contents of the package. In one embodiment, the present invention can have child safety protection functions and can be given a grade called F value. The F value is the number of unit doses for which contact is considered a test failure. The F value is determined based on the number of unit doses that may cause serious personal injury or serious illness to a child weighing 25 pounds (11.4 kg). In an embodiment of the present invention, the single-dose medicine box 250 can be a packaging with F=1. In another embodiment, the single-dose medicine box 250 of the present invention can be a packaging with F=3. In another embodiment, the single-dose medicine box 250 of the present invention can be a packaging with F=4. In another embodiment, the single-dose medicine box 250 of the present invention can be a packaging with F=5. In a preferred embodiment of the present invention, the single-dose medicine box is a packaging with F=2.

[0039] The child-resistant test results show that the single-dose kit 250 is more than 70% child-resistant when packaged in F=1, F=2, F=3, F=4, or F=5. In another embodiment, the single-dose kit is more than 80% child-resistant when packaged in F=1, F=2, F=3, F=4, or F=5. In a preferred embodiment, the single-dose kit is 100% child-resistant when packaged in F=1, F=2, F=3, F=4, or F=5. In some embodiments, the single-dose kit is packaged in F=1, and in the child-resistant test, at least 70% or more of children are unable to obtain one dose. In some embodiments, the single-dose kit is packaged in F=2, and in the child-resistant test, at least 70% or more of children are unable to obtain two or fewer doses. In some embodiments, the single-dose kit is packaged in F=3, and in the child-resistant test, at least 70% or more of children are unable to obtain three or fewer doses. In some embodiments, the single-dose kit is packaged with F=4, and in child safety testing, at least 70% or more of children are unable to obtain four doses or less. In some embodiments, the single-dose kit is packaged with F=5, and in child safety testing, at least 70% or more of children are unable to obtain five doses or less. In some embodiments, the single-dose kit is packaged with F=1, and in child safety testing, at least 80% or more of children are unable to obtain one dose. In some embodiments, the single-dose kit is packaged with F=2, and in child safety testing, at least 80% or more of children are unable to obtain two doses or less. In some embodiments, the single-dose kit is packaged with F=3, and in child safety testing, at least 80% or more of children are unable to obtain three doses or less. In some embodiments, the single-dose kit is packaged with F=4, and in child safety testing, at least 80% or more of children are unable to obtain four doses or less. In some embodiments, the single-dose kit is packaged with F=5 and, in child-resistant testing, at least 80% or more of children are unable to obtain five or fewer doses. In preferred embodiments, the single-dose kit is packaged with F=1, F=2, F=3, F=4, or F=5 and, in child-resistant testing, 100% of children are unable to obtain one dose. For the avoidance of doubt, reference to one or more doses in this paragraph refers to one or more doses of the API contained in the kit.

[0040] Other aspects of the present invention may relate to methods of treating symptoms of colds and / or flu, allergies, or other illnesses, comprising preparing a drink as described herein, and administering or drinking the prepared drink. Other aspects of the present invention may relate to the use of a drink as described herein for treating symptoms of colds and / or flu, allergies, or other illnesses.

[0041] Example 1

[0042] Example 1 details the test methods and test results of the child resistance testing conducted on the present invention to ensure its compliance with the regulations of the Poison Prevention Packaging Act of 1970 and the provisions of Title 16 of the Code of Federal Regulations: Part 1700.20. The test methods and test results are detailed below.

[0043] Child safety protection test method:

[0044] Testing was conducted on 14 children aged 42 to 51 months, including those aged 51 months. Fourteen percent of the children were aged 42 to 44 months, 50% were aged 45 to 48 months, and 0% were aged 49 to 51 months. All children had been appropriately prepared in advance and provided detailed information.

[0045] First, two children were placed in a room, given identical packages, and prompted by an administrator to "Please try to open this for me." Each child was then given five minutes to attempt to open their package. Throughout the test, the administrator closely observed the children and refrained from influencing them in any way, either verbally or nonverbally. The children were allowed to freely open the packages, including standing up, lying on the floor, and banging or prying. The children were also allowed to discuss the package opening with each other and could watch each other attempt to open the packages. If a child successfully opened the package, the administrator would say "thank you," take the package from the child, and place it out of the child's reach. The child was not asked to open the package again.

