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Development Solutions
for Challenging Drug Compounds
Have a NCE that is poorly water soluble? We can help.
Discovering viable and profitable new drugs today often requires working with NCE's that are poorly water soluble. These NCE's require time-consuming experimentation and analysis in order to achieve satisfactory drug absorption from a solid oral dosage form - a challenge that can some times take years of development without yielding positive results.
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By formulating in lipid-based liquid or semi-solid formats, bioavailability may be significantly improved. |
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Lipid-based systems may also be used to improve content uniformity, particularly at low dosage levels. |
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Formulating in lipid-based liquid or semi-solid formats is also an excellent way to reformulate existing drugs in an effort to extend patent protection, or to create exciting new line extensions for OTC drugs. |
The possibilities are limitless. The results profound.
Not only does formulating in liquids help overcome obstacles once thought to be insurmountable, but it also can reduce the development time. The time saved translates directly into more time selling under patent protection. For blockbuster drugs, this could mean billions of dollars in additional revenue.
Helping clients achieve their goals of bringing promising NCEs to market, working with them to reformulate existing drugs into liquids, or assisting them with new OTC liquid products are key initiatives at Capsugel. It is why we created the Licaps® Drug Delivery System - a suite of products, services and patented technologies supported by a team of dedicated scientists devoted to liquid formulations. From initial discovery to full-scale commercial production, Capsugel has the global resources, knowledge, and talent to help clients exceed their objectives.
For more information on our development solutions, Contact Us
Product Development Services
Improving the bioavailability of poorly soluble drugs requires a multifaceted approach, including innovative technologies, unique products and most of all highly-knowledge scientists who have the experience needed to achieve the desired results. At Capsugel, we bring together each of these key elements at our new, state-of-the-art Product Development Center.
The Product Development Center includes Formulation Development, Analytical Development and Small-scale GMP Manufacturing departments. Experts in the filed of microemulsions utilize patented technologies and sophisticated computer-based modeling that draws on both conventional and proprietary technical information to solve difficult formulation challenges quickly, including:
- Low aqueous solubility
- High potency
- Waxy/oily entities
- Cytotoxicity
- Poor/variable bioavailability
- Sub-optimal drug release
Learn more about Capsugel's Product Development Centers.
For more information, Contact Us.
Unique Hard Capsules
Licaps® Capsules, created specifically for our Licaps Drug Delivery System, are specialized two-piece capsules for liquid and semi-solid formulations. Available in both gelatin and HPMC, Licaps capsules are used in our R&D liquid filling and sealing machine (CFS 1200) and our commercial-scale sealing LEMS machine.
Learn more about the unique benefits of Licaps Capsules.
For more information on Licaps Capsules Contact Us.
Specialized Equipment Line
Utilizing our patented LEMS (Liquid Encapsulation Microspray Sealing) technology, Capsugel has developed both an R&D benchtop liquid filling and sealing machine for clinical trial batches and a commercial-scale sealing machine.
Learn more about the CFS 1200 R&D Liquid Filling and Sealing Machine.
To learn more about commercial-scale capsule sealing using LEMS® technology, please contact your local Sales Representative.
Scale-up & Support Services
Upon successful development of a client's liquid formulation, Capsugel offers the services and patented technology to assist clients with clinical batches, and to scale up to full-scale production. Small-scale clinical trial batches for Phase I clinical trials can be provided by Capsugel, and are supported by strong analytical capabilities, including:
- CGMP analytical development and validation
- Specification development
- ICH regulatory stability studies
- Cleaning method development and validation
Once Phase I trails are completed, Capsugel can assist clients with Phase II & III clinical activities, including:
- Formulation optimization to enhance manufacturing process or stability
- Continued analytical development and transfer of methods
- Scale up to commercial grade equipment and technology transfer support
For more information, Contact Us.
Manufacturing Capabilities
Capsugel offers manufacturing options to suit practically any client need. Contract commercial manufacturing is available for drugs developed by our Product Development Centers or customer developed liquid formulations. And for customers wishing to do in-house manufacturing, Capsugel offers the specialized equipment and products needed to get the job done effectively.
For more information, Contact Us.
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Pharmaceutical / OTC
