It is important to consider each step or stage in the development of a new pharmaceutical product as both central to the process as well as part of the big picture. While all stages are important, drug formulation development plays a critical role for all future steps, including the clinical trials and final approval.
Drug Action and Reaction
The stage of drug formulation development allows the researchers and scientists to study and determine how the active ingredients in the drug combined with the inactive ingredients. The correct combination provides a stable drug where the active and inactive ingredients bind but to do not interact to change the mechanism or chemical properties of the active ingredient.
An incorrect combination of active and inactive ingredients results in a drug that is unstable. Instability in the drug can occur if there are incompatible pH levels that create changes in the medication or if the particle size and solubility of the drug are not correct and do not provide the results required for the patient.
Special types of coatings may also be required for tablets and capsules. These can delay the release of the drug or even speed up the delivery of the medication once it is in the body.
Interactions of the Drug
While it may be evident that the drug formulation development needs to consider how the ingredients in the dosage form interact with each other, there are other factors to consider as well.
The drug will need to be stored in some type of packaging, which may include bulk storage such as plastic or glass bottles or blister packs of different plastics and foils. How the drug interacts with the packaging will need to be considered. Issues such exposure to UV light, heat or cold may also be considerations with some of the medications.
