There are many different contract manufacturing companies that offer drug formulation development as part of their service. At its most basic, this is the method of determining how to combine the active and inactive ingredients for a medication and to develop an effective dosage form and delivery system.
In the past, the choices for drug formulation development were relatively limited. The contract manufacturing organizations (CMOs) generally had to consider tablets and capsules and then create the best formulation based on those two possibilities.
Today, there is a range of different dosage forms possible from multi-layer tablets with multiple medications through to micro, fast release and film-coated oral dosage options.
Semi-solids, liquids, and specialty dosage forms are also on the market, providing a much wider range of options for CMOs and pharmaceutical companies to consider.
Understanding the Options
Based on the scientific experience of the team completing the drug formulation phase, there may be obvious best solutions for any drug given the combination of active and inactive ingredients and the dosage form.
When a CMO can utilize this past experience in working through drug formulations they can often eliminate possibilities that are not possible or that will not produce a stable final product.
However, at the same time, it is critical for the team in the drug formulation development phase to also consider the clinical use of the drug and the patient use of the drug. Other factors such as manufacturing requirements or specialized storage issues will also need to be addressed.
Finally, the ability to produce the drug will also need to be considered. This will not only be the physical ability to produce the drug, but also the cost involved and if it is feasible given the desired price to the consumer.
