New Chemical Entity (NCE) formulation development
Sai Life Sciences supports New Chemical Entity (NCE) formulation development from pre-formulation through early clinical supply. Our teams combine physicochemical understanding with formulation science to address challenges related to solubility, permeability, and stability. Working in coordination with particle science, analytical development, DMPK, toxicology, and process teams, we design scalable, patient-appropriate dosage forms that enhance bioavailability and support progression into clinical development.
Our Capabilities
Pre-Formulation & Developability Assessment
Solid-state characterization, physicochemical profiling, and excipient compatibility studies to guide formulation strategy.
Dosage Form Development
Development of solid oral, liquid, and parenteral dosage forms across preclinical and clinical stages.
Bioavailability Enhancement
Application of particle engineering, lipid-based systems, solubilization approaches, salt and co-crystal strategies, polymorph screening, and micronization.
Stability & Compatibility Testing
Stress testing and stability evaluation to ensure quality, performance, and regulatory readiness.
Cross-Functional Collaboration
Close coordination with medicinal chemistry, particle science, DMPK, toxicology, process chemistry, and analytical teams to enable smooth development progression.
Our Capabilities
Pre-Formulation & Developability Assessment
Solid-state characterization, physicochemical profiling, and excipient compatibility studies to guide formulation strategy.
Dosage Form Development
Development of solid oral, liquid, and parenteral dosage forms across preclinical and clinical stages.
Bioavailability Enhancement
Application of particle engineering, lipid-based systems, solubilization approaches, salt and co-crystal strategies, polymorph screening, and micronization.
Stability & Compatibility Testing
Stress testing and stability evaluation to ensure quality, performance, and regulatory readiness.
Cross-Functional Collaboration
Close coordination with medicinal chemistry, particle science, DMPK, toxicology, process chemistry, and analytical teams to enable smooth development progression.
Technology & Infrastructure
- Instrumentation for particle characterization and solid-form evaluation
- Solubility and dissolution profiling systems
- Enabling formulation suites supporting:
- Spray-dried amorphous solid dispersions (ASD)
- Nanosuspensions
- Nanoemulsions
- Processing equipment scalable from benchtop to pilot scale
- Integrated analytical facilities and automated systems to support reproducibility and compliance
Frequently Asked Questions
Physicochemical profiling is conducted during developability assessment and includes evaluation of pKa, log P, solubility across aqueous buffers and biorelevant media, melting point, molecular weight, and polar surface area. Stability, solid-form behavior, and manufacturability are also assessed to inform formulation strategy.
Enabling strategies include amorphous solid dispersions (ASD), nanosuspensions, nanoemulsions, lipid-based formulations, salt and co-crystal approaches, polymorph screening, and micronization.
Supporting equipment includes spray dryers, homogenizers, high-pressure homogenizers, jet mills, and parallel crystallizers to enable scalable formulation development.
Compatibility is evaluated through systematic pre-formulation studies, including stress testing and accelerated stability assessments. Analytical techniques are used to monitor physical and chemical changes to ensure excipient selection supports product stability and performance.
Yes. High-throughput screening, automated platforms, and coordinated collaboration with particle science and analytical teams support efficient decision-making. Structured project management enables accelerated development timelines while maintaining quality and compliance.