Injectable formulation development is a critical step in the pharmaceutical development process. An injectable formulation must be developed to ensure that the active pharmaceutical ingredient (API) is compatible with the chosen delivery system and to ensure that the API is delivered in a safe and effective manner.
The first step in injectable formulation development is to select the appropriate delivery system. Once the delivery system has been selected, the API must be formulated to be soluble and stable in the chosen delivery system.
The route of administration must be considered when developing the formulation. The route of administration will determine the amount of API that can be delivered to the patient and the rate at which the API will be delivered.
With the delivery system and route of administration selected, the next step is to select the excipients. Excipients are inactive ingredients that are added to the formulation to improve the stability, solubility, or delivery of the API.
The next step is to determine the stability of the API in the chosen delivery system. The API must be stable in the chosen delivery system for the duration of the shelf life of the product. It must also be stable when stored at the appropriate temperature, humidity, and light conditions.
Finally, it’s time to validate the manufacturing process. The manufacturing process must be validated to ensure that the final product meets all quality specifications.
To execute these steps properly, companies must work with experienced formulation development scientists. For more information on the development of injectable formulations, contact Renaissance Lakewood, LLC.