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SOLID FORM CONTRACT RESEARCH
SCANNING SERVICES |
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X-ray Powder
Diffraction (XRPD) |
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Differential Scanning
Calorimetry (DSC) |
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Thermogravimetric
analysis (TGA) |
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Storage testing |
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Polarised Light
Microscopy (PLM) |
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Scanning Electron
Microscopy (SEM) |
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| POLYMORPH SCREENING |
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Solid Form Solutions provide
polymorph screening services that focus on
delivering the most developable solid form,
coupled with a thorough understanding of the
polymorphic space surrounding an API. Furthermore,
our extensive polymorph screening program and
thorough examination of data, ensures better
protection of our customer’s intellectual property
(IP).
Our unique approach to polymorphism allows us to
carry out a very large number of experiments on a
very small amount of drug material. Our study read
out time can be very short (2 weeks) without any
comprise on data quality, or process space
investigated. Our dedicated and experienced solid
form scientists consistently deliver on service
and ensure our clients are updated on a very
regular basis, whilst always being on hand to
provide on-the-spot updates and general
information on polymorphism.
In addition to our screening services, the Solid
Form Solutions’ team welcomes the opportunity to
work with clients on their specific polymorphism
issues, and construct work plans that deliver
effective solutions. Whether a drug development
program is on the critical path or not, Solid Form
Solutions will always provide rapid study read
out. |
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| SALT SELECTION STUDIES |
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| Solid Form Solutions aim to
deliver a salt screening and selection program
that is tailored to meet the needs of our clients.
Our services are focused on screening a range of
counterions based on: |
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The pKa of the API |
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The market precedence of each |
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counterion |
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The available toxicology data of
each |
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counterion |
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Past salt screening experience |
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We aim to deliver a number of
pharmaceutically acceptable salts (sometimes
called versions) that satisfy specific physical
and developabilty criteria. Our risk based
approach ensures that all our salt studies are
carried out within ICH guidelines and alerts our
clients to any potential problems that might occur
in downstream development.
Similar to our polymorph screening program, the
scope of our salt selection studies can be
tailored to meet the requirements of our
customers. |
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| CO-CRYSTAL SCREENING |
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| Co-crystal screening is a
relatively new technology to pharmaceutical
material science that provides an extra tool to
modify the physicochemical properties of an API.
Solid Form Solutions’ approach to co-crystals is
based on over ten years experience in the
co-crystal sector, coupled with detailed in-house
research. The design of our screens incorporates a
wide range of methods that include amongst others: |
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Modeling Techniques |
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Grinding |
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Solvent Drop Grinding |
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Slurrying Experiments |
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| At Solid Form Solutions we
understand the difficultly in delivering a
scaleable solution using some of these techniques
and therefore provide (as part of the service)
further crystallisation development that will
deliver scaleable alternatives. As well as aiming
to modify the physicochemical, co-crystal
screening at Solid Form Solutions is extensive
enough to provide our customers with the further
IP protection of their APIs. |
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| CRYSTALLISATION DEVELOPMENT |
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| Often when an API enters into
development the solid form is not crystalline.
Solid Form Solutions offers an extensive
crystallisation service focusing on obtaining a
crystalline and easily isolated form of the drug.
Our program employs a very large number of
crystallisation experiments and aims to deliver a
process that can be easily transferred to a
scale-up or manufacturing facility. |
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| In all our studies, we employ the
most advanced techniques in solid-state
characterization which include: X-ray Powder
Diffraction (XRPD); Differential Scanning
Calorimetry (DSC); thermal gravimetry (TGA),
whilst also interrogating our materials using a
range of developability tests, i.e. GVS,
thermodynamic solubility; storage tests. |
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