Knowledge Centre



STEPS IN FORMULATION DEVELOPMENT

There are few steps which are to be followed during formulation development of a generic product:

  1. Patent search and literature search.
  2. Active pharmaceutical ingredient (API) characterization
    • Physical observation
    • Loss on drying
    • Water content
    • Potency/Assay
    • Solubility
    • Particle size analysis
  3. Characterization of reference product
    • Weight of the tablets
    • Colour of the tablets / capsules
    • Coated or uncoated tablets
    • Scored or unscored tablets
    • Shape of the tablets
    • Size of the tablets / length & breadth of capsules
    • Hardness of the tablets
    • Thickness of the tablets
    • LOD of the tablets
    • Disintegration time of the tablets/capsules
    • Dissolution of the tablets/capsules in release and multimedia
    • Packaging details of the reference product
  4. Developing strategy for formulation of a product based on patent search report, literature, reference product label, API characterization and reference product characterization.
  5. Compatibility study.
  6. Experiments of formulation based on strategy and analytical method development.
  7. Completion of Prototype formulation.
  8. Dissolution profile matching –Test vs. Reference product.
  9. Stability testing of both test and reference products at 40 ̊C / 75% RH open exposure for 15 days to 30 days, at 40 ̊C / 75% RH and 25 ̊ C / 60 % RH closed packing condition for 6 months.
  10. Multimedia dissolution profile matching (Test vs. Reference) in Water, 0.1 N HCl and USP buffer media at pH 4.5 and pH 6.8.
  11. Checking scalability and reproducibility of prototype formulation.
  12. Matching the stability results of test product with reference product.
  13. Pilot bio study (Test product vs. Reference product).
  14. Process evaluation batch.
  15. Exhibit batch with proper documentation.
  16. Pivotal bioequivalence study.
  17. Pivotal stability study and product development report.
  18. Dossier preparation and filing.
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