The process of pharmaceutical product development may be classified into four stages including preformulation, prototype development, scale-up studies and commercialisation of pharmaceutical formulations. Pharmaceutical product development begins with the estimation of physicochemical properties of new chemical entity with druggable properties. These physicochemical properties are determined in the first stage and one of the foremost steps in the development of pharmaceutical formulation, i.e. preformulation studies. Preformulation studies aid in determining the possible obstacles which could be anticipated in pharmaceutical formulation development; further, it also assists in identifying the appropriate dosage form and route of administration to develop a prototype, which could be finally developed in a safe, effective and stable pharmaceutical product for the new drug molecule. In this chapter, we have discussed advances in pharmaceutical product development as well as about all these four important stages, i.e. preformulation, prototype development, scale-up studies and commercialisation of pharmaceutical formulations involved in pharmaceutical product development.

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Advances in Development of Pharmaceutical Products

  • Keerti Jain,
  • Sofiya Tarannum,
  • Gijith K. Mohan,
  • Manisha Patel,
  • Anchal Pathak,
  • Parth Patel,
  • Vineet K. Jain,
  • Ashish Baldi,
  • Harvinder Popli

摘要

The process of pharmaceutical product development may be classified into four stages including preformulation, prototype development, scale-up studies and commercialisation of pharmaceutical formulations. Pharmaceutical product development begins with the estimation of physicochemical properties of new chemical entity with druggable properties. These physicochemical properties are determined in the first stage and one of the foremost steps in the development of pharmaceutical formulation, i.e. preformulation studies. Preformulation studies aid in determining the possible obstacles which could be anticipated in pharmaceutical formulation development; further, it also assists in identifying the appropriate dosage form and route of administration to develop a prototype, which could be finally developed in a safe, effective and stable pharmaceutical product for the new drug molecule. In this chapter, we have discussed advances in pharmaceutical product development as well as about all these four important stages, i.e. preformulation, prototype development, scale-up studies and commercialisation of pharmaceutical formulations involved in pharmaceutical product development.