Wheat-Free Mannitol Innovation for Gluten-Free Vitamin & Dietary Supplements

Providing on-the-go, health-conscious consumers with fast-acting, easy-to-take and affordable healthcare products is a top priority for OTC drug and nutraceutical manufacturers and marketers. Nutritional supplements are growing 7.5% globally according to market sources. This growth is owed to rising chronic diseases, including obesity and diabetes, an aging population and rising healthcare costs, encouraging individuals to become more proactive in managing their health through lifestyle and vitamin and dietary supplement choices.

For over 40 years, Roquette has been supplying industry-leading, plant-based excipients and raw materials. Our expertise and technical resources are enhanced with three innovation centers of excellence located worldwide (France, United States and Singapore). Roquette invests to innovate multifunctional excipients and ready-to-use co-processed platforms to meet customer needs for efficient tablet manufacturing and quick-to-market product development. Leveraging this position, Roquette saw a need to support excipient innovation in nutraceutical supplements and formed a market-facing segment within its Pharma Global Business Unit to focus on custom products and innovation for the growing nutraceutical industry, offering a broad product line that includes long-standing products:

Maltodextrins and dried glucose syrups
Native and modified starches
Powder and liquid polyols, including co-processed products
Cellulosics
Cyclodextrins
Soluble fibers
Proteins

Functionalities for tablets and capsules include sugar-free fillers, binders and sweeteners, disintegrants and superdisintegrants, solubilizers, taste-masking, film coatings and suspension aids. Roquette further has a specialty focus, offering a range of its fillers and binders in direct compression (DC) grades that provide nutraceutical formulators with tools to develop efficient to manufacture and appealing to consumer dosage forms, especially oral disintegrating tablets (ODT), chewables, effervescents, lozenges and medicated gums. In particular, PEARLITOL 200SD mannitol is a preferred spray-dried DC excipient that provides optimal flow and compressibility (i.e. tablets of high hardness at low to medium compression force) for efficient tablet development and manufacturing, while stabilizing actives. This is because of high chemical compatibility with actives and, as demonstrated in the figure, mannitol is inherently non-hygroscopic, being the only soluble excipient to exhibit this temperature versus moisture uptake profile. Mannitol further contains no unstable crystalline forms and has a negative heat of solution, which imparts a slight cooling effect to nutraceutical tablets, giving consumers pleasing taste and texture.

For these reasons, many nutraceutical supplement products, for example multivitamin ODT and chewable tablets, are on the global market formulated with this non-GMO, sugar-free excipient.

Increasingly there is a trend for clean label drivers (e.g. natural, organic, allergen free), spurred by health conscious consumers. Gluten-free is one such driver for consumers in general and with dietary restrictions or celiac disease. For this food product and supplement claim, wheat-free ingredients are needed by formulators. For Roquette, the challenge was to replicate the DC performance of PEARLITOL SD products so that nutraceutical developers can realize the required manufacturing efficiencies and dosage form delivery benefits in a wheat-free mannitol excipient.

Roquette leveraged its secure global supply chain and scale-up competency in spray-drying to innovate a solution. The result is offering more choices in its range of PEARLITOL SD grades by introducing two new wheat-free grades, PEARLITOL SW-F 100 and 200, having comparable direct compression performance. New benefits to nutraceutical supplements formulators are the result:

Wheat-free composition through a secure supply chain & manufacturing process controls
Gluten-free supplement label claim supportive

Laboratory experiments employing the new wheat-free mannitol spray-dried grades confirmed their comparable DC performance versus commercial PEARLITOL 100SD and 200SD. Compression speed versus varying compression force experiments on a rotary tablet press simulator (STYLCAM 200R) demonstrate in the figures below that PEARLITOL SW-F 100 and 200 tableting performance data are comparable to PEARLITOL 100SD & 200SD grades.

Depending on the nutraceutical formulation, particle size distribution and bulk density can have an impact on the powder flow and powder blend homogeneity. Thus, it is anticipated that tablet process parameters will need to be optimized when switching excipient formulations between commercial PEARLITOL SD and PEARLITOL SW-F grades. Roquette’s technical services will provide formulation assistance for tablet design and scale-up with these new mannitol product grades.