FORMULATIONS
The formulation development process involves several stages, including pre-formulation studies, formulation design and evaluation, manufacturing scale-up and process development, analytical development and characterization, and stability and shelf-life determinations.
Drug formulation is one of the most critical aspects of the pharmaceutical development process. If a drug cannot be delivered in a stable form that is acceptable to the patient, it is unlikely to find a sizable market, and it may not even go beyond Phase I clinical trials. At Allice drugs LLP, we provide drug formulation development for both clinical trials and final dosages. Below, we share our insight into the drug formulation process.
Drug reformulations studies are the first step in formulation development. During this phase, we identify the chemical, physical, and mechanical properties of a drug to determine the inactive ingredients, or excipients that should be paired with it. The goal is to create a formulation that is stable under a variety of conditions, from extreme cold to extreme heat. Adding excipients can change a drug’s qualities and ensure an end-product that doesn’t degrade during shipment or storage.
