A drug’s formulation development phase is vital in order for the drug to meet all regulations to be able to move to market. Pharmaceutical formulation development is the entire process of an Active Pharmaceutical Ingredient (API) being combined with various chemical substances in order to produce a final medicinal product. This process includes the clinical testings to see the drug’s side effects on various test subjects.
In order to be manufactured, a formulation must be chemically and physically stable throughout the manufacturing process, hold a significant shelf-life, and be bioavailable.
Prefomulation
Understanding an Active Pharmaceutical Ingredient completely is vital in the initial stages of developing a pharmaceutical formulation. Understanding an API’s characteristics to identify its solubility, stability, and performance. With this base understanding, chemists are able to match different compounds with the API that will enhance its stability and performance.
Technology
Of the crucial factors in pharmaceutical formulation development which needs to be assessed is the lab’s technology. Appropriate equipment needs to be present in order for a medicinal product to be developed. The technology plays an integral part in the pharmaceutical formulation development as it can change or enhance a compound.
Design of Experiments
Once a drug formulation has been developed, a design of experiments must be configured in order to evaluate the drug. DOE enables potential factors to be evaluated simultaneously and systematically in order for scientists and chemists to see the effects of the compound. These critical factors need to be identified in order for the pharmaceutical formulation development to be corrected and optimized for the best product to be produced.
Once a pharmaceutical formulation development is complete has has passed all regulatory inspection and exams, the product is ready to move to mass manufacturing to bring to market.