ORAL 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: A differential scanning calorimetry (DSC) study is usually conducted to determine active drug/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 . The exact nature of tests carried out depends on the product and individual customer requests.
ORAL 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, it 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.
ORAL 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 or those selected by our clients.
ORAL PHARMACEUTICALS
Integrated project development
Registration
APR prepares Common Technical Dossiers (CTD) for submission to the relevant regulatory body for approval/registration.
Holding website 