Formulation Development
Custom Formulation Development, From Concept to Clinic
Harness decades of sterile-product expertise to turn your molecule into a stable, scalable, and compliant drug product.
At Derren, an interdisciplinary team partners with you to solve everything from dosage-form selection to drug-product stability and solubility. Using state-of-the-art analytics, we assess component compatibility, extractables & leachables, and precipitation risk—then tailor a solution around your exact needs.
Formulation Development Work Profile
Research & development services for sterile products such as Injectable solution, Suspension, Emulsion, Lyophilized Injection, Opthalmic solution & suspension.
Packaging development including reference product characterization, product specific cost consideration and related document support.
Dossier Development
NCE, Generics and Value Added Generics 505(b)(2)
Pre formulation studies
Prototype formulation development
Process development
Stability studies
Trouble shooting of existing product
Support in GMP Manufacturing for NCE Clinical phase-I/II/III, 505(b)(2) and Generic product
Specifications, Tech transfer documents .
Identification of New Products & Licensing of Dossier
Scale up at the manufacturing site
Tech Transfer Launch and support
Equipments
Dehumidification cabinet (can achieve 10% of humidity for hygroscopic substance handling)
Magnetic stirrer equipped with heating elements
Head space oxygen meter (HSO meter)
Dissolve oxygen meter (DO meter)
Overhead stirrer
Direct drive stirrer
pH meter
Jacketed manufacturing vessel equipped with heating & cooling facility.
High pressure jacketed filtration assembly
Autoclave (for moist heat sterilization)
Laminar air flow
Other ancillary equipment
Stability chambers
Centrifuge