Natural Products Insider

MAY-JUN 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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26 INSIDER May /June 2019 acceptable laboratory tests. All products do not behave in similar fashion when identifying appropriate blending times. Bulk densities of individual components or particle sizes often play a vital role in fi nding the "sweet spot" of uniform content distribution in a blend for a batch. Further consideration must be given to particle separation by overblending materials. Many times this comes as a shock to the producer when fi nished products demonstrate wide variability in actual content as measured against batch or product label claims. While overages may be judiciously deployed to ensure label claim adherence, multiple jurisdictions globally often restrict the amount of overages permitted, further leading to the inevitable conclusion that a simple blend of all ingredients may not be a suffi cient step to ensure uniformity and consistent label claim. Consequently, companies with robust research and development (R&D) departments, and a well-staffed and trained pilot manufacturing facility, have been producing pre-blends of sensitive or micronutrients for decades, often deploying triturating technologies to further ensure content uniformity. Take, for example, two micronutrients generally found in dietary supplements of a general nature, e.g., biotin and vitamin B12 (cyanocobalamin). While B12 is probably the largest known molecule in the vitamin family from a chemical structure, it is seldom presented to industry in a pure crystalline form, but rather in a triturated material with 1 percent activity, thereby reducing the chance of agglomerating or overdosing in some tablets or capsules at the expense of having little or none of the nutrient in others. Both compounds are generally presented in microgram label claim amounts in fi nished products that are weighed in milligrams or even grams, so missing the arithmetic can lead to seismic errors. The best practices in designing, blending and producing fi nished products in dietary supplements then must include segregating micronutrients and their triturates into a pre-blend, whereby samples can be taken at the top, middle and bottom of the blending equipment. These samples, taken at timed intervals, evaluate the best blending time to create full desegregation of these ingredients into a homogeneous pre-blend suitable for inclusion in fi nished product blend batches. This helps ensure that macronutrients, along with compression and fl ow agents, or other lubricating compounds, can be encapsulated or compressed into fi nished products that meet label claims. For years, the baking and confectionery industries have deployed nutrient pre- blends into their processes to achieve fi nished products. Likewise, the world of pharmacology has determined that the same process is mandatory to ensure adequate and uniform distribution of active pharmaceutical ingredients (APIs) in medicines at the per-dosage level. To appropriately make sophisticated multi- vitamin or mineral presentations or other complex products requires the same attention to detail when determining how to achieve adequate stability, content Contract Manufacturing: Premixes

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