Micronization of supplements is a well established manufacturing technique for improving the solubility of poorly soluble supplements and enhancing the overall bioavailability. Several techniques are used to process supplements which depend on the material properties (crystalline, amorphous or fibrous), thermal sensitivity and the desired particle size distribution of the customer.
Typical development includes:
A small sample will be requested to evaluate the raw material particle size distribution and physical properties. A material safety data sheet is also requested to determine occupational exposure limits (OELs) and explosivity.
Low cost “proof of concept” sample will be evaluated using laboratory milling equipment and will be returned to the customer to evaluate the benefit of the milling or micronisation in their application. The laboratory trial will also allow an estimation of throughput, cost and process parameters required for commercial scale milling.
Production Scale up
Once laboratory sample is evaluated and approved by the customer, then limits for processing parameters, defining manufacturing batch documentation, labelling, cleaning requirements and analytical method will be defined prior to the commencement of scale up production.