Softgel and Liquid-Filled Hard Capsule Manufacturing: Ploërmel and Edinburgh

From Feasibility to Commercial Supply

Both sites take a lipid-based programme through the same defined sequence:

1. Pre-formulation: API solubility screening and excipient compatibility

2. Analytical development: method development and validation, including in vitro performance evaluation by lipolysis and micro-dissolution at Ploërmel

3. Formulation: SEDDS and SMEDDS lipid systems; fill matrix and shell selection

4. Process development: encapsulation, banding and sealing parameters

5. Clinical supplies: clinical and registration batch manufacturing, Phase I to Phase III

6. Scale-up: from bench and pilot scale through to commercial encapsulation

7. Industrialisation: validation, stability, tech transfer and CTD documentation

A liquid-fill programme depends on parameters set during encapsulation itself: shell and fill compatibility, seal or band integrity, and the fill viscosity and temperature at which the matrix runs correctly on the line. These are established on the equipment that will produce commercial batches, so moving a programme to another manufacturer means re-establishing them and re-confirming stability on the new configuration. At NextPharma Ploërmel and NextPharma Edinburgh, formulation development, clinical supply and commercial encapsulation sit on the same site, so the fill formulation, encapsulation parameters and analytical methods established during development carry into commercial batches.

Certifications and Inspection History

Both sites accept regular customer audits. For the full range of oral solid and liquid dosage forms available across the network, see the Commercial Manufacturing and Packaging hub.