TOPICAL PHARMACEUTICALS
Integrated project development
Galenic development
> Pre-formulation development: physical and chemical characteristics of the proposed drug are analyzed to allow selection of optimal excipients and dosage forms.
> Formulation design: based on the product's physicochemical/release characteristics and other important aspects, a range of theoretical formulations is proposed to determine how they affect the final product's characteristics such as in vitro/in vivo performance and stability.
> Compatibility tests: If necessary a compatibility test (i.e. stability at stressed condition) can be conducted in order to determine functional ingredients/excipient compatibility.
> Prototype development: APR's contract development team develop a prototype in the laboratory using data from pre-formulation development/design and compatibility tests. Generally, only minor modifications to the prototype are required when the process is scaled up to large-scale manufacturing
> Preliminary stability studies: using International Conference on Harmonization (ICH) guidelines and validated analytical methods, the prototype is tested to determine if the selected formulation(s) can be considered stable in terms of chemical , physical and microbiological point of view. The exact nature of tests carried out depends on the product and individual customer requests.
TOPICAL PHARMACEUTICALS
Integrated project development
Up-scaling
and validation
APR manages all steps in the transfer to GMP facility (technical and analytical transfers) and the activities are the following:
> Up-scaling: Usually, before the preparation of the GMP Batch is necessary the preparation of an up-scaled batch.
> Production of batch according to GMP for clinical purpose: If required a GMP Batch for a clinical purpose is manufactured as well as the formal analytical validations. On the GMP Batch a stability study according to the ICH guidelines is then performed.
> Validation: is completed with the manufacture of three validation batches.
TOPICAL PHARMACEUTICALS
Integrated project development
Clinical Phase
APR has a dedicated clinical department that is involved in all stages of the clinical trial program from designing protocols to supervision, monitoring and conduction of clinical studies. We work with a network of existing partners and/or those selected by our clients.
TOPICAL PHARMACEUTICALS
Integrated project development
Registration
APR prepares Common Technical Document (CTD) for submission to the relevant regulatory bodies for approval/registration.
Holding website 