In the previous blog post, we addressed the challenge of successfully formulating such compounds for oral administration. However, once you have successfully encapsulated an API, the next task is to characterize that product and understand its release kinetics.
In part 1 of a 2 part blog series, we will explore some of the critical factors to consider when beginning work with these types of formulations.
Because of the expense and risks in evaluating new drug entities, minimizing the parenteral formulation process/time is critical to initiating clinical studies. Companies have initiated clinical studies with frozen solution for this reason. However, this creates other problems in processing and distribution. A more feasible approach to short circuit the formulation process is lyophilization (freeze drying). Here’s why:
No matter where your product is in the pharmaceutical pipeline, from early formulation development to commercial production, analytical procedures will be used to ensure the identity, quality, purity and potency of the drug substance or product. As a product moves from research and development to manufacturing, it may be necessary to order an analytical method transfer of your established (validated) procedure from one laboratory to another to achieve product realization. Here are 5 elements to ensure success:
