Natural Products Insider, December 5, 2008
What are some of the key considerations in optimizing blending of ingredients (i.e., weight, density, solubility, etc.)?
Blending is the most widely used process in the pharmaceutical and nutritional industry, though sometimes the least understood. The most critical parameter in blending is the raw materials and the properties that they possess. Understanding how materials flow, the density, crystal shape, moisture, cohesion properties, and the particle size can be the decisive factors that influence the blending of ingredients. Consistency and regularity in particle size will allow a better blending of solids, leading to less segregation and a more uniform blend.
Another property overlooked is blending time. Not many manufacturers run optimization trials to better understand efficient blending times. This might be an area where manufacturers can save time – i.e. a blend which might be complete in 10 minutes is blended for 25 minutes due to historical trials without optimization. Accurate sampling using standard tools (thief probes) is a key technical need for quality control and optimization of the blending process.
What type of overages do you encourage for dietary supplement blends? What variable parameters impact that decision?
Regulations require that the actual content of nutritional products be equal to or greater than the label claim after taking into account processing effects and shelf life degradation.
Depending on the stability characteristics each dietary supplement will require a different overage. To minimize overages, precautions can be put in place during manufacturing to prevent environmental effects such as moisture, heat, oxidation and general degradation properties of ingredients. Another way to reduce degradation effects is the packaging and handling of the raw materials and the final product.
The best way to determine overages is to test and understand the life-cycle of the product. Running stability studies at standard (25ºC/60%RH) and accelerated conditions (40ºC/75%RH) can help formulate a robust product and market a product with a meaningful expiry date.
What are some methods you use to protect sensitive ingredients during the blending process?
When handling sensitive ingredients - procedures, protocols and training become critical. The first step is to research the ingredients that you will be using and understand how they react to different environments. This starts with general receiving of raw materials, to sampling, to weighing and mixing, to final packaging of the finished product.
Controlling the environmental conditions (temperature, relative humidity, etc.) is the key to protection. Other precautions can be utilized such as special lighting, pre-blends and order of blending.
Emphasis should always be stressed on training and appreciation for the sensitivity of raw materials.
When selecting a method for processing, whether freeze drying or oven drying an ingredient, for example, what are the considerations that must be addressed to maximize functional outcome?
Knowing one’s capacities and limits should be the deciding factor for selecting methods of processing. Understanding how much time will be required, the costs associated with the process, and the overall effect on the materials being manufactured can all influence the decision for the type of method selected.
Are you seeing increased interest in multi-ingredient blends that address certain health conditions?
As a contract manufacturer with a vast product listing, it is clear to CPC that the amount of combination products is on the rise. Customers are excited about the one stop product that has multiple indications. With that said, there are difficulties in bringing these types of products to market. The laboratory requirements become more challenging and understanding compatibilities of ingredients is crucial.
How does the use of pre-blends factor into making a top-notch full load blend?
Pre-blends are a necessity when working with a low dose API (active pharmaceutical ingredient) or ADI (active dietary ingredient). To enhance the distribution properties of a blend, step-wise increases in the disbursement of lower concentration ingredients will help with content uniformity.
Dr. Jeffrey Reingold
Director, R&D