TOPICAL DERMOCOSMETICS
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: APR creates a range of theoretical formulations that meet the clients' needs in terms of release characteristics, stability and performance of the product.
> 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 extensive experience combined with ongoing research allows us to propose (and produce) the best formulation for the intended purpose. The APR team develops a prototype in the laboratory taking into account the subsequent need to scale-up. This ensures that only minor modifications are necessary when the process is scaled up.
> Preliminary stability studies: using International Conference on Harmonization (ICH) guidelines and our validated procedures, 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 DERMOCOSMETICS
Integrated project development
Up-scaling
and validation
APR manages all steps in 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
> Production of batch for clinical purpose: If required a 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: if required is completed with the manufacture of three validation batches.
TOPICAL DERMOCOSMETICS
Integrated project development
Clinical Phase
Manufacturers have an obligation to demonstrate that cosmetic products satisfy the purpose it was designed for. APR devises and carries out the necessary protocols/analyses to demonstrate this.
TOPICAL DERMOCOSMETICS
Integrated project development
Registration
APR produces a complete Product Information File of all the information as required by regulatory authorities including safety data as certified by an independent assessor.
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