Latest Communications

18 January 2012
APR Applied Pharma Research s.a. (“APR”), Labtec GmbH (“Labtec”) and Norgine BV (“Norgine”) announce the signature of an exclusive licensing agreement under which Norgine will market and distribute Setofilm™ Ondansetron Oral Dispersible Film (“ODF”), in Europe and selected non-European countries.

12 July 2011
MonoSol Rx Announces Availability of Zuplenz® Oral Soluble Film for Licensing to New Commercialization Partners

13 June 2011
APR Applied Pharma Research s.a. and Labtec GmbH announce Ondansetron Oral Dispersible Film (“ODF”) is now available for licensing in Europe and selected non European countries, after having received marketing authorization in most countries of Europe.


oral

ORAL NUTRACEUTICALS

Integrated project development



GALENIC DEVELOPMENT

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.

UP-SCALING & VALIDATION

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.



CLINICAL PHASE

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.

NOTIFICATION

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.



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