Our services

Concepts

Due to the problems of low solubility, bioavailability and permeability of active pharmaceutical ingredients or instability and incompatibility of active pharmaceuticalingredients (BCS class II-IV) in dosage forms the design of the optimal formulation is today of high importance. These aspects have also to be considered in the re-formulation of known active ingredients.

In order to achieve the optimal design for Your formulation fast and cost efficient IPhaTec starts the development in a small scale (10-500g, non GMP) first by using standard technologies (e.g. Granulation) and modern, innovative technologies (e.g. Nanoparticles, Hot Melt) in parallel.

Obtained pre-formulations are analytical tested and suitable pre-formulations will be selected for a first animal trial. However, before these animal trials are conducted, testing of the pre-formulations will be conducted in special biorelevant dissolution media (FaSSGF, FaSSIF, FeSSIF) or precipitation models in-vitro to achieve a better in-vivo prediction and to avoid screening of formulations in animals which are normally expensive.

Technologies

IPhaTec uses not only standard technologies but also modern, innovative technologies for formulation development in addition to the use of standard technologies:

Hot Melt Technology
Systems with Nanoparticles
Silicate Systems with Mesopores
Amorphous Systems
Self-emulsifying systems
Systems with complexes

Consultancies

IPhaTec has a long experience in the implementation of technologies and transfer of manufacturing processes (oral or parenteral products), analytical methods or regulatory aspects under cGMP (EMA. FDA) and offers this service on a consultancy basis. Special focus is given to the risk management according to ICH Q9 and pharmaceutical quality management system according to ICH Q10. In addition aspects of Quality by Design and the pharmaceutical development in accordance with ICH Q8 are considered as well.

Reports

Reports are important to document the results of an investigation, a development, a transfer or a process implementation. The reports at IPhaTec are prepared in a CTD compatible formate. The long experience of IPhaTec in the preparation of reports helps to circumvent not clear expressions and to avoid regulatory problems. IPhaTec can prepare all reports relevant for development, GMP or regulatory aspects.

Patent evaluations

An important element in the development of new formulation is the possible patent protection.

IPhaTec offers the conduction of a literature research, the drafting of a new patent application by considering the prior-art descriptions and if requested to discuss the patent application with a patent lawyer to come to a final patent application.