This master thesis is on the one hand intended to provide basic information about orodispersible films, and on the other hand to describe special contents of CTD-module3 for this new dosage form. Associates in regulatory affairs may use this document as a guidance during compilation of a dossier for an orodispersible film. Basis for the information provided are the existing EU quality dossiers of approved products, as well as data from current development projects.

The manufacturing process of orodispersible films is very similar to that of matrix-based TTS. All manufacturing steps are described, starting with the production of the coating liquid and ending with the primary packaging of the single dosage forms. Critical parameters that could possibly influence the quality of the finished product are discussed and typical in-process controls are explained. Additionally, the packaging material selected for several products developed so far is presented.

The chapter Pharmaceutical Development describes physico-chemical properties of the API that have to be taken into account if the substance is intended for use in an orodispersible film. The possible impact of these properties on the quality of the final product is discussed. Furthermore, the formulation development and the choice of excipients are described. It is shown how the main demands in the development of an orodispersible film are reached: Quick disintegration, an acceptable taste, chemical and physical stability, dose proportionality and acceptable weights and sizes of the single dosage form. The last part of this section describes the in-vitro release testing of orodispersible films and in case of generic products the in-vivo bioequivalence studies.

Orodispersible films are currently not described in pharmacopoeias. Therefore, testing procedures for this dosage form are not explicitly regulated. The specifications of products developed so far are described in this section, presenting a typical set of analytical procedures and the corresponding test procedures.

Over the last years, several orodispersible films have been developed. Some applications were filed in the European Union and in the meantime, a few DCP were finalized. For all procedures, the RMS assessment reports and CMS comments have been received and answered. In this section, important and possibly recurrent issues raised by the EU member states authorities regarding the drug product are presented and discussed.

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