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Formulation Development Services for the Parenteral Route
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Ellipse Pharmaceuticals is offering adapted services for the development of parental formulations from NCEs to biotech-derived products. Formulation of SVIs (Small Volume Injectable as described in the USP) depends mainly on the drug candidate characteristics, such as: solubility, stability and pharmacokinetic properties.Our competent and dedicated team will assist you for the complete pharmaceutical development of immediate release and long-lasting formulations.
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Aqueous and non aqueous solutions/emulsions
Injectable liquids are primarily aqueous solutions. For poorly-soluble or totally insoluble therapeutic agents in water, oily solvents and water-miscible solvents are used to prepare ready to use solutions.
Emulsions can also be prepared as a mixture of oil and water-based vehicles with an appropriate surface active agent.
Dry Solids
Some product and especially most therapeutic proteins are unstable in solutions and can only be envisaged as dry products.
These are freeze-dried or powder obtained by sterile crytallisation.
Suspensions
Drugs are formulated as suspension dosage forms for two main reasons :
- Poorly solubility in aqueous solution ( excluding IV injection),
- Need for long-lasting injection.
Polymeric Sustained Release Systems
For molecules exhibiting shirt half life which an extended release is required, polymeric sustained release formulations are needed.
Those systems are particularly appropriate for Biotech molecules such as peptides and proteins.
They include biodegradable microspheres and monolithic implants.
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Selection of Appropriate Sterilisation Method :
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- Terminal Sterilisation,
- Sterilisation of Drug & Solvent separately and Combinaison of two aseptically,
- Sterile Filtering and Aseptic Filling.
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Evaluation of Primary Packaging :
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- Vials,
- Ampoules,
- Pre-filled Syringes,
- Cartridges,
- Botttles,
including the evaluation of interaction with selected formulation.
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In-Use Stability
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- A well qualified team supported by recognized experts,
- A dedicated platform with last generation equipments,
- A National & European network of pilot and manufacturing sites,
- A perfect knowledge of regulatory guidelines & requirements.
