We are experts for formulation development. Not only in theory but also in practice. We love to assist you on specific issues in formulation development. We can also support you by conducting particular trials or even by taking care of the entire formulation development. Our lab provides the equipment required for all relevant trials. We can get started promptly as we aren‘t bound to any GMP regulations in our lab. This allows us to quickly obtain conclusive results.
Small Scale Development
We developed a method that allows us to obtain reliable results even with a very little amount of API. We call this method „Small Scale Development“. Using this method, we can save up to 95 % of API compared to conventional early-stage procedures and still make valid predictions about tabletability and future producibility. We‘d love to explain this method to you in a personal conversation. Just give us a call at +49(0)214 500 42 88 3.
The „Small Scale Development“ method enables us to perform many trials relevant for the formulation at a very early stage of drug development — exactly during the phase when the API is still very costly and produced only in limited quantities. The possibility to determine the basics of formulation and production method even prior to clinical trials can reduce the time for market access considerably.
We develop formulations for direct tableting, dry granulation, fluid bed and high shear granulation. We can apply our „Small Scale Development“ to all these procedures. Naturally, we also support you during transitions in manufacturing processes or with other challenges connected to formulation development, for example if you already have a formulation and wish to optimize it.
Once the formulation is established, we do not leave you high and dry: We also perform scale-ups, define manufacturing instructions including in-process controls, and supervise the transfer to production sites.
First of all, we want to fully understand your situation and the precise challenges. On this basis, we will work out a proposal for solution. This proposal greatly depends on the type of problem and will be tailored individually for you. Below, you can see our basic model for formulation development:
As a rule, we start by characterizing the pure API. Based on these results and your ideas for production setting and excipients we will create first suggestions for the formulation. Depending on the desired quantity of active ingredient and the API‘s characteristics we will be able to already narrow down the manufacturing methods. This is important as the manufacturing method influences the choice of excipients and excipient qualities. In case you already determined or favor a manufacturing method we can go according to your choice, of course. We support you with the development of formulations for direct tableting, dry or, wet granulation.
The actual formulation development (2nd step in diagram) is an iterative and agile process. Once the first formulations are tested we will analyze the results and adjust the formulation accordingly. We prefer keeping in close contact with you during these iterative steps. However, you can also give us free rein and will receive a reliable formulation in the end. Naturally, we also keep an eye on flowability, however, this can only be tested ultimately with larger product quantities and on a rotary tablet press (3rd step in diagram). As a general rule, we always develop formulations with an eye towards future production. Already at this point, we pay attention to the basics for a potential scale-up and feasible production processes. At this stage, the focus is on the formulation itself and we prefer not to apply any pre-compaction forces. Pre-compaction force and slight reductions of tableting speed should be reserved as resource of vernier adjustment for the production process when the formulation is established.
The next step of a comprehensive formulation development is to test the most promising candidates from step 2 on a rotary tablet press in order to determine the flowability by reference to the standard deviation of weight. If necessary, this step can also be postponed to a time when the supply of API is not as short anymore. We can perform these trials either on a small rotary press in our lab, or on your actual production press or within the manufacturer‘s facilities.