Chapter 4: The Pros and Cons of Early Formulation Development
programme. By identifying challenges early, companies can save money by avoiding costly formulation changes or even complete product failure later in the development process. • Improved drug performance: An optimized formulation can help improve the drug's therapeutic performance, such as increasing its bioavailability, stability, or patient compliance, resulting in better patient outcomes. • Intellectual property protection: Early formulation development activities can help establish data to support patent protection for the drug product, which is an essential consideration for the long-term viability/commercialisation of a drug product. • Time savings: An optimized/enabled formulation can help speed up the transition between early clinical phases, which ultimately reduces the duration to regulatory approval and the timeframe for return on investment.
Formulation development activities are an essential step in the drug product development process, where the initial formulation is designed and optimized to achieve the desired drug product characteristics. In many cases, it is ideal to perform the formulation step early in the development process; however, it is essential to carefully consider the potential challenges and limitations associated with early formulation development to ensure that it is done efficiently and effectively. Some potential pros and cons of early formulation development include: PROS: • Cost savings: Performing formulation development activities early (particularly pre-formulation studies) can help identify potential challenges with the drug substance such as stability, solubility and permeability (bioavailability). This data allows pharmaceutical companies to design an approach to achieve an optimal formulation for administration, enabling these challenges to be overcome early in the development
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