Preformulation studies involve the determination of certain fundamental physicochemical properties of potential drug molecules and other derived properties of the active pharmaceutical ingredient (API). These studies form an important step in drug development as they help to examine and get the understanding of the API characteristics early on and this is very crucial step in having successful drug development process. We have a wide range of experience in pre-clinical formulation development for solid dosage forms, liquid dosage forms, and dispersed systems. Pre-clinical formulation development is often a challenging field for molecules possessing poor aqueous solubility, and our laboratory has the ability to conduct small scale testing to meet specific need of your projects.
Our services include:
Pre-clinical drug candidate characterization
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Solubility
- Intrinsic solubility
- pH Solubility profile in various compendial buffers
- Solubility in other pharmaceutical solvents
- Solubility in bio-relevant media
- Stability: Solution and solid state stability
- Inherent properties: Ionization constant (pKa), partition coefficient, and intrinsic dissolution
- Excipients screening for formulation development
- Vehicle selection
- Surfactant solubilization
- Amorphous solid dispersion
- Solid-state characterization
- HPLC methods development and validation
- Dissolution assay development and testing
For more information about preformulation studies and how we can help you, please contact us.