Research and development

Research and development are our ongoing effort to develop and improve products and services undertaken by teams of our highly skilled scientists.

Our capabilities

  • Development to support generic formulation (NCE-1/PIV/PIII/PII certifications)
  • Development of drug product to support NDA (505b2) applications
  • Paediatric formulation development
  • Drug product development for Phytopharmaceuticals
  • Drug product development for cytotoxic/non-cytotoxic drugs
  • Drug product development for penicillin category drugs
  • Pre-clinical formulation development
  • NCE- formulation development for FIH (First-In-human) and various clinical phases
  • Veterinary formulation development
  • Pre-formulation services – Our formulation team supports pre-formulation studies by conducting various investigation on physicochemical properties of the molecule. This study helps the clients to develop stable and bioavailable dosage form.

We perform wide range of pre-formulation studies as mentioned below that helps to generate useful data required for the development of good quality dosage formulation

  • Solubility studies
    • Solution stability studies
    • Sorption/Desorption studies
    • Thermal characterization
    • Powder properties characterization
    • Log P/Log D determination
    • pKa determination
    • Polymorphic conversion potential

    Pharmaceutical Formulation Development

    We offer formulation services for oral solids, oral liquids, parenteral and formulations using various enabling technologies.

    The oral solid formulations expertise includes

    • Capsules &Tablets with different release profile
    • Effervescent, Chewable,
    • Sub-lingual & Dispersible tablets (ODT)
    • Pellets with different release profile
    • Pellets into tablets
    • Bilayer tablets
    • Mini-tablets in capsules

    The oral liquid formulations expertise includes

    • RTU Solution
    • RTU Suspension
    • Powder for solution
    • Powder for suspension
    • Sachets
    • Emulsion

    The parenteral formulations expertise includes

    • Solution injectable
    • Suspension injectable
    • Lyophilized product
    • Peptide injectable
    • Depot injectable
    • Ophthalmic formulation
    • Solution for inhalation
    • Emulsions
    • Vials, Ampoules, Bags
    • Pre-filled-Syringes &Cartridges

    Enabling technologies – Our expertise in using enabling technologies for the drug development helps in enhancing drug quality and efficiency. Our development capabilities in this space range from ideation, dosage design, and PK profile selection to establishing proof-of-concept, formulation development, process development, stability, scale-up, and clinical studies. (Comparator graphs in each case studies

    • Hot melt extrusion (case study for veterinary pdt)
    • Solid dispersion (case study of ivacaftor- PXRD graph)
    • Lyophilisation
    • CD complexation
    • Melt granulation (CHL)
    • SEDDS (case isotretonin capsule)
    • Drug-nano particles (enzalutamide)
    • Taste masking (Chl)
    • Liquid-filled capsules (isotretonin capsule)

      Analytical Development services

      We offer the analytical standalone services like

      • Analytical method development and validation for API and drug product
      • Stability studies to support development of API and drug product
      • Reverse engineering of innovator products
      • Unknown impurities identification and characterization
      • Cleaning method development & validation for drug products
      • Method transfers to customer quality control labs

      Our Capabilities & infrastructure

      • HPLCs (UV, PDA, RI and ELSD   detectors)
      • Viscosity Measurement
      • Differential Scanning Calorimetry
      • Elemental Impurities Assessment
      • DVS (Sorption/Desorption)
      • Delamination Studies
      • Gas Chromatography
      • Leachable & Extractables
      • Particle Size Analysis
      • Photo stability Assessment
      • Osmolality
      • Dissolved and Head Space Oxygen Quantification
      • Moisture Quantification
      • FDM
      • Solid state characterization for API and in drug product
      • End to End development services –

        • We offer services for the development of pharmaceutical formulations for oral solid, liquid and parenteral dosage forms. IDRS provides pharmaceutical formulation development services for various dosage forms using state-of-the-art infrastructure and an expert team with diverse experience. Our end-to-end services extend from early-phase product development to clinical supplies for new chemical entities, generics, and life cycle extension products such as 505(b)2.