Formulation Development.
Scalable quality.
A good formulation must not only prove itself in the laboratory, but also remain stable in production. We support you in developing your recipe so that it is scalable, process-reliable, and regulatory-compliant. This creates a stable foundation that supports everything from the first trial run to routine production.
Formulation Development Services
On the basis of your formulation data, we analyze the composition, evaluate critical ingredient components, and identify suitable excipients for improved processability. We also provide a theoretical recommendation on appropriate process management and summarize the results in a comprehensive report. As this service is purely theoretical, we recommend a powder compaction analysis to confirm the assessment experimentally and verify the compaction behavior of the material.
Formulation Development Services
Our theoretical formulation development service offers a sound initial assessment of your tablet recipe.
Powder Compaction Analysis
The powder compaction analysis provides in-depth insights into the compaction and compacting behavior of powders – a decisive factor for product quality and process stability. We use the F Lab 10 to analyze how your powder behaves under various pressing forces. We compare the results with data from our QED knowledge database and compile them into a clear and practical report – including recommendations for action in development and production. Together with the material characterization, this analysis forms one of the decisive elements for reliable process development.
Powder Compaction Analysis
Would you like to know how your powder reacts under pressure?
Feasibility Study
The feasibility study comprehensively assesses whether new formulations, formulation changes, or process adjustments are sensible and feasible. Building on the powder and material analysis, it is often the first step toward a safe new formulation. We analyze risks and processability, plan targeted tests, and document all of the results in a transparent manner. At the end, you will receive a structured decision-making framework with realistic next steps – including time requirements and material usage.
Feasibility Study
Before you commit resources, we provide clarity.
Insights into Feasibility Study.
Learn more about our feasibility study, its applications, and the specific benefits it offers for your development processes. Here you’ll find answers to important questions about conducting the study and collaborating with Fette Compacting.
What are the key benefits of Fette Compacting's Feasibility Study for tablet formulation and process development?
A Feasibility Study provides a reliable basis for decision-making before significant development, material, or capital investments are made. It delivers a comprehensive assessment of technical feasibility, potential risks, process capability, economic viability, and the most suitable equipment and process concepts.
At what stage of formulation and process development is it best to perform a Feasibility Study?
A Feasibility Study is recommended for new formulations, reformulations, raw material changes, scale-up projects, process modifications, batch-to-continuous manufacturing decisions, and new development projects where the appropriate equipment or process concept has not yet been defined.
What are the benefits of Fette Compacting's Feasibility Study compared to in-house formulation and process development trials?
Compared to in-house testing alone, Fette Compacting's Feasibility Study combines practical trial execution with extensive expertise in process development, equipment, and tablet manufacturing applications. Before any trials begin, the formulation, ingredients, and potential risks are assessed using existing material and process data, including benchmarking against Fette Compacting's Qualified Expert Database (QED). The trials are then carefully planned, executed according to clearly defined acceptance criteria, and evaluated with respect to technical feasibility, process robustness, critical quality attributes, and optimization potential. As a result, end users receive not only analytical data but also actionable recommendations for the next stages of development.
Where can I have a Feasibility Study performed by Fette Compacting?
A Feasibility Study can be performed either at one of Fette Compacting's global Competence Centers or directly at the end user's site.
What is the typical turnaround time for a Fette Compacting Feasibility Study?
The duration depends on the project. It is determined by the research question, material availability, experimental design, and the scope of the report.
How does Fette Compacting ensure the reproducibility of Feasibility Study results?
Reproducibility is ensured through a structured and predefined test plan. This includes well-defined process conditions, clearly established acceptance criteria, systematic collection of process parameters and critical quality attributes, and fully documented trial execution.
What is and will
continue to be important.
Articles and reports on current developments and technological innovations. For even more efficiency!