Having a concept for a new type of medication is the first step in contract development and manufacturing of a new medicine. However, just having an idea for a new pharmaceutical product is not enough, there are many different steps in bringing that idea to an actual product that is safe, effective and approved for human use.
Preformulation development of a pharmaceutical product is the first step in the actual contract development and manufacturing organization. It is the stage that addresses the chemical and molecular properties of the medication that will ensure it is stable and can be safely and effectively marketed in a specific formulation.
This will include information on the stability of the drug at a molecular level, the best form of the medication as well as to determine if the drug will be bioavailable to people once it has been developed.
What is Researched?
All preformulation development is done through specific chemical and analytical processes that provide data on the drug formulation. This includes determining the chemical and physical stability of the sample, characterizing the active pharmaceutical ingredient or API as well as to determine the solubility of the ingredients.
There are several different types of tests that are used to develop this analytical data. These include thermal analysis, partition coefficient services as well as a hygroscopicity evaluation. This last test evaluates the chemical for its ability to pull moisture out of the air and how it behaves afterward, a key factor in the formulation as well as the packaging phases of the drug manufacturing process.
The research data provided in the preformulation sets the foundation for all other steps in the contract development and manufacturing process. Taking the time and choosing a company with expertise and experience in this early work will limit any oversights or errors that can often complicate the process later on in the trails.