Gummies – Something for pharma to chew on?

Data and commentary provided by Mathys & Squire has featured in an article by Nutraceuticals World, providing an update on the growth of the medicinal gummies market.

A condensed version of the article is available below.

Nutraceuticals (i.e. supplements, functional foods and functional beverages) continue to grow in popularity amongst consumers, reflecting a more active approach to health and wellbeing awareness and management, and a shift toward a preventative healthcare paradigm. According to estimates from Research and Markets, the global nutraceutical market (covering supplements, as well as functional foods and beverages) is valued at US$330.6 billion for 2022 and is projected to reach US$441.7 billion by 2026, growing at a rate of 7.8% over the period. 

Since starting out as a gelatinous confectionary, gummy sweets were first commandeered as a popular oral delivery vehicle for vitamin and mineral supplements for children in the mid-1990s. Unsurprisingly, those that enjoyed gummy vitamins as children have retained an affection for them into adulthood. Nevertheless, the gummy vitamin market has been dynamic in evolving and innovating to cater for broad consumer preferences to attract new gummy converts, particularly those who have ‘pill fatigue’. With that in mind, vitamin gummies can now be formulated to be plant-based, low sugar or sugar free, and free from artificial flavours or colourings.

What have been the stumbling blocks to medicinal gummies? 

Given the popularity of gummies in the nutraceutical sector and prevailing issues with patient adherence, particularly with poor tasting paediatric oral medicaments and patients suffering chronic conditions, it might not be surprising that pharmaceutical companies would consider the viability of the gummy as a vehicle for active pharmaceutical ingredients (APIs), in order to improve patient experience with certain oral medications.

Historically, there have been a number of reasons which have stalled the gummy’s use as a vehicle for APIs. The reliance on heat in traditional gummy manufacture can have unwanted effects on medicament stability compared with normal pharmaceutical tabletting processes. Moreover, gummies are not typically protected by films (e.g. in a blister pack), which can also contribute to stability and degradation issues. Indeed, in the nutraceutical sector, it is not uncommon to use excess amounts of a vitamin or supplement during gummy manufacture to counteract a level of degradation of the active during processing or storage. This is not an acceptable scenario in the pharmaceutical industry where dosage level is of paramount importance and APIs can be extremely expensive.

Another problem can relate to the solubility and/or chemical stability of APIs in the gummy formulation itself. The particular API may, for instance, undergo unwanted reactions with components of the gummy formulation or lack sufficient solubility within it, which can complicate the accurate dosing of API in individual gummies. A further issue relates to potential microbial contamination resulting from the use of traditional gummy manufacturing processes, which can fall short of required pharmaceutical standards.

However, it seems that more recent innovations in gummy formulation and manufacture have improved compatibility, such that medicinal gummies might be a realistic offering in the future.

Process innovation

Traditional gummy manufacture has relied on the use of a ‘starch mogul’ system which relies on a starch-based mould within which the gummy formulation is deposited, set and removed, before the starch is recycled. However, the use of starch/recycled starch moulds can pose difficulties in maintaining sufficient hygiene levels and ensuring that there is no cross-contamination, particularly for pharmaceutical grade products.

Manufacturers have looked to provide alternative starch-free systems to overcome those problems and one of the latest inventions includes enabling a gelatine gummy mixture to be deposited into silicone or metal-based moulds, or directly into blister packs, as a hygienic alternative to starch-moguls. This not only elevates hygiene levels up to pharmaceutical standards it also reduces gelatine setting times from approximately 24 hours to less than 15 minutes, thereby increasing output potential significantly.    

Centre-filled gummies

Another development that may offer the greatest impact in bringing medicinal gummies to market is the centre-filled gummy, in which a gummy outer shell is provided with a liquid core. Different gelatine formulations have been developed that are increasingly compatible with low temperature processing. However, the centre-filled gummy allows separation of gummy formulation ingredients in the shell, which may be processed at high temperature, from those of a liquid core formulation which contain functional ingredients (such as APIs).

The separation can also prevent unwanted interactions between functional ingredients and those of the gummy formulation, whilst the gummy shell can act as a barrier to the functional core, thereby having a protective effect, helping to ensure adequate stability and shelf life to functional ingredients. The liquid core can also facilitate more accurate dosing of an active functional ingredient in an individual gummy, so that there can be certainty in dose levels to satisfy pharmaceutical requirements.

First investigational new drug (IND) application

An illustration that the tide may finally be turning toward medicinal gummies is also in the award of a first IND (140312) from the FDA in respect of Seattle Gummy Company’s allergy gummy medication. The company also claims to have a large pipeline of gummy drugs in development, with patent applications having been filed to gummy compositions with APIs, including antihistamines and analgesics (WO 2022/119959 A1, US2021386732 A1).

Summary

Given the continuing growth of gummies in the nutraceutical sector and the shift in consumer preferences, it seems that pharmaceutical companies would be missing a trick not to develop their own gummy product lines for their APIs, particularly with the threat of a patent cliff as original APIs come off patent.  

The gummy sector is a particularly fast-growing branch of the nutraceutical sector and there appear to be signs that historic barriers to the use of gummies as an oral delivery vehicle for APIs are being removed by continued innovation in the sector. Given the popularity of gummies in the nutraceutical space, it seems only a matter of time before medicinal gummies are available, particularly to paediatric or geriatric patients, or those with chronic conditions, where traditional pill form medicaments may be poorly tolerated or there may be issues with non-adherence to treatment regimes.