The traditional role of the contract manufacturing organization has evolved significantly in recent years, in line with the rapidly changing dietary supplements industry. It is clear; however, the contract manufacturer plays an important role in this arena. This demonstrates that many supplement brands still turn to contract manufacturers to plug a gap in product manufacturing expertise. What is new is the contract manufacturer’s ability to meet the diverse needs of each customer, whether that is simply manufacturing a company’s product or supporting them from concept and research and development (R&D) to delivery of the final product.
This expertise and expanding skillset have enabled the modern contract manufacturer to take a more collaborative approach than previously possible. As such, contract manufacturers now play an important role in supporting their customers to develop supplement products that are not only safe, but also effective and achieve their objectives. A key factor in this is helping ensure that the correct ingredients are delivered in the correct doses, so that the end product meets industry standards in quality and safety, as well as the latest consumer preferences.
Determining Efficacious Doses
While, historically, the process of establishing supplement product dosages may have been handled by the brand owner, the contract manufacturer now plays a more advisory role. Its contribution in getting their customers’ products to market and making sure they meet consumer demands is, of course, still important, but supporting them to deliver doses that are safe is also key. The expertise provided by the contract manufacturer during the initial stages of product development is essential to getting this right.
The process of determining efficacious and safe ingredient doses is specific to each product and its product category, as well as the health benefit it aims to deliver. Typically, doses are determined and validated by scientific literature, where records of an observed health benefit at a particular dose are used as a reference for dosage development. The disadvantage of this, however, is that it limits ingredient innovation, as it does not build on new concepts. Leading contract manufacturers that have in-house R&D facilities continuously invest in pioneering research. This feeds into optimizing dose and formulation during the product development process to ensure efficacy and safety, with the peace of mind that doses are supported by science.
It is vital that contract manufacturers stay up-to-date with the latest research. This not only ensures that they and their customers remain at the forefront of innovation, but also that the contract manufacturer is equipped to advise and support the determination of safe and efficacious doses during the development of new products. This includes ingredient sourcing and dosage forms for enhanced bioavailability and absorption, and therefore, efficacy. Contract manufacturers can also help customers safely combine ingredients to achieve synergistic and targeted effects that deliver the desired results, helping to drive innovation and, ultimately, create new opportunities.
Approaches to Testing Efficacy
Regular testing throughout product development is an important factor in delivering efficacious doses and products. Contract manufacturers can collaborate with their customers to develop testing and quality protocols at the start of the process. This helps streamline production and reduce the risk of challenges arising further down the line. Failing to optimize environmental and processing conditions, for instance, can have a negative impact on efficacy. This also means that tests can be designed to measure what a specific customer wants to deliver and ensure product efficacy. Individual ingredients can then be tested prior to formulation.
Once ingredient doses and the resulting efficacy have been assessed, the delivery system must also be evaluated. In the case of capsules, for instance, the choice of dosage form plays a significant role in influencing ingredient stability and efficacy. To meet a specific health claim, testing is often focused on physical capabilities and chemical stabilities to ensure that an ingredient is protected and will withstand its shelf life, without compromising on efficacy. From a physical standpoint, texture analyses, as well as humidity and viscosity tolerance tests, are carried out to ensure that the delivery system’s components are consistently robust enough to protect ingredients. The chemical stability of ingredients is also determined via testing at room temperature and accelerated stability chamber testing. Measuring these parameters is fundamental, as they consider the efficacy of a complex finished product, rather than just the potency of isolated ingredients.
Innovative dosage forms can also protect ingredients which are, for example, acid-, light- or oxygen-sensitive, ensuring that they do not degrade and inactivate the ingredient—particularly if they are unstable in nature. Probiotic ingredients, for instance, can be delivered via capsules with modified release profiles to ensure the active ingredients are not released until they reach the upper gastrointestinal (GI) tract, to help optimize efficacy.
Navigating Challenges Regarding Product Efficacy
Challenges with delivering efficacy also extend to regulatory requirements, which typically vary country-to-country. In the U.S., for instance, manufacturers must adhere to the Dietary Supplement Health and Education Act of 1994 (DSHEA), while in Europe, they must meet Directive 2002/46/European Commission (EC). It is therefore important that contract manufacturers understand and adapt to the varied global regulations. When doing so, it is best practice to develop doses that will satisfy all geographic regulations for intended areas of marketing.
In the U.S. specifically, however, regulatory changes imposed by the FDA in the dietary supplements market mean that dosage forms now operate under food regulations, instead of excipient regulations. These have a more stringent set of rules and have led to an increased emphasis on the labeling and scientific substantiation of claims. The in-house regulatory expertise offered by some leading contract manufacturers is essential in helping customers navigate the regulatory landscape while also delivering safe, science-backed and efficacious products.
Designing for Efficacious Doses
The changing role of the contract manufacturer within the dietary supplements space creates a new set of challenges to navigate, but it also presents new opportunities to become a valuable partner to supplement manufacturers and marketers. Contract manufacturers are now delivering added value to their customers by using their R&D, scientific and regulatory expertise to drive the delivery of innovative, efficacious products that meet market trends and the latest consumer preferences.
Barri Sigvertsen, is marketing manager at Lonza Consumer Health & Nutrition.