Any pharmaceutical company that is working to bring a new drug or product to market understands the importance of each phase in the process. Attention to detail, understanding of all regulations and standards as well as experience and expertise is essential to ensure the drug will be approved.
In the pharmaceutical formulation development phase, trying to rush through the testing and analysis can result in errors, issues and potential problems that can cause delays in future trials and testing. Not only is this something that can be easily avoided by working with the best CDMO (Contract Development Manufacturing Company), but it can result in extended costs that simply cannot be sustained.
The Basics of the Phase
With the results of the testing and research in the pre-formulation phase, the pharmaceutical formulation development is really the center of the scientific and practical aspects of the medication.
There are multiple factors that have to be considered, including the best options in the medical and non-medical components of the medication. In other words, what active pharmaceutical ingredients can be combined with suitable inactive (non-pharmaceutical) components of the formulation, so there is no interaction but also a favorable combination.
This chemical stability is not just about the actual formulation, although that is an essential part of the phase. It is also about ensuring the active ingredient is available to the individual in the form. It must be able to be absorbed into the body and to be available to the patient in the form and the method developed through the research phase.
For some medications, there may be the need for different types of formulas. For example, there may be a liquid form as well as a capsule or perhaps a topical cream or a capsule option. Determining dosage amounts across different forms of the medication will also be addressed in the pharmaceutical formulation development phase.
