A new structure of porous silica to overcome drug solubility challenges in oral formulations
The pharmaceutical industry is facing a serious issue: a shortage of new drugs. Existing patents are expiring and therapeutic pipelines are shrinking as ever more drug candidates fail in development. Poor bioavailability causes around 40% of failures, often due to low solubility. Today, developers are faced with this issue in over 90% of projects. Several technologies are available to address this, but no universal solution – every tool has strengths and weaknesses. Many solubility problems in early drug development remain unsolved, leading to high failure rates.
Bimodal silica is a promising drug carrier to enhance bioavailability of poorly-water soluble drugs, and has been shown to improve performance for numerous APIs in-vitro and in-vivo. This will benefit NCE development projects where low solubility is an issue. As more patents expire, reformulation of currently marketed drugs will enhance lifecycle management. This new tool can also be used to recover former drug candidates which failed due to low solubility, and to introduce alternative solutions for established drugs in the case of generic APIs with solubility issues.
Literature increasingly describes mesoporous silica as a potential drug carrier. But how can mesopores’ huge surface area inside silica particles be made accessible? Join in this discussion to understand how this innovative material, but not a novel excipient, contains both mesopores and macropores for good accessibility.
Presented by
Dr. Hans-Leonhard Ohrem,
Portfolio Development Manager
Leo Ohrem is the Portfolio Development Manager at Merck Millipore, a life science division of Merck KGaA, Darmstadt, Germany. With an engineering background and degrees from Aachen, Germany and Cornell University, NY, USA, he gained experience in biotechnology as well as in pharmaceutical technology. For 15 years he has been responsible for product development and technical marketing of functional solid dose excipients and deals with end users and developers in this field on a worldwide basis.
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Key Learning Objectives
- How to enhance solubility of low soluble drugs for oral administration by using monographed silica as a carrier.
- Get to know an innovative structure of silica particles combining meso- and macropores.
- Learn about loading, performance and stability of a silica supported enabeling formulation.
- See how you can get versatile help and application support for bioavailability issues.
Audience
- VP/Director/ Head of R&D
- Heads of Licensing
- Heads of Formulation R&D
- Heads of Preclinical Drug Development
- Heads of Drug Discovery
- Heads of Innovation Technology