The process of moving a new drug from an idea or a concept through to approval by the FDA or other governing bodies and into production is a multi-year, multi-phase project.
Each of the phases from initial research and approval of the idea through to choosing packaging and marketing options are equally important, with the success and accuracy of the previous phase essential to the work in the next phase. Choosing a provider for drug formulation development and throughout the clinical trial process will be a key factor in staying on a strict deadline and working with a quality service provider.
What is Considered?
During the drug formulation development stage, there are several important issues and steps that have to be completed. At this phase of development, the contract drug manufacturing organization (CDMO) will have teams of scientists and researchers completing a variety of different tasks.
Central to the work will be the consideration of the non-active or non-drug compounds used in the medication and how they interact and work with the actual active ingredients.
In addition, the team will be working with the formulation as well as within the goals of the customer to develop the ideal dosage form. This can range from a specific type of tablet or capsule to a semi-solid option or even a liquid.
With new technology for the dosage forms of solids, it is possible to consider the fast release types of medications or even controlled or targeted release. It is also possible to combine synergistic types of active ingredients in one solid dosage form, allowing for the correct administration of the various medications at set time intervals after the patient has taken the drug.
The drug formulation development stage is a very important stage in the overall drug development timeline. Working with an experienced CDMO will ensure this essential phase is completed accurately and with all required documentation and verification.