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///Strategy

///Pre-formulation studies


It is a combined study which includes physicochemical properties of a new drug candidate that could affect the drug performance and the development of a dosage form. This may provide important insight for formulation design and development. The following parameters will be studied:

  • Drug Solubility:- intrinsic solubility, pKa, Partition Coefficient.
  • Rate of Dissolution.
  • Stability studies.

Basic knowledge can be gained from literature search about

  • Properties Of Drug
  • Potency Of Drug
  • Potency Relative to Competitive Products and the Dosage Form.
  • Search Regarding Stability and Date about Its Degradation.
  • Proposed Route Of Drug Administration
  • Formulation Approaches
  • Bioavailability And Pharmacokinetics Of Chemically Related Drugs.
  • Approaches Towards Molecular Modifications.
  • Solid State Compatibility.
  • Thermal Analysis.
  • Absorbance Spectra.
  • Physicochemical Properties.
  • Other Studies Such As Plasma Protein Binding, Ionization Constant.
  • Hygroscopy
  • Crystallanity And Polymorphism.
  • Particle Characterization.
  • Powder Flow Properties
  • Compression properties
  • Solution Stability.
  • Organoleptic properties.

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