EP4734768A1

EP4734768A1 - Delivery of pharmaceuticals or nutritional supplements

Info

Publication number: EP4734768A1
Application number: EP24740495.7A
Authority: EP
Inventors: Lindsay MCCULLAGH ROSE
Original assignee: Noya Health Ltd
Current assignee: Noya Health Ltd
Priority date: 2023-06-29
Filing date: 2024-06-27
Publication date: 2026-05-06
Also published as: GB202309833D0; GB2632917A9; CN121463881A; GB2632917B; GB202409253D0; GB2632917A

Abstract

A method is described for providing a pharmaceutical or nutritional supplement in a chewable deliverable form. A pre-formed gummy candy is provided. One or more cavities are created within the pre-formed gummy candy. The pharmaceutical or nutritional supplement is introduced into the one or more cavities without applying heat, thereby avoiding chemical or biological degradation that would otherwise be caused to the pharmaceutical or nutritional supplement by heat. A pharmaceutical or nutritional supplement in a chewable deliverable form is also described. The pharmaceutical or nutritional supplement is a material that degrades when subjected to heat. The pharmaceutical or nutritional supplement comprises a chewable gummy candy having one or more interior cavities formed after manufacture of the gummy at least partially filled with the said pharmaceutical or nutritional supplement in a non- heat degraded state.

Description

DELIVERY OF PHARMACEUTICALS OR NUTRITIONAL SUPPLEMENTS

This disclosure relates to the delivery of pharmaceuticals or nutritional supplements to a person or animal in need of such supplements or pharmaceuticals.

It has recently been proposed to provide personalised pharmaceutical or nutritional supplements specifically designed to match, complement or adapt a person’s nutritional, microbiome or health needs.

Most traditional means of delivery of pharmaceutical or nutritional supplements, such as by incorporation in a pill, tablet, or capsule do not lend themselves to provision of personalised supplements. Either the costs involved in the delivery mechanisms preclude them being used for personalised use, or the exigences of the manufacturing process, such as desiccation for a powder or heat and compression preclude them being employed with the pharmaceuticals or supplements required, or both.

In recent years, chewable gummy candies have become a popular alternative to pills, tablets and capsules for delivering pharmaceutical and nutritional products, especially for children, but they also suffer from manufacturing problems. Supplements could be incorporated into a gummy during manufacture. However, typical manufacturing temperatures are in the range of 75°C to 150°C, which is more than enough to destroy or cause significant degradation to many pharmaceuticals or nutritional supplements. Personalised formulation of supplements is described in US 2021/0298343. However, this method still requires heat and a curing time, causing a delay between manufacture and delivery to the customer.

Probiotics, for example, are a form of nutritional supplement that have recently attracted a lot of attention for their numerous potential medical applications. Probiotics comprise a number of different strains of live microorganisms, such as bacteria and/or yeast, which, in many cases, are highly sensitive to even a minimal quantity of heat. It is desirable to have a greater diversity of microorganism strains in a single probiotic product in order to deliver enhanced health benefits. While a small number of heat-resistant probiotic strains have been developed, their number is very limited, so that probiotic products with a desirable strain diversity are likely to include heat-sensitive microorganism strains. Heretofore, no acceptable method has been available for providing a sufficiently diverse probiotic supplement in a chewable candy form without damaging a significant proportion of the microorganisms present as a consequence of heat exposure.

Vitamins, such as vitamin C and B-complex vitamins, are another form of nutritional supplement subject to heat degradation.

A common method used by gummy manufacturers to mitigate heat degradation of an active product is to use overage. This involves adding more of the active ingredients than the required dose, in the hope that enough of it survives the heat exposure to be effective. This is an imprecise method and, in the case of pharmaceutical actives, could potentially lead to underdosing or overdosing.

