Delivery of pharmaceuticals or nutritional supplements

Abstract

The pharmaceutical or nutritional supplement will be provided in a delivery form that can be chewed and ingested. [Solution] The present invention provides a method for avoiding chemical or biological degradation of pharmaceuticals or nutritional supplements that may occur due to heat by providing a pre-formed gummy candy, forming one or more cavities within the pre-formed gummy candy, and introducing a pharmaceutical or nutritional supplement into the one or more cavities without applying heat. The present invention also provides a pharmaceutical or nutritional supplement that includes a chewable gummy candy in which a pharmaceutical or nutritional supplement, which is made of a material that degrades when exposed to heat, is filled into the internal cavity in a non-heat-degraded state.

Description

Technical Field

[0001] The present disclosure relates to the delivery of pharmaceuticals or dietary supplements to humans or animals in need of such supplements or pharmaceuticals.

Background Art

[0002] In recent years, it has been proposed to provide personalized pharmaceuticals or dietary supplements that are specifically designed to match, complement or adapt to an individual's nutritional, microbiome or health needs.

[0003] Many conventional means for delivering pharmaceuticals or dietary supplements, such as by incorporation into tablets, pills or capsules, are not suitable for providing personalized supplements. This is because the cost required for the delivery mechanism prevents use for individual applications, or manufacturing requirements such as drying for powderization, or heating and compression are not applicable to the required pharmaceuticals or supplements, or both of the above situations exist.

[0004] In recent years, chewable gummy candies have gained popularity as an alternative to tablets, pills and capsules for delivering pharmaceuticals and nutritional products, especially for children, but these also have manufacturing problems. Although supplements can be incorporated into gummies during manufacturing, typical manufacturing temperatures range from 75° C. to 150° C., which is sufficient to destroy or significantly degrade many pharmaceuticals or dietary supplements. Although personalized formulations of supplements are described in US 2021 / 0298343, this method still requires heating and curing time, resulting in a delay from manufacturing to delivery to the customer.

[0005] For example, probiotics are a form of dietary supplement that has recently attracted attention for numerous potential medical applications. Probiotics consist of multiple different strains of live microorganisms, such as bacteria and / or yeast, and are often highly sensitive to even small amounts of heat. Including a greater diversity of microbial strains in a single probiotic product is desirable to provide enhanced health benefits. Although a small number of heat-resistant probiotic strains have been developed, their number is very limited, so probiotic products with desirable strain diversity are likely to contain heat-sensitive microbial strains. Traditionally, there has been no acceptable method for providing a sufficiently diverse probiotic supplement in a chewable candy form without damaging a significant portion of the microorganisms present as a result of heat exposure.

[0006] Vitamins such as vitamin C and B vitamins are also a form of nutritional supplement that is susceptible to heat degradation.

[0007] A common method used by gummy manufacturers to mitigate the thermal degradation of active ingredients is over-aging. This involves adding more active ingredient than the effective amount, hoping that a sufficient amount will remain effective after heat exposure. This method is inaccurate and, in the case of pharmaceutical active ingredients, can lead to under-dosing or over-dosing.

[0008] Instead of using live probiotic microbial species themselves, Mannatech, Inc.'s EP 3170410 discloses the use of probiotic microbial species to treat natural polysaccharides to produce novel postbiotics, i.e., probiotic-treated polysaccharides, for use as a food supplement. Probiotic-treated polysaccharides may be provided in powder form or filled into split rigid gelatin capsules. Probiotic-treated polysaccharides may be dissolved in edible oil and injected into soft gelatin capsules by a positive-volume pump. Probiotic-treated polysaccharides may be formed as tablets, effervescent tablets, or suspensions. Rigid gelatin capsules, soft gelatin capsules, tablets, effervescent tablets, or suspensions may contain some probiotic bacteria. Probiotic-treated polysaccharides may be mixed with a glycerinated gelatin matrix and formed into gummies by conventional processing, or added to gelan gum and carrageenan and then conventionally processed to produce gelatin-free gummies. While some probiotic bacteria may be present alongside the processed polysaccharides, no measures are taken to address the thermal degradation of the probiotic bacteria or other components due to the temperatures involved in gummy production.

