Even under ideal circumstances, tablet development will encounter unknown variables before a final product is realized. To reduce problems, performing several simple experaments and and creating characteristic profiles enables R&D and production to accurately evaluate new drugs as oral solid dosages. Experimental data is used to characterize formulation performance with both patients and manufacturing organizations 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 SUPAC compliance or other regulatory guidelines.The pharmaceutical industry benefits from utilizing 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 adn analysis outlined in this article also provide smoother transitions from R&D to full-scale production.