Tablets & Capsules

TCMay/June21

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Tablets & Capsules May/June 2021 43 improved flow upstream helps to achieve proper addition and mixing within a formulation, improving per- formance of the final dosage form. It's the little things that will make CM work The shifting priorities along the continuous manufacturing line pres- ent formulators with considerable challenges when choosing excipi- ents. Some manufacturers may not even be fully aware that demands on excipients vary depending on the step of the continuous process. As discussed, attributes such as pow- der flow and multi-functionality may be critical in the early stages but not as important during granu- lation. Again, these factors are not inherently negative but must be con- sidered as part of both process and formulation development. There's no doubt that the indus- try at large recognizes the advantages offered by CM, especially when it comes to improved throughput and reduced complexity. Hopefully, it now also understands the granularity needed to make CM processes work well. Excipient properties deserve careful consideration at every stage of CM operations. Formulators need to understand how excipients might per- form during manufacturing and how a continuous process might impact or alter them, if at all. Characteriz- ing these attributes is the first step in establishing a robust CM process. Taking these small steps could bridge the gap to wider industry adoption of CM in the very near future. T&C Kathryn Hewlett, Elizabeth Tocce, and Meinolf Brackhagen are applica- tion and development scientists at IFF ( formerly DuPont Nutrition & Biosci- ences) (www.iff.com). lation, where the lower dose of API means the excipient performance can have a greater impact. In this case, appropriate blending and flow is crit- ical to ensuring even distribution of API throughout the tablets. Again, of MCC and silica. In both model formulations, the SMCC enables improved content uniformity that is also closer to the target of 100 per- cent. This is especially evident with the dextromethorphan HBr formu- Figure 7 API content uniformity with different Avicel grades Avicel SMCC 50 Avicel PH 101 Avicel PH 101 + SiO 2 Avicel SMCC 50 Avicel PH 101 Avicel PH 101 + SiO 2 104 103 102 101 100 99 98 97 96 95 API percentage Dextromethorphan Propranolol HCI Model API Figure 6 Tablet weight (mg) vs Avicel grade 156 155 154 153 152 151 150 149 Tablet weight (mg) Avicel SMCC 50 Avicel PH 101 Avicel PH 101 + SiO 2 Avicel SMCC 50 Avicel PH 101 Avicel PH 101 + SiO 2 Dextromethorphan Propranolol HCI Model API

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