Tablets Capsules

TC0618_SB

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Additionally, the opera- tional differences between R&D and production presses would significantly affect a continuous manufacturing environment as powder is timed to flow at a certain rate and thus the ability to vary turret speeds is severely lim- ited. While developing a for- mulation on a manufacturing press would eliminate chal- lenges associated with scale- up, manufacturing presses use a large amount of active pharmaceutical ingredient (API), which is costly and im- practical. Natoli Engineering Com- pany has drawn on many decades of tablet compres- sion experience to develop an innovative solution to mit- igate the operational dif- ferences between R&D and production presses. Nato- li Quick-Release™ Tooling Figure 2. Natoli Quick-Release™ Tooling comes with a set of three interchangeable punch heads. Punch heads are available to meet TSM or EU specifications in either B or D sizes. (Figure 1) allows researchers to test different dwell times during the tablet R&D process without the expense of buying several different sets of tools or the time needed to change complete sets of tooling. Each Natoli Quick-Release™ Tool- ing set comes with a punch barrel, three interchangeable heads—domed head config- uration, extended flat domed head configuration, and no flat/full radius head config- uration (Figure 2)—and one punch tip that can be custom selected by the customer. Many Formulation Challenges Can Now Be Solved Before Scale-up During tablet develop- ment it is crucial to con- duct experiments to collect data that will characterize formulation performance and help researchers un- derstand compaction and compression characteristics before full-scale production begins. Changes to a pro- duction-ready formulation due to compaction issues are costly and time-consuming, and domestic manufacturers must follow the FDA's scale- up and post-approval change (SUPAC) guidelines. Ensur- ing a formulation performs correctly a™er scale-up will minimize the risk of post-ap- proval changes and the asso- ciated delays and costs. One critical component to consider during scale-up from an R&D press to a large manufacturing press is com- paction dwell time. Dwell time – expressed in millisec- onds – is the time in which punches achieve maximum penetration in the die under the main compression roll- ers and are no longer moving vertically. It is a contributing

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