An Overview Of The Drug Formulation Development Process

In the development of any new pharmaceutical product, each step in the process is equally as important to achieving approval for the medication and completing all the steps from concept through to production and marketing.

With that being said, one of the most challenges steps in the process is often the drug formulation development stage. This is the place in the process where the form of the drug, specifically the dosage form and the delivery method, is tested and verified.

Determining Form

This process starts before the pre-clinical phase and during the early research. Testing is done to determine if the best method of delivery of the drug is in a table, a liquid form, a topical gel or perhaps in an inhaler, an injection or delivered through an IV. This is also dependent on the type of medication, the intended patient and if it will patient administered or administered by a medical professional.

Each of these different delivery methods for medication will be tested differently in the drug formulation development. It is also critical to understand that different forms of medications can impact how the drug performs, the speed of absorption in the body and even the dosage requirements.

The formulation process is designed to test for all of these factors. In addition to testing for all these, it also has to look at the impact on the patient and if the drug form is meeting the needs of the individual.

For example, the most stable and durable form of medication may be in a capsule. However, in this form, the drug is not as fast acting as an injection or an inhaler. If this is a drug used emergency situations, such as anaphylactic reactions, the drug formulation developmentphase will focus on optimizing the formulation to combine the stability of the mediation with a fast acting delivery method for the patient.

This is a complicated and complex phase that has to be completed before the initial clinical trials. This can be a lengthy stage so working with a top lab will be central to streamlining the process.