Softgel technologies are becoming an increasingly popular dosage form in both the prescription (Rx) and over-the-counter (OTC) markets. From better stability to easier swallowability, softgel formulations offer numerous benefits.
Decades of experience. Capabilities spanning development through commercialization. Our dedicated encapsulation facilities in High Point, NC, and Tilburg, Netherlands have the capacity to produce 10–12 billion softgels annually. Our scientists are skilled in developing softgel formulations in early development to overcome low solubility challenges, speeding new molecules to clinic. We develop softgel formulations for late stage life cycle management as well, helping clients retain market share and maximize product lifetime value. Development and manufacturing capabilities for specialized products include highly potent drugs, hormones, DEA-controlled substances (Schedule I–V and List I) and abuse-deterrent products. And when existing Rx products need new revenue streams, product and brand managers can tap into our softgel expertise and proprietary technologies for new softgel product formulations. We offer cost-effective and flexible business models ranging from fee for service, licensing of existing products and (co)-development of proof of concepts. Patheon, by Thermo Fisher Scientific, brings value to pharmaceutical and consumer health care companies through ideation sessions and flexible business models that can:
Our wide range of diverse softgel technologies meet the needs of your molecules and markets, including advanced solutions for enhancing solubility and bioavailability.
Sofgels® Technology is suitable for liquid formulations, applications requiring faster onset of action, low-dose products and those with poor bioavailability that would benefit from a lipid system or nanoparticle delivery method. These capsules are easy to swallow and twist-off options are available.
EnteriCare® Softgels protect compounds from harsh gastric acids for targeted delivery and also protect APIs that normally cause local irritation such as ibuprofen. Also reduces the risk of reflux.
Soflet® Gelcaps are a gelatin-enrobing technology that makes capsules easy to swallow. A broad palette of colors is available.
Chewels® Chewable Gels can be formulated with various sensory properties and offers a chewable option for patients (pediatric and geriatric) that have difficulty swallowing. No water is needed. Can also be formulated as a lozenge.
With a soft-chewable shell, LiquiSoft™ Softgels are perfect for liquid fills that require a fast onset of action and/or buccal absorption.
Our regulatory affairs team in Tilburg provides unmatched support for clients during development/pre-approval and post-approval for dossier maintenance. Our experience with various regulatory bodies and close relationship with your drug’s development team, make us easy to work with and can help you get to market quickly.
Our offerings throughout development and pre-approval include:
Our regulatory affairs assistance does not end at drug approval. We offer post-approval compliance review of dossiers according to ICH, EMA and FDA legislation, as well as maintenance throughout the dossier lifecycle, such as variations and renewal applications submitted to the competent authorities.
To learn more about how our team can make your submission a success, please contact our experts here.
Softgel formulations are an attractive, popular dosage form for patients, making them ideal solutions for new prescriptions and new product lines resulting from Rx to OTC switches and life cycle management projects. Interested in learning more about our softgel capabilities? Download our softgels brochure here.
Have a question about softgels? Ask our Softgel Experts!