Hands-on expertise on tablets and hard capsules
We offer in-depth knowledge of all types of formulation, processes and equipment for solid dosage forms—from standard direct compression processes to dry and wet agglomeration techniques and film-coatings.
How we can help
Formulation concepts and process expertise
Based on years of experience, we know what type of formulation works for which substance. From concept to first prototype, we also consider regulatory and production aspects early on.
Expertise in modified release forms
We match the target dissolution profile by considering various factors such as excipient grades, moisture, compression, and coating parameters.
Tailored solutions based on your needs
From orphan drugs and NCEs to generics, our portfolio spans over 70 solid dosage form developments, from immediate-release tablets to modified-release dosage forms including MUPS. We work hand-in-hand in personalized fashion with our clients.
Case study: Process optimisation for an extended-release CNS drug with narrow therapeutical window
The client: A pharmaceutical CMO for solid dosage forms.
The task: A commercial product, a multiple-unit extended-release tablet containing a high-dosed CNS drug with a narrow therapeutical window exhibited significant variability of dissolution behavior at release and stability.
The challenge: Identify the root cause and optimize the manufacturing process to reduce the variability of the dissolution behavior without change resulting in a variation of the registration file.
The outcome:
We began by conducting a comprehensive document review, which included raw material specifications, Certificates of Analysis (CoAs), intermediate products, and batch documentation. We then performed on-site visits to supervise and train operational personnel.
The initial analysis uncovered significant inter-batch variability in water balance during the application of the functional film coat on the active granulate in the fluid bed.
By actively controlling key process factors, such as inlet air temperature, inlet air volume, inlet air moisture, and spray rate, and optimizing the tableting process, we successfully established an extremely robust manufacturing process. Finally, our team adapted master batch records and conducted on-site training for operational personnel.
We distinctly improved the variability in dissolution within the specified ranges in the dossier.