Preformulation and formulation development

Whatever you need, from stand alone services to full development program, Bertin Pharma can provide tailored-made solutions including:

• Finished dosage forms development
• Optimisation of existing formulations
• Life Cycle Management
• Generic & Generic Plus development

All conventional dosage forms can be developed at Bertin Pharma, manufactured and packed for use in clinical trials, such as:

Dry Formulations (oral route)

• Blending
• Compression
• Tablets (mono/multi-layers, plain or coated)
• Capsules
• Multi-particle systems (powder, pellets, granules, micro-tablets)
• Implants
• Soft & liquid filled capsules

Liquid & Semi-Solid Formulations
(oral and topical route)

• Aqueous and non aqueous solutions
• Aqueous and non aqueous suspensions
• Gels, emulsions, micro-emulsions
• Ointments
• Syrups
• Micro/Nano-emulsions
• Semi-solids such as creams, gels, ointments

Formulations for the Parenteral Route

• Aqueous and non aqueous solutions/emulsions
• Dry solids
• Suspensions
• Polymeric Sustained Release Systems
• Sachets of powder, semi-solids or liquids
• Injectables
  
  

Modified release tablets
Selection of Appropriate Sterilisation Methods

Our experts are trained on a wide range of dosage forms with small to medium-size manufacturing equipment from 2 kg/5 liters up to 120 kg/50 liters.

Development and manufacturing reports are generated to fill-in the IMPD or the CTD.

For the specific needs of double-blind clinical trials, Bertin Pharma can develop a placebo matching the study drug product or an over-encapsulated solid dosage form.

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Related services
- Equipment and technologies
- Industrial transfer
- Manufacturing & packaging
- Quality control & dispatch of clinical supplies
- Analytical development & stability studies
- Regulatory affairs