Pre-formulation Study

Pre-formulation studies are an important aspect for various stages of clinical trials & it is the the 1st stem in the formation of dosage form. Before formulation of the pharmaceutical product the pre-formulation studies are necessary. The main objective is to generate information useful to the formulation in developing physicochemically & biochemically stable & bioavailable dosage form. Various pre formulation study are – 1. Bulk Properties; 2. Polymorphism & Particle Size; 3. Hygroscopicity; 4. Aqueous Solubility; 4. Ionization Constant; 5. Partition Coefficient; 6. Drug Dissolution; 7. Drug Stability; 8. Drug Compatibility; 9. Half Life of drug; 10. Drug Absorption.

Through determination of physicochemical properties of inventing molecule, It states the steps of preparing drug delivery that enhance the drug performance & development of an efficacious, stable and safe dosage form. Nowadays the pre-formulation studies are become more accurate & comfortable with the help of statistical software based on artificial neural networking. These approaches accumulate the data regarding the degradation process, toxicological effects and adverse reaction. So Pre-formulation is a necessity in drug development & discovery.

 

  • Evaluation parameters in pre-formulation studies
  • Application of Analytical techniques in pre-formulation studies
  • Pre-formulation studies for generic products
  • Drug- excipient compatibility studies
  • Environment, health and safety considerations
  • Clinical Trials

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