Issue link: https://www.e-digitaleditions.com/i/1022930
Tablets & Capsules September 2018 19 always inadequate by themselves to predict sticking. Moreover, the selection of drug substance properties is often entirely out of the formulator/engineer's control (for example, milling of the drug substance based on bio- pharmaceutical performance). This underscores the fact that tablet sticking is a com- plex, multifactorial problem involving not only drug sub- stance properties, but also formulation properties, manu- facturing equipment, and processing conditions. As an illustrative example of the multifactorial nature of the problem, it is worth noting that nearly half of the respon- dents (5/11) replied that co-processing the drug sub- stance with excipients as part of the final drug substance manufacturing process has reduced the risk of sticking. Several write-in examples of this approach were pro- vided, including milling with silicon dioxide, co-process- ing with solvent and binder, and spray drying. Formulation properties. As previously described, respondents ranked changing the formulation as the most effective means for eliminating sticking, which is likely due to the fact that there are multiple different levers for- mulators can pull. Figure 3 shows the relative rank order of formulation strategies that had the biggest impact on eliminating sticking. Not surprisingly, respondents rated changing the drug load and lubricant concentration as the most effective. Under some circumstances, however, changing the drug load enough to reduce sticking risk may not be practical. For example, maximizing the drug load for high-dose formulations is desirable to maintain a smaller overall tablet size for swallowability. As a result, optimiz- ing the lubricant concentration and selecting the correct Figure 3 Relative rank order of formulation strategies to mitigate sticking Most effective Least effective • Change the drug load • Change the lubricant concentration • Remove a component ◊ Mannitol included in five responses ◊ Silicon dioxide, organic acids (such as citric acid), PEG • Add a component ◊ Dry binders, lubricants, silicon dioxide, talc, poloxamer • Change the lubricant • Combine functional components ◊ Lubricant/lubricant, lubricant/glidant, lubricant/ anti-adherent Superior line optimization. Especially for the laugh lines around your mouth. Are you looking for a production line from A to Z as made from one piece? A solution that can grow with your business? And ideally from a single partner? We will provide the right solution. From process technology to primary and secondary packaging machines, as well as handling and inspection equipment for solid and liquid food and pharmaceuticals. Sophisti- cated lines and scalable system concepts, including data management, offer clear advantages: coordinated interfaces, faster time to market, and efficient, connected production. Processing. Packaging. Excitement. www.boschpackaging.com Pack Expo International October 14 – 17, 2018 Chicago, USA Visit us at booth S-3514 We look forward to seeing you!