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Almac solid state presentation 2013
The document describes the solid state services provided by ALMAC including polymorph screens, salt/cocrystal screens, amorphous dispersion screens, and crystallization development. It discusses how the solid state group acts as a link between chemistry and formulation to transfer knowledge about active pharmaceutical ingredients. A range of expert services and in-house technologies are available to support drug development including rapid formulation screening, analytical support, and pre-formulation studies.
Almac solid state presentation 2013
- 1. Physical Sciences 2013
- 2. Solid State Services Polymorph Polymorph screens screens Preformulation Preformulation Salt/Cocrystal Salt/Cocrystal support support screens screens Routine Amorphous Routine Solid state Solid state Amorphous physicochemical physicochemical dispersion dispersion testing services services screens testing screens Drug substance Drug substance Crystallisation Crystallisation and drug product and drug product development development trouble shooting trouble shooting Legal Legal support support 2
- 3. Purpose ALMAC Solid Chemistry Formulation state group Our solid state group acts as a link, for the seamless transfer of knowledge and understanding of the API between chemistry and formulation 3
- 4. Adding value Form Selection Process development •Screens for polymorphs, •Crystallization issues salts, cocrystals and amorphous forms •Crystal shape / PSD control •Identify the best physical form •Solid-liquid separation for development •Form robustness •Detailed interpretive report with recommendations Product development Scale up •Purity •API robustness to process conditions •Yield •Qualitative and quantitative •Solvent efficiency determination of physical form in dosage forms 4
- 5. Adding value Range of expert services – Analytical, biologics, pre-formulation, and formulation. Faster and smarter solutions Efficient development timelines Producing enhanced products 5
- 6. Almac Advantage • Vastexperience and knowledge gained from years of industry experience • Clients range from virtual companies to multinationals • Studies designed to the customer needs and API properties • Significant expertise in supporting Discovery and Early Clinical phase development projects • Excellent understanding of the requirements for process development and drug product development 6
- 7. In house Technologies formufast™ rapid formulation micro screens for preclinical formulations • Ideal for use where material is limited • Identify excipients based on solubilising capacity • A rational formulation development program for poorly soluble drugs • The risks associated with drug precipitation can be minimised. • Not just solubility in media, but the solubilising capacity in the GI tract The following screens are available • formufast™ PO • formufast™ IV • formufast™ SD 7
- 8. Research at Almac • PhD sponsored at QUB titled - Raman studies of the formation and structure of pharmaceutically relevant crystals. • Identified the following – Crystal orientation was identified to effect the reproducibility of Raman data, investigated methods to remove these effects. – PCA identified a consistent component which is strongly indicative of the presence of nuclei at the preliminary stages of crystal formation. – XRD / Raman the combination of these two techniques provides valuable information about the crystal. Excitation Crystal Excitation Solution Ex 1600 1400 1200 1000 800 600 400 cit at ion XXII International Conference On Raman Spectroscopy, Volume 1267, 724-725, 2010 8
- 9. Research at Almac • Cocrystals are unique crystalline solids made from stoichiometric amounts of API and pharmaceutically-acceptable coformers • New, patentable solid forms that can exhibit improved properties – Crystallinity, solubility, stability, flow properties, hygroscopicity • Study to improve solubility/BA of poorly soluble Fenamic acids – Pharmaceutically-acceptable coformers selected – Screening generated cocrystals for several fenamic acids with different coformers • Improved aqueous stability of cocrystals • Robust crystallisations developed using phase diagrams Crystal Growth & Design, 11(8), 3522-3528, 2011 9
- 10. Research at Almac • Cocrystals are unique crystalline solids made from stoichiometric amounts of API and pharmaceutically-acceptable coformers • New, patentable solid forms that can exhibit improved properties – Crystallinity, solubility, stability, flow properties, hygroscopicity • Study to improve solubility/BA of poorly soluble Fenamic acids – Pharmaceutically-acceptable coformers selected – Screening generated cocrystals for several fenamic acids with different coformers • Improved aqueous stability of cocrystals • Robust crystallisations developed using phase diagrams Crystal Growth & Design, 11(8), 3522-3528, 2011 9