Pharmaceutical Preformulation Studies

Preformulation was improvement in analytical methods that stimulate the first programs that might bear the name “Preformulation”. The overall objective of preformulation testing is to generate information useful to the formulator in developing stable and bioavailable dosage forms which can be mass produced. During the early development of a new drug substance, the synthetic chemist, alone or in co-operation with specialists in other disciplines including preformulation, may record some data which can be appropriately considered as Preformulation data.

 Preformulation also includes preliminary investigations and molecular optimization by the drug should be tested to determine the magnitude of each suspected problem area, if a deficiency is detected, a molecular modification should be done. To overcome this deficiency molecular modification is done be salts, prodrugs, solvates, polymorphs or even new analogues. The dissolution rate of a salt form of a drug is generally quite different from that of the parent compound.

Physicochemical parameters: 

  • Organoleptic properties:
  • Bulk characterization studies:
     Crystallinity and polymorphism
     Hygroscopicity
     Fine particle characterization
      Bulk density
     Compression
  • Solubility analysis:
     Intrinsic solubility determination
      PKa determination
      Partition coefficient
     Dissolution studies
  • Stability analysis:
       In toxicology formulations
       Solution stability
       Solid state stability

 

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