Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development and regulatory strategy for a generic dry powder inhaler for submission in EU as per the in-vitro only option in section 5.2 of OIP guideline (CPMP/EWP/4151/00 REV. 1) ***

Dr. Christine Gescher (ehemals Kundinger) (Abschlußjahr: 2013)

Summary

Language: English

The aim of this master thesis is the evaluation and discussion of major challenges and issues for the development of a generic dry powder inhaler for a specific reference medicinal product with the associated device inhalation device. The medicinal product is indicated for the treatment of COPD. The application in the EU is intended according to the in-vitro only approach based upon in-vitro comparability as described in the so-called OIP guideline.
The incidence and prevalence of COPD is constantly increasing worldwide and the treatment of patients put a high burden on the local health funds and insurances and is one of the major requirements for the development of generic medicinal products.

The performance of a DPI is determined by many variables with complex relations and interactions and for such a generic development project, the reliable and comprehensive assessment of requirements is urgently necessary. First of all, the dry powder inhaler as one type of inhalation product, its operation principle and the basis of pulmonary drug delivery has been analysed. Furthermore, the reference medicinal product has been introduced and additional topics like the regulatory situation, challenges and guidelines within the EU have been discussed.
Another main part of the project is the pharmaceutical development and the specialised regulatory requirements for the quality of the active substance and the finished medicinal product. It covers the engineering process for the active substance, the choice and function of the carrier substance, the capsule material, the assessment of the performance in the impactor, manufacturing of the finished medicinal product, the generic inhalation device and points to consider for the handling study. For a development of a generic DPI according to the in-vitro only approach of guideline (CPMP/EWP/4151/00 Rev. 1) demonstration of therapeutic equivalence to the reference medicinal product is one of the most important issues.
Based on this information, in summary the development project for a generic dry powder inhaler for the reference medicinal product in question is challenging, but when successfully developed and authorised it has also the potential to reach and help many COPD patients and to relieve the health funds and insurances in Europe.

Pages: 58