EP-4734768-A1 - DELIVERY OF PHARMACEUTICALS OR NUTRITIONAL SUPPLEMENTS

EP4734768A1EP 4734768 A1EP4734768 A1EP 4734768A1EP-4734768-A1

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.

Inventors

MCCULLAGH ROSE, Lindsay

Assignees

Noya Health Ltd

Dates

Publication Date: 20260506
Application Date: 20240627

Claims (4)

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.

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