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Pre-formulation Research of Generic Drugs

2021-07-30
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The purpose and importance of pre-prescription research

The purpose of the Pre-formulation research is to provide the basis for the prescription process design, and to provide a clear mechanism of targeted solutions to the problems in the prescription process research.

The quality characteristics of the final product are largely determined by the nature of the drug substance: Although there are many methods to improve the quality characteristics and process reliability of the drug product, the effectiveness of these methods is often not as good as the control of the characteristics of the drug substance. ;

The trend of modern product development is to move the control point forward;

Pre-formulation Research of Generic Drugs

In the QbD research and development requirements, another important purpose of pre-prescription research is to provide a basis for preliminary risk assessment for formulation research, and to determine the direction and scope of formulation research;

Main content of pre-prescription research

The main content of pre-prescription research is to figure out the physical, chemical, biological, and mechanical properties of APIs and excipients.

Physical properties of raw materials: solubility, crystal form, particle size, crystal habit, etc.

Chemical properties of raw materials: stability, compatibility of excipients, etc.

Biological properties of raw materials: permeability, BCS classification, enzyme metabolic stability

The mechanical properties of the API: fluidity, compressibility (plasticity and elasticity), density, etc.

Pre-prescription research also needs to be combined with preparation research to determine the key attribute CQA of the raw material drug: the effect of the nature of the raw material on the preparation is not only the work of preparation research, but also the work of pre-prescription research.

The physical and chemical properties of the raw materials declared by the general NDA

  • SOLID‑STATE PROPERTIES

m.p., pKa, logD

  • POLYMORPHS

  • SOLUBILITY AND PERMEABILITY

  • WATER CONTENT (hygroscopicity)

  • CHEMICAL AND PHYSICAL STABILITY

  • PARTICLE SIZE, SURFACE AREA, AND DENSITY

  • MECHANICAL PROPERTIES:

PLASTICITY, ELASTICITY,

COMPRESSIBILITY, FLOWABILITY

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