R&D and Process Support – by MEDELPHARM
Leverage our Expertise and Advanced Technologies to Streamline Product Development and Process Optimization
KORSCH & MEDELPHARM :
Your Trusted Partner for Tableting Solutions!
Understand & Develop
Material Characterizations
Formulation Development Support
Transfer & Optimize
Scale-Up Support
Process Optimization
Process Troubleshooting
Enhance & Maximize
Training Programs
Consulting Services
Non-GMP Contract Manufacturing
Understand Powder Behavior to Develop Robust Formulations
API characterization, excipient selection, and manufacturing process determination are essential in every tablet development to achieve a robust formulation.
Material Characterization
Fingerprint your API with our scientists by assessing flowability, particle morphology, compactibility, strain rate sensitivity, and ejection stress which are amongst potential Critical Material Attributes (CMAs).
Consider batch-to-batch consistency and raw material second source approval early in the development stage to secure production efficiency.
Our pharmacists and formulation experts provide insights based on experiments and data to define the best combination of excipients and processes to target optimal quality attributes.
Tablet Formulation Development
Study formulation blends and manufacturing processes following USP <1062> guidelines with our pharmacists to meet tablet Critical Quality Attributes (CQAs) such as dissolution, disintegration, or tensile strength. As an example, assess the impact of dry granulation process on flowability and re-compactibility with minimal amount of material.
Design the process to maximize production output, control cost, and ensure superior quality. Compaction simulators are essential to predict potential tablet defects and solve them
during development stage. For example, sticking can be related
to temperature or tooling surface which can be evaluated
with our formulators prior to scale-up.
Transfer R&D Findings to Production or Optimize Existing Processes
Successful scale-up, troubleshooting, and process optimization are key for tablet manufacturing efficiency. Will your formulation withstand high compression speed? What will be your maximum production output?
Scale-Up Support
De-risk scale-up by transferring Process Parameters (PPs) determined by compaction simulators to high-speed rotary tablet presses or production-scale roller compactors.
Process Optimization
Optimize your production process parameters with our engineers to achieve consistent filling, optimal output, and minimal product loss.
Leverage our process specialists’ know-how and experience to define your optimal process parameters enabling high-quality production and yield increase. Our facilities also offer non-GMP tablet contract manufacturing.
Process Troubleshooting
Adjusting process parameters (compression speed, edge thickness, pre-compression ratio) on production tablet presses can be challenging and might require a great number of iterations to succeed.
Replicate tablet defects on compaction simulators using your tooling and your powder sample.
Find root cause and optimize rotary tablet press setup with our technology and our expertise.
On-site-support from our experienced technical team to tackle your production issues.
Enhance your Skills and Maximize the Performance of your Tableting Equipment
Continuing education on Oral Solid Dosage (OSD) formulation development and production processes contributes to shortened time-to-market and enhanced manufacturing efficiency.
Training Programs
Maximize the skills of your team of formulation scientists, process engineers and production operators by integrating our various theoretical and practical training programs on compression, equipment, data analysis, and press maintenance.
Consulting Services
Take advantage of our experience and expertise to successfully develop your formulation or optimize your production performance.
Non-GMP Contract Manufacturing
Use our complete product range and facility for the production of tablets from small volume to high volume batches.
Transferring knowledge and know-how is part of our DNA. Our formulation scientists and process specialists provide inhouse and on-site trainings to communicate best practices and make the most of your tableting equipment.
See the full technical brochure on R&D and Process Support here
(click the picture to download the brochure)
Source: MEDELPHARM technical brochure R&D and Process Support
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