MemFis – A Predictive Tool Supporting Quality by Design
Posted on January 30, 2014
Empirical methodologies have been used extensively to identify polymer-drug pairs and saturation concentrations in solid dispersion formulation development. Here, different mixtures of API and polymers, possibly in combination with solubilisers, are evaluated. This requires long development times and it is questionable if the optimum composition is identified.
Systematic approaches to formulation development of solid dispersions can significantly reduce the number of experiments and hence speed up development. Rather than relying on random mixing of ingredients, the initial formulations in screening studies are selected based upon physico-chemical properties, such as solubility parameters, hydrogen bonding and thermal behaviour.
MemFis (Melt Extrusion Modelling & Formulation Information System) - a predictive in-silico tool developed by Evonik - allows formulators a systematic screening of formulations and initial processing conditions at early stages of solid dispersion product development. It applies well-established solubility parameters and the extensive pharmaceutical melt extrusion knowledge of Evonik Pharma Polymers & Services.
At a glance - MemFis facilitates QbD and saves development time and costs by…
• Implementing proven solubility parameters and molecular interaction considerations
• Providing estimations for both extrusion process and formulation composition
• Combining Evonik information technology and pharmaceutical melt extrusion expertise
• Reducing the number of experiments
• Saving API as well as development time and costs
• Enabling development start with small API quantities
• Being applicable to all solid dispersion process technologies including melt extrusion and spray drying
• Including all pharmaceutical polymers commonly used in solid dispersions, e.g. (meth)acrylics (EUDRAGIT
® polymers), cellulosics (HPMC, HPMCAS, HPC, EC, MC, CAP), vinyl pyrrolidones, vinyl acetates, vinyl pyrrolidones-co-vinyl acetates, and Soluplus
®.
www.eudragit.com
www.biomaterials.evonik.com
www.eudragit.com/e-lab
