Developing a capsule or tablet product is fraught with hurdles, both financial and technical. Traditional process development generally involves what seems like an endless cycle of batch manufacture, followed by testing/characterization, followed by more batch manufacture and even more testing. Execution of just one simple Design of Experiments (DOE) could easily take several days, if not weeks, only to be followed by additional batches.
But, there is good news. In 2021, you no longer have to endure the long and tortuous path of traditional process development. That was how capsule and tablet development was done in the past. Today there are varieties of tools available that can help shorten your process development project significantly. At Syntegon, we offer a lineup of products and services that take the guesswork out of developing a capsule filling or tablet compression process. Our complete line of tablet presses and capsule fillers offers a variety of features that simplify batch scale-up, each with the available option of utilizing our unique and patented Automated Process Development (APD) system. In addition, Syntegon recently opened a brand new Customer Center that features the latest in manufacturing solutions technology, so we can effectively perform trial runs on your product and offer cost-efficient development solutions.
Automated Process Development (APD)
Wouldn’t it be great if there were a way to reduce the complexity and burden of extensive Designs-of-Experiment during process development? Fortunately, there is. Syntegon’s unique APD system utilizes a fully automated and instrumented TPR tablet press or GKF capsule filler that can run a full DOE in a matter of hours, not days or weeks (> 50 experiments in two hours). This powerful system is a sophisticated and efficient approach to Quality by Design (QbD), powered by software that not only develops a DOE, but also automatically executes the full array of experiments on the tablet press or capsule filler. The fully instrumented machine monitors and records a variety of process parameters during operation, helping you to fully understand the complex interaction of parameters such as feeder speed and configuration, tablet press speed and pre and main compression forces, for tablet development, or powder bed height, tamping pressure and machine speed for capsule filling. In just a matter of hours, you will clearly see how each parameter influences your manufacturing process, providing you with a roadmap to the combination of parameter settings that results in the optimal process.
In addition, the APD system can help uncover any formulation deficiencies that might exist. If your formulation is under or over-lubricated, or perhaps prone to segregation or sticking, the APD system can help you identify the problem. No longer will you have to guess at whether your formulation will prove robust when scaling up and increasing throughput.
The APD system is available at Syntegon’s new OSD Customer Center, as well as at Parsolex (capsule filling), one of our partner labs in the United States.
OSD Customer Center
Whether you are interested in developing your tableting or capsule filling process on Syntegon’s unique APD system, or simply want to execute batch trials or get the latest in training, the new Customer Center at Syntegon likely has exactly what you need to accelerate process development. A completely new facility within Syntegon’s Waiblingen campus, the state-of-the-art Customer Center has a dedicated training center, four meeting and project rooms, and five processing rooms capable of handling products as potent as OEB 5. The full lineup of Syntegon technologies is available, including GKF capsule fillers, TPR tablet presses and dosing and inspection technologies, as well as all lab equipment needed to characterize your product. In addition, Syntegon’s experts are at your disposal to ensure that your project goes smoothly, whether you are running trials to trouble shoot a problematic manufacturing process, or attending expert training to make sure you can get the most out of your Syntegon equipment.
The new OSD Customer Center and Automated Process Development for capsule filling and tablet compression are just two of the tools available to accelerate your product development. Don’t go-it alone. Syntegon’s experts, backed by decades of designing and manufacturing cutting edge solutions for the pharmaceutical and nutraceutical industries, have the tools and experience to help you develop your product quicker and more efficiently.