Rather than using a live probiotic microbial species as such, EP 3170410 of Mannatech, Inc. uses the probiotic microbial species to process natural polysaccharides to create novel postbiotics, namely probiotic processed polysaccharides, which are then employed as supplements. The probiotic -processed polysaccharides may be provided in powder form or filled into a two-piece hard gelatin capsule. The probiotic-processed polysaccharide may be dissolved into an edible oil and injected into a soft gelatin capsule by a positive displacement pump. The probiotic-processed polysaccharide may be formed into a tablet, into an effervescent tablet or into a suspension. The hard gelatine capsule, soft gelatin capsule, tablet, effervescent tablet or suspension may also contain some of the probiotic bacteria. The probiotic -processed polysaccharide may be admixed with a glycerated gelatine matrix and formed into a gummy by conventional processing, or may be added to gellam gum and carrageenan followed by conventional processing to create a gelatin-free gummy. Some of the probiotic bacteria may be present with the processed polysaccharide. No effort is made to address thermal degradation of any probiotic bacteria present or other ingredients by the temperatures involved in gummy creation. WO 2016/164470 of Church & Dwight Co Inc. incorporates a heat-sensitive ingredient into a viscous liquid core composition, which is co-deposited together with a liquid gummy composition to form a gummy supplement in a shell-and-core formation. The liquid gummy composition is held at a temperature of about 95 °C prior to co-depositing. The viscous liquid core composition is held separately and below 60 °C but above its melting point to maintain it in liquid form. The two compositions are then co-deposited into a gummy mould in a carefully timed and controlled manner such that the gummy composition forms a shell that completely envelopes the liquid core composition, the co-deposited compositions then being cooled to solidify into the final gummy product. Segregation of the gummy and core compositions prior to co-depositing is the Patentee’s solution to limiting heat exposure to the heat-sensitive ingredient during the candy manufacturing process. However, there are evidently a number of stages at which the heat-sensitive ingredient is exposed to a considerable amount of heat. For example, the core composition must initially be held at a temperature above its melting point, so that any heat-sensitive ingredients incapable of withstanding such temperatures are unsuitable for use in this method. Further, for a short time during co-depositing, the core composition is subject to around 95 °C from direct exposure to the hot liquid gummy composition, thus presenting a significant risk of degradation to many heat-sensitive ingredients. The selection of heat- sensitive ingredients must also be capable of being provided in viscous liquid form, further limiting the selection of ingredients that may be employed. These restrictions do not lend the teachings of this document to the provision of pharmaceuticals and nutritional supplements susceptible to degradation from heat exposure, nor to the provision of personalised pharmaceuticals and nutritional supplements in gummy form.

WO 2012/092391 of Hero Nutritional Products, LLC. et al purports to disclose methods for adding heat-sensitive ingredients to chewable supplements, such as gummies, during the candy manufacturing process. None of the methods disclosed that involve adding the heat-sensitive ingredients before the gummy is fully cured will avoid heat-degradation. For example, it is suggested that the heat-sensitive ingredient may be encapsulated in a heat-resistant soft gel cap that is then incorporated into a gummy stock. Alternatively, it is suggested that the heat-sensitive ingredient be dissolved in a syrup subsequently deposited in a partially cooled gummy stock. In either such arrangement, by the time the gummies are fully cured, the heat-sensitive ingredient will have been at least partially degraded by the heat. The only suggestion made in WO 2012/092391 for adding the supplement to the gummy without the involvement of heat is by incorporating the supplement into solid sugar particles, which are then applied to the exterior of a gummy after the gummy has been cooled and cured. In practice, this system comes with a number of deficiencies. Because the supplement is applied to the gummy’s exterior, there is a significant risk of contamination should anything non-sterile come into contact with those gummies, for instance, when a consumer’s hand enters a container holding a number of these gummies. It is also inevitable that movement of these gummies during any kind of transport will cause the externally applied sugar particles to detach from the gummy. As a consequence, the dose present on each gummy is inconsistent, and, worse yet, unreliable.

The present disclosure has arisen from our work seeking to improve upon the prior proposed methods.