[0009] Church & Dwight Co Inc.'s WO 2016 / 164470 incorporates a heat-sensitive component into a viscous liquid core composition, which is co-deposited with a liquid gummy composition to form a gummy supplement with a shell-and-core structure. The liquid gummy composition is held at approximately 95°C before co-deposition. The viscous liquid core composition is held separately above its melting point but below 60°C to maintain its liquid state. Both compositions are co-deposited into a gummy mold in a carefully timed and controlled manner so that the gummy composition forms a shell completely enclosing the liquid core composition, and are then cooled to solidify as the final gummy product.

[0010] Separating the gummy composition from the core composition before co-deposition has been proposed as a solution to limit the thermal exposure of heat-sensitive components during the candy manufacturing process. However, it is clear that there are numerous stages in which heat-sensitive components are exposed to significant amounts of heat. For example, the core composition must be held at a temperature above its melting point initially, and heat-sensitive components that cannot withstand such temperatures cannot be used. Also, for a short period during co-deposition, the core composition is exposed to approximately 95°C by direct exposure from the hot liquid gummy composition, posing a significant degradation risk to many heat-sensitive components. Furthermore, heat-sensitive components must be available in viscous liquid form, further limiting the selection of usable components. Due to these constraints, the teachings in this document are not suitable for providing heat-sensitive pharmaceuticals and dietary supplements, as well as personalized pharmaceuticals and dietary supplements, in gummy form.

[0011] Hero Nutritional Products, LLC et al., in WO 2012 / 092391, claim to disclose a method for adding heat-sensitive ingredients to chewable supplements such as gummies during the candy manufacturing process. However, any method of adding heat-sensitive ingredients before the gummies are fully hardened cannot avoid thermal degradation. For example, it has been proposed to encapsulate the heat-sensitive ingredients in heat-resistant soft gel capsules and incorporate them into the gummy ingredients, or to dissolve the heat-sensitive ingredients in syrup and deposit them into the partially cooled gummy ingredients. However, in either case, the heat-sensitive ingredients will degrade, at least partially, by the time the gummies are fully hardened.

[0012] In WO 2012 / 092391, the only proposal for adding supplements to gummies without heat is to incorporate the supplements into solid sugar particles and attach them to the outer surface of the gummies after they have cooled and hardened. In practice, this method has numerous drawbacks. Because the supplements are attached to the outer surface of the gummies, there is a significant risk of contamination if non-sterile objects come into contact with them, for example, if a consumer's hands enter a container holding many gummies. Furthermore, any movement during transport inevitably causes the sugar particles attached to the outside to detach from the gummies. As a result, the dosage present in each gummy becomes uneven and unreliable.

[0013] This disclosure is based on the inventors' research aimed at improving upon previously proposed methods. [Overview of the project] [Means for solving the problem]

[0014] According to the first aspect of this disclosure, a method is provided for providing a pharmaceutical or dietary supplement in a chewable delivery form, comprising the following steps:

[0015] A process of providing pre-formed gummy candies, The process of forming one or more cavities within the pre-formed gummy candy, The process includes a step of introducing the pharmaceutical or nutritional supplement into one or more cavities without applying heat, thereby avoiding chemical or biological deterioration that may occur in the pharmaceutical or nutritional supplement due to heat.

[0016] In a preferred embodiment, each cavity is formed and filled individually in a single operation.

[0017] According to an alternative aspect of this disclosure, a drug or dietary supplement is provided in a chewable delivery form, wherein the drug or dietary supplement is made of a material that degrades when exposed to heat, and the drug or dietary supplement in a chewable form is, The gummy candy includes a chewable gummy candy having one or more internal cavities formed after the gummy is manufactured, the internal cavities being at least partially filled with the pharmaceutical or nutritional supplement in an unheated, degraded state.

