Formula Optimization Key to Product Development

When developing a new product, formulators have myriad variables to consider, from determining the optimal thickness at a given run weight to adjusting excipients to provide controlled release. What are the barriers to entry? Is the delivery system appropriate for the product? What type of packaging system is needed? What testing methods are required?

Producers of dietary supplements must be efficient, cost effective, productive and, at the end of the day, able to deliver a working product. This is easier said than done, especially as the demand for extended release products grows. Formulation scientists at contract manufacturing companies must experiment and research more than ever. Such research starts at the earliest stages of development—toward understanding not only what the customer wants, but how the materials will perform.

A final product is only as good as the raw materials, and formulation optimization begins with proper sourcing. The days in which manufacturers sourced raw materials only from a limited group of trusted suppliers or simply purchased the lowest priced material are over. Legislation changes, stricter regulations and the general increase in quality awareness have changed the playing field. The demand for lower-cost production is creating markets in many countries. Consequently, the sourcing process can be an obstacle in the production of consistent, high-quality products. This need to understand the global commodity of suppliers and the actively changing market has led many companies to appoint a principal sourcing agent dedicated to raw materials.

However, procuring material from a reliable source is only the first step. Pharmaceutical applications require extensive material testing (i.e., particle size, polymorphism, solubility, water content, binary studies, etc.) to confirm the physicochemical properties and quality. While comprehensive testing is a given for prescription products, manufacturers are starting to adopt such standards for dietary supplements as well. By applying rigorous testing and stability protocols to all formulated products, such firms are paving the way for higher quality products. Tighter control on the raw materials equates to tighter control on the products and fewer, if any, customer complaints.