In accordance with a first aspect of the present disclosure, there is provided a method of providing a pharmaceutical or nutritional supplement in a chewable deliverable form, comprising the steps of: providing a pre-formed gummy candy; creating one or more cavities within the pre-formed gummy candy; and introducing the pharmaceutical or nutritional supplement into the one or more cavities without applying heat, thereby avoiding chemical or biological degradation that would otherwise be caused to the pharmaceutical or nutritional supplement by heat.

In preferred embodiments, each cavity is individually created and filled in a single operation.

In accordance with an alternative aspect of the present disclosure, there is provided a pharmaceutical or nutritional supplement in a chewable deliverable form, where the pharmaceutical or nutritional supplement is a material that degrades when subjected to heat, the pharmaceutical or nutritional supplement in chewable form comprising: a chewable gummy candy having one or more interior cavities formed after manufacture of the gummy at least partially filled with the said pharmaceutical or nutritional supplement in a non-heat degraded state.

A key feature of the present disclosure is that Applicant employs fully preformed gummies. Exposure of the pharmaceutical or nutritional supplement to heat inherent in gummy formation is completely avoided. Applicant’s system has the advantage that the composition of the pharmaceutical or nutritional supplement may be selected, and thus personalised, and delivered in a reliable and consistent dosage form. Small-scale production, required for delivery of personalised supplements, or pharmaceuticals to be economically feasible, becomes possible.

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

Reference may now be made, by way of example only, to the accompanying drawings and description of a preferred embodiment, in which:

Fig. 1 is a side elevation view of an individual injection station forming part of a production line for providing pharmaceuticals or nutritional supplements in a chewable deliverable form;

Fig. 2 is a longitudinal sectional view of the apparatus shown in Fig. 1;

Fig. 3 is a side elevation view of the injection station of Fig. 1 shown as a gummy is being injected with a pharmaceutical or nutritional supplement;

Fig. 4 is a view similar to Fig. 2 in the condition shown in Fig. 3.

Fig. 5 is a perspective view of a gummy showing an incision line to be made by a scalpel;

Fig. 6 is a view similar to Fig. 5 showing the incision made and a desired pharmaceutical or nutritional supplement inserted within the gummy;

Fig. 7 is a perspective view of an alternative arrangement using kinetic energy to propel a pharmaceutical or nutritional supplement into a gummy; and

Fig. 8 is a schematic view showing the separate cavities where powder has been injected into a gummy. Use of the word “gummy” throughout this disclosure refers to the candy conventionally made from materials such as gelatine or pectin in a homogenous or solid form.

Figs. 1 to 4 show a production line for pharmaceuticals or nutritional supplements in a chewable deliverable form which comprises at least one, but preferably up to as many as thirty injection stations, each loaded with a different powdered pharmaceutical or nutritional supplement for injection into a gummy. As a gummy moves along the production line, it passes through each of the 30 injection stations. User-configurable computer software determines at which injection stations a particular gummy requires injection.

As shown in Figs. 1 to 4, a multiple-faced turret 1 is located at an injection station 2, at which a supply of a powdered pharmaceutical or nutritional supplement is loaded within a hopper 3. Turret 1 serves as a holder 4 for a single gummy, which is rotatable by motor 5. Each of the ten faces of the turret 1 has an opening 6 through which the gummy in the holder 4 may be accessed for injection. The turret 1 is covered by a corresponding ten-faced lid 7, which has an opening 8 on each of its ten faces corresponding to and aligned with opening 6 on the gummy holder 4. When the gummy holder 4 is closed by lid 7, the gummy loaded in the holder 4 is distorted to present a stretched gummy face at each of the aligned openings 6, 8.

Depending on the intended filling for the gummy, the pharmaceutical or nutritional supplement loaded into hopper 3 in powder form can then be injected into that gummy within holder 4 of turret 1 through one of the stretched surfaces of that gummy presented at aligned openings 6, 8 to an injection needle 9 of an injector unit 10, as described below, and into the interior of that gummy.

