Gummies have become the second best-selling delivery model in all of vitamins, mineral and supplements (VMS) space, said Mitchell Slade, President at PLD Gummy Co, at the ongoing CPHI Europe conference.
In the pharmaceutical space, a gummy form of a drug can improve compliance among patients who can’t take pills or liquid forms, Slade said while speaking at a session on the second day of the conference, which is taking place 8–10 October in Milan, Italy. Gummies can be tasty, easy to chew and swallow, encourage high compliance, and hold promise as a drug delivery system because according to Slade, they “sell for a price premium per dose over other leading forms”.
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By GlobalDataHowever, there are several challenges with this approach such as the cost and complexity of their manufacturing process.
According to Slade, the ability to stabilise the active pharmaceutical ingredient (API) and taste masking are the primary challenges in gummy manufacturing. Stability control is an issue when dealing with complex liquid matrices and is critical to ensure shelf stability. A three-way mixing process that uses high shear speed can ensure uniformity. Slade also highlighted the need for a highly controlled and precise manufacturing process including temperature control to avoid issues like skin formation on the gummies.
Achieving the right texture of the product is also critical in gummy manufacturing, Slade said. If substances like pectin are handled incorrectly then a jelly-like consistency can form, which is unfavourable from a stability standpoint, he explained.
The market is now moving from gelatin to pectin-based products, and pH and viscosity control in manufacturing processes are key to achieving the ideal texture and ensuring product consistency across batches.
With regards to coating, Slade highlighted that “coating needs a delicate balance” as it is important to coat APIs and also mask taste, but also stay within regulatory guidelines.
Additionally, a starchless process and formulation allows to control cross-contamination and also blends better with pectin, according to Slade. The use of small batch production to test and then scale up to large-scale manufacturing is a good practice in gummy manufacturing to ensure appropriate texture, dose accuracy, and product consistency. Separately, a conservative approach to flavour and colour selection is more ethical to ensure safety and avoid a confectionary-like appearance, said Slade.
The jury is still out on the potential US Food and Drug Administration (FDA) approval of gummies. In October 2020, Seattle Gummy Company became the first company to get an Investigational New Drug (IND) approval for its allergy gummy medication called IND 140312. But there are no approved gummy-based drug products. Still, Slade said that since the FDA has not yet taken action against any companies using drug gummies, it may indicate a potentially accepting regulatory environment.
