The development of a formulation involves several stages: 1. Preformulation Studies: Initial studies to understand the physical and chemical properties of the API. 2. Formulation Design: Selection of excipients and initial formulation prototypes. 3. Optimization: Refinement of the formulation to achieve the desired characteristics. 4. Stability Testing: Evaluation of the formulation's stability under various conditions. 5. Scale-Up: Adaptation of the formulation for large-scale manufacturing.
