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TKI for NSCLC - BCS Class II Solubility

I'm developing a novel tyrosine kinase inhibitor for EGFR-mutant non-small cell lung cancer. The API is classified as BCS Class II with very poor aqueous solubility (8.5 µg/mL) but high permeability. Our current capsule formulation shows highly variable bioavailability and significant food effects in Phase I trials. I need to explore advanced formulation strategies that can improve dissolution rate, reduce fed/fasted variability, and enable consistent systemic exposure at the 150 mg daily dose.

DEEPC Formulation Agent

Solubility Enhancement Strategy for NSCLC TKI

Four BCS Class II solubility-enhanced formulations with cost, timeline, and bioavailability projections.
35 more steps
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DeepCeutix is used by top pharma teams for IV-to-Oral Conversion, Solid Dispersion Design, HME Pre-Screening, Polymorph Screening, Formulation Design, Generic Formulations, Biosimilar Development, Biologics CMC, High-Concentration mAbs, Bispecific Antibodies, LNP-mRNA Formulations, ADC Formulations, CAR-T Formulations, AAV Gene Therapy, Excipient Selection, Bioavailability Enhancement, Stability Optimization, Solubility Screening, Dissolution Profiling, IVIVC Modeling, Process Scale-Up, Toxicology Synthesis, Freedom-to-Operate, Patent Landscape Analysis, Patent Drafting, Nitrosamine Assessment, Environmental Risk Assessment, Extractables Qualification, Leachables Assessment, OEL Derivation, PDE Derivation, Cleaning Validation, Regulatory Filing.
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Specialist agents thread through every stage where formulation, CMC, and regulatory work compounds, from preclinical development to commercial lifecycle. One co-scientist across the pipeline that takes your molecule to market.

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