[0046] After five minutes, if any child had not opened their package, the administrator demonstrated how to open it. The administrator used a separate demonstration package. Before the demonstration, the children were asked to set their packages aside and were not allowed to continue attempting to open them. The tester asked the children, "Watch me open my package," to get their attention. During the demonstration, the administrator held the package about two feet from the children and opened it at a normal pace, as if the administrator were about to use the contents. The administrator did not exaggerate any of the movements. Nor did the administrator discuss or describe how to open the package.

[0047] After the demonstration, the administrator instructed the children to begin a second 5-minute testing period by prompting, "Now try to open your package." If one or both children did not use their teeth to open their package during the first 5-minute testing period, the administrator told the children, "You can use your teeth if you want," before the second 5-minute testing period began. The administrator then observed the children during the second 5-minute testing period or until both children opened their package (whichever came first).

[0048] Child safety test results:

[0049] During the first 5-minute test period (before the demonstration), zero opens were recorded. Additionally, during the second 5-minute test period (after the demonstration), zero opens were recorded. For the entire 10-minute test period, zero opens were recorded. This equates to a total percentage of 0.00% for the entire 10-minute test, which is within the meaning of US 16 CFR 1626. 1700.20. Therefore, the present invention complies with US 16 CFR The child safety protection test requirements of 1700.20 are shown in Table 7.

[0050] These results are based on the assumption that package opening is defined as a situation where a child obtains 1 unit from the package. This corresponds to a failure rate of F = 1.

Claims

1. A single-dose kit for use with an automatic brewing machine, comprising: Single-serve kits, including: a cup having a bottom portion and a sidewall portion extending from the bottom portion to a rim surrounding an opening, the space between the bottom portion and the sidewall portion defining an interior space, At least one pharmaceutically active ingredient is provided in the interior space of the cup, and a lid attached to the rim of the cup, thereby closing the opening and securing at least one pharmaceutically active ingredient within the interior space of the cup; wherein the cover forms a barrier to the passage of liquids and / or gases, and The cover is a multi-layer structure, comprising a first layer of biaxially oriented polyethylene terephthalate layer, a second layer of polyethylene layer, a third layer of aluminum foil layer, and a fourth layer of a sealing layer.

2. The single-dose kit of claim 1 , wherein the at least one pharmaceutically active ingredient is acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, ibuprofen, pseudoephedrine, guaifenesin, acetylcysteine, chlorpheniramine, cetirizine, levocetirizine, doxylamine succinate, loratadine, doxylamine, or a combination thereof.

3. The single-dose kit of claim 2, wherein the at least one pharmaceutically active ingredient is acetaminophen.

4. The single-dose kit of claim 2, wherein the at least one pharmaceutically active ingredient is a combination of acetaminophen, phenylephrine, and dextromethorphan.

5. The single-dose kit of claim 2, wherein the at least one pharmaceutically active ingredient is a combination of acetaminophen, phenylephrine, and diphenhydramine.

6. The single-dose kit of claim 2, wherein the at least one pharmaceutically active ingredient is a combination of guaifenesin and dextromethorphan.

7. The single-dose kit of claim 1 , wherein the single-dose kit is child-resistant to greater than 70% as determined by a child-resistant test.

8. The single-dose package of claim 7, wherein the single-dose kit is 100% child-resistant as determined by a child-resistant test.

9. The single-dose kit of claim 1, wherein the sealing layer is an ionomer layer, a polyethylene layer, a polyethylene-based ionomer layer, or a combination thereof.

10. The single-dose kit of claim 1 , wherein the lid has a viscosity of less than 0.001 g H2O / 100 in 2 / 24 hours water vapor transmission rate.

11. The single-dose kit of claim 1 , wherein the cap has a viscosity of less than 0.005 cc / 100 in. 2 / 24 hours oxygen transmission rate.

12. The single-dose kit according to claim 1, wherein the cover forms a barrier against the passage of liquids and gases, in particular water and oxygen.

13. The single-dose kit of claim 12, wherein the lid has a viscosity of less than 0.001 g H2O / 100 in 2 / 24 hours water vapor transmission rate, and less than 0.005cc / 100 in 2 / 24 hours oxygen transmission rate.

14. The single-dose kit according to any one of the preceding claims, wherein the lid is connected to the rim of the cup by heat sealing, thereby closing the opening and securing the at least one pharmaceutically active ingredient within the interior space of the cup.

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