Formulating active ingredients into industrializable products

Formulation development is integrated from the earliest R&D phases to ensure a stable and effective formulation and a reproducible and easily industrializable manufacturing process.

This approach relies on in-depth technical expertise, covering liquid (sterile and non-sterile), semi-solid, and solid forms, while integrating scale-up, regulatory, and commercial manufacturing constraints from the design stage.

Each formulation thus targets a dual objective: meeting therapeutic needs and ensuring reliable large-scale production.

Formulation development services

Comprehensive support in all phases of pharmaceutical formulation:

Pre-formulation

Solubility study, excipient compatibility, active ingredient study, etc.

Formulation

Development plan, selection of dosage(s), pharmaceutical form, and excipients, with preliminary stability studies

Pilot formulation

Production of R&D batches for preclinical studies or feasibility tests

Development and optimization of the manufacturing process

Process adaptation and transposition to equipment and GMP standards

Compatibility & interactions

Active ingredient, excipients, packaging, and stability studies in accordance with ICH guidelines

CMC documentation

Drafting of the optimal formula, analytical specifications, and technical documents required for regulatory submissions.

Recognized expertise in ophthalmic formulation

Gel

A global leader in ophthalmic products, Unither Pharmaceuticals leverages long-standing expertise in ophthalmology, with hundreds of products developed, transferred, and produced for laboratories worldwide.

This specialization is based on:

 

 

  • In-depth expertise in eye drop formulation: solutions, gels, emulsions, and suspensions packaged in sterile single-dose or multi-dose units with or without ophthalmic preservatives.

 

  • State-of-the-art facilities equipped with dedicated rooms for different pharmaceutical forms and for the manufacturing of preclinical batches.

 

  • The development of innovative proprietary products, including a patented sol-gel eye drop that is liquid during instillation and then transforms into a gel to optimize ocular retention.

 

  • Tailored support capabilities for complex and differentiating projects, from prototype to commercialization.

Why choose Unither Pharmaceuticals sites for your formulation development?

A site in France dedicated to innovation and development

Design for industrialization, from the pre-formulation stages

More than 100 products developed and available on the market

Collaborative work between internal R&D teams and external partners

Up to 30% funding via the Research Tax Credit (for French companies)

FAQ - Pharmaceutical formulation development

Sterile and non-sterile liquid forms (solutions, suspensions, syrups, (nano)emulsions), semi-solid forms (gels, creams, suppositories) and solid forms (powders, tablets, capsules).

Yes. We conduct pre-stability studies in parallel with development to ensure the durability of the formulation over time.

Yes. Our formulation teams work directly with industrial teams to ensure smooth scale-up, in compliance with GMP standards. Production for sterile and non-sterile liquid forms is possible at our sites.