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Tablets & Capsules March/April 2021 17 disintegrating granules (ODGs), for example, are easy to swallow and convenient to take but can be more prone to stability issues than conventional tablets and capsules, pos- ing a problem for manufacturers. For example, effervescent tablets must dissolve quickly and completely in water so patients can take their medicine without having to swallow a tablet. As a result, they have an inherent sensitivity to moisture that creates a need to control the humidity in their environment during manufacturing and storage. In addition to responding to patient and consumer pref- erences and providing a positive experience, manufactur- ers must also update their approaches to meet regulatory demands. Regulations are becoming increasingly stringent, as evidenced by strict shelf-life specifications and decreas- ing tolerance levels for unwanted chemicals and impurities that result from a breakdown of intermediate materials or final products (otherwise known as degradation products). In the face of these collective pressures, investment in improved product stability is not a "necessary evil" but rather a smart business decision that enables pharmaceutical com- panies to remain competitive. This article will explore some of the many technologies and approaches for overcoming instability issues. Costs of instability While safety and efficacy are key priorities for manu- facturers, they are not the only reasons for ensuring that products are stable. Poor or variable stability can result in an unappealing product appearance (such as brown spots) or smell, affecting user experience, reducing compliance, and likely impacting future purchasing choices by patients and consumers. Perhaps more significantly for manufacturers, product instability typically indicates a failure to meet strict regula- tory guidelines. Regulatory bodies clearly define acceptable limits for degradation products and are often trying to reduce these limits further. If the amount of degradation product exceeds the strict quantity limits within a product's defined shelf life, the product may be recalled to mitigate the risk to patients or consumers. Manufacturers consider such an event a worst-case scenario, not only because of the potential risk to patients or consumers, but also because of the costs and negative consequences that can occur downstream. Following a batch or product recall, manufacturers are required to submit their products for stability testing more Investment in improved product stability is not a "necessary evil" but rather a smart business decision that enables pharmaceutical companies to remain competitive. Allendale, New Jersey Óä£ÈÓnÓääÊUÊÜÜÜ°À>iiÀÕðV `Ài°*iÌÀVJÀ>iiÀÕðV For 35 YEARS the pharmaceutical industry has relied upon ÀBiÀ to de-dust, de-burr and convey tablets with the highest efficiency. To learn more about how to *,"6 the EFFICIENCY of your tableting lines contact Kraemer U.S. Tablet de-dusting solutions from the Global Leader