Motor 5 rotates the turret 1 to present one stretched surface of the gummy contained within holder 4 towards hollow needle 9 present on one end of injector unit 10. Motor 11 is adapted to drive injector unit 10 and its hollow needle 9 towards the turret 1 and through the aligned openings 6, 8, and through the stretched surface of the gummy into its interior, as shown in Figs. 3 and 4. This piercing action forms within the gummy a cavity into which the powdered pharmaceutical or nutritional supplement is deposited, as explained below.

Hopper 3 contains a reservoir of the powdered pharmaceutical or nutritional supplement, and feeds it into a large auger 12 within the injector unit 10. Large auger 12 is rotated by a motor 13 to transport the powdered pharmaceutical or nutritional supplement fed from hopper 3 towards cavity 14 at a forward end of the injection unit 10. A small auger 15 is located on the longitudinal central axis of the injection unit 10 and extends through to the end of hollow needle 9. While hollow needle 9 is still pierced into the gummy, small auger 15 is rotated by a motor 16 to transport the pharmaceutical or nutritional supplement from cavity 14 out through the end of hollow needle 9 and into the cavity formed within the gummy. Motor 11 then drives injector unit 10 away from the gummy holder 4 so as to slowly retract hollow needle 9 from the gummy while the pharmaceutical or nutritional supplement is deposited into the cavity within the gummy, until hollow needle 9 is fully retracted from the gummy.

If the gummy requires a higher dose of the same pharmaceutical or nutritional supplement at that same injection site, then the turret 1 is rotated to present further stretched faces of the gummy loaded into the holder 4 of that turret 1 for further injections of the specific pharmaceutical or nutritional supplement loaded into hopper 3. If the gummy requires a dose of the pharmaceutical or nutritional supplement of the next injection station, then the turret as a whole is moved by a transportation mechanism (not shown) to that next injection station for the gummy to be injected in a similar fashion.

When the gummy is released from its holder 4 in turret 1 , The elastic nature of the gummy causes the gummy to reform to its original undistorted shape when released from holder 4. Relaxing of the stretched surfaces presented at the aligned openings 6, 8 causes the holes created by the hollow needles 9 through the stretched surfaces of the gummy to shrink. The shrinking of these holes and the tacky nature of the interior of the gummy effectively retain the pharmaceuticals and/or nutritional supplements within the gummy, thereby simultaneously preventing any of the pharmaceutical/supplement from escaping while also preventing outside contaminants from accessing the gummy’s contents.

Motor 5 is suitably a Nema stepper motor, while motors 11, 13 and 16 are preferably Nema 8 motors.

A typical round gummy is employed in the apparatus described above, and can be easily sourced from a large number of manufacturers, such as Sirio Pharma Co. Ltd. Obviously, any other suitable gummy shape or formation may be used. The gummies used are confectionery, but they may be supplied while already containing supplements, such as inulin prebiotics, within their composition.

It is noteworthy that in the apparatus described, the pharmaceutical or nutritional supplement is not exposed to any heat. There is therefore no risk that a pharmaceutical or nutritional supplement, such as a heat-sensitive probiotic, may be degraded as a result of its inclusion in a chewable deliverable form following Applicant’s teaching.

It will also be readily appreciated that, by use of a plurality of injection stations, each injecting a specific component and quantity of a pharmaceutical or nutritional supplement into a gummy, this readily enables the creation of pharmaceutical products or nutritional supplements in a chewable deliverable form that are engineered specifically for the needs of a specific consumer, and, moreover, this is achievable at minimal cost. The solid texture of a gummy is particularly useful in this scenario as it allows for different pharmaceuticals or nutritional supplements to be introduced into the gummy through separate channels 18 without them touching or interacting, as shown in Fig. 8. This has the further advantage of allowing for easier control of the dose injected into a gummy by simply varying the number of channels injected with a quantity of pharmaceutical or nutritional supplement.

