Pharmaceutical preformulation : Basics and industrial applications

Birefringence

Hydroquinone crystals in polarized light showing birefringence

Drug molecules are rarely administered alone. They are administered as dosage forms or formulations. Formulation development can be involved at various stages like animal studies, first time in human studies, clinical trials and commercialization of the product. Before any formulation development is initiated, the drug molecule is characterized for certain fundamental physical, chemical properties and physico-technical properties. A thorough understanding of these properties allows science based development of formulations, by enabling identification of challenges during formulation development. These activities, done prior to initiation of formulation development are called as pre-formulation studies. Pre-formulation can be considered as the learning phase about the molecule.

Apart from helping formulation development, preformulation studies also help in lead identification during drug discovery phase. A new chemical entity should possess optimal biopharmaceutical properties to become a drug molecule. Mere possession of potency and selectivity does not ensure ‘drugability’. Preformulation studies help in assessing the drugability of a molecule. Preformulation can thus be considered as critical decision-making tool during both – drug discovery and development phase. A comprehensive understanding of physicochemical properties and its effect on biological performance, allows selection of potential lead molecules and in identification of drug delivery challenges.

This course work shall be covering the following contents –

  1. Introduction to drug discovery and role of preformulation studies
  2. Introduction to drug development and role of preformulation studies
  3. Components of preformulation profiling – fundamental and derived properties
  4. Solubility and permeability
  5. Stability
  6. Solid state properties
  7. Compaction studies
  8. Preformulation report
  9. Preformulation studies for generic products.

At the end of this course work we shall be in a position to understand the role of preformulation studies in drug discovery, drug development and development of generic products. This course shall help in a theoretical understanding of the topic and its application in an industrial formulation development setting.

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