Natoli Engineering explains how to help organisations reduce the stress and loss of product development and delivery with Quality by Design.
Experimental
A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. Even under ideal circumstances, tablet development will encounter unknown variables before a final product is realised. To reduce problems, performing several simple experiments and creating characteristic profiles enables R&D and production to accurately evaluate new drugs as oral solid dosages. Experimental data is used to characterise formulation performance with both patients and manufacturing organisations as ultimate customers. Understanding these compaction and compression characteristics is fundamental because they often drive changes in production requirements.
These anticipatory experiments result in less formulation changes prior to full-scale production. Changes to production-ready formulations are the costliest and most time-consuming because they must meet FDA, scale-up and post-approval changes (SUPAC) compliance, or other regulatory guidelines. The pharmaceutical industry benefits from utilising vendor partnerships for troubleshooting techniques and solutions. A quality tooling vendor can provide help to prevent tableting issues with information provided in compactability, tabletability and compressibility profiles. The study completion and analysis outlined below also provides smoother transitions from R&D to full-scale production.