Charlie Cunningham, Technical Director, Americas, Colorcon
As consumer demand for natural and recognizable ingredients in tablet and capsule nutritional supplements increases, manufacturers are actively seeking ingredients that will enable efficient production while meeting regulatory requirements for labeL friendly products.
Understanding the importance of delivering a dependable and high-quality product that consumers prefer and trust is key to success in this competitive industry. Subtle and evident distinctions for dietary supplements can impact consumer choice and the inclusion of label-friendly ingredients is becoming increasingly necessary. Visual appearance also plays a role with shape, size, and color, significantly contributing to distinguishing your product and gaining consumer preference.
While clean label is gaining traction due to consumer sentiment, there is no specific definition or regulation associated with this term. Nevertheless, a product is more likely to be considered as having a clean label if it contains a limited number of ingredients, recognizable and easily pronounced components derived from natural rather than artificial sources, is non-GMO, and sustainable.
Navigating Challenges in Development and Manufacturing
Tableting is a widely adopted manufacturing method for nutritional products and offers commercial advantages due to its process efficiency and cost-effectiveness. Tablets can be easily manufactured, coated, packed, transported, and have the added advantage of an extended product shelf life.
Manufacturers of nutritional and dietary supplements often face difficulties due to the use of ingredients with unpleasant tastes and odors, plus challenges with flow, compression, and sensitivity to atmospheric moisture. Formulators can also encounter issues with fragile tablet cores that are prone to breakage and concerns regarding the long-term effects of moisture and oxygen on ingredient stability. As an example, traditional powder flow aids such as silicon dioxide can be deemed unacceptable from both a clean label perspective and handling difficulty during manufacturing. To tackle these challenges, producers are seeking innovative ingredients that enhance manufacturing performance in a consistent manner.
Starting with the tablet or capsule core, Colorcon’s naturally derived Nutracore Label Friendly ExcipientsTM provide the flow, compressibility and lubricity that makes tablet processing of nutritional products easy while contributing to the clean label ethos. To overcome the often-seen problems with moisture-sensitive ingredients, Colorcon’s naturally derived pregelatinized starches help to stabilize the core by scavenging moisture and reducing degradation (Figure 3).
For decades, the industry has had to rely on excipients and practices developed for pharmaceutical production, such as lubricants for capsule and tablet formulations. Magnesium stearate has been used to ensure that powder blends and tablets are ejected cleanly in encapsulation or compression processes, but it can also cause issues with tablet hardness. Nutracore lubricants derived from plant-based materials can be used as a substitute for magnesium stearate in nutritional products. Unlike formulations using magnesium stearate, studies carried out by Colorcon show that Nutracore lubricants result in consistent tablet hardness irrespective of lubricant blending times (Figure 1). Results also show that ejection forces were low and minimally affected by blend time (Figure 2). Blending time was also seen to have no impact on tablet disintegration with all tablets fully disintegrating in less than 30 minutes.
A product that demonstrates strong manufacturability is one that can be efficiently produced using existing processes and equipment, requiring minimal adjustments. To achieve this, it’s important to choose the right materials and processing methods to make the product consistent and of good quality.
With the use of innovative label-friendly excipients (Nutracore), multiple core ingredients (shown as Marketed A, B, C) can be replaced to facilitate process simplification, such as the ease of blending and tablet compression as shown in the resulting powder flowability (Figure 4).
Perfect Your Product Finish to Differentiate Your Brand
When it comes to branding, careful consideration should be given to the color and finish of your tablet. The color of a tablet is not just a visual aspect but plays a significant role in enhancing brand recognition by as much as 80%. Coated tablets protect consumers from unpleasant tastes and odors, while also safeguarding the ingredients from any degradation caused by moisture, light, or air sensitivity. Film coatings form a protective barrier that ensures the potency of the active ingredients remains intact, maximizing effectiveness.
Nutrafinish® Dietary Supplement Coatings from Colorcon offer manufacturers the advantages of a functional yet appealing finish, with coatings specifically designed to address consumer preference for non-synthetic and label-friendly ingredients. In response to consumer demand and regulatory changes, there is an ongoing effort to remove titanium dioxide (TiO2) from food products. TiO2 has historically been used as an opacifier in coatings, enhancing the appearance and protection of tablets. However, the European Union has banned the use of TiO2 as a food additive. To adapt, manufacturers are seeking alternative, sustainable ingredients that align with labeling preferences without sacrificing product quality, manufacturing efficiency, or cost.
The removal of TiO2 from film coatings can be challenging since it is used as an opacifier and a white pigment. When removing TiO2 from an existing coating formulation, other pigments appear brighter due to the absence of the white pigment; making it more difficult to match directly to existing colors. Compromise is needed to find a closer match, or simply accept the marginal color difference.
TiO2 removal also results in reduced opacity, which means it will typically require a higher coating application level or percent weight gain to reach the same hiding power. This makes it difficult to obtain a uniform color on darker or mottled cores without increasing the amount of coating to be applied.
Calcium carbonate is used as an alternative in Nutrafinish®, TiO2 Free Film Coatings, but has lower opacity and so requires other proprietary ingredients to maximize whiteness and hiding power. Nutrafinish TiO2 Free Coating can provide a white and opaque finish even on the darkest of cores, at relatively low weight gains (Figure 5). In unique cases where pH sensitive pigments in the formulation may be affected by the slight alkalinity of calcium carbonate, alternative optimized mineral free/TiO2 Free coatings are available (Figure 6).
By improving the palatability, stability, and effectiveness of nutritional tablets, the application of a film coating elevates quality and enhances both the product functionality and the consumer experience.
Align with Market Preferences and Gain Consumer Trust
Manufacturers seek more effective and consistent manufacturing performance for their products, while also needing to comply with consumer and regulatory demands. To achieve this, it is crucial to have access to a reliable supplier with technical and regulatory expertise for the development of high-quality nutritional or dietary supplement products, ensuring a competitive edge to fuel business growth. Colorcon carefully selects materials for the core, coating and packaging ensuring they meet regulatory standards and provide a superior consumer experience. To meet the rising demand for clear label, the Nutra Natural AdvantageTM portfolio from Colorcon includes unique tablet coatings and innovative core ingredients that are easy to implement, cost-effective and help drive consumer preference.