Development
Possible formulations include unfilmed and filmed tablets, capsules, powder, granules and pellets for fast- or slow-release forms. We can employ our special expertise to develop more targeted release systems, e.g. for delayed release, long-term release or release in specific sections of the intestine.
For combination products, we also have specific technology for the development of multi-layer tablets, coat-core tablets or capsule filling with multiple components.
Alongside formulation development, we also handle the creation, transfer and development from scratch of the required analytical methods that enable the testing of both active ingredients and intermediate and end products.
We also have special expertise and equipment for targeted release system methods. Validation and recording of all methods on registration documents are also standard.
In addition to formulation development, the search for the perfect manufacturing process is a central part of development. It is important in this respect, for example, to choose the best possible technology for pellet manufacturing (pelletisation development vs neutral pellets vs extrusion/rounding).
Testing and establishing process parameters for every stage of manufacturing also play a vital role in creating a robust manufacturing process that is crucial for transfer projects, too.
In many cases, the development process can begin with tiny quantities of active ingredients. This is why we have the STYL'One – a tablet press that can process even the smallest amounts. The versions of the coater and the granulator that we have in our laboratory can easily be scaled up, eventually to industrial scale, without necessitating a complicated and risky switch to another device type.
Manufacturing suitable pilot batches is standard practice in a development process, usually for the transfer of previously established processes.
Once technically feasible and commercially desirable batch sizes have been defined, the manufacturing process is validated and documented as per the international requirements of the customer and the registration authorities.
Over the course of development, clinical batches of the products and, if necessary, a placebo variant often have to be manufactured in small to medium quantities. This is also part of our standard programme, as is blistering these batches – if necessary, in several alternative packaging materials – and conducting a stability analysis under different climatic conditions, as per ICH guidelines.
At your request, our approvals department can also help you to compile the necessary documentation, e.g. IMPDs.