Lipid-based formulations and versatile liquid-filled hard capsule (LFHC) technology are core strengths of Lonza. LFHC technology has a proven track record in addressing a range of complex formulation challenges inclusive of solubility/bioavailability and low dose/highly potent API issues. We provide integrated services for LFHC development and manufacturing from proof-of-concept studies through clinical trial manufacture and commercialization.  

Liquid-filled hard capsule technology provides an advanced dosage form for liquid and semi-solid formulations. LFHC technology has been utilized in bringing new molecules to market and repositioning existing molecules for improved performance or new indications. Our product development teams utilize LFHC across a range of applications, which result in innovative dosage forms that are leak-proof, airtight, and impermeable to moisture, oxygen and light. 

Alongside the ability to formulate and deliver challenging poorly aqueous soluble APIs, liquid-filled capsule-based systems have a number of advantages. Lipid-based formulations can be formulated and manufactured in soft gel capsules or hard capsule shells. When developing a liquid-filled hard capsule, capsule selection is fundamental and needs to be assessed early on in the process, with a view to scale up to be performed.

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Processing Low Viscosity Products Using Liquid Filling and Banding Technology

liquid-filled hard capsules: proven applications

Liquid-filled hard capsule (LFHC) technology is used to address a broad array of formulation challenges, often incorporating a variety of biopharmaceutically-approved lipid and non-lipid excipients.  Formulation flexibility is a hallmark of LFHC formulations and we have successfully utilized the technology to achieve:

  • Bioavailability enhancement
  • Dose uniformity 
  • Safe formulation of highly potent API 
  • Improved API stability 
  • Combination products 
  • Colonic delivery
  • Abuse deterrence

Additionally, LFHC technology can be used for rapid screening of compounds and accelerated development timelines for compounds requiring an LBF approach. Its relatively simple manufacturing process, which has been refined through decades of process engineering, offers a shortened development cycle for CTM manufacture and scale-up.

Our focus on science and engineering has led to the development of proprietary equipment and processing techniques, which in turn provide greater efficiency, reliability and productivity of LFHC manufacture.

The choice between capsule banding versus capsule fusion technology is application and customer-specific. Capsule banding, where a visible band of gelatin or HPMC is applied around the capsule joint, is one approach often favored for client branding, dose identification, or for tamper-evidence considerations. The second option is our proprietary LEMS® (Liquid Encapsulation Micro-Spray) or “Fusion” Technology, which utilizes the application of a fine micro-spray of sealing solution around the joint and between the capsule body and cap. Both sealing approaches are fully validated with commercial precedence in ensuring product quality and robust, leak-free performance.

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