Tablets & Capsules

TC0317

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measuring SF may be operator-dependent and thus incon- sistent from one operator to another. If so, that makes facil- ity-to-facility comparisons of SF measurements difficult. Laser-based SF measurements are not operator-dependent and are more reproducible. Table 1 summarizes the results of an informal repro- ducibility study. To conduct the study, four batches of ribbons were measured in our US laboratory, then mea- sured by multiple, newly trained operators in Denmark, and finally measured using a different instrument in the USA. The results are nearly identical [5]. These data sug- gest that the laser-based tech- nique can facilitate inter-facil- ity comparisons of the SFs of pharmaceutical compacts, including those formulated at one facility and produced at another. Likewise, if production must shift from an old roller compactor to a new one, the settings will likely need to be changed to ensure that ribbons for each affected product will have the same SF as those produced on the old model. A laser-based measurement system can minimize the time and effort required to make that type of transition. Changing roller compactor units within the same model. It's been said that, with some compactor brands, changing compactor units—even within the same com- pactor model—sometimes requires adjusting the settings to achieve the same SF. Here, too, laser-based SF mea- surement can reduce the time, risk, and effort associated with that change. Other applications Routine monitoring. Because the laser-based technique is quick and doesn't use consumables, it is suitable for rou- tine at-line (or near at-line) monitoring of SF. It can check whether machine-related issues have caused the SF to drift or whether the SF has been affected by unanticipated changes in the formulation's excipients. Because laser-based measurements are fast and can be performed on multiple pre- loaded ribbon samples, the operator can step away to per- form other activities. Furthermore, one central system could potentially serve several production lines. Compaction simulation. When a formulation study involves a very expensive API, scientists seek to conserve API and will often use a compactor simulator instead of a roller compactor for the initial work. Compaction simula- tors estimate the force and other settings required to cre- ate a ribbon that will—after granulation—achieve the desired flowability and re-compactability. This typically involves making tablet-like compacts using knurled rollers or rollers with special surface characteristics. By providing rapid feedback about the SF of these compacts, Tablets & Capsules March 2017 43 Batch ID Date Country Location Status Number SF SF Standard of ribbons average range deviation 1A 12/14 USA Vendor Acceptance testing 4 0.628 0.006 0.002 facility 1A 3/15 Denmark Customer Operator training 7 0.663 0.007 0.003 facility 1A 4/15 USA Vendor Testing new 9 0.633 0.011 0.004 facility instrument 2A 12/14 USA Vendor Acceptance testing 4 0.744 0.008 0.003 facility 2A 3/15 Denmark Operator training 3 0.751 0.002 0.001 2A 4/15 USA Vendor Testing new 7 0.752 0.008 0.003 facility instrument 3A 12/1 USA Vendor Acceptance testing 3 0.565 0.012 0.006 facility 3A 3/15 Denmark Operator training 6 0.574 0.012 0.005 3A 4/15 USA Vendor Testing new 9 0.582 0.012 0.004 facility instrument 4A 12/1 USA Vendor Acceptance testing 3 0.684 0.009 0.005 facility 4A 3/15 Denmark Operator training 3 0.674 0.002 0.001 4A 4/15 USA Vendor Testing new 9 0.671 0.008 0.002 facility instrument Table 1 Reliability and reproducibility of SF ribbon measurements [5] The SF/porosity of tablets is one of the most important factors governing their disintegration and dissolution rates.

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