Moving from the research stage of the individual chemicals and active pharmaceutical ingredients (API) in a new medication to combining the API with a nondrug ingredient in a dosage form is at the heart of the pharmaceutical formulation development phase.
The specifics of how the pharmaceutical formulation development will unfold are similar even with different dosage forms. The most common options are orally administered medications with are usually in the form of capsules or tablets.
This same process is also used for semi-solids, which are considered gels, creams, and ointments, as well as liquids or medications that will be marketed in the form of suppositories or ophthalmics.
The focus of the phase is not just to determine the best dosage form for the medication, but to also ensure it is fully compatible for patient and medical use as well as avoids any interactions or reactions between the API and the nondrug ingredients.
Bioavailability
Even if the API itself is chemically stable, it may not be a form that can be absorbed by the human body. In the pharmaceutical formulation development stage, tests will be complete that ensure the particle size, solubility and even the pH of the drug is a match for what the human body can process.
Additionally, this phase will also ensure that the combination of inactive and active ingredients in the pharmaceutical is standardized and delivers the correct dosage to the patient in the specific dosage form. As some medications may be available in different forms, such as a liquid or a capsule, this can be a complex process.
For more medications, the formulation phase is not completed at the start of the initial clinical trials. Often a capsule form is used for orally administered drugs as it can be carefully controlled and manufactured for the small amounts required for the trials.
After the end of the small sample clinical trials, the final formulation will be fully developed and will be used for the large clinical trials needed before final approval.
