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| Project Consulting |
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PolyCrystalLine addresses complex issues arising in the preparation of the regCMC section of an IND.
For example, we can optimize characterization research to focus on an API crystalline form with the most desirable physical properties. By doing so...
Date: 28/05/2013
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| In Vitro Bioequivalence Testing (BE) |
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The Bioequivalence study is requested to determine rate/extent of absorption of each therapeutic moiety for:
– Potential generic products for which there is a reference listed drug (RLD) approved for marketing,
– Potential n...
Date: 04/09/2012
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| Patent and Literature Search |
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Patent and literature search is the first step of every project in order to know and identify all relevant publications and patents.
This is possible thanks to our crystallographic, scientific, technical and patent databases. This information allows...
Date: 15/03/2011
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| Polymorph Screening |
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Polymorphic forms of a drug substance can have different chemical and physical properties, including melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapour pressure and density. These prop...
Date: 18/02/2011
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| Salt & Co-crystal Screening |
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PolyCrystalLine can explore the formation of API salts and co-crystals with pharmaceutically acceptable guest molecules using different stoichiometric ratios.
Two types of screening can be performed:
Solvent free screening e.g. grinding, kneading...
Date: 18/02/2011
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| Amorphous Screening |
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In our laboratory we are able to produce amorphous materials using several techniques such as spray drying, quench cooling, desolvation, etc.
The stability of an amorphous phase is also investigated by solid state NMR and RAMAN spectroscopy techniqu...
Date: 18/02/2011
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| Thermal Screening |
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PolyCrystalLine studies the thermal behavior of pharmaceutical compounds by means of a broad range of techniques such as variable temperature X-ray powder diffraction, calorimetric, thermogravimetric and evolved gas analysis....
Date: 18/02/2011
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| Stability Screening |
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The stability of API with temperature, pressure, mechanical stress and humidity is assessed by diffraction, spectroscopic, calorimetric and thermogravimetric methods.
Conversion and interconversion of polymorph, amorphous, hydrate or solvate phases...
Date: 18/02/2011
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| Formulation Study |
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Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and studies have ...
Date: 01/03/2011
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