almac solid state chemistry feb 10 linked in
DESCRIPTION
An overview of Solid State Chemistry Services at AlmacTRANSCRIPT
Confidential © Almac Sciences 2010 www.almacgroup.com
Solid State Servicesat
ALMAC
Supporting the development of APIs from invention to launch
February 2010
Confidential © Almac Sciences 2010 www.almacgroup.com
Overview
Almac has extensive experience of API and drug product development. Our comprehensive range of solid state services and know-how will help strengthen the success of your product.
Expertise in:• Polymorph screening & selection• Salt & Cocrystal selection• Amorphous materials• Pharmaceutical materials science• Formulation development
Confidential © Almac Sciences 2010 www.almacgroup.com
• Polymorph Screening– Indication of polymorphism– Polymorph selection– Stable form determination
• Physical Form Selection– Optimum form for development– Reproducible drug substance
• Crystal Engineering– Salt and Cocrystal screening– Crystal modification
• Troubleshooting– Batch to batch variation?– Problems meeting specs?
• Characterisation– Drug product– Drug substance
• Crystallisation Development– Process development, scale-up
• Routine Analyses– DSC, TGA, XPRD– Lot release– GMP compliant
• Method validation• Legal support
– Regulatory and IP– Litigation
• Pre-formulation & Formulation Development Services
Solid State Services
Confidential © Almac Sciences 2010 www.almacgroup.com
Screens tailored to customer requirements– Mini screens requiring as little as 200mg of material
– Conventional and novel crystallisation techniques
Screens driven by science not robotics– Highly trained chemists and analysts
– Directed investigation: not just following protocols
Integrating drug substance and drug product – Crystallisation development and scale up under GMP
– Uniting process, operations and formulation
What makes us different?
Confidential © Almac Sciences 2010 www.almacgroup.com
Crystal Form
It is somewhat ironic, that after years of high-tech complex research including target validation, cell biology, pharmacology, medicinal chemistry and computational modelling, a simplistic thing like a new crystal form with a slightly higher melting point can de-rail (or almost de-rail) a program. 1
…structure prediction, which would be most valuable for process chemistry, still has some way to go…2
1. Polymorphs and Salts http://pipeline.corante.com/archives/2009/08/25/
2. Editorial, OPRD 15 Jan 2010
Confidential © Almac Sciences 2010 www.almacgroup.com
Effect of Polymorphism on Solubility
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Form I Form III
One Hour
One Day
Three Days
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Form I Form III
One Hour
One Day
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Solubility of the fluoroquinolone (US Patent 5,985,893)
Confidential © Almac Sciences 2010 www.almacgroup.com
We consider the Whole Process
Solid liquid separation
Issues:PurityYieldParticle sizePolymorph
Drying
Issues:Solvent removalPolymorphParticle sizeAgglomerationLumpingBreakage
Micronise
Issues:Form change
De-lumpingParticle size reductionProvides consistency
Preferred FormDesired properties
Crystallisation
Issues:SupersaturationNucleationPolymorphPurityYieldParticle sizeHabit
Final ProductPreferred Form
Desired properties
Confidential © Almac Sciences 2010 www.almacgroup.com
Pre-formulation & Formulation Development Services
• Formulation feasibility studies• Preclinical formulation development for
Pharmacology and toxicology• Formulation, process scale up and technology
transfer• Formulation consultancy• IP services - We support patent applications /
EPO oppositions
Confidential © Almac Sciences 2010 www.almacgroup.com
Legal support (technical)
• Expertise built from a large volume of diverse projects puts Almac in a unique position to provide expert witnessing services to pharma litigation cases, as a testifying or non-testifying witness. We provide services to both infringement and Paragraph IV cases.
• We provide technical expertise to assist in successful patent prosecution. This service includes technical consultancy for IP and technical support for successful prosecution to overcome rejections and oppositions.
• In addition, Almac provides counterfeit analysis to pharma industry using our state of the art technology.
Confidential © Almac Sciences 2010 www.almacgroup.com
Conclusion
Almac can support every stage of the drug development process.
We have solid state services to support differing research needs and budgets.
Almac provides an integrated approach to drug substance and drug product.