Pharmaceutical Technology
Formulation development:
We provide services in pharmaceutical formulation development from conceptual stage to scale up & tech transfer and support commercial launch.
Pre formulation studies
- API characterization: Solubility studies, PSD, BD/TD, flow properties, DCS, Polymorphism, melting point, chiral, OVI, Organic impurity profile, heavy metals, nitrosamine, genotoxic etc.,
- Drug-excipients compatibility
Formulation Studies
- QbD based formulation development.
- Bench scale prototype formulation development activities
- Dissolution method development (as per US FDA, EMEA & other regulatory guidelines)
- Stability studies of prototype formulations
- Optimization of formulation composition with respect to stability & IVIVC
- Optimization of process parameters
- Support scale up & tech transfer
- Support validation/submission batches
- Support commercial launch
Specializations
- Immediate release Tablets: IR, oral dispersable, chewable, buccal, sub lingual, gummies, sprinkles etc.,
- Modified release Tablets; sustained release, controlled release, pulstile, dual release, osmotic controlled release, gastro retentive etc.,
- Oral films
- Pellets: IR, DR, modified release, sprinkles, MUPS etc.,
- Capsules: IR, DR, modified release etc.,
- Oral liquids: solutions, emulsions, syrups, suspensions, etc.,
- Injectables: Sterile liquid, sterile solid powder for injection, emulsions, depot etc.,
- Semi solids: Creams, ointments, gels, pastes etc.,
