Once the material is selected and timeline solidified, it is time to set a product goal, which must include dosage form, size, delivery mechanism and appearance. Determining these aspects of the final product helps establish formulation strategies and keeps formulation efforts focused and efficient. Instead of using the common trial and error method of product development, an arguably better approach is to use existing research to inform and help create an experimental design in which independent variables are identified and modified. This model ensures more stability and an optimal product. The FDA Guidance outlined in International Conference on Harmonization (ICH) Q8 describes the establishment of a design space. Implementing an experimental research methodology represents an efficient approach for solving such optimization problems. Consider how formulators are regularly faced with the optimization of an excipient mixture composition. Using the design space, the focus is preparing a product with the required characteristics, determining the optimal choice in each excipient category (i.e. binders, diluents, glidants, lubricants, etc.) and the ideal level of each excipient.
One common oversight made by less experienced contract manufacturers is the failure to include the production team in the formulation process. Open communication is necessary throughout all areas of the developmental process. As progress is made on trial batches, it is critical to be mindful of both the final production-scale process for the commercialized product as well as the company’s manufacturing capabilities to support the product. Keeping the end process in mind will save time in the scale up and commercialized production and the product will see the market that much sooner.
Developing a product utilizing the design space concept will help in preparing a formulation or product development report, a summary of all work done from initial conception to the final commercialized product. This story tells the tale of how the product evolved into an optimal, commercialized entity. Setting a target for the different parameters and giving reasoning for the specifications will display a higher degree of knowledge and understanding of the product, and the critical attributes will be identified and understood.
Developing dietary supplements requires the ability to wear many hats while keeping a keen eye focused on the urgency of moving to market on time. Utilizing the appropriate technology is only half the battle. The real test is in formulating a robust, optimized product. The challenge is there, and the stage is set; success depends on the execution.
Jeffrey Reingold, Ph.D., is the manager of research and development (R&D) at Contract Pharmacal Corp. (ContractPharmacal.com), a Hauppauge, N.Y.-based full-service contract manufacturer and packager of dietary supplements, OTC drugs and pharmaceuticals.
Email this article
Add a comment
Printer version
Order reprints
RSS Feed
Bookmark article