Scale-up and Quality by Design (QbD) processes
Product Description
Skyepharma Production S.A.S
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FR
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2017On CPHI since
Categories
Skyepharma Production S.A.S
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FR
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2017On CPHI since
More Products from Skyepharma Production S.A.S (15)
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Product Regulatory services
NDA/ANDA MAA-CTD writing Regulatory support -
Product Worldwide production and supply (US, EU, Russia, Asia/Pacific, EMEA, Latam)
Certifications : FDA, Europe, ANVISA, Korean FDA etc. -
Product Early stage formulation Development & Process Design
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... -
Product Clinical trial material (CTM) manufacturing and release
We offer capabilities for manufacturing of small and large scale clinical trial material (CTM) as well as characterization and release from phase 1 to phase 3. -
Product Manufacturing of complex and classic oral solid dosage forms
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. -
Product Analytical Development and expertise
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... -
Product Packaging in Blister
Primary packaging: Forming station for both PVCs and aluminium and all kind of feeder for tablets and capsules. Secondary packaging: Labelling, carton and casepacker. -
Product Packaging in Bottle
Primary packaging : Plastic and glass bottles (round and square) loading station. Secondary packaging : sealing, labelling, carton and casepacker. -
Product Packaging in Stick Pack
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. -
Product Serialization and Aggregation
Bottle and blister lines fully serialized and aggregate. -
Product Geoclock® Technology_Customisable chronotherapy
Geoclock® allows for timed release of drugs that is independent of food or pH. Geoclock® is a validated oral drug delivery technology that can be used to release the drug from the tablet after a pre-determined lag-time that is independent of food or pH. Geoclock® can additionally be used for multi... -
Product Geomatrix® Technology_Customisable drug delivery platform
Geomatrix® provides a customisable drug delivery platform for controlled release versions of orally available molecules. The combination of layers, each with different rates of swelling, gelling and erosion, controls the drug release rate within the body Geomatrix® is is currently used in 8 produ...
Skyepharma Production S.A.S resources (2)
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News Skyepharma selects Veratrak platform to ensure secure data storing and sharing
Using Veratrak's platform, the CDMO will have full oversight of data, including an audit trail of data and document processes -
Whitepaper Recent development in complex tablet formulation design
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.
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