PhysChem Solutions Ltd, Doherty Building, Pentlands Science Park, Bush Loan, Penicuik, Midlothian, EH26 0PZ, Scotland, UK

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Scientific Solutions through Scientific Excellence

Scientific Solutions through Scientific Excellence

During Early-stage Preclinical Development

Physical and Chemical Characterisation

PhysChem Solutions characterise the physical and chemical properties of our client’s early development and API batches including establishing the properties of the current form of the compound to assess the potential for developability.


The benefits and deliverables from this assessment include understanding the current properties of the new chemical entity, API candidate or a specific batch of API with respect to:


  • Assessment of the crystallinity
  • Nature of crystalline form i.e. anhydrous, hydrate, solvate
  • Melting point and critical thermal events
  • Hygroscopicity
  • Chemical integrity
  • Early indicative physical and chemical stability
  • Solubility over pH range
  • Identification of early risks of developing current form of API


Our physical and chemical characterisation package aids in understanding the requirement for improvement in properties such as solubility, stability, crystallinity, hygroscopicity and thermal properties for further development.

PHYSICAL AND CHEMICAL CHARACTERISATION
SALT SCREENING AND SELECTION

Salt Screening and Selection

PhysChem Solutions carry out an assessment of our client’s compound including the structural features, development requirements, and compound history to design an appropriate and specific salt screening study. Our study designs include a range of experimental techniques for effective salt formation and an in-depth understanding of the physical and chemical properties of the salt forms located.


Our team carry out a side-by-side developability comparison of located salts and the free form of our client’s compound and based on the scientific results, make recommendations of the most suitable entity (salt or free form) for further development.

Co-crystal Screening and Selection

As with our Salt Screening studies, PhysChem Solutions design and implement compound and development specific co-crystal screening studies. Prior to practical co-crystallisation experimentation, our study designs include an initial theoretical assessment of potentially suitable co-crystal formers based on the structural features of the molecule to maximise positive co-crystallisation results.


The co-crystal screening design ensures an in-depth understanding of the physical and chemical properties of the co-crystal forms located, and a side-by-side developability comparison of located co-crystals with the free form of our client’s compound and recommendations for further development.

CO-CRYSTAL SCREENING AND SELECTION

Polymorph Screening and Landscape Assessment

PhysChem Solutions design and implement appropriate polymorph screening studies for our client’s compounds in order to meet regulatory development requirements, determining the most stable and suitable solid form for further development and its relationship with alternate solid forms (i.e. anhydrous forms, hydrates and solvates).


Through process relevant experimentation, our study designs also allow for an assessment of the risks associated with obtaining undesired forms during downstream processing, including drug substance and drug product manufacturing.

Crystallisation of Amorphous Materials

Crystallisation of amorphous materials can have significant benefits in improving the properties of the material and can also offer a means for more effective purification. PhysChem Solutions employ our extensive experience and expertise in implementing a compound specific experimental work program to locate crystalline forms, understand their properties, and determine processes for re-preparation and scale-up of the crystalline forms.

Early Crystallisation Development

Based on the results obtained from the solid state screening work programs, PhysChem Solutions design and conduct early crystallisation process assessments for the desired solid form to provide our clients with critical information for further crystallisation scale-up development.

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