Drug formulation plays a vital role in the success of any pharmaceutical development program. From early preclinical investigations through to late stage clinical trials, formulation chemistry is used throughout the development process and is essential for the design of a safe and effective product.
Yet, formulation’s importance is often overlooked during early drug design, with planning typically coming much later in development. This approach can leave pharmaceutical development programs open to costly delays or even failure. So how can commercial sponsors ensure their projects stay on schedule and on budget? An integrated approach to formulation could be the answer.
The importance of phase appropriate formulation
When designing a formulation for a preclinical or clinical investigation, it’s essential that the dosage form is appropriate for the particular study phase. After all, you can’t simply administer a tablet formulation to a mouse or rat. Careful consideration must be paid to the aim of each test, as well as the characteristics of the API.
For preclinical studies, for example, formulations are often liquids or suspensions and are ‘purpose built’ for the animal they are being administered to. Factors such as the animal’s gastro-intestinal tract conditions can strongly affect the performance of the formulation, and must be taken into account during the design process.
Clinical studies require formulations that are more appropriate for humans to take. Here, more complex bio-enhanced formulation strategies are typically required. These are often based on more specialist formulation technologies such as amorphous solid dispersions, where the API is stabilized with an inert excipient.
An integrated approach saves time and resources
With effective formulation essential at all stages of development, pharmaceutical companies can’t afford to make design decisions on an ad hoc basis. To minimize the risks associated with developing a drug product, formulation efforts should be focused around the needs of the specific phase of study, and must be supported by a comprehensive understanding of the API’s physicochemical and biochemical properties.
In other words, the more effort you spend getting to know your API early on, the easier it is to predict and plan for potential development issues, and the less time, resources and funding will be required solving problems downstream.
However, in order to ensure this information is used in the right way, good communication between teams is essential. Here, pharmaceutical companies can increase the effectiveness and efficiency of their projects by adopting an integrated approach to formulation projects as early as possible during development.
That’s why our formulation chemist’s work closely with our discovery teams during API development, ensuring formulation is always an integral part of the development process. This way, formulation decisions are always based on what’s best for the goals of the study and the program as a whole.
Successful drug development programs rely on robust formulation strategies at every stage of the process. By adopting an early integrated approach to formulation development, pharmaceutical sponsors can reduce risk, maximize efficiency and ensure that products reach patients in the shortest possible time.
Want to learn more about how Aptuit’s integrated approach can create successful products on time and on budget? Read our full interview with formulation expert Mark Saunders here.