undergo a long drying process. Often, special starch moulds are used to absorb water from the gummies. However, this can lead to leaching of active ingredients into the moulds, reducing the dosage in the gummies and potentially risking mould contamination in subsequent production batches. Cleaning these starch moulds is also challenging and may render the starch unusable. Moreover, some starch may be reused to cut costs, but this risks cross-contamination if the moulds are not thoroughly cleaned. As a result, some manufacturers resort to overdosing, which does not guarantee consistent dosage across each gummy. While silicone moulds can prevent the loss


of active ingredients and cross-contamination and are not involved in the drying process, they require a specific gummy formula for unmoulding before drying. This can lead to a poorer gummy texture. In its research phase, Boncha Bio considered the use of silicone moulds but ultimately found the limitations in the formulas too prohibitive. Instead, its solution has eliminated the need for traditional moulding and drying. This is achieved through the use of low compression at low temperatures to achieve the right shape. Consequently, the active ingredients remain intact, effectively preventing any risk of cross- contamination.


Preserving ingredient stability A significant issue in the manufacturing of soft gel products is the exposure to oxygen during the shaping process, which combines the filling with the soft gel’s outer shell. Since this process cannot be conducted under vacuum conditions, oxygen from the air, which constitutes about 20% of its composition, gets entrapped within the soft gel and contacts the active ingredients throughout the prolonged shaping process, triggering preliminary oxidation reactions. Oxygen naturally reacts with many active ingredients, leading to their inactivation. Although soft gels and their formulas are often reinforced with antioxidants, the quantities are generally too minimal to be fully effective, resulting in the gradual degradation of active ingredients over time.


Boncha Bio has implemented proprietary vacuum technology in the manufacturing and shaping of its candyceuticals. This process ensures the product’s purity and diminishes the risk of oxidation. The vacuum machinery employed is finely calibrated to maintain oxygen levels below 1% in a substantially reduced pressure environment.


KennedysConfection.com


Packaging challenges Traditional packaging methods, such as bottles, offer product protection when sealed but do have drawbacks as they will typically contain air instead of nitrogen. Supplements in soft gels and gummies are not airtight, which fails to prevent oxygen infiltration into the shell, candy base, and even central filling. Consequently, products like omega-3 soft gels will start oxidising even before the bottle is opened, reducing effectiveness. Upon opening the bottles, the exposure to oxygen and humidity accelerates the degradation of active ingredients, significantly shortening the product’s shelf life. Boncha Bio overcame this challenge by individually sealing each candyceutical in an aluminum foil sachet infused with nitrogen. This nitrogen-infused environment maintains the oxygen concentration below 1%, reducing the risk of oxidation during storage. Sachet packaging also offers protection against humidity, and the absence of a drying process in this method significantly minimises oxygen exposure. The effectiveness of this solution has been corroborated by low TOTOX values and a high preservation rate of omega-3, as evidenced in accelerated stability tests. Additionally, 20-month real-time stability studies conducted in Zone IVb (ICH guidelines


Given that 80% of active ingredients


and nutrients are sensitive to heat, oxygen, and pressure, a crucial question that needed to be addressed was how these vulnerabilities could be tackled”


for stability studies), characterised by high temperature and humidity, demonstrated the benefits of this packaging innovation in maintaining consistent low oxygen levels inside the sachets.


Protecting the actives The central filling of candyceuticals contains active nutrients encapsulated within a protective layer of saturated fatty acids, such as palmitic oil. This coating layer effectively shields the actives from stomach acids, thereby enhancing the product’s stability by both masking the unpleasant odours and improving the bioavailability of the active ingredients. The saturated fatty acid coating enables


the combination of otherwise incompatible ingredients in a single health supplement formula. In the intestinal environment, the fatty acid layer is naturally diluted by pancreatic juices and enzymes, effectively preparing the active ingredient for optimal absorption. This critical coating step is implemented during the low-temperature production process, maintained below 40°C, and under vacuum. Responding to the increasing preference


for vegetarian and vegan supplements, candyceuticals are also formulated with vegetable oils and dietary fibres, enabling them to be easily adapted to 100% vegan, halal, and kosher standards. Boncha Bio’s approach has already elevated the market position of numerous health supplement companies globally. Analysis of data from various online shopping platforms shows that more than 90% of customers express satisfaction with the product. Boncha Bio is committed to expanding its reach and impact through collaboration and innovation. The factory adheres to the highest standards, being GMP, ISO, HACCP, and FDA registered, and employs rigorous 3rd party testing to ensure product quality and safety. The company invites industry leaders and brands to explore partnership opportunities and leverage the advantages of candyceuticals.


Kennedy’s Confection May 2024 19


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