Syntegon Drug & Process Development and Optimization

Drug & Process Development

Today Time-to-Market is very important for the pharmaceutical industry. In this respect the path of development from R&D via pilot Scale-up to production scale must occur quickly and sustainably.

We support the complete development with our product portfolio, R&D capabilities and pharmaceutical knowledge. Representing a century’s worth of knowledge in solid dosage formulations and designing of related equipment Syntegon is your qualified partner.

Formulation development (batch sizes 30 g to 10 kg)

  • Research articles in publications
  • Formulation strategy
  • Pre-formulation studies
  • Selection of excipients
  • Manufacturing of finished powder, granules, tablets, pellets and analysis
Syntegon Huettlin Xelum Continuous Manufacturing Fluid bed

Solid dosage forms

Today powder, granules, (micro-)tablets, pellets, liquids and all their derivates are the most used dosage forms. New drugs or market driven efficiency programs are forcing our customers to improve the formulation of these dosage forms. Due to the high amount of active substance in the formulation, the amount of excipients needs to be minimized.

Syntegon solid dosage forms: powder, tablets, capsules and pellets.

Process development and optimization for oral solid dosage production

Process safety, robustness and efficiency are the key factors in the manufacturing of pharmaceuticals. Based on modern scientific approaches like QbD (Quality by Design), PAT (Process Analytic Technology) and data mining a technically stable and commercially efficient process can be designed and developed.

Process optimization

  • Holistic approach for the whole production chain of all oral solid dosage forms
  • Analysis and optimization of all machine and process parameters to enhance efficiency

         - Data mining with various applications and approaches
         - Optimum machine design and overall process performance
  • Access to all current machine features, e.g.:

         - Format and size parts
         - Sensors
         - Air handling
         - Automated Process Development (APD)
  • Optimization consulting for existing processes

         - Risk analysis of each process step
         - Dosing process
         - Product and format changeover, upscaling
         - Maintenance
  • OSD customer center with current machines and machine features for testing under controlled environment (production conditions)
  • Scale-up and product transfer

         - NexStep scale-up software

Trouble shooting

Examples for trouble shooting and process optimization:

  • Yield
  • Process time
  • Dissolution
  • Capping
  • Optical defects
  • Avoid capsule issues like e.g. slicers, re-opening
  • Handling of complex materials like e.g. sticky or fluffy cohesive powders
  • Establish stable process (high dosing accuracy)
  • Minimize waste, optimize yield and OEE
  • Explanation for quality fluctuations or problems

Automated process development & Automated Design of Experiments

Despite the benefits of Design of Experiments (DoE), the execution of the planned experiments is often a major challenge. Even with statistically optimized planned experiments, still many experiments have to be executed, i.e., to determine interactions. We propose to perform such experiments with a high automation level. The machine adjusts all process parameters automatically and all or at least most of the critical quality attributes are measured directly in or at the system. The experiments are executed automatically without or with only reduced human interaction. As a result, several experiments can be executed in a reduced amount of time. Processes can easily be better understood by applying a combination of automation and DoE.

  • Automated Process Development (APD)

         - Unique combination of statistical trial planning (DoE) and process automation
         - Statistical trial planning
         - Automated adjustment and testing of process parameters
           with direct and digital measurement of critical quality attributes
         - Evaluation of trial results and identification of critical process parameters
         - Efficient process optimization and formulation development
         - Real machine tests allow “real quality by design”
  • Development of new machine features for specific customer products
  • Perfect basis for continuous manufacturing
Dr. Thomas Brinz, Head of Department Pharma Services & OSD Customer Center, Waiblingen

Dr. Thomas Brinz

Head of Department
Pharma Services & OSD Customer Center, Waiblingen
Phone: +49 7151 14-2160

E-mail

Dr. Marcus Knöll

Head of Department
Pharma Services & OSD Customer Center, Schopfheim
Phone: +49 7622 6884-121

E-mail 

Dr. Marcus Knoell, Head of Department Pharma Services & Customer Center, Schopfheim