Clinical trial material (CTM) manufacturing and release

Soctec® was developed for drugs that need to be retained in the stomach for an extended period of time to then being slowly released either for a local effect in the stomach or for absorption in the upper intestine. Soctec® is a versatile extended release gastro-retentive platform technology that ...

Our proprietary medicated chewing gum technology uses an approach similar to multilayer tableting. A combination of layers modulates the release rate of the active ingredients and flavouring agents when the gum is chewed.

By using microfluidization technology process, Skyepharma provides solution to increase bioavailabity of poorly soluble APIs (micro and nanoparticule). It is also an interesting technology for micro and nano emulsion manufacturing.

NDA/ANDA MAA-CTD writing Regulatory support

Certifications : FDA, Europe, ANVISA, Korean FDA etc.

We have extensive experience in solving complex formulation challenges. Our experts can apply our extensive range of proprietary technologies for immediate (IR) and modified (MR) / sustained, slow (SR) / controlled (CR) / extended (XR, ER) / pulsed / timed release as well as enteric and gastro reten...

Manufacturing of classic and complex oral solid dosage forms:  single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules, powder & pellets.

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...

Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps. 
Our capabilities :...

Primary packaging: Forming station for both PVCs and aluminium and all kind of feeder for tablets and capsules. Secondary packaging: Labelling, carton and casepacker.

Primary packaging : Plastic and glass bottles (round and square) loading station. Secondary packaging : sealing, labelling, carton and casepacker.

We can offer batch sizes from a few kilograms to several hundreds and the equipment is versatile in terms of material: powder, granules or pellets can be filled with PET / ALU / PE complex films up to 17 mm wide and up to 150 mm long. 

Using Veratrak's platform, the CDMO will have full oversight of data, including an audit trail of data and document processes

In this article, Mathieu Degomme, PharmD, Pharmaceutical Development Project Manager, and Aline Moulin, PhD, Pharmaceutical Development Director, both of Skyepharma, outline three case studies from recent early-stage development programmes to illustrate what kind of complex tablets can be developed to meet specific target dissolution profiles for versatile applications.