Skyepharma enhances CDMO capabilities with Medelpharm STYL’One

Beynost, France: – Research-based powder compaction specialists Medelpharm has assisted CDMO Skyepharma AG in strengthening its formulation and upscaling capabilities, significantly, thus reducing time to market.

This “evolution” of Skyepharma’s business model is largely based on the installation of the latest STYL’One Evolution Multilayer Tableting Instrument at its small scale GMP lab in Saint-Quentin Fallavier, near Lyon. The STYL’One is installed next to processing equipment for providing very small to medium size batches.

Skyepharma, part of the Vectura Group, specializes in developing modified release dosage forms for contract manufacture. Historically it has developed proprietary solutions based on multilayer and dry coated tablets. STYL’One Evolution had the great advantage of supporting both these technologies alongside conventional high speed tableting and dry granulation studies.

Matching process parameters for QbD

Where Skyepharma is responsible for formulating the product, it aims to provide a formulation that matches the quality target product profile (QTPP) as closely and quickly as possible. If involved at a later stage, the company’s goal is to study and characterize the process parameters to ensure proper upscaling to commercial supply. In either respect, site change could also be a challenge with possible equipment change or process simplification. Skyepharma needed a single platform that could cover all these aspects reliably.

Skyepharma specified its STYL’One with Analis Production software that is 21 CFR compliant for production of clinical material. Medelpharm also supplied customized solutions for specific requirements of multilayer and press coated tablets, including increased scale sensors and micrometric core centering systems.

Standardizing on Quality by Design approach

In order to produce tablets at very small scale under highly controlled conditions, SkyePharma needs to study inert as well as active ingredient tableting characteristics, with STYL’One making it much easier for us to interpret dissolution profiles for various formulations in prototype, allowing efficient screening of formulation candidates to match target product profile.

Once target profiles have been matched, the accuracy of STYL’One compression simulator makes it easier to conduct studies on formulation variables with QbD in mind using minimal API quantities.

With complex formulations such as multilayer or press coated tablets, compression pressures play a major role in the final dissolution profile. STYL’One generates invaluable data which allow Skyepharma to validate critical parameters at a very early stage with confidence.

Science-based approach accelerates tablet development

This investment has unlocked a series of greater efficiencies for Skyepharma in much reduced time for change of tooling, setting of parameters, cleaning, etc., allowing its formulation scientists to concentrate more effectively on analyzing results, planning next tests and ultimately providing a better service to clients.

STYL’One’s reliability and versatility plus high level of correlation with industrial presses has allowed the laboratory to prototype solutions far more economically, such as testing new punch design using just one set of tooling and conducting intensive test programs without impacting production planning.

In all these ways, final yield and timelines of production are less impacted, allowing Skyepharma to uphold key performances indicators in a “On Time Delivery” and “Right First Time” philosophy.

Key asset for one-stop CDMO

Acquisition of STYL’One has dramatically changed the way Skyepharma deals with development and scale up of products, ultimately helping clients reach market quicker without compromising product quality.

Skyepharma President, David Lescuyer, commented “This tool has created a true win/win situation between Skyepharma and its clients.”

“The STYL’One Evolution has been a major asset in our transformation into a ‘One Stop Shop CDMO’, offering full coverage from formulation to manufacturing and commercial packaging including serialization,” said M. Lescuyer.

About Medelpharm

Medelpharm is an international enterprise, located in Lyon, making available the most powerful, still easy-to-use R&D tableting presses like STYLCAM and STYL’One to every formulator and development scientist.

You are looking for assistance in API and excipient characterization, solid dosage formulation or production trouble shooting? Please come and visit our powder characterization laboratory in Lyon.

Medelpharm offers a comprehensive portfolio of Mechanical Compaction simulators, Multifunction R&D Tablet Presses, and Process equipment and extensive Services in tableting, granulation and coating.

Made by people for people.
Website link: www.medelpharm.com

Resources

Click on STYL’One at SkyePharma to download full case study.