May 29 2012
Molecular Profiles, a leading specialist contract research and manufacturing organisation, announces that it has entered into a strategic collaboration with GEA Process Engineering - the company behind the world-recognized GEA Niro spray drying technology.
Using the GEA Niro DRYNETICS™, single particle spray drying approach, the collaboration will assess early screening of poorly water soluble drugs and polymer compositions for the improvement in solubility.
This partnership further highlights Molecular Profiles’ comprehensive materials characterisation capabilities for supporting formulation development strategies through an expert assessment and understanding of the link between structure, function and stability.
Developed with the aim to ensure the improved screening of drug candidates earlier on in the development process, Molecular Profiles and GEA Process Engineering are working to develop a unique way of preparing solid dispersions of drugs and polymers.
The purpose is to understand the viability of the potential drug delivery platform at single particle scale by comparing with batch produced spray dried approaches.
GEA Process Engineering is the world leader in process engineering, process equipment and plant engineering, specialising in the manufacture of products in powder, granular or agglomerate form in the food, chemical and pharmaceutical industries. With 79 years experience in supplying spray drying solutions to the pharmaceutical industry, the Danish-based company has gained a wealth of data in this industry.
The benefits of using the GEA Niro technology for this application are the ability to assess the stability of drugs in polymer systems where only an extremely limited amount of API is available and where multiple polymer types/drug loadings are required to be screened for developability.
Claire Madden-Smith, Commercial Director at Molecular Profiles, comments “We are pleased to have partnered with GEA Process Engineering on this project which enables us to collaboratively bring an innovative research approach to formulation development”.
Jesper Jensen, Research Engineer, GEA Process Engineering, comments “The combined efforts of GEA Process Engineering and Molecular Profiles will rigorously test new approaches in spray drying formulations and we’re looking forward to being able to offer improved processes and efficiencies for formulation development”.
The collaboration highlights Molecular Profiles’ ability to characterise the physicochemical properties of ‘single’ particle spray dried materials and compare with conventional spray dried material prepared at bulk scale.
Griseofulvin-PEG6000 solid dispersion samples at 2.5 % and 20 % loading are analysed using X-ray Photoelectron Spectroscopy (XPS), Atomic Force Microscopy (AFM), confocal Raman microscopy, FT Raman/FTIR, powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM) to compare surface vs. bulk properties and determine equivalence of the materials produced using the two processes.
More information about Molecular Profiles’ award-winning services is available at http://www.molprofiles.co.uk/