Steps In Formulation Development Of Tablets

Drug Product Development & Manufacturing

Determining the ideal formulation for a new medication is never a simple task. There will be the determination of the dosage form as well as the right type of delivery technologies to ensure the medicine is delivered to the patient in an optimal manner.

For many medications, the best choice for both dosage form, as well as the delivery of the medication, start with the exacting processes of formulation development of tablets. New options in tablets from micro tablets for multi-layer options allow for a far greater level of precision delivery technologies that often require significant numbers of steps and sub-steps to get the formulation correct.

The Starting Point

With any formulation development of tablets, the most critical aspect for success is a successful preformulation. This allows the researchers to gain an insight into the chemicals in the drug and how they will react in different formulations. This reaction is both to the stability and safety of the medication in different dosage forms as well as with regards to the safety for the end-user, the patient.

With that information, the formulation process begins. As all medications combine both active ingredients as well as non-active, it will be essential to carefully test all possible options to ensure full stability. It will also be necessary to test and verify that the nonactive ingredients (the non-medical components) do not interact with or chemically change the active ingredients.

Additional Steps

Additionally, in the formulation development of tablets, it will be important to consider the options in delivery technology. Does there need to be a coating for a time delay that will require a multi-layer technology? Does the medication need to be absorbed quickly into the body or are there other requirements to consider?

There are even new pharmaceutical developments where one single tablet may contain several medications that are taken together. In these situations, the formulation and development become even more complex and requires additional testing in this critical step.