Solid state science and pre-formulation study― The bridge between drug substance and drug product
Solid state science and pre-formulation research are important parts for pharmaceutical drug R&D. It is a bridge that connects drug substance and drug product. Asymchem can provide clients with comprehensive and systematic solid state science and pre-formulation research services, including solid state science research, pre-formulation study and pre-clinical formulation development.
Solid state science research
Asymchem provides clients with tailor-made crystal form research services at different stages of their projects. The specific services include the following aspects:
● Polymorph screening, scale up and evaluation
● Salt screening, scale up and evaluation
● Co-crystal screening, scale up and evaluation
● Single crystal growth and crystal structure analysis
● Qualitative and quantitative analysis of polymorph, including method development and validation for both drug substances and drug products
In the pre-clinical stage, through systematic crystal form screening, Asymchem can help customers to obtain stable crystal forms and minimize the risk of more stable crystal forms identified in the later stages of development. In the clinical stage, Asymchem can provide customers with strategy for patent protection of crystal forms.
● Preclinical phase: Salt/co-crystal/polymorph screening, evaluation and selection; Relationship investigation; Solubility and stability study
● Phase I/Ⅱ: Full evaluation for selected salt or polymorph; Full screening for solid forms
● Phase Ⅲ: strategy for patent protection of crystal forms
The systematic pre-formulation research will effectively guide the design of formulations at clinical phase and the development of safe, effective, stable, controllable, and easy to use formulations. Asymchem has an experienced pre-formulation research team, which can provide customers with professional pre-formulation research services, including the following items:
● Solid state characterization
● Solubility study
● Stability study
● Drug-excipient compatibility study
● In vivo Biopharmaceutical prediction
Preclinical formulation development
Animal study at preclinical phase is an essential part for drug development. Asymchem can provide clients with a variety of formulation development and evaluation services to support pharmacokinetics, pharmacodynamics, and toxicity studies, and provide clinical formulation development strategies.
● Development and evaluation of various dosages for animal experiments
● Provide clinical formulation development strategies