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Formulation Development & Optimization
QbD Approach for Generics per ICH Q8(Q2 R2)
Capzerpharma Manufacturing develops and optimizes generic formulations for oral solids, liquids, and ophthalmics using integrated R&D and 20,000 sq. ft. GMP facility. Our U.S.-based team leverages pilot-scale equipment for Empagliflozin tablets and Gabapentin from prototype to exhibit batches, ensuring bioequivalence and PAI readiness.
Risk-based QbD identifies critical quality attributes (CQAs) like dissolution and impurity control.
Preformulation: Compatibility, solubility enhancement (e.g., amorphous dispersions).
Prototyping: DOE with DoE software for excipient ratios, granulation variables.
Scale-up: High-shear wet granulation to tablet press validation.
Iterative refinement targets target product profile (TPP).
In vitro BE: f2 similarity, IVIVC modeling.
Process: PAT tools for endpoint control, QbD design space establishment.
Stability bracketing for 25/30/40°C zones.
Partners achieve first-pass ANDA approval for late-stage assets like Empagliflozin from our vertically integrated platform, reducing timelines by 6–12 months.
Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.