Tablets & Capsules


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D 10 September 2014 Tablets & Capsules tabletting Making better tablets: A QbD approach Michael Gamlen Gamlen Tableting Joe Domingue SciMark International To improve the formulation development process, test the prop- erties of tablet materials on an instrumented press early and often. In this article, the authors describe how a benchtop tablet press and material tester characterizes both tablets and materials to help you develop a robust formulation. It also touches on the shortcomings of the FDA's SUPAC guidances in improving existing tablet formulations. Later in the book, he correctly identifies many of the key problems that afflict tablet production, such as cap- ping, sticking, and picking, and pinpoints some of their causes. He also recommends solutions. See Table 1. It is humbling to realize that, despite 108 years of sci- entific endeavor since the publication of Wood's book, we still cannot reliably identify the root causes of many tabletting problems nor how to fix them. Our lack of progress in this area stems both from the nature of con- ventional tablet presses and from the traditional, century- old approach to tablet development. Consider first the equipment. Regardless whether it's a single-punch lab press or a rotary production machine, the principle of operation is the same: Compress the material to a particular thickness. On a single-punch machine, the position of the upper punch determines the thickness, while on rotary presses, thickness depends on the distance between the upper and lower rollers. Small eveloping and manufacturing tablets are complex activities, as Joseph Woods noted more than a century ago: The many difficulties constantly presenting them- selves to the author and his assistants in the manu- facture of tab lets, and the marked absence of litera- ture relating to the sub ject, have led to the preparation of this little volume [1].

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