Pre-formulation provides the information on the active ingredients in the new medications and how they can be combined with inactive ingredients to develop a stable, consistent product. The drug formulation development stage then moves into the ability to create dosage forms and the delivery methods that are most effective given the drug, the patient and the requirements of the pharmaceutical company.
This is a critical component of the process. Mistakes and errors at this stage can have costly consequences, both in the timing of the process as well as the actual investment of the pharmaceutical company and investors.
Working with a top contract development and manufacturing organization (CMDO) will be essential for all the steps, tests and verification required during the drug formulation development stage.
Drug Market Knowledge
The dosage form for any new medication has to be effective for patients to use while also meeting all drug requirements across all potential markets. For example, a drug may be sold in a semi-solid dosage form from a gel to a cream or lotion. Understanding how those dosage forms will be utilized by patients as well as how to ensure the efficacy of the drug during manufacturing, shipping, and even storage after the sale will all be critical considerations.
What is the Competition Offering?
Even with revolutionary types of pharmaceutical products, it is critical to think of what the closest current product on the market offers. In many cases, safer formulations and easier to use options for the patient will be given priority over a more advanced pharmaceutical product that has challenges in these areas.
Finding a CMDO that has the ability to work with drug formulation development and create dosage forms that are ideal for the drug, offers a new option in the market and also provides patient safety and drug efficacy is a critical part of the overall success of the medication.
