Within STIMIUM Laboratories, many of us have worked in large Pharmaceutical Laboratories and it is obvious that we cannot duplicate the development model of a drug which generally takes more than 10 years, with a development process of 'a food supplement. However, the development of a new product must take into account from its design the quality and safety requirements conditioning the quality and sustainability of the future product and we have therefore duplicated within Stimium these drug requirements for our food supplements. .
1.Input data for the design of a dietary supplement
The development of a formula and the choice of a presentation are based, (1) on the one hand on the technical and scientific knowledge within our team of engineers, doctors and pharmacists and (2) on the other hand on the needs of consumers, whether they are professional clubs or amateur sportspeople for example, pharmacies or health practitioners. At Stimium we have adopted a term and a document used in our previous Laboratories, the TPP (for “Target Product Profile) including the following aspects in particular:
- Analysis of consumer needs and expectations, knowledge of nutritional needs (general population and specific groups, e.g. triathletes)
- Monitoring new market developments (raw materials, products, manufacturing processes, etc.),
- Bibliographic research before developing a new product,
- Assessment of risks linked to raw materials (allergies, maximum thresholds, sourcing),
- Assessment of the regulatory environment,
- Compatibility studies between raw materials used in the same product,
- Search for the most suitable form of presentation for each
- A target price, because developing an excellent product that is too expensive will never find its audience.
The product definition may include the following:
- final form of the product,
- nutritional profile,
- regulatory constraints,
- organoleptic profile,
- packaging, practicality, safety of use,
2. Development of the food supplement formula
The Research and Development teams at Stimium rely on scientific work including at least a bibliographical file and ideally an observational study which will generally be carried out on a population of around fifty individuals (on Sport products, we work very often with 1 or 2 clubs beforehand).
We are currently paying great attention to raw materials, particularly in a context of very significant increases in raw materials, with classic specifications:
- their specifications, that is to say the nutritional, organoleptic, physicochemical, microbiological characteristics and their quality controls,
- their synergies, the idea being to formulate active ingredients which, combined, will have even greater effects (we speak of potentiated effects). the stability they offer in formulation,
- their nutritional qualities,
- their organoleptic qualities,
- their physicochemical characteristics,
- their microbiological criteria,
The raw materials must be adapted to the desired nutritional objective during formulation and must be documented, especially since within Stimium Laboratories, we register our products in many countries around the world, some of which are more " demanding” than others, will require extremely precise documents, including on the raw materials used.
3.Design validation
Design validation generally consists of the practical performance of formulation tests at different scales depending on the size of the batch manufactured and the nature of the controls to be carried out. Validation of the design and therefore of the formula therefore includes the carrying out of test batches in “ laboratory ” conditions intended to provide information on the feasibility of the formula through the analysis of:
- the compatibility of its ingredients,
- interactions with the container,
- the first stability tests,
- his qualities
On our ProNrj Gums for example, we did 17 tests before arriving at an acceptable prototype, in terms of taste, stability and release of ingredients. We probably made some errors in ingredient compatibility and switching to a Vegan gum with a pectin base and no longer gelatin did not turn out to be very simple. Finally, on these first samples, we worked with a triathlon club to validate that the chewing of our gums was always easy and the sensation pleasant, obviously coupled with an effectiveness questionnaire.
On Vital LLR , the objective was to deliver the active ingredients in 3 phases (5 minutes, 45 minutes and 8 hours) both so that our consumers feel the effects over a longer time, and to avoid side effects – for example it does not There is no point in delivering a large dose of magnesium if (1) the salt used is bad and (2) if the dose released in a single dose is too large, because stomach aches would be 100% guaranteed. The three-layer tablet has thus established itself, even if it is a real technological challenge in terms of manufacturing.
4. The role of the Industrial Lot
Once the first “Laboratory” samples are satisfactory, we carry out pilot batches in “ factory ” conditions, covering a larger volume in order to establish specifications and controls to validate industrial feasibility as well as confirm the manufacturing procedure. If we take Stimium PreWorkOut for example, a powder product is generally quite simple to formulate, but when the formula is very rich like ours, having a homogeneous formula is not so simple, and as our manufacturing line does not is not dedicated to this product, it is obviously necessary to take into account the cleaning procedures at the end of manufacturing, in order to be able to move on to the manufacturing of another product.
Unlike a medicine where a minimum of 3 industrial batches are necessary, there is no specific obligation in terms of food supplement, we can therefore finalize the development of the industrial process on the basis of a single batch, the implementation of controls and qualification of the manufacturing process. Putting the packaging items through the machine is also part of this step.
5. Development of methods
Before being able to place the food supplement on the market, it is necessary to:
- Develop adequate control methods , with verification of the stability of the product to determine the optimal use-by date (DLUO) or the expiration date (DLC), and its safety - The DLUO (Expiration Date Optimal Use) or the DLC (Expiration Date) of the product is determined from the date of manufacture and must be able to be justified using data from:
- stability studies in real time or accelerated,
- similar products for which the DLUO or DLC have already been determined,
- and bibliographic data allowing the results to be extrapolated to the product tested.
To go faster and put a product on the market quickly, we carry out stability and accelerated aging studies at Stimium under controlled storage conditions: temperature, humidity based on ICH methods, i.e. at predefined temperature and humidity conditions (www.ich.org).
- Carry out hazard analysis (HACCP)
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Establish routine controls and specifications and verify the adequacy of the results of the “test” batch and the “pilot” batch to the requirements of the input elements (what we will call the “product specifications”),
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Carry out nutritional analyses ,
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And possibly carry out studies of the effectiveness of the formula according to the claims made: in vitro, in vivo, bibliographic studies, consumer tests, clinical studies, which may aim to evaluate the nutritional effectiveness, safety and tolerance as well as acceptability and practicality.
6. Design review & Creation of the Product File
The design review covers the legal and regulatory requirements of the product, it is a bit like the Product identity sheet. This complete file will allow:
- Ensure the conformity of information media (labelling, instructions, documentation) and any other element used during communication, advertising, and declaration.
- Check claims, in particular health claims and nutritional claims against the
- Create justification files to be made available to supervisory authorities such as the DGCCRF.
- ensure that quality and aesthetic properties are maintained because a change in appearance often indicates a deterioration in quality.
There you go, you know a little better how we develop our new products at Stimium , it's not simple, it takes a lot of time, a lot of resources (human and financial), for food supplements, which we do. We hope we can satisfy you!
