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22 April 2015 Tablets & Capsules result was poor distribution of the coating on the tablets. When the spray rate was reduced, thereby extending the process time, the RSD of content uniformity decreased, and API distribution over the tablet mass improved (Figure 5). Figure 6 illustrates how spray rate and pan speed affected the RSD of content uniformity. Based on the results of the screening DoE studies, the spray rate and nozzle-to-bed distance were identified as CPPs. The design space was determined from the com- mon region of successful operating ranges for multiple CQAs at the 1.5-kilogram scale. The overlay plot (Figure 7) indicates that the process parameters within the over- lap region gave an assay within the target range of 97 to 103 percent and good process efficiency. They also allowed the maximum range of operation to achieve the desired quality attributes. Thus spray rate and nozzle-to-bed distance level had significant impacts on tablet assay. Curvature effects were observed for all responses studied, and the main effect and interaction effects were identified using a full factor- ial DoE. The DoE models were used to establish accept- able ranges for formulation variables. Figure 7 shows the overlay plot of all responses, and the yellow zone indi- cates that all the responses were achieved simultaneously. The combination of a higher spray rate and shorter noz- zle-to-bed distance enhanced assay because spray drying was minimized. T&C References 1. Wang, Jennifer et al. An evaluation of process para- meters to improve coating efficiency of an active tablet film-coating process. Int J Pharm 427 (2012) 163-169. 2. Rege, Bhagwant D. et al. Identification of critical process variables for coating actives onto tablets via sta- tistically designed experiments. Int J Pharm 237 (2002) 87-94. 3. U.S. Pharmacopoeia XXIV, 2000. U.S. Pharma - copoeial Convention, Rockville, MD, pp. 2001-2002. 4. Quest TCM from ACG Pharma Technologies, Mumbai, India. Vasant Shetty is head of process technology and support; Sameer Borate is senior research associate; Anuprita Landge is research associate; and Shweta Suman is analytical associate at ACG Pharma Technologies, Mumbai, India. E-mail: vas- ant.shetty@acg-world.com. The company's US affiliate is ACG North America, 229 Durham Avenue, South Plainfield, NJ 07080. Tel. 908 757 3425, fax 908 757 3287. Website: www.acg-northamerica.com. Figure 7 Overlay plot of the effect of process variables on responses Assay 97 Assay CI: 97 RSD of CU CI: 4 RSD of CU: 4 3 4 5 6 7 8 9 16 15 14 13 12 11 10 Spray rate (g/min) Nozzle-to-bed distance (cm) Note: Pan speed = 14 rpm and atomizing-air pressure = 1.5 bar Figure 5 Effect of spray rate and nozzle-to-bed distance on RSD of content uniformity 5.5 5 4.5 4 3.5 3 2.5 Spray rate (g/min) Nozzle-to-bed distance (cm) Note: Pan speed = 14 rpm and atomizing-air pressure = 1.4 bar RSD of content uniformity (%) 3 16 15 13 12 11 10 14 4 6 7 8 9 5 Figure 6 Effect of pan speed and spray rate on RSD of content uniformity 5.5 5 4.5 4 3.5 3 2.5 Spray rate (g/min) Pan speed (rpm) Note: Atomizing-air pressure = 1.4 bar and nozzle-to-bed distance = 13 cm RSD of content uniformity (%) 3 16 14 13 12 15 4 6 7 8 9 5