TOPICAL DERMOCOSMETIC

Integrated project development

GALENIC DEVELOPMENT

This phase foreseen the following activities:

> Pre-formulation development: the component/s selected is/are analyzed in terms of physical, chemical characteristics in order to identify the best components selection and topical form.

> Formulation design: APR is able to set up a range of hypothetical formulations base on its background to achieve the requested characteristics both in terms of performances and in terms of chemical, physical, texture and taste aspect. Generally several possible formulation are taken into account during this phase in order to evaluate different prototypes that could give different results especially as it concerns the long terms stability in terms of textures and cosmetic performances.

> Prototypes development: based on our background united with the continuous research of innovation that permit to find out the best formulation, the best topical form and its manufacturing method are set up on our laboratory equipment thinking at the successive technology transfer and the consequent scale up; only minor modifications are generally necessary after the technological transfer.

> Preliminary stability study: a preliminary stability study in stressed and/or ICH storage conditions can be performed on the hypothetic formulation, as adjunctive information before the selection of the formulation/s able to achieve the big laboratory batch/es production. Both the aspects characteristics and the stability one are evaluated during the study. The best conditions for the preliminary evaluations are defined case by case and they are established looking at each product and formulation and at further particular customers requests. If necessary an analytical supports is given by the GMP analytical laboratory.

> Microbiological analysis: Microbial contamination of dermo cosmetic products is a matter of great importance. Water and the main part of the components promote the growing of microorganism which often cause organoleptic alterations (offensive odours, changes in viscosity and colour...) or, in some case, the formation of substances potentially hazardous for the consumer. In order to detect this risk a pool of test are carried out according to pharmacopoeias and cosmetic organisations during all the estimated shelf life taking into account also the consumer use as source of contamination. In order to evaluate the microbiological quality of the prototype developed by APR, various test are carried out to demonstrate that the product will not be contaminated during its shelf-life, especially by the consumer's use. The assay advised by different pharmacopoeias and by cosmetic organizations CTFA, FDA, …,