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breaking force profiles showed an indirect correlation between API p a r t i c l e s i z e a n d c o m p a c t i o n behavior for the vitamin B 2 and C systems. Retesting the mini-tablets after 1 month at 25°C and 60 per- cent RH showed no significant c h a n g e s i n t a b l e t d i a m e t e r o r thickness, but breaking force varia- tions were slightly larger. These study results clearly demonstrate design and equipment feasibility and material performance. T&C References 1. N. Passerini, C. Funaro, G. Mondelli, G. Calogéra, B. Albertini, A. Fiorino, L. Rodriguez, 49th AFI Symposium (2009). 2. A. C. F. Rumondor, D. Harris, F. Flanagan, V. Biyvala, M. A. Johnson, D. Zhang, S. Patel; A. Pharm. Rev., (2016). 3. J. A. Zeleznik, C. Nowak, F. K. Penz ; AAPS, (2014). Federica Giatti is process development technologist, R&D laboratory, and Caterina Funaro is process laboratory manager at IMA Active, a manufacturer of solid dose processing equipment (978 537 8534, www.ima.it). Vera Fichtner is senior project manager, R&D, and Franz Penz is head of application technology at Meggle, which supplies excipients to the pharmaceutical industry (845 289 0264, www.meggle-pharma.com). mulations, monitoring tablet dimen- sions and breaking forces. The goal was to evaluate possible elastic recov- ery impact on final tablet dimensions and/or storage-induced changes in tablet breaking force pertaining to API release. For that reason, tablet diameter, thickness, and breaking force changes were investigated at 7 and 28 days after compaction at 25°C and 60 percent relative humidity (RH) using mini-tablets compacted at 10 kilonewtons compaction force. Overall dimensional changes were small and did not exceed 7 percent for RetaLac and 1 percent for FlowLac 100 when the tablet diameter was measured after one month. At 4 weeks, tablet thickness had increased by 2 percent for both formulations. Breaking force differed by approxi- mately 28 percent for the FlowLac and 18 percent for the RetaLac. Conclusions This study compared the lac- tose-based CPEs, CombiLac and RetaLac, to spray-dried lactose, FlowLac 100, in mini-tablet manufac- turing unit operations using an 8-sta- tion Prexima 80 rotary tablet press. All materials performed within expected ranges with respect to com- pactibility, tablet mass uniformity, and vitamin B 2 API release. The study confirmed that blend flowability was critical for tablet weight uniformity. Compression- RSD values (3 to 4 percent) com- pared to vitamin B 2 (1 to 2 percent). The flowability change "sensitivity" was also found to be different for the two example formulations as indi- cated by the overall regression line inclinations shown in Figure 2. Tablet mass RSD increased more than 4 times faster when compacting the vitamin B 2 blend. The results showed that the vita- min B 2 sustained drug release when using RetaLac as an excipient was independent from mini-tablet break- ing force between 28 and 48 new- tons, which is in full agreement with typical tablets with 80 percent release between 4 and 5 hours [3]. In comparison, FlowLac 100 showed immediate-release performance, with 80 percent release after 15 minutes. Subsequently, a limited stability study has been conducted for RetaLac- and FlowLac 100-based for- Photo 1: Mini-tablets are typically less than 3.0 millimeters in diameter, making them a good alternative dosage form for patients that have difficulty swallowing traditional tablets and capsules. 42 March 2019 Tablets & Capsules Figure 2 Tablet mass relative standard deviation (RSD) and powder angle of repose for 10-percent vitamin B 2 and C formulations at 6 ( ), 8 ( ), and 10 ( ) kilonewtons compaction force and 20 rpm 6 5 4 3 2 1 0 Mass RSD [%] 6 5 4 3 2 1 0 Mass RSD [%] Angle of repose [°] 36 38 40 42 44 46 48 Angle of repose [°] 27 29 31 33 35 37 39 Vitamin B 2 Vitamin C CombiLac CombiLac FlowLac 100 FlowLac 100 y= 0.56x-21.056 y= 0.1205x-0.9808 RetaLac RetaLac