lipid and liquid-based formulations

Our lipid and liquid-based formulation services provide flexible, fit for purpose solutions to a wide range of formulation challenges including solubility / bioavailability improvement, addressing food effect issues, and low dose applications.

Lipid and liquid-based formulations (LBF) based on oils, surfactants and cosolvents represent a robust approach for bioavailability enhancement in either liquid-filled hard capsules or soft gelatin capsules. Liquid and semi-solid fill technologies are well suited to compounds with low aqueous solubility or poor permeability and have long-established market precedence. LBF approaches are also utilized in addressing other key formulation challenges, including:

• Low dose applications: optimization of dose and content uniformity
• High potency applications: safe handling of HPAPI via liquid processing
• Abuse deterrence: liquid-based formulations incorporating a range of excipients which can deter routes of abuse specific to the active compound
• Colonic delivery: liquid-filled approaches for improved drug delivery to the colon
• Combination products: dual liquid-filled capsule systems for fixed dose combinations or dual release profiles 

Our integrated services include phase-appropriate processing across proof-of-concept studies through clinical trials and commercial production.

Lonza lipid and liquid-based formulation benefits

Lipidic vehicles are generally well absorbed from the gastrointestinal tract, providing better oral bioavailability than can be achieved with the solid drug substance. We have extensive experience and capabilities across all oil-based and oil-free approaches as categorized using the Lipid Formulation Classification System (LFCS): 

Our scientists have extensive experience in designing and formulating self-emulsifying drug-delivery systems (SEDDS) and self-micro emulsifying drug-delivery systems (SMEDDS) for the oral administration of drugs with poor aqueous solubility. 

Our proprietary Lipid Expert System™ supports and accelerates lipid-based formulation development by allowing rapid selection of the optimal lipid approach. This system, based on an extensive database of phase diagrams, offers several distinct advantages versus traditional trial and error approaches, including:

• Quality by Design (QbD)
• Efficient candidate screening
• Intellectual property

We have a full range of development and production capabilities for liquid-filled hard capsules, soft gels or lipid multiparticulates appropriate for laboratory scale to commercial scale. Specialized filling and sealing equipment is in place for feasibility, ICH stability and clinical batch manufacture. Our production facilities are inspected by FDA, MHRA, ANVISA, and EMA-based regulatory authorities.