gpharma

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.,