Developability & Pre-Formulation
At Sai Life Sciences, Developability & Pre-Formulation studies bridge the gap between discovery chemistry and formulation development. By understanding the physicochemical and biopharmaceutical properties of new chemical entities (NCEs) early, we identify potential developability risks and define the most appropriate solid form and formulation strategy.
Scientific Foundations for Formulation Success
Our multidisciplinary team evaluates solubility, stability, permeability, and hygroscopicity to guide selection of optimal solid forms and delivery approaches. Through data-driven screening, predictive modelling, and integration with process and analytical teams, we build a strong scientific foundation for formulation success — enabling promising molecules to move forward with clarity and confidence.
Our Capabilities
Physicochemical Profiling
Comprehensive characterization of solubility, stability, hygroscopicity, Log P, and pKa to assess molecular developability.
Solid Form & Excipient Compatibility
Evaluation of salts, polymorphs, and co-crystals, along with excipient screening to support suitable formulation development at preclinical and clinical stages.
Pre-formulation Studies
Design and execution of formulation feasibility studies focused on enhancing bioavailability of poorly soluble NCEs and ensuring manufacturability.
Analytical Method Development
Development of analytical methods for solubility, dissolution, and forced degradation profiling to guide formulation design.
Predictive Modelling & Risk Assessment
Use of computational tools and empirical data to anticipate developability challenges and mitigate risks early.
Bridging to Formulation Development
Transfer of pre-formulation learnings into formulation development to enable seamless scale-up and clinical readiness.
Our Capabilities
Physicochemical Profiling
Comprehensive characterization of solubility, stability, hygroscopicity, Log P, and pKa to assess molecular developability.
Solid Form & Excipient Compatibility
Evaluation of salts, polymorphs, and co-crystals, along with excipient screening to support suitable formulation development at preclinical and clinical stages.
Pre-formulation Studies
Design and execution of formulation feasibility studies focused on enhancing bioavailability of poorly soluble NCEs and ensuring manufacturability.
Analytical Method Development
Development of analytical methods for solubility, dissolution, and forced degradation profiling to guide formulation design.
Predictive Modelling & Risk Assessment
Use of computational tools and empirical data to anticipate developability challenges and mitigate risks early.
Bridging to Formulation Development
Transfer of pre-formulation learnings into formulation development to enable seamless scale-up and clinical readiness.
Technology & Infrastructure
- Automated solubility and stability screening systems
- Laser diffraction particle size analyzers
- Dynamic Vapor Sorption (DVS)
- Differential Scanning Calorimetry (DSC)
- Powder X-ray Diffractometry (PXRD)
- HPLC platforms
- Spray drying, air jet mill & high pressure homogenizer
- High-throughput and miniaturized solid form screening setups and solid-state behaviour under stress conditions
- Data integration tools linking analytical and formulation data for predictive modelling and risk-based decision-making
Frequently Asked Questions
During developability screening, we assess key physicochemical properties including dissociation constant (pKa), partition coefficient (Log P), molecular weight, melting point, and solubility in aqueous buffers and biorelevant media to help predict the in vivo fate of the molecule.
Biopharmaceutical factors such as solubility in physiological media, membrane permeability, susceptibility to efflux transporters (P-gp transporters), and metabolism via CYP450 enzymes are also evaluated. In addition, mechanical and bulk properties, stability, and manufacturability are assessed to ensure the compound can be formulated into a safe, stable, and efficacious drug product for clinical development.
We identify potential formulation challenges through a comprehensive developability assessment of new chemical entities (NCEs). This includes evaluation of physicochemical properties such as pKa, Log P, molecular weight, melting point, and solubility, which influence absorption and stability.
Biopharmaceutical parameters — including solubility in physiological media, membrane permeability, and susceptibility to efflux transporters and metabolism via P-gp transporters and CYP450 enzymes — are also assessed. These insights help predict formulation behaviour and enable proactive strategies to support development of a safe, stable, and efficacious drug product.
We conduct solubility and permeability studies as part of the developability assessment for new chemical entities (NCEs). These studies evaluate solubility in physiologically relevant media and the compound’s ability to permeate biological membranes, particularly for oral administration.
Physicochemical parameters such as pKa, Log P, molecular weight, and melting point are analyzed to predict absorption and systemic availability. Potential interactions with P-gp efflux transporters and CYP450 enzymes are also assessed to anticipate pre-systemic metabolism and support optimal formulation strategies and bioavailability.
Hygroscopicity, stability, and compatibility are evaluated during developability screening of new chemical entities (NCEs). Hygroscopicity is determined using the DVS technique to understand moisture uptake risks.
Stability studies assess compound behaviour under various environmental conditions, while compatibility studies evaluate interactions with excipients and packaging materials. These assessments help anticipate formulation challenges and guide development of a stable and efficacious drug product.