ORAL NUTRACEUTICALS
Integrated project development
Galenic development
> Pre-formulation development: physical and chemical characteristics of the proposed active ingredients are analyzed to allow selection of optimal excipients and dosage forms.
> Formulation design: based on the product's organoleptic and physicochemical characteristics, a range of theoretical formulations is proposed to determine how they may influence the final product's characteristics such as the in vitro/in vivo performance and stability.
> Compatibility tests: If necessary a differential scanning calorimetry (DSC) study is usually conducted to determine active ingredients/excipient compatibility.
> Prototype development: APR's contract development team develops a prototype in the laboratory using data from 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, 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 NUTRACEUTICALS
Integrated project development
Up-scaling
and validation
APR manages the transfer to qualified facility (technical and analytical transfers) and the activities are the following:
> Up-scaling: Usually, before the preparation of the industrial batch is necessary the preparation of an up-scaled batch - in order to minimize possible risks
> Production of batch for clinical purpose: If required a batch for a clinical purpose is manufactured as well as the formal analytical validations. On this batch a stability study according to the ICH guidelines is then performed.
> Validation: is completed , if required, with the manufacture of three validation batches.
ORAL NUTRACEUTICALS
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 NUTRACEUTICALS
Integrated project development
Registration
APR prepares all the required documents for submission to the relevant regulatory authorities for notification/approval/registration.
Holding website 