Formulation development

The Formulation Development department has dealt with over one hundred marketed products.

Thanks to its full-service capability (from analytical characterization of the active compound through to industrial scale-up) or specific project tasks (trial batch manufacturing, analytical validation, clinical packaging, etc.), our multidisciplinary team can design simple or innovative, more complex solutions.

With over 20 years of experience and a team of expert pharmacist and engineers, the Formulation Department offers a broad range of services and technologies for producing the following type of formulation:

 

DRY FORMULATIONS: batches from 0.5 to 50 kg

- tablets (coated or non-coated)
- semi-automated or automated capsule filling with pre-compression
- sachets of powders
- powder sticks
- dry mixing and dry or wet granulation processes

 

LIQUID FORMULATIONS: from 0.1 to 50 l or kg

- drinkable oral solutions and suspensions
- liquid stick packs
- creams, gels, ointments

 

PLACEBOS

In some clinical trials, the study drug is compared with a placebo. Unither develops and produces all types of placebo in solid or liquid formulations and also performs ICH stability studies.

 

MASKED TABLETS

For double-blind, comparative clinical trials, Unither can produce batches of masked tablets. It can also develop dissolution methods and perform ICH stability studies.

 

PRIMARY PACKAGING

  • blister packs: PVC/ALU, PVC-PVDC/ALU, ALU/ALU, Aclar, Triplex, etc.
  • sachets
  • rigid tubes, flexible HDPE tubes, aluminium tubes
  • pillboxes
  • flasks and bottles

 

 

Types of equipment

Mixers, mixer-granulators, ovens, fluidized bed air drying systems, compactors, grinders, calibration sieves.

Coating in perforated or non-perforated pans

Compacting in dual-motion or rotary presses

Semi-automated or automated capsule filling with pre-compacting

Mixing tanks for liquids and pastes, vacuum jacketed tank

Blister and sachet packing, tube filling

All items of equipment have been qualified

 

 

Premises

GMP-compliant installations, approved for pharmaceutical manufacturing by the AFSSAPS.

Four manufacturing suites and a development suite.

Climate control.

Prevention of cross-contamination thanks to use of an independent clean air supply system for each suite and a corridor/suite overpressure airlock.

The premises have been qualified for manufacturing operations. 
unither - 41 rue de la Chaussée d'Antin, 75009 PARIS    +33 (0)1 44 63 51 70