Soft-Gelatin Technology

Capsugel uses soft-gelatin capsule technology, as well as liquid-filled hard capsules, to bring a number of formulation and commercial benefits to biopharmaceutical and health & nutrition customers. Softgel capsule technology is a key offering within our suite of technologies for bioavailability enhancement, as well as for specialized product development for low-dose products, hormones and other challenging applications.

The one-piece softgel capsule features an easy-to-swallow shell that meets all global quality standards under a state-of-the-art Quality Assurance system that enables traceability of raw materials. The shell is tamper-resistant, masks taste and smell, and is available in a broad range of unique shapes and colors.  

A wide variety of lipid-based fill excipients is used to improve the bioavailability of poorly water-soluble compounds, reduce food effects, and improve drug stability. The wide range of shapes and colors available for the shell meet objectives for branding, line extension and lifecycle management.  

Dosage Form Flexibility

Softgel capsules offer unparalleled dosage-form flexibility:

  • Encapsulation of a wide variety of fill formulations 
  • Wide array of sizes, shapes, colors and forms
  • Oral, topical, ophthalmic and vaginal administration

Proven Applications

Softgel capsules address a broad array of formulation challenges, often incorporating a variety of pharmaceutical-approved lipid-based excipients. Formulation flexibility is a hallmark of softgel formulation and manufacturing technology.

Bioavailability

Allows multi-fold improvement in bioavailability and reduction of food effect as demonstrated in preclinical and clinical studies

Dose Uniformity

Assures dose uniformity of low dose APIs

High Potency

Provides safe handling of high potency API

API Stability

Constitutes a suitable dosage form for oxygen and/or light sensitive APIs and APIs with a low melting point 

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. 

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 vitroevaluation 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)