The clock ticks relentlessly in pharmaceutical development. Many hurdles stand between the initial formulation idea and the market-ready tablet. Wasting time here reduces the remaining patent life post-launch, shortening the period where exclusive sales rights secure maximum returns. Late discovery of critical issues proves especially costly. The solution requires an early, holistic approach to the entire development process.
Fette Compacting supports manufacturers from the initial formulation idea to validated mass production. This approach marks a paradigm shift: moving away from isolated development steps toward a continuous process partnership.
Securing quality – from the start
Modern tablet development is not "trial and error" but a highly structured process. The key term is Quality by Design (QbD). This approach ensures quality is embedded into the product from the start, rather than just tested at the end. It focuses on understanding the interactions between three factors:
Critical Material Attributes (CMAs)
Critical Process Parameters (CPPs)
Critical Quality Attributes (CQAs) of the end product
Doreen Dunst, Application Specialist at Fette Compacting, summarizes the challenge: "Robust processes can only be established by thoroughly understanding the interaction between product and machine." Consequently, Fette Compacting has entirely aligned its service portfolio with this principle. The goal is to define "Design Spaces": safe parameter ranges where production runs reliably and tablets meet desired quality standards consistently.
A deeper look into the powder
The process begins with a question: What properties does this powder have? Experts know the answer is complex. Particle size, flow behavior, moisture content, compaction properties: these critical material attributes determine whether a formulation can be compressed reliably.
Material characterization provides the answers. Methods like laser diffraction spectroscopy determine relevant properties. Additionally, compaction analysis using the F Lab 10 from Fette Compacting examines how powders behave under different compression forces. This requires only minimal powder quantities, a crucial advantage for new developments. The result is a detailed profile for every powder - a fingerprint serving as the foundation for all subsequent decisions.
Knowledge instead of trial and error
Raw material knowledge must now become a recipe suitable for pressing high-quality tablets. Determining which excipients and machine configurations fit the formulation often leads to extensive test series and costs valuable time.
The Qualified Expert Database (QED) from Fette Compacting fundamentally changes this workflow. It bundles experience from over seven decades of tableting technology and uses AI-supported algorithms to link new analysis results with historical data. "Instead of laboriously feeling your way toward optimal settings, the system provides early, concrete recommendations for the ideal machine configuration and suitable components," explains Dunst regarding the database's benefit. "This saves lab time and leads to satisfactory results faster during initial production-scale trials."
Scale-up without unpleasant surprises
What works on a small scale does not necessarily succeed on a large one. Transitioning from lab to production scale represents another classic cost driver. Different batch sizes, changed throughput rates, or altered machine dynamics can disrupt the process.
"This is exactly where our emulator technologies come in," says Dunst. "They allow us to optimize individual process steps before actual production starts." The results are directly transferable, facilitating the scale-up.
Fette Compacting also supports pharmaceutical companies with feasibility studies. Targeted tests and careful documentation provide manufacturers with a solid basis for decision-making. This allows comprehensive evaluation of planned formulation changes or process adjustments and early identification of potential risks.
Real-Time control instead of rejects
Once production runs, quality must remain stable. Errors detected only during final inspection can render entire batches unusable. The solution is Embedded Process Analytical Technology, or ePAT. Using near-infrared spectroscopy, the system measures quality attributes like the active ingredient content in real time. "ePAT performs measurements without damaging the tablets," explains Dunst. "If quality or composition deviations are detected, defective tablets are immediately sorted out. Corrections can occur immediately during production before larger quantities are affected."
Everything from a single source
A stable production process alone is insufficient: the path to market readiness ends only with regulatory approval. Therefore, Fette Compacting’s R&D Solutions include GMP services at its cooperation partner CMIC in the USA. These range from process transfer support to production scale—including planning and statistical evaluation of validation runs—to support in manufacturing clinical batches.
The complexity of modern drug manufacturing requires a rethink: away from pure machine purchasing toward a strategic process partnership. For pharmaceutical manufacturers, this integrated approach means fewer interfaces, shorter project durations, and a solid methodological basis. Quality by Design provides the common thread connecting all phases—from the initial question about the powder to the approved tablet.
Advantages of Fette Compacting R&D Solutions
Shorter development cycles: Data-driven recommendations instead of lengthy test series
Fewer rejects: Real-time control detects manufacturing process deviations immediately
Predictable scale-ups: Emulators prepare the production transition
Faster market launch: Optimized processes shorten time-to-market