[0018] A key feature of this disclosure is that the applicant uses fully pre-formed gummies. Exposure of the pharmaceutical or dietary supplement to the heat inherent in gummy formation is completely avoided. The applicant's system has the advantage that the composition of the pharmaceutical or dietary supplement can be selected, and therefore individualized, and delivered in a reliable and consistent dosage form. Small-scale production is possible, which is necessary to deliver individualized supplements or pharmaceuticals in an economically viable manner.

[0019] Preferably, the pharmaceutical or nutritional supplement is in the form of a powder, powder aggregate, or fine particles.

[0020] The following is for illustrative purposes only and refers to the attached drawings and descriptions of preferred embodiments. [Brief explanation of the drawing]

[0021] [Figure 1] Figure 1 is a side view of an individual infusion station, which constitutes part of a production line for providing pharmaceuticals or nutritional supplements in a chewable delivery form. [Figure 2] Figure 2 is a longitudinal cross-sectional view of the apparatus shown in Figure 1. [Figure 3] Figure 3 is a side view of the injection station shown in Figure 1, illustrating the state in which pharmaceuticals or nutritional supplements are injected into the gummies. [Figure 4] Figure 4 is similar to Figure 2 in the state shown in Figure 3. [Figure 5] Figure 5 is a perspective view of a gummy candy showing the incision line formed by a scalpel. [Figure 6] Figure 6 is similar to Figure 5, but shows the state after an incision has been made and the desired pharmaceutical or nutritional supplement has been inserted into the gummy. [Figure 7]Figure 7 is a perspective view showing an alternative configuration for propelling a pharmaceutical or dietary supplement into a gummy using kinetic energy. [Figure 8] Figure 8 is a schematic diagram showing a separate cavity into which a powder is injected within a gummy. MODE FOR CARRYING OUT THE INVENTION

[0022] As used throughout this disclosure, the term "gummy" refers to a candy conventionally produced from materials such as gelatin or pectin in a homogeneous or solid form.

[0023] Figures 1 to 4 show a production line for a chewable delivery form of a pharmaceutical or dietary supplement, comprising at least one, and preferably up to 30 injection stations, each injection station being loaded with a different powdered pharmaceutical or dietary supplement for injection into a gummy. As the gummies move along the production line, each gummy passes through each of the 30 injection stations. User-configurable computer software determines at which injection station a particular gummy requires injection.

[0024] As shown in Figures 1 to 4, a polyhedral turret 1 is arranged at an injection station 2, and the injection station 2 is loaded with a supply of powdered pharmaceutical or dietary supplement in a hopper 3. The turret 1 functions as a holder 4 for holding a single gummy and is rotatable by a motor 5. Each of the ten faces of the turret 1 is provided with an opening 6 that allows access to the gummy in the holder 4 for injection.

[0025] The turret 1 is covered by a corresponding ten-faced lid 7, and each of the ten faces of the lid 7 is provided with an opening 8 corresponding to and aligned with the opening 6 of the gummy holder 4. When the gummy holder 4 is closed by the lid 7, the gummy loaded in the holder 4 is deformed, and a stretched gummy surface is presented at each of the aligned openings 6 and 8.

[0026] Depending on the desired filling for the gummy, the pharmaceutical or nutritional supplement loaded in powder form into the hopper 3 is injected into the gummy in the holder 4 of the turret 1 by the injection needle 9 of the injection unit 10 described below, through one of the stretched surfaces of the gummy presented in aligned openings 6, 8, and introduced into the interior of the gummy.

[0027] Motor 5 rotates turret 1 so that one of the stretched surfaces of the gummy held in holder 4 is presented toward a hollow needle 9 located at one end of injection unit 10. Motor 11 is configured to drive injection unit 10 and its hollow needle 9 toward turret 1, passing through aligned openings 6 and 8, and further penetrating the stretched surface of the gummy into the interior of the gummy, as shown in Figures 3 and 4. This puncture action creates a cavity inside the gummy into which powdered pharmaceuticals or nutritional supplements are deposited, as will be described later.

