Tablets & Capsules

TC0321

Issue link: https://www.e-digitaleditions.com/i/1349974

Contents of this Issue

Navigation

Page 22 of 59

Tablets & Capsules March/April 2021 21 protect UV-sensitive APIs. Air conditioning is also critical for maintaining a low humidity level for moisture-sensitive APIs and ingredients. Packaging is another important consideration for main- taining the stability of certain products during transport and storage. Such packaging should minimize exposure to moisture, oxygen, and/or UV light as needed, and it may be necessary to package each dose in isolation. Optimizing packaging involves choosing the right material, such as polypropylene or aluminum tubes, PET, or paper aluminum foil, and considering additional features, such as tubes with stoppers that contain a water-absorbing molecular sieve. Many packaging options are available that both optimize product stability and provide user-friendly features, making the product convenient and easy to open. Optimizing logistics and quality control When dealing with raw materials, intermediate ingredi- ents, or final products that are easily degraded upon exposure to certain physical conditions, it is necessary to take logisti- cal considerations into account. Planning is key to reducing the amount of time materials are exposed to moisture, light, and oxygen, for example. The goal is to minimize exposure time between weighing raw materials and blending as well as between blending and filling. To minimize exposure time, consider the ingredients' bulk-holding periods when booking time slots for equip- ment. Raw materials typically must be used within weeks or months of opening, but this time frame can be significantly shorter for sensitive APIs. For instance, bulk holding times for omega-3s should not exceed one to two days. Effective production planning is critical to avoid wasting material. Timing is also important when ordering new raw materials for a campaign. Where possible, use internal quality control checks to further improve the chance of success. For example, using accelerated stability tests ensures confidence in product stability, particularly for products that are highly sensitive to moisture and other elements. Laying a foundation for success As consumers demand greater levels of convenience in all aspects of their lives, pharmaceutical and dietary supplement manufacturers face increasing pressure to deliver easily con- sumable, user-friendly products. But delivering these prod- ucts to the market requires effective stabilization strategies. Approaches to ensuring stability vary widely depending on the APIs, the ingredients being used in the manufacturing process, and the selected dosage form. ODGs, effervescent tablets, and instant drinks are just a few examples of user- friendly alternatives to conventional tablets and capsules, but each has its own production challenges. Product sta- bility has always been and will always be a challenge, but prioritizing stability is a smart business decision and can be greatly complemented by the application of expert knowl- edge and appropriate technology during process develop- ment or improvement. With this combination, consistent, high-quality production is within reach, enabling consumers and regulatory bodies to trust your product and processes, which is key for ongoing commercial success. T&C Reference 1. National Institutes of Health, Office of Dietary Supplements. "Omega-3 Fatty Acids: Fact Sheet for Health Professionals." 2017. Accessed October 30, 2020. ods.od.nih.gov/factsheets/Omega3FattyAcids- HealthProfessional/. Dr. Martin Koeberle (martin.koeberle@hermes-pharma.com) is head of analytical development and stability testing and Verena Garsuch is manager of analytical and clinical devel- opment and stability testing at Hermes Pharma, a division of Hermes Arzneimittel GmbH (+49 89 79102 261, www. hermes- pharma.com).

Articles in this issue

Links on this page

Archives of this issue

view archives of Tablets & Capsules - TC0321