Soft Gelatin Capsule Manufacturing
Liquid and semi-solid fill technology and manufacture are core strengths of Capsugel. These technologies are routinely employed for improved bioavailability, high potency compounds, addressing food effects, improved active ingredient stability, taste and odor masking, as well as effective product differentiation and branding.
Capsugel has built a robust soft gelatin capsule option to complement our leadership in the liquid filling of hard shell capsules (LFHC). Our Softgel Center of Excellence is located in Ploermel, France and serves a global market with integrated product design, development and manufacturing of pharmaceutical softgel products. The facility has an extensive track record in designing optimized lipid / semi-solid / liquid formulations, and advancing compounds from feasibility through clinic to commercialization. The Ploermel site has been inspected by global regulatory authorities, including the US FDA, EMA (ANSM), and ANVISA.
Focus on Challenging Pharmaceutical Compounds
- Hormones (e.g. progesterone)
- Light or oxygen-sensitive compounds (e.g. (iso)tretinoin, pharmaceutical-grade fish oils)
Manufacturing Track Record
- Over 20 years of experience in softgel product development and manufacturing
- Inspected by US FDA, EMA and ANVISA
Capsugel Ploërmel has 3 state-of-the-art manufacturing units to support feasibility, stability, clinical and commercial product manufacture.
- Integrated product development and commercial manufacturing at one site
- Specialized isolation capabilities for potent and highly potent compounds
- In-house-developed dosing pumps for difficult-to-fill formulations
- 11 softgel production lines (plus 2 liquid-fill hard capsule lines)
- Pilot and commercial manufacturing
– Non-GMP and GMP capabilities
– Feasibility, stability and clinical batches
- On-site capsule printing capabilities
The product development team at Ploermel benefits from the entire network of Capsugel product development sites in Europe and the US, and shares best practices in identifying optimal technologies and approaches for formulation challenges. A full range of pre-formulation and feasibility studies – including lipid-based solubility screening for new chemical entities and in vitro evaluation of lipid-based formulations to predict in vivo behavior – is conducted for client compounds. Dedicated suites are used for small-scale lab encapsulation for feasibility assessments, stability data generation, and final formulation selection.
Product Design Expertise
- Extensive know-how on lipid-based excipients
- Expert databases to speed up product development
- Specialized in-vitro tools (e.g. dispersion and digestion testing) to predict in vivo behavior of lipid-based formulations
- Network of academic experts in lipid-based drug delivery (e.g. Monash University, Australia)