[0028] The hopper 3 contains a reservoir for powdered pharmaceuticals or nutritional supplements, which are supplied to a large auger 12 in the injection unit 10. The large auger 12 is rotationally driven by a motor 13 and transports the powdered pharmaceuticals or nutritional supplements supplied from the hopper 3 toward a cavity 14 located at the front end of the injection unit 10.

[0029] The small auger 15 is positioned on the longitudinal central axis of the injection unit 10 and extends to the end of the hollow needle 9. While the hollow needle 9 remains punctured inside the gummy, the small auger 15 is rotationally driven by the motor 16 to transport the pharmaceutical or nutritional supplement from the cavity 14 through the end of the hollow needle 9 into the cavity formed inside the gummy.

[0030] Subsequently, the motor 11 drives the injection unit 10 away from the gummy holder 4, gradually withdrawing the hollow needle 9 from the gummy while the pharmaceutical or nutritional supplement is deposited in the cavity inside the gummy, until the hollow needle 9 is completely withdrawn from the gummy.

[0031] If a gummy requires a higher dose of the same drug or nutritional supplement at the same injection location, the turret 1 is rotated to present another stretched surface of the gummy loaded in the holder 4 of the turret 1, and an additional injection of the specific drug or nutritional supplement loaded in the hopper 3 is performed.

[0032] On the other hand, if the gummy requires a dose of pharmaceutical or nutritional supplement from the next infusion station, the entire turret is moved to the next infusion station by a transport mechanism (not shown), and the gummy is infused in the same manner.

[0033] When the gummy is released from the holder 4 of turret 1, its elastic properties cause it to return to its original non-deformable shape. As the stretched surface presented in the aligned openings 6, 8 relaxes, the pores in the gummy surface formed by the hollow needle 9 contract. Due to the contraction of these pores and the tackiness inside the gummy, the pharmaceutical and / or nutritional supplement is effectively held inside the gummy, thereby preventing the pharmaceutical or supplement from leaking out and preventing external contaminants from accessing the gummy contents.

[0034] Motor 5 is preferably a Nema stepping motor, and motors 11, 13, and 16 are preferably Nema 8 motors.

[0035] The above apparatus uses typical round gummies, which are readily available from numerous manufacturers, such as Sirio Pharma Co. Ltd. Obviously, any other suitable gummy shape or form can also be used. The gummies used are candies, but may be supplied already containing supplements such as inulin prebiotics in their composition.

[0036] A notable feature of the above-described apparatus is that the pharmaceutical or nutritional supplement is not exposed to any heat. Therefore, there is no risk of deterioration of heat-sensitive pharmaceuticals or nutritional supplements, such as probiotics, as a result of being contained in a delivery form that can be chewed and ingested according to the instructions of the present inventor.

[0037] Furthermore, by using multiple infusion stations, each infusing specific components and amounts of pharmaceuticals or dietary supplements into the gummies, it is possible to easily create chewable delivery forms of pharmaceutical products or dietary supplements specifically designed to meet the needs of particular consumers, and this can be achieved at minimal cost. The solid texture of the gummies is particularly useful in this scenario, as shown in Figure 8, allowing different pharmaceuticals or dietary supplements to be introduced into the gummies through separate channels 18 without them coming into contact with or interacting with each other. This also has the advantage that the amount of pharmaceutical or dietary supplement being infused can be easily controlled simply by changing the number of channels through which it is injected.

