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This phase includes the following activities:
> Pre-formulation development: the drug candidate is analyzed in terms of physical, chemical characteristics in order to
identify the best excipients selection and the most suitable 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 release and in terms of chemical, physical and, where necessary, taste aspect.
Generally several possible formulations are taken into account during this phase in order to evaluate different prototypes
that could give different results especially in terms of long term stability and the in vitro / in vivo performances.
> Compatibility tests: a DSC study is generally performed on the selected excipients combined with the other ones and
with the active ingredient/s. A first selection between all the candidates can be so done in order to test them as it
concerns all the other aspects.
> Prototypes development: based on the pre-formulation development, formulation design and compatibility test, APR
R&D team selects different formulation options based on its background coupled with the continuing research of
innovation that permit us to find out the best formulation. The manufacturing method is set up on a laboratory equipments
thinking at the successive technology transfer and the consequent scale up; only minor modifications are so generally
necessary after the technological transfer. All the manufacturing phases are under control in terms of analytical aspect: in
process control are managed by the analytical research and development department laboratory which is at complete
service for a continuous and ready analytical support.
> Preliminary stability study: a preliminary stability study in stressed and/or ICH storage conditions can be performed on
the hypothetical prototypes, as additional information before the selection of the final 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. In this phase, the
analytical methods are set up and , in some case, validated according our internal procedures.
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Manufacturing of big-laboratory batch/es: the formulations selected for their performances in terms of technological,
analytical, and in vitro release, 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 GMP batch for a clinical purpose: on the base of the stability results, winner prototype/s is/are selected
for the GMP 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 GMP 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 Module 3 and/or the CMC.
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 a complete CTD Dossier ready for the submission to the Health Authorities for a Registration
purpose
Important note: Customer 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.
