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This phase foreseen the following activities:
> PPre-formulation development: the nourishing formulation is analyzed in terms of physical, chemical characteristics in
order to identify the best excipients selection and the oral nutraceutical dosage form.
> Formulation design: APR is able to set up a range of hypothetical formulations based on its background to achieve the
requested characteristics both in terms of performances and in terms of chemical, physical and, where necessary, taste
aspect. Generally several possible formulation options 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.
> Prototypes development: based on the pre-formulation development and formulation set up, APR R&D team selects
different prototypes based on our background coupled with the continuous research of innovation that permit us to find
out the best solution. The manufacturing method is set up on a laboratory equipment thinking at the successive
technology transfer and the consequent scale up; only minor modifications are generally necessary after the
technological transfer. The GMP laboratory is at disposal as analytical support.
> Preliminary stability study: a preliminary stability study in stressed and/or ICH storage conditions can be performed on
the hypothetic prototypes, as adjunctive information before the selection of the formulation/s able to achieve the big
laboratory batch/es production. 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.
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This phase foreseen the following activities:
> Manufacturing of big-laboratory batch/es: the formulations selected for their performances in terms of taste and
technological, analytical and in vitro performances, are manufactured as big laboratory batches. In this phase the GMP analytical laboratory
supports the R&D department managing the stability study according to the ICH conditions on these
batches taking into account also the packaging aspect.
> Production of industrial batch for a clinical purpose: on the base of the stability results , winner prototype/s, is/are
selected for the industrial production using a network of partners or the one selected by the costumer. A stability study
according to the ICH guidelines is so performed on the GMP batch/es packaged in the selected material; the formal
technological and analytical transfer to the equipped facilities is managed by APR.
>The up scaling phase is closed by the manufacturing of three validation batch; a complete documentation of the
performed activities is redacted in order to prepare the Technical Dossier.
APR structure includes also a complete clinical department able to design clinical trial protocols and supervise and
monitor execution of clinical studies using a network of partners or the one selected by the costumer.
APR is able to prepare the complete documentation ready for the submission to the Health Authorities for a Notification
purpose.
Important note: Customers Reports describing all the activities performed and related results are monthly
delivered, in this way customers have always the project under control to face the GO/NO GO decisions with all
the necessary information.