[0038] While the above embodiments demonstrate a method for incorporating pharmaceuticals and / or nutritional supplements into gummies using injection, it will be readily apparent that other techniques can be used instead of injection. For example, cavities can be formed by disturbing the inside of the gummy using heat, lasers, vibrations, and / or other physical or chemical interventions. At the time of these disturbances, even in the case of thermal techniques, the pharmaceuticals or nutritional supplements are not yet present. The pharmaceuticals or nutritional supplements can then be delivered into the formed cavities by pumping injection as described above, or by propelling them through the gummy walls using means such as kinetic energy.

[0039] For example, hopper 3 can supply powdered pharmaceuticals or nutritional supplements to an auger (not shown) in an air gun 17. The auger is rotated by a motor (not shown) to transport a predetermined dose of the pharmaceutical or nutritional supplement to an internal chamber (not shown) in the air gun 17. The air gun 17 is connected to an operable pressurized air source (not shown), which is used to accelerate the pharmaceutical or nutritional supplement in the internal chamber through a barrel (not shown). One end of the barrel is connected to the internal chamber of the air gun 17, and the other end is open. As shown in Figure 7, the surface of the gummy is presented to the air gun 17 at the open end of the barrel. The pressurized air source is then activated, and pressurized air is released through the internal chamber and the barrel, causing the pharmaceutical or nutritional supplement loaded in the chamber to accelerate through the barrel with sufficient kinetic energy, be released from the open end, and penetrate the presented gummy surface, forcibly pushing the powder particles into the gummy. In this way, a cavity is formed when the pharmaceutical or nutritional supplement is propelled into the gummy by its kinetic energy. The pierced gummy surface can self-seal due to the sticky texture inside the gummy, or a food adhesive can be applied.

[0040] As a further alternative, the stretched gummy surface and its interior are disturbed with a scalpel to allow insertion of the drug or nutritional supplement, and then the gummy is returned to its original shape, thereby substantially closing the opening created by the scalpel. As shown in Figures 5 and 6, this can be done simply by forming an incision 19 along the perimeter of the gummy. As previously described, the gummy can self-seal due to its sticky texture inside, or food-grade adhesive can be applied. In this case as well, no heat is used, so there is no risk of thermal degradation of the drug or nutritional supplement.

[0041] Although pharmaceuticals or dietary supplements are described above in powder form, they can also be used in the form of powder aggregates or fine granules. These forms are advantageous in that they do not significantly alter the texture or mouthfeel of the gummy compared to liquid or solid tablet forms. The inventors have also found that the use of powders, powder aggregates, or fine particles is particularly advantageous in that the gummy candy effectively masks the flavor of the pharmaceutical or dietary supplement in these forms, thereby improving the sensory experience for the user.

[0042] Most conventional dietary supplements, probiotics, and pharmaceutical products are manufactured and sold in powder form. Directly injecting the powder into gummies reduces the number of steps required to produce the final supplement-containing gummy product. Direct insertion of dietary supplement, probiotic, and pharmaceutical powders also allows for high-density ingredient delivery.

Claims

1. A method for providing pharmaceuticals or nutritional supplements in a delivery form that can be chewed and ingested, A process of providing pre-formed gummy candies, The steps include forming one or more cavities within the pre-formed gummy candy, A method comprising the step of introducing the pharmaceutical product or the nutritional supplement into one or more cavities without applying heat, thereby avoiding chemical or biological degradation that may occur in the pharmaceutical product or the nutritional supplement due to heat.

2. A method according to claim 1, wherein each cavity is formed and filled individually in a single operation.

3. A pharmaceutical or nutritional supplement in a delivery form that can be chewed, wherein the pharmaceutical or nutritional supplement is made of a material that deteriorates when exposed to heat. A pharmaceutical or nutritional supplement comprising a chewable gummy candy having one or more internal cavities formed after the manufacture of the gummy, wherein the internal cavities are at least partially filled with the pharmaceutical or nutritional supplement in a non-heat-degraded state.

4. A pharmaceutical or nutritional supplement in a chewable delivery form according to claim 3, wherein the pharmaceutical or nutritional supplement is in the form of a powder, powder aggregate, or fine particles.

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