While the above-described embodiment shows how injection may be used to incorporate pharmaceuticals and/or nutritional supplements in a gummy, it will be readily appreciated that other technologies may be substituted for injection. For example, a cavity within the gummy may be formed by disrupting the interior of that gummy using heat, lasers, vibration and/or other physical or chemical interventions. No pharmaceutical or nutritional supplement is yet present at the time of these disruptions, even in the case of those technologies that involve heat. A pharmaceutical or nutritional supplement may then be delivered to the cavity so created by pumpaction injection in a manner similar to that described above, or by propelling the pharmaceutical or nutritional supplement through the wall of the gummy by means such as kinetic energy.

For example, hopper 3 may feed the powdered pharmaceutical or nutritional supplement into an auger (not shown) within an air gun 17. The auger is then rotated by a motor (not shown) to transport a specific dose of the pharmaceutical or nutritional supplement towards and into an internal chamber (not shown) within the air gun 17. The air gun 17 is connected to an actuatable source of pressurised air (not shown), which is used to accelerate the pharmaceutical or nutritional supplement in said internal chamber through a barrel (not shown). The barrel is connected at one end to the internal chamber of air gun 17 and is open at the other end. The surface of a gummy is presented to the air gun 17 at the open end of the barrel, as shown in Fig. 7. The source of pressurised air is then actuated to release the pressurised air into the internal chamber and through the barrel, causing the pharmaceutical or nutritional supplement loaded in the chamber to accelerate through the barrel with sufficient kinetic energy to exit the barrel at the open end and penetrate the presented surface of the gummy so as to force the powdered particles of that pharmaceutical or nutritional supplement into the interior of the gummy. Thus, the kinetic energy of the pharmaceutical or nutritional supplement creates a cavity for that pharmaceutical or nutritional supplement as it is propelled into the gummy. The penetrated surface of the gummy may ‘self-seal’ due to the sticky texture of the gummy interior, or a food glue could be applied.

A further alternative would be to use a scalpel to disrupt a stretched surface of the gummy and its interior to allow insertion of a pharmaceutical or nutritional supplement, the gummy then being allowed to resume its previous shape, effectively closing the opening created by the scalpel. As shown in Figs. 5 and 6, this may simply be done by making an incision 19 around the circumference of the gummy. As before, the gummy may ‘self-seal’ due to the sticky texture of the gummy interior, or a food glue could be applied. Again, since no heat is employed, there is no risk of heat degradation of the pharmaceutical or nutritional supplement.

While the described pharmaceutical or nutritional supplement is in the form of a powder, it may equally well be a powder aggregate or fine granules. These particular forms are advantageous in that they do not significantly change the texture or mouth feel of the gummy, especially in comparison to, say, liquid or solid tablet forms. The present Inventor has also found that the use of powder, powder aggregate or fine particles is particularly advantageous in that gummy candies effectively mask the flavour of most pharmaceutical or nutritional supplements in such forms, leading to an improved sensory experience for the user.

The majority of conventional nutritional, probiotic and pharmaceutical products are produced and sold in powder form. By injecting powder directly into a gummy, we are reducing the number of steps required to create a final supplemented gummy product. Inserting nutritional, probiotic and pharmaceutical powder directly allows high density ingredient dosing.

Claims

1. A method of providing a pharmaceutical or nutritional supplement in a chewable deliverable form, comprising the steps of: providing a pre-formed gummy candy; creating one or more cavities within the pre-formed gummy candy; and introducing the pharmaceutical or nutritional supplement into the one or more cavities without applying heat, thereby avoiding chemical or biological degradation that would otherwise be caused to the pharmaceutical or nutritional supplement by heat.

2. A method according to Claim 1, wherein each cavity is individually created and fdled in a single operation.

3. A pharmaceutical or nutritional supplement in a chewable deliverable form, where the pharmaceutical or nutritional supplement is a material that degrades when subjected to heat, the pharmaceutical or nutritional supplement in chewable form comprising: a chewable gummy candy having one or more interior cavities formed after manufacture of the gummy at least partially filled with the said pharmaceutical or nutritional supplement in a non-heat degraded state.

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