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Edinburgh, Scotland
Capsugel’s facilities in Edinburgh, Scotland, are home to its Center of Excellence for Liquid-Filled Hard-Capsule (LFHC) Technology. This enabling technology platform serves a global market with integrated product design, development, and manufacturing of pharmaceutical products. The Edinburgh facility is the largest dedicated pharmaceutical liquid and semisolid production site for LFHC technology in the world and Capsugel has an extensive record there designing and optimizing lipid, semi-solid and liquid formulations, as well as advancing compounds from feasibility through the clinic to commercialization.
Encap Drug Delivery
Units 4,5 & 6
Oakbank Park Way
Livingston
West Lothian
United Kingdom EH53 0TH
Technology Expertise
Capsugel is a global contract manufacturing and development organization and its Edinburgh facility is the world's number one site for liquid and semisolid capsule products. At Edinburgh, Capsugel offers integrated onsite expertise in all aspects of the product development and manufacture of pharmaceuticals for oral drug delivery. The site’s specialty as a Center of Excellence for liquid-filled hard capsule (LFHC) technology, offers clients an advanced dosage-form solution for liquid, semisolid, paste, and multiparticulate applications, overcoming the formulation challenges associated with other types of liquid-filled capsules. In addition to our product-design and manufacturing experience with LFHC and other drug-delivery systems, Edinburgh scientists offer a variety of capabilities to clients dealing with problematic compounds.
Center Of Excellence For Liquid-Filled Hard Capsule (Lfhc) Technology
The Capsugel site in Edinburgh has more than 25 years of experience in the development and optimization of LFHC technology, making it the world leader and expert in this flexible and elegant dosage form. LFHC technology has a proven record for addressing complex formulation challenges, particularly since the capsules are leak proof and protect the active pharmaceutical ingredient (API) from moisture, oxygen, and light. The capsules can be used with an array of pharmaceutically approved lipid and non-lipid excipients, offering unprecedented formulation flexibility. Because of these characteristics, LFHC dosage forms offer an ideal way to improve or reposition existing formulations.
Drug-Delivery Technologies
Capsugel’s Edinburgh staff has extensive expertise in all aspects of oral drug delivery and provides clients with simple, scalable formulations designed for a successful clinical outcome. Technological solutions are available for immediate- and controlled-release formulations; and combination products.
Particular areas of expertise include the following
- poorly soluble drugs which require bioavailability enhancement (lipid formulations including self-emulsifying drug-delivery systems [SEDDS] and self-microemulsifying drug-delivery system [SMEDDS]);
- hygroscopic and oxidation sensitive compounds;
- highly potent and cytotoxic drugs ;
- immediate-, controlled- and sustained-release formulations;
- compounds requiring delivery to specific regions of the GI tract (e.g., small intestine or colon), such as small molecules, proteins and peptides;
- compounds with low melting points; and
- compounds with sensitivity to air, moisture, light, or other active ingredients.
Pharmaceutical Development Services
As the world’s largest company dedicated to liquid and semi-solid encapsulation, Capsugel understands product development. The company offers a full range of preformulation and formulation development services for new substances or upgrades of existing products. In Edinburgh, product design expertise includes lipid/solvent/cosolvent formulations, liquid/semi-solid products, targeted colonic-delivery products using LFHC and specialized coatings, dual delivery products with specialized capsule-in-capsule technology, and abuse-deterrent formulations.
Formulation Expertise and Product Development
Capsugel's experienced team at Edinburgh has helped hundreds of clients advance their molecules quickly and cost effectively to clinical evaluation, while minimizing the risk of formulation failure.
We provide a full range of Pharmaceutical Development Services from preformulation to prototype formulations for clinical trials, tailoring these to the needs of the client—whether they want a rapid first-in-human development program or a formulation optimized with commercial manufacturing in mind.
Our technologies include:
- capsule-in-capsule for delivery of the same or different APIs,
- formulations for targeted delivery to the colon, and
- abuse-deterrent formulations to deter extraction of controlled drugs or pain medicines.
Capsugel technologies are applicable to
- all compounds and especially those which are poorly soluble, have poor bioavailability or are oxygen- or moisture-sensitive;
- small molecules and biomolecules (e.g., proteins and peptides);
- controlled drugs; and
- compounds which are highly potent (e.g., cytotoxics, cytostatics).
Our technologies offer the following advantages
- formulation is fast for First-in-Human, providing an excellent development tool to get to decision making points faster;
- less API is required for formulation development compared to tablet and IV formulation;
- ease of scale-up enables faster development during all phases of clinical development;
- enables targeted delivery of drugs; and
- appropriate for lifecycle management and patent life extension.
Manufacturing Services
Capsugel supports clients for all their clinical trial manufacturing needs (Phase I to IV) and with full commercial-scale manufacturing. This includes high-containment manufacturing for highly potent and cytotoxic products.
Our state-of-the-art facility in the United Kingdom is the largest in the world for the manufacture of liquid and semi-solid filled capsule pharmaceutical products, offering clients unrivalled capacity and flexibility. This facility is approved by the FDA and licensed by the MHRA. The staff at Edinburgh has built up an unrivalled level of experience and track record in this area, offering
- more than 25 years of experience of capsule manufacturing (filling, banding and coating of capsules);
- a focus on regulated pharmaceutical products (e.g., rather than nutraceuticals);
- experience in scale up and validation required for commercial manufacture;
- experience manufacturing more than 20 commercial products;
- manufacturing capacity to transfer in existing commercial products, including soft-gel switches and capsules sealed with alternative technologies (LEMS);
- flexibility in terms of manufacturing batch sizes and experience with commercial volumes from less than 1 M to 100 M; and
- expanding capacity and a commitment to invest in our facility and equipment